Drugs Details

Drugs Info of Pediarix
Drugs Details
  • Drugs Type  : FDA
  • Date : 21st Jan 2015 12:06 am
  • Brand Name : Pediarix
  • Generic Name : diphtheria, hepatitis B, pertussis (acellular), polio, and tetanus vaccine (Pronunciation: dif THEER ee a, hep a TYE tis B, per TUS iss, POE lee oh, and TET a nus)
Descriptions

PEDIARIX® [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined] is a noninfectious, sterile, multivalent vaccine for intramuscular administration manufactured by GlaxoSmithKline Biologicals. It contains diphtheria and tetanus toxoids, 3 pertussis antigens (inactivated pertussis toxin [PT] and formaldehyde-treated filamentous hemagglutinin [FHA] and pertactin [69 kiloDalton outer membrane protein]), hepatitis B surface antigen, plus poliovirus Type 1 (Mahoney), Type 2 (MEF-1), and Type 3 (Saukett). The diphtheria toxoid, tetanus toxoid, and pertussis antigens are the same as those in INFANRIX® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed). The hepatitis B surface antigen is the same as that in ENGERIX-B® [Hepatitis B Vaccine (Recombinant)]. 

The diphtheria toxin is produced by growing Corynebacterium diphtheriae in Fenton medium containing a bovineextract. Tetanus toxin is produced by growing Clostridium tetani in a modified Latham medium derived from bovine casein. The bovine materials used in these extracts are sourced from countries which the United States Department of Agriculture (USDA) has determined neither have nor are at risk of bovine spongiform encephalopathy (BSE). Both toxins are detoxified with formaldehyde, concentrated by ultrafiltration, and purified by precipitation, dialysis, and sterile filtration. 

The 3 acellular pertussis antigens (PT, FHA, and pertactin) are isolated from Bordetella pertussis culture grown in modified Stainer-Scholte liquid medium. PT and FHA are isolated from the fermentation broth; pertactin is extracted from the cells by heat treatment and flocculation. The antigens are purified in successive chromatographic and precipitation steps. PT is detoxified using glutaraldehyde and formaldehyde. FHA and pertactin are treated with formaldehyde. 

The hepatitis B surface antigen (HBsAg) is obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus, in synthetic medium. The surface antigen expressed in the S. cerevisiae cells is purified by several physiochemical steps, which include precipitation, ion exchange chromatography, and ultrafiltration. 

The inactivated poliovirus component of PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) is an enhanced potency component. Each of the 3 strains of poliovirus is individually grown in VERO cells, a continuous line of monkey kidney cells, cultivated on microcarriers. Calf serum and lactalbumin hydrolysate are used during VERO cell culture and/or virus culture. Calf serum is sourced from countries the USDA has determined neither have nor are at risk of BSE. After clarification, each viral suspension is purified by ultrafiltration, diafiltration, and successive chromatographic steps, and inactivated with formaldehyde. The 3 purified viral strains are then pooled to form a trivalent concentrate. 

The diphtheria, tetanus, and pertussis antigens are individually adsorbed onto aluminum hydroxide; hepatitis B component is adsorbed onto aluminum phosphate. All antigens are then diluted and combined to produce the final formulated vaccine. Each 0.5-mL dose is formulated to contain 25 Lf of diphtheria toxoid, 10 Lf of tetanus toxoid, 25 mcg of inactivated PT, 25 mcg of FHA, 8 mcg of pertactin, 10 mcg of HBsAg, 40 D-antigen Units (DU) of Type 1 poliovirus, 8 DU of Type 2 poliovirus, and 32 DU of Type 3 poliovirus. 

Diphtheria and tetanus toxoid potency is determined by measuring the amount of neutralizing antitoxin in previously immunized guinea pigs. The potency of the acellular pertussis components (inactivated PT and formaldehyde-treated FHA and pertactin) is determined by enzyme-linked immunosorbent assay (ELISA) on sera from previously immunized mice. Potency of the hepatitis B component is established by HBsAg ELISA. The potency of the inactivated poliovirus component is determined by using the D-antigen ELISA and by a poliovirus neutralizing cell culture assay on sera from previously immunized rats. 

Each 0.5-mL dose also contains 4.5 mg of NaCl and aluminum adjuvant (not more than 0.85 mg aluminum by assay). Each dose also contains   ≤ 100 mcg of residual formaldehyde and ≤ 100 mcg of polysorbate 80 (Tween 80). Neomycin sulfate and polymyxin B are used in the polio vaccine manufacturing process and may be present in the final vaccine at   ≤ 0.05 ng neomycin and  0.01 ng polymyxin B per dose. The procedures used to manufacture the HBsAg antigen result in a product that contains ≤ 5% yeast protein.  

PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) is formulated without preservatives. 

The vaccine must be well shaken before administration to obtain a homogeneous, turbid, white suspension. 

Diphtheria and Tetanus Toxoids Adsorbed Combined Bulk (For Further Manufacturing Use) is manufactured by Novartis Vaccines and Diagnostics GmbH & Co. KG, Marburg, Germany. The acellular pertussis antigens, the hepatitis B surface antigen, and the inactivated poliovirus antigens are manufactured by GlaxoSmithKline Biologicals, Rixensart, Belgium. Formulation, filling, testing, packaging, and release of the vaccine are performed by GlaxoSmithKline Biologicals.

What are the possible side effects of this vaccine (Pediarix)?

Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with diphtheria, hepatitis B, pertussis, polio, or tetanus is much more dangerous to your child's health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of...

Read All Potential Side Effects and See Pictures of Pediarix »


This monograph has been modified to include the generic and brand name in many instances.

Indications

PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) is indicated for active immunization against diphtheria, tetanus, pertussis (whooping cough), all known subtypes of hepatitis B virus, and poliomyelitis caused by poliovirus Types 1, 2, and 3 as a three-dose primary series in infants born of HBsAg-negative mothers, beginning as early as 6 weeks of age. PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) should not be administered to any infant before the age of 6 weeks, or to individuals 7 years of age or older. 

Infants born of HBsAg-positive mothers should receive Hepatitis B Immune Globulin (Human) (HBIG) and monovalent Hepatitis B Vaccine (Recombinant) within 12 hours of birth and should complete the hepatitis B vaccination series according to a particular schedule.18 (See manufacturer's prescribing information for Hepatitis B Vaccine [Recombinant]) (see DOSAGE AND ADMINISTRATION). 

Infants born of mothers of unknown HBsAg status should receive monovalent Hepatitis B Vaccine (Recombinant) within 12 hours of birth and should complete the hepatitis B vaccination series according to a particular schedule.18 (See manufacturer's prescribing information for Hepatitis B Vaccine [Recombinant]) (see DOSAGE AND ADMINISTRATION). 

PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) will not prevent hepatitis caused by other agents, such as hepatitis A, C, and E viruses, or other pathogens known to infect the liver. As hepatitis D (caused by the delta virus) does not occur in the absence of hepatitis B infection, hepatitis D will also be prevented by vaccination with PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) . 

Hepatitis B has a long incubation period. Vaccination with PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) may not prevent hepatitis B infection in individuals who had an unrecognized hepatitis B infection at the time of vaccine administration. 

As with any vaccine, PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) may not protect 100% of individuals receiving the vaccine. PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) is not recommended for treatment of actual infections.

Dosage Administration

Preparation for Administration

PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) contains an adjuvant; therefore shake vigorously to obtain a homogeneous, turbid, white suspension. Do not use if a gel-like substance is present or if resuspension does not occur with vigorous shaking. Inspect PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) visually for particulate matter, discoloration, and cracks in the vial or syringe prior to administration. If any of these conditions exist, the vaccine should not be administered. After removal of the dose, any vaccine remaining in the vial should be discarded. 

Before injection, the skin at the injection site should be cleaned and prepared with a suitable germicide.

Recommended Schedule

The primary immunization series for PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) is 3 doses of 0.5 mL, given intramuscularly, at 6- to 8-week intervals (preferably 8 weeks). The customary age for the first dose is 2 months of age, but it may be given starting at 6 weeks of age. The preferred administration site is the anterolateral aspect of the thigh for children younger than 1 year. In older children, the deltoid muscle is usually large enough for an intramuscular injection. The vaccine should not be injected in the gluteal area or areas where there may be a major nerve trunk. Gluteal injections may result in suboptimal hepatitis B immune response. 

