Drugs Details

Drugs Info of Menactra, Menveo
Drugs Details
  • Drugs Type  : FDA
  • Date : 26th Feb 2015 11:43 pm
  • Brand Name : Menactra, Menveo
  • Generic Name : meningococcal conjugate vaccine (Pronunciation: me NIN je KOK al KON je gate vax EEN)
Descriptions

Menactra®, Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine, is a sterile, intramuscularly administered vaccine that contains Neisseria meningitidis serogroup A, C, Y and W-135 capsular polysaccharide antigens individually conjugated to diphtheria toxoid protein. Nmeningitidis A, C, Y and W-135 strains are cultured on Mueller Hinton agar3 and grown in Watson Scherp4 media. The polysaccharides are extracted from the N meningitidis cells and purified by centrifugation, detergent precipitation, alcohol precipitation, solvent extraction and diafiltration. To prepare the polysaccharides for conjugation, they are depolymerized, derivatized, and purified by diafiltration.Corynebacterium diphtheriae cultures are grown in a modified Mueller and Miller medium5 and detoxified with formaldehyde. The diphtheria toxoid protein is purified by ammonium sulfate fractionation and diafiltration. The derivatized polysaccharides are covalently linked to diphtheria toxoid and purified by serial diafiltration. The four meningococcal components, present as individual serogroup-specific glycoconjugates, compose the final formulated vaccine. No preservative or adjuvant is added during manufacture. Each 0.5 mL dose may contain residual amounts of formaldehyde of less than 2.66 mcg (0.000532%), by calculation. Potency of Menactra vaccine is determined by quantifying the amount of each polysaccharide antigen that is conjugated to diphtheria toxoid protein and the amount of unconjugated polysaccharide present.

Menactra vaccine is manufactured as a sterile, clear to slightly turbid liquid. Each 0.5 mL dose of vaccine is formulated in sodium phosphate buffered isotonic sodium chloride solution to contain 4 mcg each of meningococcal A, C, Y and W-135 polysaccharides conjugated to approximately 48 mcg of diphtheria toxoid protein carrier.

There is no latex in any component of the vial.

REFERENCES

3 Mueller JH, et al. A Protein-Free Medium for Primary Isolation of the Gonococcus and Meningococcus. Proc Soc Exp Biol Med 1941;48:330-333.

4 Watson RG, et al. The specific hapten of group C (group IIa) meningococcus. I. Preparation and immunological behavior. J Immunol 1958;81:331-336.

5 Mueller JH, et al. Production of diphtheria toxin of high potency (100 Lf) on a reproducible medium. J Immunol 1941;40:21-32.

 

What are the possible side effects of meningococcal conjugate vaccine (Menactra, Menveo)?

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

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

You may feel faint after receiving this vaccine. Some people...

Read All Potential Side Effects and See Pictures of Menactra »

What are the precautions when taking polysaccharide diphtheria toxoid conjugate vaccine (Menactra)?

Before receiving this vaccine, tell your doctor or pharmacist if you are allergic to it; or to latex; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before receiving this vaccination, tell your doctor or pharmacist your medical history, especially of: current fever/illness, a certain nerve disease (Guillain-Barre syndrome), bleeding disorders (such as hemophilia, thrombocytopenia).

During pregnancy, this vaccine should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before...

Read All Potential Precautions of Menactra »

 

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

Indications

Menactra®, Meningococcal (Groups A, C, Y and W-135) PolysaccharideDiphtheria Toxoid Conjugate Vaccine, is indicated for active immunization to prevent invasive meningococcal disease caused by N meningitidisserogroups A, C, Y and W-135. Menactra is approved for use in individuals 9 months through 55 years of age. Menactra vaccine does not prevent N meningitides serogroup B disease.

Preparation For Administration

Menactra vaccine is a clear to slightly turbid solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If any of these conditions exist, the vaccine should not be administered.

Withdraw the 0.5 mL dose of vaccine from the single-dose vial using a sterile needle and syringe.

Dose And Schedule

Menactra vaccine is administered as a 0.5 mL dose by intramuscular injection.

In children 9 through 23 months of age, Menactra is given as a 2-dose series three months apart.

Individuals 2 through 55 years of age receive a single dose.

Do not administer this product intravenously or subcutaneously.

Dosage Administration

Revaccination

The need for a booster dose of Menactra vaccine has not yet been determined.

How Supplied

Dosage Forms And Strengths

Menactra vaccine is a liquid solution supplied in 0.5 mL single-dose vials. [See DESCRIPTIONfor a complete listing of ingredients.]

Vial, 1 Dose (NDC 49281-589-58) supplied as a package of 5 vials (NDC49281-589-05).

Storage And Handling

Store at 2° to 8°C (35° to 46°F). DO NOT FREEZE. Frozen/previously frozen product should not be used. Do not use after the expiration date.

Manufactured by: Sanofi Pasteur Inc., Swiftwater PA 18370 USA

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

 
 

Side Effects

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction 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.