Do not administer this product subcutaneously or intravenously. 

PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) should not be administered to any infant before the age of 6 weeks. Only monovalent hepatitis B vaccine can be used for the birth dose. 

Infants born of HBsAg-positive mothers should receive HBIG and Hepatitis B Vaccine (Recombinant) within 12 hours of birth at separate sites and should complete the hepatitis B vaccination series according to a particular schedule.18 (See manufacturer's prescribing information for Hepatitis B Vaccine [Recombinant]).  Infants born of mothers of unknown HBsAg status should receive Hepatitis B Vaccine (Recombinant) within 12 hours of birth and should complete the hepatitis B vaccination series according to a particular schedule.18 (See manufacturer's prescribing information for Hepatitis B Vaccine [Recombinant]). 

The administration of PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) for completion of the hepatitis B vaccination series in infants who were born of HBsAg-positive mothers and who received monovalent Hepatitis B Vaccine (Recombinant) and HBIG has not been studied.

Modified Schedules

Children Previously Vaccinated With One or More Doses of Hepatitis B Vaccine

Infants born of HBsAg-negative mothers and who received a dose of hepatitis B vaccine at or shortly after birth may be administered 3 doses of PEDIARIX according to the recommended schedule. However, data are limited regarding the safety of PEDIARIX in such infants (see ADVERSE REACTIONS). There are no data to support the use of a 3-dose series of PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) in infants who have previously received more than one dose of hepatitis B vaccine. PEDIARIX may be used to complete a hepatitis B vaccination series in infants who have received 1 or more doses of Hepatitis B Vaccine (Recombinant) and who are also scheduled to receive the other vaccine components of PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) . However, the safety and efficacy of PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) in such infants have not been studied.

Children Previously Vaccinated With One or More Doses of INFANRIX

PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) may be used to complete the first 3 doses of the DTaP series in infants who have received 1 or 2 doses of INFANRIX and are also scheduled to receive the other vaccine components of PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) . However, the safety and efficacy of PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) in such infants have not been evaluated.

Children Previously Vaccinated With One or More Doses of IPV

PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) may be used to complete the first 3 doses of the IPV series in infants who have received 1 or 2 doses of IPV and are also scheduled to receive the other vaccine components of PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) . However, the safety and efficacy of PEDIARIX in such infants have not been studied.

Interchangeability of PEDIARIX and Licensed DTaP, IPV, or Recombinant Hepatitis B Vaccines

It is recommended that PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) be given for all 3 doses because data are limited regarding the safety and efficacy of using DTaP vaccines from different manufacturers for successive doses of the pertussis vaccination series. PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) is not recommended for completion of the first 3 doses of the DTaP vaccination series initiated with a DTaP vaccine from a different manufacturer because no data are available regarding the safety or efficacy of using such a regimen. 

PEDIARIX may be used to complete a hepatitis B vaccination series initiated with a licensed Hepatitis B Vaccine (Recombinant) vaccine from a different manufacturer. 

PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) may be used to complete the first 3 doses of the IPV vaccination series initiated with IPV from a different manufacturer.

Additional Dosing Information

If any recommended dose of pertussis vaccine cannot be given, DT (For Pediatric Use), Hepatitis B (Recombinant), and inactivated poliovirus vaccines should be given as needed to complete the series. 

Interruption of the recommended schedule with a delay between doses should not interfere with the final immunity achieved with PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) . There is no need to start the series over again, regardless of the time elapsed between doses.

The use of reduced volume (fractional doses) is not recommended. The effect of such practices on the frequency of serious adverse events and on protection against disease has not been determined.5 

Preterm infants should be vaccinated according to their chronological age from birth.5 

PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) is not indicated for use as a booster dose following a 3-dose primary series of PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) . Children who have received a 3-dose primary series of PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) should receive a fourth dose of IPV at 4 to 6 years of age and a fourth dose of DTaP vaccine at 15 to 18 months of age. Because the pertussis antigen components of INFANRIX are the same as those components in PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) , these children should receive INFANRIX as their fourth and fifth dose of DTaP. However, data are insufficient to evaluate the safety of INFANRIX following 3 doses of PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) .

Concomitant Vaccine Administration

In clinical trials, PEDIARIX was routinely administered, at separate sites, concomitantly with Hib conjugate vaccine (see CLINICAL PHARMACOLOGY). Data are also available from 2 clinical studies in which PEDIARIX was administered concomitantly, at separate sites, with Hib and 7-valent pneumococcal conjugate vaccines (see CLINICAL PHARMACOLOGY and ADVERSE REACTIONS). 

When concomitant administration of other vaccines is required, they should be given with separate syringes and at different injection sites.

How Supplied

PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) is supplied as a turbid white suspension in single-dose (0.5 mL) vials and disposable prefilled TIP-LOK® syringes. 

Single-Dose Vials and Prefilled Syringes (Preservative Free Formulation)

NDC 58160-811-11 Package of 10 Single-Dose Vials
NDC 58160-811-46 Package of 5 Single-Dose Prefilled Disposable TIP-LOK Syringes (packaged without needles)

Storage           

Store refrigerated between 2º and 8ºC (36º and 46ºF). Improper storage may result in the formation of a gel-like substance (see DOSAGE AND ADMINISTRATION). Do not freeze. Discard if the vaccine has been frozen. Do not use after expiration date shown on the label.

REFERENCES

5. Centers for Disease Control and Prevention. General recommendations on immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians (AAFP). MMWR 2002;51(RR-2):1-35.

18. Centers for Disease Control and Prevention. Recommended childhood and adolescent immunization schedule — United States, 2006. MMWR 2005;54(51,52):Q1-Q4.

Manufactured by GlaxoSmithKline Biologicals Rixensart, Belgium. Distributed by GlaxoSmithKline Research Triangle Park, NC 27709. July 2009.


This monograph has been modified to include the generic and brand name in many instances.

Side Effects

A total of 23,849 doses of PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) have been administered to 8,088 infants who received one or more doses as part of a 3-dose primary series during 14 clinical studies. The most common adverse reactions observed in clinical trials were local injection site reactions (pain, redness, or swelling), fever, and fussiness. In comparative studies, administration of PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) was associated with higher rates of fever relative to separately administered vaccines (see WARNINGS; see ADVERSE REACTIONS Table 3). The prevalence of fever was highest on the day of vaccination and the day following vaccination. More than 96% of episodes of fever resolved within the 4-day period following vaccination (i.e., the period including the day of vaccination and the next 3 days). 

In the largest of the 14 studies, conducted in Germany, safety data were available for 4,666 infants who received PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) administered concomitantly at separate sites with 1 of 4 Hib conjugate vaccines (GlaxoSmithKline Biologicals [not US-licensed]; Wyeth Pharmaceuticals Inc., Sanofi Pasteur SA, or Merck & Co, Inc. [all US-licensed]) at 3, 4, and 5 months of age and for 768 infants in the control group that received separate US-licensed vaccines (INFANRIX, Hib conjugate vaccine [Sanofi Pasteur SA], and OPV [Wyeth Pharmaceuticals Inc.]). Data on adverse events were collected by parents using standardized diary cards for 4 consecutive days following each vaccine dose (i.e., day of vaccination and the next 3 days). Infants were also monitored for unsolicited adverse events that occurred within 30 days following vaccination using diaries which were returned at subsequent visits and were supplemented by spontaneous reports and a medical history as reported by parents. More than 95% of study participants were white. 

In a US study, the safety of PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) administered to 673 infants was compared to the safety of separately administered INFANRIX, ENGERIX-B, IPV (Sanofi Pasteur SA) in 335 infants. In both groups, infants received Hib and 7-valent pneumococcal conjugate vaccines (Wyeth Pharmaceuticals Inc.) concomitantly at separate sites. All vaccines were administered at 2, 4, and 6 months of age. The study was powered to evaluate fever > 101.3°F following dose 1. Data on solicited adverse events were collected by parents using standardized diary cards for 4 consecutive days following each vaccine dose (i.e., day of vaccination and the next 3 days) and are presented in Table 3. Telephone follow-up was conducted 1 month and 6 months after the third vaccination to inquire about serious adverse events. At the 6-month follow-up, information also was collected on new onset of chronic illnesses. 638 subjects who received PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) and 313 subjects who received INFANRIX, ENGERIX-B, and IPV completed the 6-month follow-up. Among subjects in both study groups combined, 69% were white, 18% were Hispanic, 7% were black, 3% were Oriental, and 3% were of other racial/ethnic groups. 

The adverse event information from clinical trials provides a basis for identifying adverse events that appear to be related to vaccine use and for approximating rates. However, because clinical trials are conducted under widely varying conditions, adverse event rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine, and may not reflect the rates observed in practice. As with any vaccine, there is the possibility that broad use of PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) could reveal adverse events not observed in clinical trials.

Deaths

In 14 clinical trials, 5 deaths were reported among 8,088 (0.06%) recipients of PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) and 1 death was reported among 2,287 (0.04%) recipients of comparator vaccines. Causes of death in the group that received PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) included 2 cases of Sudden Infant Death Syndrome (SIDS) and one case of each of the following: Convulsive disorder, congenital immunodeficiency with sepsis, and neuroblastoma. One case of SIDS was reported in the comparator group. The rate of SIDS among all recipients of PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) across the 14 trials was 0.25/1,000. The rate of SIDS observed for recipients of PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) in the German safety study was 0.2/1,000 infants (reported rate of SIDS in Germany in the latter part of the 1990s was 0.7/1,000 newborns).22 The reported rate of SIDS in the United States from 1990 to 1994 was 1.2/1,000 live births.23 By chance alone, some cases of SIDS can be expected to follow receipt of pertussis-containing vaccines.20

Serious Adverse Events

Within 30 days following any dose of vaccine in the US safety study in which all subjects received concomitant pneumococcal and Hib conjugate vaccines, 7 serious adverse events were reported in 7 subjects (1% [7/673]) who received PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) (1 case each of pyrexia, gastroenteritis, and culture negative clinical sepsis and 4 cases of bronchiolitis) and 5 serious adverse events were reported in 4 subjects (1% [4/335]) who received INFANRIX, ENGERIX-B, and IPV (uteropelvic junction obstruction and testicular atrophy in one subject and 3 cases of bronchiolitis).

Onset of Chronic Illnesses

In the US safety study in which all subjects received concomitant pneumococcal and Hib conjugate vaccines, 21 subjects (3%) who received PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) and 14 subjects (4%) who received INFANRIX, ENGERIX-B, and IPV reported new onset of a chronic illness during the period from 1 to 6 months following the last dose of study vaccines. Among the chronic illnesses reported in the subjects who received PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) , there were 4 cases of asthma and 1 case each of diabetes mellitus and chronic neutropenia. There were 4 cases of asthma in subjects who received INFANRIX, ENGERIX-B, and IPV.

Seizures

In the German safety study over the entire study period, 6 subjects in the group that received PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) reported seizures. Two of these subjects had a febrile seizure, 1 of whom also developed afebrile seizures. The remaining 4 subjects had afebrile seizures, including 2 with infantile spasms. Two subjects reported seizures within 7 days following vaccination (1 subject had both febrile and afebrile seizures, and 1 subject had afebrile seizures), corresponding to a rate of 0.22 seizures per 1,000 doses (febrile seizures 0.07 per 1,000 doses, afebrile seizures 0.14 per 1,000 doses). No subject who received concomitant INFANRIX, Hib vaccine, and OPV reported seizures. In a separate German study that evaluated the safety of INFANRIX in 22,505 infants who received 66,867 doses of INFANRIX administered as a 3-dose primary series, the rate of seizures within 7 days of vaccination with INFANRIX was 0.13 per 1,000 doses (febrile seizures 0.0 per 1,000 doses, afebrile seizures 0.13 per 1,000 doses). 

Over the entire study period in the US safety study in which all subjects received concomitant pneumococcal and Hib conjugate vaccines, 4 subjects in the group that received PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) reported seizures. Three of these subjects had a febrile seizure and 1 had an afebrile seizure. Over the entire study period, 2 subjects in the group that received INFANRIX, ENGERIX-B, and IPV reported febrile seizures. There were no afebrile seizures in this group. No subject in either study group had seizures within 7 days following vaccination.

Other Neurological Events of Interest

No cases of hypotonic-hyporesponsiveness or encephalopathy were reported in either the German safety study or the US safety study.

Solicited Adverse Events

Table 3 presents data from the US safety study on solicited local and systemic adverse events within 4 days of vaccination with PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) or INFANRIX, ENGERIX-B, and IPV, administered concomitantly with Hib and 7-valent pneumococcal conjugate vaccines (Wyeth Pharmaceuticals Inc.). In this study, medical attention (a visit to or from medical personnel) for fever within 4 days following vaccination was sought in the group who received PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) for 8 infants after the first dose (1.2%), 1 infant following the second dose (0.2%), and 5 infants following the third dose (0.8%) (Table 3). Following dose 2, medical attention for fever was sought for 2 infants (0.6%) who received separately administered vaccines (Table 3). Among infants who had a medical visit for fever within 4 days following vaccination, 9 of 14 who received PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) and 1 of 2 who received separately administered vaccines, had one or more diagnostic studies performed to evaluate the cause of fever.

Safety of PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) After a Previous Dose of Hepatitis B Vaccine

Limited data are available on the safety of administering PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) after a previous dose of hepatitis B vaccine. In 2 separate studies, 160 Moldovan infants and 96 US infants, respectively, received 3 doses of PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) following 1 previous dose of hepatitis B vaccine. Neither study was designed to detect significant differences in rates of adverse events associated with PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) administered after a previous dose of hepatitis B vaccine compared to PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) administered without a previous dose of hepatitis B vaccine.

Table 3 : Percentage of US Infants With Solicited Local Reactions or Systemic Adverse Events Within 4 Days of Vaccinationa at 2, 4, and 6 Months of Age With PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) Administered Concomitantly With Hib Conjugate Vaccine and 7-valent Pneumococcal Conjugate Vaccine (PCV7) or With Separate Concomitant Administration of INFANRIX, ENGERIX-B, IPV, Hib Conjugate Vaccine, and PCV7 (Modified ITT cohort)

  PEDIARIX, Hib Vaccine, & PCV7 INFANRIX, ENGERIX-B, IPV, HibVaccine, & PCV7
  Dose 1 Dose 2 Dose 3 Dose 1 Dose 2 Dose 3
Localb            
N 671 653 648 335 323 315
Pain, any 36.1 36.1 31.2 31.9 30.0 29.8
Pain, grade 2 or 3 11.5 10.9 10.6 9.0 8.7 8.9
Pain, grade 3 2.4 2.5 1.7 2.7 1.5 1.3
Redness, any 24.9c 37.2 40.1 18.2 32.8 39.0
Redness, > 5 mm 6.0c 9.6c 12.7c 1.8 5.9 7.3
Redness, > 20 mm 0.9 1.2c 2.8 0.3 0.0 1.9
Swelling, any 17.3c 26.5c 28.7 9.6 20.4 24.8
Swelling, > 5 mm 5.8c 9.6c 9.3c 1.8 5.0 4.1
Swelling, > 20 mm 1.9 2.5c 3.1 0.6 0.0 1.3
Systemic            
N 667 644 645 333 321 311
Feverd, ≥ 100.4°F 27.9c 38.8c 33.5c 19.8 30.2 23.8
Feverd, > 101.3°F 7.0 14.1c 8.8 4.5 9.7 5.8
Feverd, > 102.2°F 2.2c 3.6 3.4 0.3 3.1 2.3
Feverd, > 103.1°F 0.4 1.4 1.1 0.0 0.3 0.3
Feverd, M.A. 1.2c 0.2 0.8 0.0 0.6 0.0
N 671 653 648 335 323 315
Drowsiness, any 57.2 51.6 40.9 54.0 48.3 38.4
Drowsiness, grade 2 or 3 15.8 13.8 11.4 17.6 12.4 11.1
Drowsiness, grade 3 2.5 1.2 0.9 3.6 0.6 1.9
Irritability/Fussiness, any 60.5 64.9 61.1 61.5 61.6 56.5
Irritability/Fussiness, grade 2 or 3 19.8 27.9c 25.2c 19.4 21.1 19.4
Irritability/Fussiness, grade 3 3.4 4.4 3.5 3.9 3.4 3.2
Loss of appetite, any 30.4 30.6 26.2 27.8 26.6 23.8
Loss of appetite, grade 2 or 3 6.6 7.8c 5.9 5.1 3.4 5.4
Loss of appetite, grade 3 0.7 0.3 0.2 0.6 0.3 0.0
Modified ITT cohort = all vaccinated subjects for whom safety data were available.
N = number of infants for whom at least one symptom sheet was completed; for fever, numbers exclude missing temperature recordings or tympanic measurements.
M.A. = Medically attended (a visit to or from medical personnel).
Grade 2 defined as sufficiently discomforting to interfere with daily activities.
Grade 3 defined as preventing normal daily activities.
a Within 4 days of vaccination defined as day of vaccination and the next 3 days.
b Local reactions at the injection site for PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) or INFANRIX.
c Rate significantly higher in the group that received PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) compared to separately administered vaccines [P < 0.05 (2-sided Fisher Exact test) or the 95% CI on the difference between groups (Separate minus PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) ) does not include 0].
d Axillary temperatures increased by 1°C and oral temperatures increased by 0.5°C to derive equivalent rectal temperature.