Children 9 Through 12 Months of Age

The safety of Menactra vaccine was evaluated in four clinical studies that enrolled 3721 participants who received Menactra vaccine at 9 and 12 months of age. At 12 months of age these children also received one or more other recommended vaccines [Measles, Mumps, Rubella and VaricellaVirus Vaccine Live (MMRV) or Measles, Mumps, and Rubella Virus Vaccine (MMR) and Varicella Virus Vaccine Live (V) each manufactured by Merck & Co., Inc., Pneumococcal 7- valent Conjugate Vaccine (Diphtheria CRM197 Protein) manufactured by Wyeth Pharmaceuticals Inc. (PCV7), Hepatitis AVaccine manufactured by Merck & Co., Inc. (HepA). A control group of 997 children was enrolled at 12 months of age and received two or more childhood vaccines [MMRV (or MMR + V), PCV7, HepA] at 12 months of age [see Concomitant Vaccine Administration]. Three percent of individuals received MMR and V, instead of MMRV, at 12 months of age.

The primary safety study was a controlled trial that enrolled 1256 children who received Menactra vaccine at 9 and 12 months of age. At 12 months of age these children received MMRV (or MMR + V), PCV7 and HepA. A control group of 522 children received MMRV, PCV7 and HepA. Of the 1778 children, 78% of participants (Menactra vaccine, N=1056; control group, N=322) were enrolled at United States (US) sites and 22% at a Chilean site. (Menactra vaccine, N=200; control group, N=200).

Individuals 2 Through 55 Years of Age

The safety of Menactra vaccine was evaluated in eight clinical studies that enrolled 10,057 participants aged 2-55 years who received Menactra vaccine and 5,266 participants who received Menomune® - A/C/Y/W-135, Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W- 135 Combined. There were no substantive differences in demographic characteristics between the vaccine groups. Among Menactra vaccine recipients 2-55 years of age 24.0%, 16.2%, 40.4% and 19.4% were in the 2-10, 11-14, 15-25 and 26-55-year age groups, respectively. Among Menomune - A/C/Y/W-135 vaccine recipients 2-55 years of age 42.3%, 9.3%, 30.0% and 18.5% were in the 2-10, 11-14, 15-25 and 26-55-year age groups, respectively. The three primary safety studies were randomized, active-controlled trials that enrolled participants 2-10 years of age (Menactra vaccine, N=1713; Menomune - A/C/Y/W-135 vaccine, N=1519), 11-18 years of age (Menactra vaccine, N=2270; Menomune - A/C/Y/W-135 vaccine, N=972) and 18-55 years of age (Menactra vaccine, N=1384; Menomune - A/C/Y/W-135 vaccine, N=1170), respectively. Of the 3232 children 2-10 years of age, 68% of participants (Menactra vaccine, N=1164; Menomune - A/C/Y/W-135 vaccine, N=1031) were enrolled at US sites and 32% (Menactra vaccine, N=549; Menomune - A/C/Y/W-135 vaccine, N=488) of participants at a Chilean site. The median ages in the Chilean and US subpopulations were 5 and 6 years, respectively. All adolescents and adults were enrolled at US sites. As the route of administration differed for the two vaccines (Menactra vaccine given intramuscularly, Menomune - A/C/Y/W-135 vaccine given subcutaneously), study personnel collecting the safety data differed from personnel administering the vaccine.

Safety Evaluation

Participants were monitored after each vaccination for 30 minutes for immediate reactions. Solicited injection site and systemic reactions were recorded in a diary card for 7 consecutive days after each vaccination. Participants were monitored for 28 days (30 days for infants and toddlers) for unsolicited adverse events and for 6 months post-vaccination for visits to an emergency room, unexpected visits to an office physician, and serious adverse events. Unsolicited adverse event information was obtained either by telephone interview or at an interim clinic visit. Information regarding adverse events that occurred in the 6-month post-vaccination time period was obtained via a scripted telephone interview.

Serious Adverse Events in All Safety Studies

Serious adverse events (SAEs) were reported during a 6-month time period following vaccinations in individuals 9 months through 55 years of age. In children who received Menactra vaccine at 9 months and at 12 months of age, SAEs occurred at a rate of 2.0% - 2.5%. In participants who received one or more childhood vaccine(s) (without co-administration of Menactra vaccine) at 12 months of age, SAEs occurred at a rate of 1.6% - 3.6%, depending on the number and type of vaccines received. In children 2-10 years of age, SAEs occurred at a rate of 0.6% following Menactra vaccine and at a rate of 0.7% following Menomune - A/C/Y/W-135 vaccine. In adolescents 11 through 18 years of age and adults 18 years through 55 years of age, SAEs occurred at a rate of 1.0% following Menactra vaccine and at a rate of 1.3% following Menomune - A/C/Y/W-135 vaccine.

Solicited Adverse Events in the Primary Safety Studies

The most frequently reported solicited injection site and systemic adverse reactions within 7 days following vaccination in children 9 months and 12 months of age (Table 1) were injection site tenderness and irritability.

The most frequently reported solicited injection site and systemic adverse reactions in US children aged 2 years through 10 years of age (Table 2) were injection site pain and irritability. Diarrhea, drowsiness, and anorexiawere also common.

The most commonly reported solicited injection site and systemic adverse reactions in adolescents, ages 11-18 years (Table 3), and adults, ages 18-55 years (Table 4), were injection site pain, headache and fatigue. Except for redness in adults, injection site reactions were more frequently reported after Menactra vaccination than after Menomune - A/C/Y/W-135 vaccination.

Table 1: Percentage of US Participants Reporting Solicited Adverse Reactions Within 7 Days Following Vaccine Administration at 9 Months and 12 Months of Age

View Enlarged Table

 

Table 2: Percentage of US Participants 2 Years Through 10 Years of Age Reporting Solicited Adverse Reactions Within 7 Days Following Vaccine Administration

REACTION MENACTRA VACCINE 
NA=1156 - 1157
MENOMUNE - A/C/Y/W-135 VACCINE 
NA=1027
ANY GRADE 2 GRADE 3 ANY GRADE 2 GRADE 3
Local/Injection Site
  Painb 45.0 4.9 0.3 26.1 2.5 0.0
  Rednessc 21.8 4.6 3.9 7.9 0.5 0.0
  Indurationc 18.9 3.4 1.4 4.2 0.6 0.0
  Swellingc 17.4 3.9 1.9 2.8 0.3 0.0
Systemic
  Irritabilityd 12.4 3.0 0.3 12.2 2.6 0.6
  Diarrheae 11.1 2.1 0.2 11.8 2.5 0.3
  Drowsinessf 10.8 2.7 0.3 11.2 2.5 0.5
  Anorexiag 8.2 1.7 0.4 8.7 1.3 0.8
  Arthralgiah 6.8 0.5 0.2 5.3 0.7 0.0
  Feveri 5.2 1.7 0.3 5.2 1.7 0.2
  Rashj 3.4 - - 3.0 - -
  Vomitingk 3.0 0.7 0.3 2.7 0.7 0.6
  Seizurel 0.0 - - 0.0 - -
a N = The total number of subjects reporting at least one solicited reaction. The median age of participants was 6 years in both vaccine groups.
b Grade 2: interferes with normal activities, Grade 3: disabling, unwilling to move arm.
c Grade 2: 1.0-2.0 inches, Grade 3: > 2.0 inches.
d Grade 2: 1-3 hours duration, Grade 3: > 3 hours duration.
e Grade 2: 3-4 episodes, Grade 3: ≥ 5 episodes.
f Grade 2: interferes with normal activities, Grade 3: disabling, unwilling to engage in play or interact with others.
g Grade 2: skipped 2 meals, Grade 3: skipped ≥ 3 meals.
h Grade 2: decreased range of motion due to pain or discomfort, Grade 3: unable to move major joints due to pain.
i Oral equivalent temperature; Grade 2: 38.4°C to 39.4°C, Grade 3: ≥ 39.5°C.
j These solicited adverse events were reported as present or absent only.
k Grade 2: 2 episodes, Grade 3: ≥ 3 episodes.
Note: During the study Grade 1, Grade 2, and Grade 3 were collected as Mild, Moderate, and Severe respectively.

 

Table 3: Percentage of Participants 11 Years Through 18 Years of Age Reporting Solicited Adverse Reactions Within 7 Days Following Vaccine Administration

REACTION MENACTRA VACCINE
NA=2264 - 2265
MENOMUNE - A/C/Y/W-135 VACCINE 
NA=970
ANY GRADE 2 GRADE 3 ANY GRADE 2 GRADE 3
Local/Injection Site
  Painb 59.2c 12.8c 0.3 28.7 2.6 0.0
  Indurationd 15.7c 2.5c 0.3 5.2 0.5 0.0
  Rednessd 10.9c 1.6c 0.6c 5.7 0.4 0.0
  Swellingd 10.8c 1.9c 0.5c 3.6 0.3 0.0
Systemic
  Headachee 35.6c 9.6c 1.1 29.3 6.5 0.4
  Fatiguee 30.0c 7.5 1.1c 25.1 6.2 0.2
  Malaisee 21.9c 5.8c 1.1 16.8 3.4 0.4
  Arthralgiae 17.4c 3.6c 0.4 10.2 2.1 0.1
  Diarrheaf 12.0 1.6 0.3 10.2 1.3 0.0
  Anorexiag 10.7c 2.0 0.3 7.7 1.1 0.2
  Chillse 7.0c 1.7c 0.2 3.5 0.4 0.1
  Feverh 5.1 c 0.6 0.0 3.0 0.3 0.1
  Vomitingi 1.9 0.4 0.3 1.4 0.5 0.3
  Rashj 1.6 - - 1.4 - -
  Seizurej 0.0 - - 0.0 - -
a N = The number of subjects with available data.
b Grade 2: interferes with or limits usual arm movement, Grade 3: disabling, unable to move arm.
c Denotes p < 0.05 level of significance. The p-values were calculated for each category and severity using Chi Square test.
d Grade 2: 1.0-2.0 inches, Grade 3: > 2.0 inches.
e Grade 2: interferes with normal activities, Grade 3: requiring bed rest.
f Grade 2: 3-4 episodes, Grade 3: ≥ 5 episodes.
g Grade 2: skipped 2 meals, Grade 3: skipped ≥ 3 meals.
h Oral equivalent temperature; Grade 2: 38.5°C to 39.4°C, Grade 3: ≥ 39.5°C.
i Grade 2: 2 episodes, Grade 3: ≥ 3 episodes.
j These solicited adverse events were reported as present or absent only.
Note: During the study Grade 1, Grade 2, and Grade 3 were collected as Mild, Moderate, and Severe respectively.