Additional Adverse Events

Rarely, an anaphylactic reaction (i.e., hives, swelling of the mouth, difficulty breathing, hypotension, or shock) has been reported after receiving preparations containing diphtheria, tetanus, and/or pertussis antigens.20 Arthus-type hypersensitivity reactions, characterized by severe local reactions, may follow receipt of tetanus toxoid. A review by the IOM found evidence for a causal relationship between receipt of tetanus toxoid and both brachial neuritis and Guillain-Barré syndrome.24 A few cases of demyelinating diseases of the CNS have been reported following some tetanus toxoid-containing vaccines or tetanus and diphtheria toxoid-containing vaccines, although the IOM concluded that the evidence was inadequate to accept or reject a causal relationship.24 A few cases of peripheral mononeuropathy and of cranial mononeuropathy have been reported following tetanus toxoid administration, although the IOM concluded that the evidence was inadequate to accept or reject a causal relationship.

Postmarketing Reports With PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine)

Worldwide voluntary reports of adverse events received for PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) since market introduction of this vaccine are listed below. This list includes serious adverse events or events which have a suspected causal connection to components of PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) or other vaccines or drugs. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. 

Cardiac Disorders: Cyanosis. 

Gastrointestinal Disorders: Diarrhea, vomiting. 

General Disorders and Administration Site Conditions: Fatigue, injection site cellulitis, injection site induration, injection site itching, injection site nodule/lump, injection site pain, injection site reaction, injection site redness, injection site swelling, injection site vesicles, injection site warmth, irritability, limb pain, limb swelling, pyrexia, Sudden Infant Death Syndrome. 

Immune System Disorders: Anaphylactic reaction, anaphylactoid reaction, hypersensitivity. 

Infections and Infestations: Upper respiratory tract infection. 

Investigations: Abnormal liver function tests. 

Metabolism and Nutrition Disorders: Anorexia. 

Nervous System Disorders: Bulging fontanelle, convulsions, depressed level of consciousness, febrile convulsion, hypotonia, hypotonic-hyporesponsive episode, lethargy, somnolence.

Psychiatric Disorders: Crying, insomnia, nervousness, restlessness, screaming, unusual crying. 

Respiratory, Thoracic, and Mediastinal Disorders: Apnea, cough, dyspnea. 

Skin and Subcutaneous Tissue Disorders: Angioedema, erythema, rash, urticaria. 

Vascular Disorders: Pallor, petechiae.

Postmarketing Reports With INFANRIX and/or ENGERIX-B

Worldwide voluntary reports of adverse events received for INFANRIX and/or ENGERIX-B in children younger than 7 years of age but not already reported for PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) are listed below. This list includes serious adverse events or events which have a suspected causal connection to components of INFANRIX and/or ENGERIX-B or other vaccines or drugs. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. 

Blood and Lymphatic System Disorders: Idiopathic thrombocytopenic purpuraa,b, lymphadenopathya, thrombocytopeniaa,b. 

Gastrointestinal Disorders: Abdominal painb, intussusceptiona,b, nauseab. 

General Disorders and Administration Site Conditions: Astheniab, malaiseb. 

Hepatobiliary Disorders: Jaundiceb. 

Immune System Disorders: Anaphylactic shocka, serum sickness–like diseaseb. 

Musculoskeletal and Connective Tissue Disorders: Arthralgiab, arthritisb, muscular weaknessb, myalgiab. 

Nervous System Disorders: Encephalitisb, encephalopathya, headacheb, meningitisb, neuritisb, neuropathyb, paralysisb. 

Skin and Subcutaneous Tissue Disorders: Alopeciab, erythema multiformeb, lichen planusb, pruritusa,b, Stevens-Johnson syndromea. 

Vascular Disorders: Vasculitisb.

a Following INFANRIX.
b Following ENGERIX-B.

Reporting Adverse Events

The National Childhood Vaccine Injury Act requires that the manufacturer and lot number of the vaccine administered be recorded by the healthcare provider in the vaccine recipient's permanent medical record, along with the date of administration of the vaccine and the name, address, and title of the person administering the vaccine.25 The Act further requires the healthcare provider to report to the US Department of Health and Human Services the occurrence following immunization of any event set forth in the Vaccine Injury Table including: Anaphylaxis or anaphylactic shock within 7 days, encephalopathy or encephalitis within 7 days, brachial neuritis within 28 days, or an acute complication or sequelae (including death) of an illness, disability, injury, or condition referred to above, or any events that would contraindicate further doses of vaccine, according to this prescribing information.25,26 These events should be reported to VAERS. The VAERS toll-free number is 1-800-822-7967. Reporting forms may also be obtained at the VAERS website at www.vaers.hhs.gov.

Read the Pediarix (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) Side Effects Center for a complete guide to possible side effects

Interactions

For information regarding concomitant administration with other vaccines, refer to DOSAGE AND ADMINISTRATION

PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) should not be mixed with any other vaccine in the same syringe or vial. 

Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune response to vaccines. The ACIP has published guidelines for vaccination of persons on such therapies (www.cdc.gov/vaccines).21

REFERENCES

20. Centers for Disease Control and Prevention. Update: Vaccine side effects, adverse reactions, contraindications, and precautions — Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1996;45(RR-12):1-35.

21. Centers for Disease Control and Prevention. Use of vaccines and immune globulins in persons with altered immunocompetence: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1993;42(RR-4):1-18.

22. Poets CF. Plötzlicher Säuglingstod. Neue Erkenntnisse. Pädiat prax 2001;60:285-292.

23. Centers for Disease Control and Prevention. Sudden Infant Death Syndrome — United States, 1983-94. MMWR 1996;45(40):859-863.

24. Institute of Medicine (IOM). Stratton KR, Howe CJ, Johnston RB, eds. Adverse events associated with childhood vaccines. Evidence bearing on causality. Washington, DC: National Academy Press; 1994.

25. Centers for Disease Control. National Childhood Vaccine Injury Act: Requirements for permanent vaccination records and for reporting of selected events after vaccination. MMWR 1988;37(13):197-200.

26. National Vaccine Injury Compensation Program: Vaccine injury table. www.hrsa.gov/osp/vicp/table.htm. Accessed May 19, 2005.


This monograph has been modified to include the generic and brand name in many instances.

Warnings

Administration of PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) is associated with higher rates of fever relative to separately administered vaccines. In a safety study that evaluated medically attended fever after PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) or separately administered vaccines when coadministered with 7-valent pneumococcal and Hib conjugate vaccines, infants who received PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) had a higher rate of medical encounters for fever within the first 4 days following the first vaccination. In some infants, these encounters included the performance of diagnostic studies to evaluate other causes of fever (see ADVERSE REACTIONS). 