 

Table 4: Percentage of Participants 18 Years Through 55 Years of Age Reporting Solicited Adverse Reactions Within 7 Days Following Vaccine Administration

REACTION MENACTRA VACCINE 
NA=1371
MENOMUNE - A/C/Y/W-135 VACCINE 
NA=1159
ANY GRADE 2 GRADE 3 ANY GRADE 2 GRADE 3
Local/Injection Site
Painb 53.9c 11.3c 0.2 48.1 3.3 0.1
Indurationd 17.1c 3.4c 0.7c 11.0 1.0 0.0
Rednessd 14.4 2.9 1.1c 16.0 1.9 0.1
Swellingd 12.6c 2.3c 0.9c 7.6 0.7 0.0
Systemic
Headachee 41.4 10.1 1.2 41.8 8.9 0.9
Fatiguee 34.7 8.3 0.9 32.3 6.6 0.4
Malaise e 23.6 6.6c 1.1 22.3 4.7 0.9
Arthralgiae 19.8c 4.7c 0.3 16.0 2.6 0.1
Diarrheaf 16.0 2.6 0.4 14.0 2.9 0.3
Anorexiag 11.8 2.3 0.4 9.9 1.6 0.4
Chillse 9.7c 2.1c 0.6c 5.6 1.0 0.0
Vomitingh 2.3 0.4 0.2 1.5 0.2 0.4
Feveri 1.5c 0.3 0.0 0.5 0.1 0.0
Rashj 1.4 - - 0.8 - -
Seizurej 0.0 - - 0.0 - -
a N = The number of subjects with available data.
b Grade 2: interferes with or limits usual arm movement, Grade 3: disabling, unable to move arm.
c Denotesp < 0.05 level of significance. The p-values were calculated for each category and severity using Chi Square test.
d Grade 2: 1.0-2.0 inches, Grade 3: > 2.0 inches.
e Grade 2: interferes with normal activities, Grade 3: requiring bed rest.
f Grade 2: 3-4 episodes, Grade 3: ≥ 5 episodes.
g Grade 2: skipped 2 meals, Grade 3: skipped ≥ 3 meals.
h Grade 2: 2 episodes, Grade 3: ≥ 3 episodes.
i Oral equivalent temperature; Grade 2: 39.0°C to 39.9°C, Grade 3: ≥ 40.0°C.
j These solicited adverse events were reported as present or absent only.
Note: During the study Grade 1, Grade 2, and Grade 3 were collected as Mild, Moderate, and Severe respectively.

 

Adverse Events in Concomitant Vaccine Studies

Solicited Injection site and Systemic Reactions when Given with Routine Pediatric Vaccines

For a description of the study design and number of participants [seeClinical Studies, Concomitant Vaccine Administration]. In the primary safety study, 1378 US children were enrolled to receive Menactra vaccine alone at 9 months of age and Menactra vaccine plus one or more other routinely administered vaccines (MMRV, PCV7 and HepA) at 12 months of age (N=961). Another group of children received two or more routinely administered vaccines (MMRV, PCV7 and HepA vaccines) (control group, n=321) at 12 months of age. The frequency of occurrence of solicited adverse events is presented in Table 1. Participants who received Menactra vaccine and the concomitant vaccines at 12 months of age described above reported similar frequencies of tenderness, redness and swelling at the Menactra vaccine injection site and at the concomitant vaccine injection sites. Tenderness was the most frequent injection site reaction (48%, 39%, 46% and 43% at the Menactra vaccine, MMRV, PCV7 and HepA vaccine sites, respectively). Irritability was the most frequent systemic reaction, reported in 62% of recipients of Menactra vaccine plus concomitant vaccines, and 65% of control group. [See Concomitant Vaccine Administration].

Solicited Injection site and Systemic Reactions when Given with Tetanus and Diphtheria Toxoid Adsorbed Vaccine

In a clinical study, rates of local and systemic reactions after Menactra vaccine and Tetanus and Diphtheria Toxoid Adsorbed (Td) vaccine manufactured by Sanofi Pasteur Inc. were compared [see DRUG INTERACTIONS, and Concomitant Vaccine Administration for study description]. Injection site pain was reported more frequently after Td vaccination than after Menactra vaccination (71% versus 53%). The overall rate of systemic adverse events was higher when Menactra and Td vaccines were given concomitantly than when Menactra vaccine was administered 28 days after Td (59% versus 36%). In both groups, the most common reactions were headache (Menactra vaccine + Td, 36%; Td + Placebo, 34%; Menactra vaccine alone, 22%) and fatigue (Menactra vaccine + Td, 32%; Td + Placebo, 29%; Menactra vaccine alone, 17%). Fever ≥ 40.0°C occurred at ≤ 0.5% in all groups.