The tip cap and the rubber plunger of the needleless prefilled syringes contain dry natural latex rubber that may cause allergic reactions in latex sensitive individuals. The vial stopper is latex-free. 

If any of the following events occur in temporal relation to receipt of DTwP or a vaccine containing an acellular pertussis component, the decision to give any pertussis vaccine, including PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) , should be based on careful consideration of the potential benefits and possible risks:19,20 

  • Temperature of ≥ 40.5°C (105°F) within 48 hours not due to another identifiable cause;
  • Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours;
  • Persistent, inconsolable crying lasting  3 hours, occurring within 48 hours;
  • Seizures with or without fever occurring within 3 days.

When a decision is made to withhold pertussis vaccination, DT vaccine, hepatitis B vaccine, and IPV should be given, as indicated. 

If Guillain-Barré syndrome occurs within 6 weeks of receipt of prior vaccine containing tetanus toxoid, the decision to give any tetanus toxoid-containing vaccine, including PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) , should be based on careful consideration of the potential benefits and possible risks.5 If tetanus toxoid is withheld, other available vaccines should be given, as indicated. 

The decision to administer a pertussis-containing vaccine to individuals with stable CNS disorders must be made by the physician on an individual basis, with consideration of all relevant factors, and assessment of potential risks and benefits for that individual. The Advisory Committee on Immunization Practices (ACIP) has issued guidelines for such individuals.19 The parent or guardian should be advised of the potential increased risk involved (see PRECAUTIONS, Information for Vaccine Recipients and Parents or Guardians). 

For children at higher risk for seizures than the general population, an appropriate antipyretic may be administered at the time of vaccination with a vaccine containing an acellular pertussis component (including PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) ) and for the ensuing 24 hours according to the respective prescribing information recommended dosage to reduce the possibility of post-vaccination fever.5,19 

The ACIP has published guidelines for vaccination of persons with recent or acute illness (www.cdc.gov/vaccines).5

Precautions

PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) should be given with caution in children with bleeding disorders such as hemophilia or thrombocytopenia and in children on anticoagulant therapy, with steps taken to avoid the risk of hematoma following the injection.5 

Before the injection of any biological, the physician should take all reasonable precautions to prevent allergic or other adverse reactions, including understanding the use of the biological concerned, and the nature of the side effects and adverse reactions that may follow its use. 

Prior to immunization, the patient's current health status and medical history should be reviewed. The physician should review the patient's immunization history for possible vaccine sensitivity, previous vaccination-related adverse reactions and occurrence of any adverse–event-related symptoms and/or signs, in order to determine the existence of any contraindication to immunization with PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) and to allow an assessment of benefits and risks. Epinephrine injection (1:1,000) and other appropriate agents used for the control of immediate allergic reactions must be immediately available should an acute anaphylactic reaction occur. 

A separate sterile syringe and sterile disposable needle or a sterile disposable unit should be used for each individual patient to prevent transmission of hepatitis or other infectious agents from one person to another. Needles should be disposed of properly and should not be recapped. 

Special care should be taken to prevent injection into a blood vessel. 

As with any vaccine, if administered to immunosuppressed persons, including individuals receiving immunosuppressive therapy, the expected immune response may not be obtained. 

The potential risk of apnea and the need for respiratory monitoring for 48 to 72 hours should be considered when administering the primary immunization series to very premature infants (born ≤ 28 weeks of gestation) who remain hospitalized at the time of vaccination and particularly for those with a previous history of respiratory immaturity. It is generally understood that the benefit of vaccination is high in very premature infants. The decision to vaccinate should be based on careful consideration of the potential benefits and possible risks.

Carcinogenesis, Mutagenesis, Impairment of Fertility

PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

Pregnancy

Pregnancy Category C

PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) is not indicated for women of child-bearing age. Animal reproduction studies have not been conducted with PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) . It is not known whether PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) can cause fetal harm when administered to a pregnant woman or if PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) can affect reproductive capacity.

Geriatric Use

PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) is not indicated for use in adult populations.

Pediatric Use

Safety and effectiveness of PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) in infants younger than 6 weeks of age have not been evaluated. 

PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) is not recommended for persons 7 years of age or older.

REFERENCES

5. Centers for Disease Control and Prevention. General recommendations on immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians (AAFP). MMWR 2002;51(RR-2):1-35.

19. Centers for Disease Control and Prevention. Pertussis vaccination: Use of acellular pertussis vaccines among infants and young children — Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1997;46(RR-7):1-25.

20. Centers for Disease Control and Prevention. Update: Vaccine side effects, adverse reactions, contraindications, and precautions — Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1996;45(RR-12):1-35.

21. Centers for Disease Control and Prevention. Use of vaccines and immune globulins in persons with altered immunocompetence: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1993;42(RR-4):1-18.


This monograph has been modified to include the generic and brand name in many instances.

OverDose

No information provided.

ContrainDications

Hypersensitivity to any component of the vaccine, including yeast, neomycin, and polymyxin B, is a contraindication (see DESCRIPTION). 

It is a contraindication to use this vaccine after a serious allergic reaction (e.g., anaphylaxis) temporally associated with a previous dose of this vaccine or with any components of this vaccine. Because of the uncertainty as to which component of the vaccine might be responsible, no further vaccination with any of these components should be given. Alternatively, such individuals may be referred to an allergist for evaluation if immunization with any of these components is considered.2 

In addition, the following events are contraindications to administration of any pertussis-containing vaccine, including PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) :5

  • Encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of administration of a previous dose of a pertussis-containing vaccine that is not attributable to another identifiable cause;
  • Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy. Pertussis vaccine should not be administered to individuals with these conditions until a treatment regimen has been established and the condition has stabilized.

REFERENCES

2. Centers for Disease Control. Diphtheria, tetanus, and pertussis: Recommendations for vaccine use and other preventive measures — Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1991;40(RR-10):1-28.

5. Centers for Disease Control and Prevention. General recommendations on immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians (AAFP). MMWR 2002;51(RR-2):1-35.


This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

The efficacy of PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) is based on the immunogenicity of the individual antigens compared to licensed vaccines. The efficacy of the pertussis component, which does not have a well established correlate of protection, was determined in clinical trials of INFANRIX. The efficacy of the HBsAg was determined in clinical studies of ENGERIX-B. Serological correlates of protection exist for the diphtheria, tetanus, hepatitis B, and poliovirus components.

Diphtheria

Diphtheria is an acute toxin-mediated infectious disease caused by toxigenic strains of C. diphtheriae. Diphtheria in the United States has been controlled through the use of diphtheria toxoid-containing vaccines. Protection against disease is due to the development of neutralizing antibodies to the diphtheria toxin. Following adequate immunization with diphtheria toxoid, protection persists for at least 10 years. A serum diphtheria antitoxin level of 0.01 IU/mL is the lowest level giving some degree of protection; a level of 0.1 IU/mL is regarded as protective.1 Levels of 1.0 IU/mL are associated with long-term protection.1 Immunization with diphtheria toxoid does not, however, eliminate carriage of C. diphtheriae in the pharynx or nares or on the skin.2

Tetanus

Tetanus is a condition manifested primarily by neuromuscular dysfunction caused by a potent exotoxin released by C. tetani. Spores of C. tetani are ubiquitous. Naturally acquired immunity to tetanus toxin does not occur. Thus, universal primary immunization and timed booster doses to maintain adequate tetanus antitoxin levels are necessary to protect all age groups.2 Protection against disease is due to the development of neutralizing antibodies to the tetanus toxin. A serum tetanus antitoxin level of at least 0.01 IU/mL, measured by neutralization assays, is considered the minimum protective level.3,4 A level ≥ 0.1 to 0.2 IU/mL has been considered as protective.5 Following immunization, protection persists for at least 10 years.2

Pertussis

Pertussis (whooping cough) is a disease of the respiratory tract caused by B. pertussis. The role of the different components produced by B. pertussis in either the pathogenesis of, or the immunity to, pertussis is not well understood. 