Solicited Injection site and Systemic Reactions when Given with Typhoid Vi Polysaccharide Vaccine

In a clinical study, rates of local and systemic reactions after Menactra vaccine and Typhoid Vi Polysaccharide Vaccine, produced by Sanofi Pasteur SA were compared [see DRUG INTERACTIONS, Concomitant Vaccine Administration] for a description of the concomitantly administered vaccine, study design and number of participants. More participants experienced pain after Typhoid vaccination than after Menactra vaccination (Typhoid + Placebo, 76% versus Menactra vaccine + Typhoid, 47%). The majority (70%-77%) of injection site solicited reactions for both groups at either injection site were reported as Grade 1 and resolved within 3 days postvaccination. In both groups, the most common systemic reaction was headache (Menactra vaccine + Typhoid, 41%; Typhoid + Placebo, 42%; Menactra vaccine alone, 33%) and fatigue (Menactra vaccine + Typhoid, 38%; Typhoid + Placebo, 35%; Menactra vaccine alone, 27%). Fever > 40.0°C and seizures were not reported in either group.

Post-Marketing Experience

In addition to reports in clinical trials, worldwide voluntary adverse events reports received since market introduction of Menactra vaccine are listed below. This list includes serious events and/or events which were included based on severity, frequency of reporting or a plausible causal connection to Menactra vaccine. Because these events were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to vaccination.

  • Immune System Disorders
    Hypersensitivity reactions such as anaphylaxis/anaphylactic reaction,wheezing, difficulty breathing, upper airway swelling, urticaria,erythema, pruritus, hypotension
  • Nervous System Disorders
    Guillain-Barre syndrome, paraesthesia, vasovagal syncope, dizziness,convulsion, facial palsy, acute disseminated encephalomyelitis,transverse myelitis
  • Musculoskeletal and Connective Tissue Disorders
    Myalgia
Post-marketing Safety Study

The risk of GBS following receipt of Menactra vaccine was evaluated in a USretrospective cohort study using healthcare claims data from 9,578,688 individuals 11 through 18 years of age, of whom 1,431,906 (15%) received Menactra vaccine. Of 72 medical chart-confirmed GBS cases, none had received Menactra vaccine within 42 days prior to symptom onset. An additional 129 potential cases of GBS could not be confirmed or excluded due to absent or insufficient medical chart information. In an analysis that took into account the missing data, estimates of the attributable risk of GBS ranged from 0 to 5 additional cases of GBS per 1,000,000 vaccinees within the 6 week period following vaccination.

Read the Menactra (polysaccharide diphtheria toxoid conjugate vaccine) Side Effects Center for a complete guide to possible side effects

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Interactions

Concomitant Administration with Other Vaccines

Menactra vaccine was concomitantly administered with Typhim Vi® [Typhoid Vi Polysaccharide Vaccine] (Typhoid) and Tetanus and Diphtheria Toxoids Adsorbed, For Adult Use (Td), in individuals 18 through 55 and 11 through 17 years of age, respectively. In children younger than 2 years of age, Menactra was co-administered with one or more of the following vaccines: PCV7, MMR, V, MMRV, or HepA vaccine [see Clinical Studies andADVERSE REACTIONS].

Data are not available to assess the safety and immunogenicity of Menactra and DTaP containing vaccines when administered concomitantly at 15 months of age.

Pneumococcal antibody responses to some serotypes in PCV7 were decreased following coadministration of Menactra vaccine and PCV7 [seeConcomitant Vaccine Administration].

Do not mix Menactra vaccine with other vaccines in the same syringe. When Menactra vaccine is administered concomitantly with other injectable vaccines, the vaccines should be administered with different syringes and given at separate injection sites.

Immunosuppressive Therapies

Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater thanphysiologic doses) may reduce the immune response to vaccines.

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

Warnings

Included as part of the PRECAUTIONS section.

Precautions

Guillain-Barre Syndrome

Persons previously diagnosed with Guillain-Barre syndrome (kGBS) may be at increased risk of GBS following receipt of Menactra vaccine. The decision to give Menactra vaccine should take into account the potential benefits and risks.

GBS has been reported in temporal relationship following administration of Menactra vaccine.1,2 The risk of GBS following Menactra vaccination was evaluated in a post-marketing retrospective cohort study [Post-Marketing Experience].

Preventing And Managing Allergic Vaccine Reactions

Prior to administration, the healthcare provider should review theimmunization history for possible vaccine sensitivity and previous vaccination-related adverse reactions to allow an assessment of benefits and risks. Epinephrine and other appropriate agents used for the control of immediate allergic reactions must be immediately available should an acute anaphylactic reaction occur.

Altered Immunocompetence

Immunocompromised persons, including individuals receivingimmunosuppressant therapy, may have a diminished immune response to Menactra vaccine.

Limitations Of Vaccine Effectiveness

Menactra vaccine may not protect all recipients.