Efficacy of a 3-dose primary series of INFANRIX has been assessed in 2 clinical studies.6,7 

A double-blind, randomized, active Diphtheria and Tetanus Toxoids (DT)-controlled trial conducted in Italy, sponsored by the National Institutes of Health (NIH), assessed the absolute protective efficacy of INFANRIX when administered at 2, 4, and 6 months of age.6 The population used in the primary analysis of the efficacy of INFANRIX included 4,481 infants vaccinated with INFANRIX and 1,470 DT vaccinees. After 3 doses, the absolute protective efficacy of INFANRIX against WHO-defined typical pertussis (21 days or more of paroxysmal cough with infection confirmed by culture and/or serologic testing) was 84% (95% CI: 76% to 89%). When the definition of pertussis was expanded to include clinically milder disease, with infection confirmed by culture and/or serologic testing, the efficacy of INFANRIX was 71% (95% CI: 60% to 78%) against > 7 days of any cough and 73% (95% CI: 63% to 80%) against ≥ 14 days of any cough. A longer unblinded follow-up period showed that after 3 doses and with no booster dose in the second year of life, the efficacy of INFANRIX against WHO-defined pertussis was 86% (95% CI: 79% to 91%) among children followed to 6 years of age.8 For details see INFANRIX prescribing information. 

A prospective efficacy trial was also conducted in Germany employing a household contact study design.7 In this study, the protective efficacy of INFANRIX administered to infants at 3, 4, and 5 months of age, against WHO-defined pertussis was 89% (95% CI: 77% to 95%). When the definition of pertussis was expanded to include clinically milder disease, with infection confirmed by culture and/or serologic testing, the efficacy of INFANRIX against ≥ 7 days of any cough was 67% (95% CI: 52% to 78%) and against ≥ 7 days of paroxysmal cough was 81% (95% CI: 68% to 89%). For details see INFANRIX prescribing information.

Hepatitis B

Infection with hepatitis B virus can have serious consequences including acute massive hepatic necrosis and chronic active hepatitis. Chronically infected persons are at increased risk for cirrhosis and hepatocellular carcinoma. According to the Centers for Disease Control and Prevention (CDC), hepatitis B vaccine is recognized as an anti-cancer vaccine because it can prevent primary liver cancer.9 In a Taiwanese study, the institution of universal childhood immunization against hepatitis B virus has been shown to decrease the incidence of hepatocellular carcinoma among children.10 In a Korean study in adult males, vaccination against the hepatitis B virus has been shown to decrease the incidence and risk of developing hepatocellular carcinoma in adults.11 

Modes of transmission of hepatitis B virus include sexual contact with an infected person, percutaneous or mucosal exposure to infectious blood, and perinatal exposure to an infected mother. Antibody concentrations ≥ 10 mIU/mL against HBsAg are recognized as conferring protection against hepatitis B.12 

Protective efficacy with ENGERIX-B has been demonstrated in a clinical trial in neonates at high risk of hepatitis B infection.13,14 Fifty-eight neonates born of mothers who were both HBsAg- and HBeAg-positive were given ENGERIX-B (10 mcg at 0, 1, and 2 months) without concomitant hepatitis B immune globulin. Two infants became chronic carriers in the 12-month follow-up period after initial inoculation. Assuming an expected carrier rate of 70%, the protective efficacy against the chronic carrier state during the first 12 months of life was 95%.

Poliomyelitis

Poliovirus is an enterovirus that belongs to the picornavirus family. Three serotypes of poliovirus have been identified (Types 1, 2, and 3). Whereas poliovirus infections are usually asymptomatic or cause nonspecific symptoms, up to 2% of infected persons have central nervous system involvement and develop paralytic disease.15 

Poliomyelitis in the United States has been controlled through the use of poliovirus vaccines.  IPV induces the production of neutralizing antibodies against each poliovirus serotype; these neutralizing antibodies are recognized as conferring protection against poliomyelitis disease.16

Immune Response to PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine)

In a US multicenter study, infants were randomized to 1 of 3 groups: (1) a combination vaccine group that received PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) coadministered with US-licensed 7-valent pneumococcal and Hib conjugate vaccines [Wyeth Pharmaceuticals Inc.]; (2) a separate vaccine group that received US-licensed INFANRIX, ENGERIX-B, and IPV [Sanofi Pasteur SA] coadministered with the same pneumococcal and Hib conjugate vaccines; and (3) a staggered vaccine group that received PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) coadministered with the same Hib conjugate vaccine but with the same pneumococcal conjugate vaccine administered 2 weeks later. The schedule of administration was 2, 4, and 6 months of age. Infants either did not receive a dose of hepatitis B vaccine prior to enrollment or were permitted to receive one dose of hepatitis B vaccine administered at least 30 days prior to enrollment. For the separate vaccine group, ENGERIX-B was not administered at 4 months of age to subjects who received a dose of hepatitis B vaccine prior to enrollment. Among subjects in all 3 vaccine groups combined, 84% were white, 7% were Hispanic, 6% were black, 0.7% Oriental, and 2.4% were of other racial/ethnic groups.

The immune responses to the pertussis (PT, FHA, and pertactin), diphtheria, tetanus, poliovirus, and hepatitis B antigens were evaluated in sera obtained one month (range 20 to 60 days) after the third dose of PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) or INFANRIX. Geometric mean antibody concentrations (GMCs) adjusted for pre-vaccination values for PT, FHA, and pertactin and the seroprotection rates for diphtheria, tetanus, and the polioviruses among subjects who received PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) in the combination vaccine group were shown to be non-inferior to those achieved following separately administered vaccines (see Table 1). There was no evidence for interference with the immune responses to PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) when 7-valent pneumococcal conjugate vaccine was concomitantly administered. 

Because of differences in the hepatitis B vaccination schedule among subjects in the study, no clinical limit for non-inferiority was pre-defined for the hepatitis B immune response. However, in a previous US study, non-inferiority of PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) relative to separately administered INFANRIX, ENGERIX-B, and an oral poliovirus vaccine, with respect to the hepatitis B immune response was demonstrated.17

Table 1: Antibody Responses Following PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) as Compared to Separate Concomitant Administration of INFANRIX, ENGERIX-B, and IPV (One Montha After Administration of Dose 3) in Infants Vaccinated at 2, 4, and 6 Months of Age When Coadministered With Hib Conjugate Vaccine and Pneumococcal Conjugate Vaccine (PCV7)

  PEDIARIX, Hib Vaccine, & PCV7 INFANRIX, ENGERIX-B, IPV, Hib Vaccine, & PCV7
  (N = 154-168) (N = 141-155)
Anti-Diphtheria
  % ≥ 0.1 IU/mLb 99.4 98.7
Anti-Tetanus
  % = 0.1 IU/mLb 100 98.1
Anti-PT
  % VRc 98.7 95.1
  GMCb 48.1 28.6
Anti-FHA
  % VRc 98.7 96.5
  GMCb 111.9 97.6
Anti-Pertactin
  % VRc 91.7 95.1
  GMCb 95.3 80.6
Anti-Polio 1
  % = 1:8bd 100 100
Anti-Polio 2
  % = 1:8bd 100 100
Anti-Polio 3
  % = 1:8bd 100 100
  (N = 114-128) (N = 111-121)
Anti-HBsAge
  % = 10 mIU/mLf 97.7 99.2
  GMC (mIU/mL)f 1032.1 614.5
Hib Conjugate Vaccine and PCV7 manufactured by Wyeth Pharmaceuticals Inc. IPV manufactured by Sanofi Pasteur SA.
VR = Vaccine response: In initially seronegative infants, appearance of antibodies (concentration ≥ 5 EL.U./mL); in initially seropositive infants, at least maintenance of pre-vaccination concentration.
GMC = Geometric mean antibody concentration. GMCs are adjusted for pre-vaccination levels.
a One month blood sampling, range 20 to 60 days.
b Seroprotection rate or GMC for PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) not inferior to separately administered vaccines [upper limit of 90% CI on GMC ratio (separate vaccine group/combination vaccine group) < 1.5 for anti-PT, anti-FHA, and anti-pertactin, and upper limit of 95% CI for the difference in seroprotection rates (separate vaccine group minus combination vaccine group) < 10% for diphtheria and tetanus and < 5% for the 3 polioviruses]. GMCs are adjusted for pre-vaccination levels.
c The upper limit of 95% CI for differences in vaccine response rates (separate vaccine group minus combination group) was 0.31, 1.52, and 9.46 for PT, FHA, and PRN, respectively. No clinical limit defined for non-inferiority.
d Poliovirus neutralizing antibody titer.
e Subjects who received a previous dose of hepatitis B vaccine were excluded from the analysis of hepatitis B seroprotection rates and GMCs presented in the table.
f No clinical limit defined for non-inferiority.

Immune Responses to Concomitantly Administered Vaccines

Anti-PRP seroprotection rates and GMCs of pneumococcal antibodies one month (range 20 to 60 days) after the third dose of vaccines for the combination vaccine group and the separate vaccine group from the US multicenter study described previously are presented in Table 2.

Table 2: Anti-PRP Seroprotection Rates and GMCs (mcg/mL) of Pneumococcal Antibodies One Montha Following the Third Dose of Hib Conjugate Vaccine and Pneumococcal Conjugate Vaccine (PCV7) Administered Concomitantly With PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) or With INFANRIX, ENGERIX-B, and IPV

  PEDIARIX, Hib Vaccine, & PCV7 INFANRIX, ENGERIX-B, IPV, Hib Vaccine, & PCV7
(N = 161-168) (N = 146-156)
% (95% CI) % (95% CI)
Anti-PRP
   ≥ 0.15 mcg/mL 100 (97.8-100) 99.4 (96.5-100)
Anti-PRP
   ≥ 1.0 mcg/mL 95.8 (91.6-98.3) 91.0 (85.3-95.0)
  GMC (95% CI) GMC (95% CI)
Pneumococcal Serotype
   4 1.7 (1.5-2.0) 2.1 (1.8-2.4)
   6B 0.8 (0.7-1.0) 0.7 (0.5-0.9)
   9V 1.6 (1.4-1.8) 1.6 (1.4-1.9)
   14 4.7 (4.0-5.4) 6.3 (5.4-7.4)
   18C 2.6 (2.3-3.0) 3.0 (2.5-3.5)
   19F 1.1 (1.0-1.3) 1.1 (0.9-1.2)
   23F 1.5 (1.2-1.8) 1.8 (1.5-2.3)
Hib Conjugate Vaccine and PCV7 manufactured by Wyeth Pharmaceuticals Inc. IPV manufactured by Sanofi Pasteur SA.
GMC = Geometric mean antibody concentration.
a One month blood sampling, range 20 to 60 days.

REFERENCES

1. Wharton M and Vitek CR. Diphtheria Toxoid. In: Plotkin SA and Orenstein WA, eds. Vaccines. 4th ed. Philadelphia , PA: Saunders Press; 2004:211-228.

2. Centers for Disease Control. Diphtheria, tetanus, and pertussis: Recommendations for vaccine use and other preventive measures — Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1991;40(RR-10):1-28.

3. Wassilak SGF, Roper MH, Murphy TV and Orenstein WA. Tetanus Toxoid. In: Plotkin SA and Orenstein WA, eds. Vaccines. 4th ed. Philadelphia , PA: Saunders Press; 2004:745-781.

4. Department of Health and Human Services, Food and Drug Administration. Biological products; Bacterial vaccines and toxoids; Implementation of efficacy review; Proposed rule. Federal Register December 13, 1985;50(240):51002-51117.

5. Centers for Disease Control and Prevention. General recommendations on immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians (AAFP). MMWR 2002;51(RR-2):1-35.

6. Greco D, Salmaso S, Mastrantonio P, et al. A controlled trial of two acellular vaccines and one whole-cell vaccine against pertussis. N Engl J Med 1996;334(6):341-348.

7. Schmitt H-J, von König CHW, Neiss A, et al. Efficacy of acellular pertussis vaccine in early childhood after household exposure. JAMA 1996;275(1):37-41.

8. Salmaso S, Mastrantonio P, Tozzi AE, et al. Sustained efficacy during the first 6 years of life of 3-component acellular pertussis vaccines administered in infancy: The Italian experience. Pediatrics 2001;108(5):E81.

9. Centers for Disease Control and Prevention. Proposed vaccine information materials for hepatitis B, Haemophilus influenza type B (Hib), varicella (chickenpox), and measles, mumps, rubella (MMR) vaccines. Federal Register September 3, 1998;63(171):47026-47031.

10. Chang MH, Chen CJ, Lai MS. Universal hepatitis B vaccination in Taiwan and the incidence of hepatocellular carcinoma in children. NEngl J Med 1997;336:1855-1859.

11. Lee MS, Kim DH, Kim H, et al. Hepatitis B vaccination and reduced risk of primary liver cancer among male adults: A cohort study in Korea. IntJ Epidemiol 1998;27(2):316-319.

12. Ambrosch F, Frisch-Niggemeyer W, Kremsner P, et al. Persistence of vaccine-induced antibodies to hepatitis B surface antigen and the need for booster vaccination in adult subjects. Postgrad MedJ 1987;63(Suppl. 2):129-135.

13. Andre FE and Safary A. Clinical experience with a yeast-derived hepatitis B vaccine. In: Zuckerman AJ, ed. Viral hepatitis and liver disease. New York, NY: Alan R Liss, Inc.; 1988:1025-1030.

14. Poovorawan Y, Sanpavat S, Pongpunlert W, et al. Protective efficacy of a recombinant DNA hepatitis B vaccine in neonates of HBe antigen-positive mothers. JAMA 1989;261(22):3278-3281.

15. Centers for Disease Control and Prevention. Poliomyelitis. In: Atkinson W and Wolfe C, eds. Epidemiology and prevention of vaccine-preventable diseases. 7th ed. Atlanta, GA: Public Health Foundation; 2002:71-82.

16. Sutter RW, Pallansch MA, Sawyer LA, et al. Defining surrogate serologic tests with respect to predicting protective vaccine efficacy: Poliovirus vaccination. In: Williams JC, Goldenthal KL, Burns DL, Lewis Jr BP, eds. Combined vaccines and simultaneous administration. Current issues and perspectives. New York, NY: The New York Academy of Sciences; 1995:289-299.

17. Yeh SH, Ward JI, Partridge S, et al. Safety and immunogenicity of a pentavalent diphtheria, tetanus, pertussis, hepatitis B and polio combination vaccine in infants. Pediatr Infect Dis J 2001;20:973-980.


This monograph has been modified to include the generic and brand name in many instances.

Patient Information

Information for Vaccine Recipients and Parents or Guardians

Parents or guardians should be informed by the healthcare provider of the potential benefits and risks of the vaccine, and of the importance of completing the immunization series. The healthcare provider should inform the parents or guardians about the potential for adverse events that have been temporally associated with administration of PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) or other vaccines containing similar components.

The parent or guardian accompanying the recipient should be told to report severe or unusual adverse events to the physician or clinic where the vaccine was administered.  The parent or guardian should be given the Vaccine Information Statements, which are required by the National Childhood Vaccine Injury Act of 1986 to be given prior to immunization. These materials are available free of charge at the CDC website (www.cdc.gov/vaccines).

The United States Department of Health and Human Services has established a Vaccine Adverse Event Reporting System (VAERS) to accept all reports of suspected adverse events after the administration of any vaccine, including but not limited to the reporting of events required by the National Childhood Vaccine Injury Act of 1986.5 The VAERS toll-free number is 1-800-822-7967. Reporting forms may also be obtained at the VAERS website at www.vaers.hhs.gov.

REFERENCES

5. Centers for Disease Control and Prevention. General recommendations on immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians (AAFP). MMWR 2002;51(RR-2):1-35.


This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

No Information Available!

Consumer Overview Side Effect

No Information Available!

Consumer Overview Missed Dose

No Information Available!