Use In Specific Populations

Pregnancy

Category C

Animal reproduction studies have not been conducted with Menactra vaccine. It is also not known whether Menactra vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. There are no adequate and well controlled studies in pregnant women. Menactra vaccine should only be given to a pregnant woman if clearly needed. Assessment of the effects on animal reproduction has not been fully conducted with Menactra vaccine as effects on male fertility in animals has not been evaluated. The effect of Menactra vaccine on embryo-fetal and pre-weaning development was evaluated in one developmental toxicity study in mice. Animals were administered Menactra vaccine on Day 14 prior to gestation and during the period of organogenesis (gestation Day 6). The total dose given per time point was 0.1 mL/mouse via intramuscular injection (900 times the human dose, adjusted by body weight). There were no adverse effects on pregnancy, parturition, lactation or pre-weaning development noted in this study. Skeletal examinations revealed one fetus (1 of 234 examined) in the vaccine group with a cleft palate. None were observed in the concurrent control group (0 of 174 examined). There are no data that suggest that this isolated finding is vaccine related, and there were no vaccine related fetal malformations or other evidence of teratogenesis observed in this study.

Healthcare providers are encouraged to register women who receive Menactra vaccine during pregnancy in Sanofi Pasteur Inc.'s vaccination pregnancy registry by calling 1-800-822-2463.

Nursing Mothers

It is not known whether Menactra vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Menactra vaccine is administered to a nursing woman.

Pediatric Use

Menactra vaccine is not approved for use in infants under 9 months of age. Available data show that infants administered three doses of Menactra vaccine (at 2, 4, and 6 months of age) had diminished responses to eachmeningococcal vaccine serogroup compared to older children given two doses at 9 and 12 months of age.

Geriatric Use

Safety and effectiveness of Menactra vaccine in adults older than 55 years of age have not been established.

REFERENCES

1 CDC. Guillain-Barre Syndrome Among Recipients of Menactra® Meningococcal Conjugate Vaccine - United States, June 2005 - September 2006. MMWR 2006;55(41);1120-1124.

2 Harvard Medical School/Harvard Pilgrim Health Care Institute. Risk of Guillain-Barre Syndrome Following Meningococcal Conjugate (MCV4) Vaccination. Final Study Report, Revised March 11, 2010.

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

OverDose

No information provided.

ContrainDications

Severe allergic reaction (eg, anaphylaxis) after a previous dose of a meningococcal capsular polysaccharide-, diphtheria toxoid- or CRM197-containing vaccine, or to any component of Menactra vaccine [seeDESCRIPTION].

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

Clinical Pharamacology

Mechanism Of Action

The presence of bactericidal anti-capsular meningococcal antibodies has been associated with protection from invasive meningococcal disease.6,7Menactra vaccine induces the production of bactericidal antibodies specific to the capsular polysaccharides of serogroups A, C, Y and W-135.

Non-Clinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Menactra vaccine has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

Clinical Studies

Efficacy

The Serum Bactericidal Assay (SBA) used to test sera contained anexogenous complement source that was either human (SBA-H) or baby rabbit (SBA-BR).8

The response to vaccination following two doses of vaccine administered to children 9 and 12 months of age and following one dose of vaccine administered to children 2 through 10 years of age was evaluated by the proportion of subjects having an SBA-H antibody titer of 1:8 or greater, for each serogroup. In individuals 11 through 55 years of age, the response to vaccination with a single dose of vaccine was evaluated by the proportion of subjects with a 4-fold or greater increase in bactericidal antibody to each serogroup as measured by SBA-BR. For individuals 2 through 55 years of age, vaccine efficacy was inferred from the demonstration of immunologic equivalence to a US-licensed meningococcal polysaccharide vaccine, Menomune - A/C/Y/W-135 vaccine as assessed by Serum Bactericidal Assay (SBA).

Immunogenicity

Children 9 through 12 Months of Age

In a randomized, US, multi-center trial, children received Menactra vaccine at 9 months and 12 months of age. The first Menactra dose was administered alone, followed by a second Menactra vaccine dose given alone (N=404), or with MMRV vaccine (N=302), or with PCV7 (N=422). For all participants, sera were obtained approximately 30 days after last vaccination. There were no substantive differences in demographic characteristics between the vaccine groups. The median age range for administration of the first dose of Menactra was 278-279 days of age.

Table 5: Bactericidal Antibody Responsesa 30 Days Following a Second Dose of Menactra Vaccine Administered Alone or Concomitantly Administered with MMRV or PCV7 Vaccines at 12 Months of Age

View Enlarged Table

 

Administration of Menactra to children at 12 months and 15 months of age was evaluated in a US study. Prior to the first dose, 33.3% [n=16/48] of participants had an hSBA titer ≥ 1:8 to Serogroup A, and 0-2% [n=0-1 of 50-51] to Serogroups C, Y and W-135. After the second dose, percentages of participants with an hSBA titer ≥ 1:8 were: 85.2%, Serogroup A [n=46/54]; 100.0%, Serogroup C [n=54/54]; 96.3%, Serogroup Y [n=52/54]; 96.2%, Serogroup W-135 [n=50/52].

Individuals 2 through 55 Years of Age

Immunogenicity was evaluated in three comparative, randomized, US, multi-center, active controlled clinical trials that enrolled children (2 through 10 years of age), adolescents (11 through 18 years of age), and adults (18 through 55 years of age). Participants received a single dose of Menactra vaccine (N=2526) or Menomune - A/C/Y/W-135 vaccine (N=2317). For all age groups studied, sera were obtained before and approximately 28 days after vaccination. [Blinding procedures for safety assessments are described in Adverse Reactions (6).]

In each of the trials, there were no substantive differences in demographic characteristics between the vaccine groups, between immunogenicity subsets or the overall study population. In the study of children 2 through 10 years of age, the median age of participants was 3 years; 95% completed the study. In the adolescent trial, the median age for both groups was 14 years; 99% completed the study. In the adult trial, the median age for both groups was 24 years; 94% completed the study.

Immunogenicity in Children 2 through 10 Years of Age

Of 1408 enrolled children 2 through 10 years of age, immune responses evaluated in a subset of Menactra vaccine participants (2 through 3 years of age, n=52; 4-10 years of age, n=84) and Menomune - A/C/Y/W-135 vaccine participants (2 through 3 years of age, n=53; 4-10 years of age, n=84) were comparable for all four serogroups (Table 6).

Table 6: Comparison of Bactericidal Antibody Responsesa to Menactra Vaccine and Menomune - A/C/Y/W-135 Vaccine 28 Days after Vaccination for a Subset of Participants 2 through 3 Years of Age and 4 through 10 Years of Age

View Enlarged Table

 

In the subset of participants 2 through 3 years of age with undetectable pre-vaccination titers (ie, < 1:4 at Day 0), seroconversion rates (defined as ≥ 1:8 at Day 28) were similar between the Menactra vaccine and Menomune - A/C/Y/W-135 vaccine recipients. Menactra vaccine participants achieved seroconversion rates of: 57%, Serogroup A (n=12/21); 62%, Serogroup C (n=29/47); 84%, Serogroup Y (n=26/31); 53%, Serogroup W-135 (n=20/38). The seroconversion rates for Menomune - A/C/Y/W-135 vaccine recipients were: 55%, Serogroup A (n=16/29); 30%, Serogroup C (n=13/43); 57%, Serogroup Y (n=17/30); 26%, Serogroup W-135 (n=11/43).

In the subset of participants 4 through 10 years of age with undetectable pre-vaccination titers (ie, < 1:4 at Day 0), seroconversion rates (defined as ≥ 1:8 at Day 28) were similar between the Menactra vaccine and Menomune - A/C/Y/W-135 vaccine recipients. Menactra vaccine participants achieved seroconversion rates of: 69%, Serogroup A (n=11/16); 81%, Serogroup C (n=50/62); 98%, Serogroup Y (n=45/46); 69%, Serogroup W-135 (n=27/39). The seroconversion rates for Menomune - A/C/Y/W-135 vaccine recipients were: 48%, Serogroup A (n=10/21); 38%, Serogroup C (n=19/50); 84%, Serogroup Y (n=38/45); 68%, Serogroup W-135 (n=26/38).

Immunogenicity in Adolescents 11 through 18 Years of Age

Results from the comparative clinical trial conducted in 881 adolescents aged 11 through 18 years showed that the immune responses to Menactra vaccine and Menomune - A/C/Y/W-135 vaccine were similar for all four serogroups (Table 7).

In participants with undetectable pre-vaccination titers (ie, less than 1:8 at Day 0), seroconversion rates (defined as a ≥ 4-fold rise in Day 28 SBA-BR titers) were similar between the Menactra vaccine and Menomune - A/C/Y/W-135 vaccine recipients. Menactra vaccine participants achieved seroconversion rates of: 100%, Serogroup A (n=81/81); 99%, Serogroup C (n=153/155); 98%, Serogroup Y (n=60/61); 99%, Serogroup W-135 (n=161/164). The seroconversion rates for Menomune - A/C/Y/W-135 vaccine recipients were: 100%, Serogroup A (n=93/93); 99%, Serogroup C (n=151/152); 100%, Serogroup Y (n=47/47); 99%, Serogroup W-135 (n=138/139).

Immunogenicity in Adults 18 through 55 Years of Age

Results from the comparative clinical trial conducted in 2554 adults aged 18 through 55 years showed that the immune responses to Menactra vaccine and Menomune - A/C/Y/W-135 vaccine were similar for all four serogroups (Table 7).

Table 7: Comparison of Bactericidal Antibody Responsesa to Menactra Vaccine and Menomune - A/C/Y/W-135 Vaccine 28 Days after Vaccination for Participants 11 through 18 Years of Age and 18 through 55 Years of Age

View Enlarged Table

 

In participants with undetectable pre-vaccination titers (ie, less than 1:8 at Day 0), seroconversion rates (defined as a ≥ 4-fold rise in Day 28 SBA-BR titers) were similar between the Menactra vaccine and Menomune - A/C/Y/W-135 vaccine recipients. Menactra vaccine participants achieved seroconversion rates of: 100%, Serogroup A (n=156/156); 99%, Serogroup C (n=343/345); 91%, Serogroup Y (n=253/279); 97%, Serogroup W-135 (n=360/373). The seroconversion rates for Menomune - A/C/Y/W-135 vaccine recipients were: 99%, Serogroup A (n=143/144); 98%, Serogroup C (n=297/304); 97%, Serogroup Y (n=221/228); 99%, Serogroup W-135 (n=325/328).