Patient Detailed Side Effect

Brand Names: Pediarix

Generic Name: diphtheria, hepatitis B, pertussis (acellular), polio, and tetanus vaccine (Pronunciation: dif THEER ee a, hep a TYE tis B, per TUS iss, POE lee oh, and TET a nus)

  • What is diphtheria, hepatitis B, pertussis acellular, polio, and tetanus vaccine (Pediarix)?
  • What are the possible side effects of this vaccine (Pediarix)?
  • What is the most important information I should know about this vaccine (Pediarix)?
  • What should I discuss with my healthcare provider before receiving this vaccine (Pediarix)?
  • How is this vaccine given (Pediarix)?
  • What happens if I miss a dose (Pediarix)?
  • What happens if I overdose (Pediarix)?
  • What should I avoid before or after receiving this vaccine (Pediarix)?
  • What other drugs will affect diphtheria, hepatitis B, pertussis, polio, and tetanus vaccine (Pediarix)?
  • Where can I get more information?

What is diphtheria, hepatitis B, pertussis acellular, polio, and tetanus vaccine (Pediarix)?

Diphtheria, pertussis, and tetanus are serious diseases caused by bacteria.

Diphtheria causes a thick coating in the nose, throat, and airways. It can lead to breathing problems, paralysis, heart failure, or death.

Pertussis (whooping cough) causes coughing so severe that it interferes with eating, drinking, or breathing. These spells can last for weeks and can lead to pneumonia, seizures (convulsions), brain damage, and death.

Tetanus (lockjaw) causes painful tightening of the muscles, usually all over the body. It can lead to "locking" of the jaw so the victim cannot open the mouth or swallow. Tetanus leads to death in about 1 out of 10 cases.

Hepatitis B and polio are serious diseases caused by virus.

Hepatitis B is a disease of the liver that is spread through blood or bodily fluids, sexual contact or sharing IV drug needles with an infected person, or during childbirth when the mother is infected. Hepatitis causes inflammation of the liver, vomiting, and jaundice (yellowing of the skin or eyes). Hepatitis can lead to liver cancer, cirrhosis, or death.

Polio affects the central nervous system and spinal cord. It can cause muscle weakness and paralysis. Polio is a life-threatening condition because it can paralyze the muscles that help you breathe.

Diphtheria, hepatitis B, pertussis, and polio are spread from person to person. Tetanus enters the body through a cut or wound.

The diphtheria, hepatitis B, pertussis acellular, polio, and tetanus vaccine is used to help prevent these diseases in children who are ages 6 weeks to 6 years old, before the child has reached his or her 7th birthday.

This vaccine works by exposing your child to a small dose of the bacteria or a protein from the bacteria, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.

Like any vaccine, the diphtheria, hepatitis B, pertussis acellular, polio, and tetanus vaccine may not provide protection from disease in every person.

What are the possible side effects of this vaccine (Pediarix)?

Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with diphtheria, hepatitis B, pertussis, polio, or tetanus is much more dangerous to your child's health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if the child has any of these serious side effects:

  • extreme drowsiness, fainting;
  • fussiness, irritability, crying for an hour or longer;
  • seizure (black-out or convulsions); or
  • high fever (can occur for up to 4 days after the vaccine).

Less serious side effects include:

  • redness, pain, tenderness, or swelling where the shot was given;
  • mild fever;
  • mild fussiness or crying;
  • joint pain, body aches;
  • loss of appetite; or
  • nausea, vomiting, diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

Read the Pediarix (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about this vaccine (Pediarix)?

The diphtheria, hepatitis B, pertussis, polio, and tetanus vaccine is given in a series of shots. The first shot is usually given when the child is 2 months old. The booster shots are then given at 4 months and 6 months of age. Your child's individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by the health department of the state you live in.

Be sure your child receives all recommended doses of this vaccine. If your child does not receive the full series of vaccines, he or she may not be fully protected against the disease.

Your child can still receive a vaccine if he or she has a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until the child gets better before receiving this vaccine.

Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with diphtheria, hepatitis B, pertussis, polio, or tetanus is much more dangerous to your child's health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Side Effects Centers
  • Pediarix

Patient Detailed How Take

What should I discuss with my healthcare provider before receiving this vaccine (Pediarix)?

A hepatitis B vaccine will not protect your child against infection with hepatitis A, C, and E, or other viruses that affect the liver. It may also not protect the child from hepatitis B if he or she is already infected with the virus, even if the child does not yet show symptoms.

Your child should not receive this vaccine if the child is allergic to yeast, neomycin, or polymyxin B, or if the child has ever had a life-threatening allergic reaction to any vaccine containing diphtheria, hepatitis B, pertussis, polio, or tetanus.

Your child should also not receive this vaccine if he or she has:

  • severe or uncontrolled epilepsy or other seizure disorder;
  • if the child has received cancer chemotherapy or radiation treatment in the past 3 months.

Your child may not be able to receive this vaccine if he or she has ever received a similar vaccine that caused any of the following:

  • a very high fever (over 104 degrees);
  • a neurologic disorder or disease affecting the brain;
  • excessive crying for 3 hours or longer;
  • fainting or going into shock;
  • Guillain-Barré syndrome (within 6 weeks after receiving a diphtheria, tetanus, or pertussis vaccine);
  • seizure (convulsions); or
  • a severe skin reaction.

Before receiving this vaccine, tell the doctor if your child has:

  • a bleeding or blood clotting disorder such as hemophilia or easy bruising;
  • a history of seizures;
  • an allergy to latex rubber;
  • a weak immune system caused by disease or by taking certain medicines or receiving cancer treatments;
  • if the child is taking a blood thinner such as warfarin (Coumadin); or
  • if it has been less than 6 weeks since the child last received a vaccine.

Your child can still receive a vaccine if he or she has a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until the child gets better before receiving this vaccine.

How is this vaccine given (Pediarix)?

This vaccine is given as an injection (shot) into a muscle. Your child will receive this injection in a doctor's office or other clinic setting.

The diphtheria, hepatitis B, pertussis, polio, and tetanus vaccine is given in a series of shots. The first shot is usually given when the child is 2 months old. The booster shots are then given at 4 months and 6 months of age. Your child's individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by the health department of the state you live in.

Your doctor may recommend treating fever and pain with an aspirin-free pain reliever such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil, and others) when the shot is given and for the next 24 hours. Follow the label directions or your doctor's instructions about how much of this medicine to give your child.

It is especially important to prevent fever from occurring in a child who has a seizure disorder such as epilepsy.

Side Effects Centers
  • Pediarix

Patient Detailed Avoid Taking

What happens if I miss a dose (Pediarix)?

Contact your doctor if you will miss a booster dose or if you get behind schedule. The next dose should be given as soon as possible. There is no need to start over.

Be sure your child receives all recommended doses of this vaccine. If your child does not receive the full series of vaccines, he or she may not be fully protected against the disease.

What happens if I overdose (Pediarix)?

An overdose of this vaccine is unlikely to occur.

What should I avoid before or after receiving this vaccine (Pediarix)?

There are no restrictions on food, beverages, or activity before or after receiving this vaccine unless your child's doctor has told you otherwise.

What other drugs will affect diphtheria, hepatitis B, pertussis, polio, and tetanus vaccine (Pediarix)?

Before receiving this vaccine, tell the doctor about all other vaccines your child has recently received.

Also tell the doctor if your child has received drugs or treatments in the past 2 weeks that can weaken the immune system, including:

  • an oral, nasal, inhaled, or injectable steroid medicine;
  • medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, such as azathioprine (Imuran), efalizumab (Raptiva), etanercept (Enbrel), leflunomide (Arava), and others; or
  • medicines to treat or prevent organ transplant rejection, such as basiliximab (Simulect), cyclosporine (Sandimmune, Neoral, Gengraf), muromonab-CD3 (Orthoclone), mycophenolate mofetil (CellCept), sirolimus (Rapamune), or tacrolimus (Prograf).

If your child is using any of these drugs, he or she may not be able to receive the vaccine.

There may be other drugs that can affect this vaccine. Tell your doctor about all the prescription and over-the-counter medications your child has received. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your child's doctor.

Where can I get more information?

Your doctor or pharmacist may have information about this vaccine written for health professionals that you may read. You may also find additional information from your local health department or the Centers for Disease Control and Prevention.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 1.10. Revision date: 12/15/2010.

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