Concomitant Vaccine Administration

MMR V (or MMR + V) or PCV7

In a US, active-controlled trial, 1179 children received Menactra vaccine at 9 months and 12 months of age. At 12 months of age these children received Menactra concomitantly with MMRV (N=616), or MMR + V (N=48), or PCV7 (N=250). Another group of 12-month old children received MMRV + PCV7 (N=485). Sera were obtained approximately 30 days after the last vaccinations. Measles, mumps, rubella and varicella antibody responses among children who received Menactra vaccine and MMRV (or MMR and V) were comparable to corresponding antibody responses among children who received MMRV and PCV7.

When Menactra was given concomitantly with PCV7, the non-inferiority criteria for comparisons of pneumococcal IgG GMCs (upper limit of the two-sided 95% CI of the GMC ratio ≤ 2) were not met for 3 of 7 serotypes (4, 6B, 18C). In a subset of subjects with available sera, pneumococcal opsonophagocytic assay GMT data were consistent with IgG GMC data.

Td

In a double-blind, randomized, controlled trial, 1021 participants aged 11 through 17 years received Td and Menactra vaccines concomitantly (N=509), or Td followed one month later by Menactra vaccine (N=512). Sera were obtained approximately 28 days after each respective vaccination. The proportion of participants with a 4-fold or greater increase in SBA-BR titer to meningococcal Serogroups C, Y and W-135 was higher when Menactra vaccine was given concomitantly with Td (86-96%) than when Menactra vaccine was given one month following Td (65-91%). Anti-tetanus and anti-diphtheria antibody responses were similar in both study groups.

Typhim Vi

In a double-blind, randomized, controlled trial, 945 participants aged 18 through 55 years received Typhim Vi and Menactra vaccines concomitantly (N=469), or Typhim Vi vaccine followed one month later by Menactra vaccine (N=476). Sera were obtained approximately 28 days after each respective vaccination. The antibody responses to Menactra vaccine and to Typhim Vi vaccine components were similar in both study groups.

REFERENCES

6 Makela PH, et al. Evolution of conjugate vaccines. Expert Rev Vaccines 2002;1(3):399- 410.

7 Goldschneider I, et al. Human immunity to the meningococcus. I. The Role of Humoral Antibodies. J Exp Med 1969;129:1307-1326.

8 Maslanka SE, et al. Standardization and a Multilaboratory Comparison of Neisseria meningitidis Serogroup A and C Serum Bactericidal Assays. Clin and Diag Lab Immunol 1997;156-167.

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

Patient Information

Vaccine Information Statements are required by the National Childhood Vaccine Injury Act of 1986 to be given prior to immunization to the patient, parent, or guardian. These materials are available free of charge at theCenters for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines.)

Inform the patients, parents or guardians about:

  • Potential benefits and risks of immunization with Menactra vaccine.
  • Potential for adverse reactions that have been temporally associated with administration of Menactra vaccine or other vaccines containing similar components.
  • Reporting any adverse reactions to their healthcare provider.
  • The Sanofi Pasteur Inc. pregnancy registry, as appropriate.

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

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

MENINGOCOCCAL CONJUGATE VACCINE - INJECTION

 

(men-in-JOE-coe-call)

 

COMMON BRAND NAME(S): Menactra, Menveo

 

USES: This vaccine is used to help prevent serious, sometimes fatal, infections (meningitis, meningococcemia) caused by a certain bacteria (Neisseria meningitidis). These infections are very serious and may cause severe problems (hearing loss, brain/nerve problems, paralysis, blindness, seizures, loss of limbs) even with proper antibiotic treatment. Therefore, preventing these infections through vaccination is very important.

This vaccine contains parts from the bacteria (Neisseria meningitidis). It works by causing the body to produce its own protection (antibodies) against the bacteria.

 

HOW TO USE: Read the Vaccine Information Statement available from your health care provider before receiving the vaccine. If you have any questions, consult your health care provider.

This vaccine is given by injection into the muscle by a health care professional. Depending on your age, the vaccine is given either as a single dose or in 2 doses.

Consumer Overview Side Effect

SIDE EFFECTS: Pain/redness/swelling at the injection site, headache, drowsiness, tiredness, joint/muscle pain, nausea, loss of appetite, chills, fever, and diarrhea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Infrequently, temporary symptoms such as fainting/dizziness/lightheadedness, vision changes, numbness/tingling, or seizure-like movements have happened after vaccine injections. Tell your health care provider right away if you have any of these symptoms soon after receiving an injection. Sitting or lying down may relieve symptoms.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but serious side effects occur: numbness/tingling of arms/legs, muscle weakness.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US, you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may report side effects to Health Canada at 1-866-234-2345.

 

Read the Menactra (polysaccharide diphtheria toxoid conjugate vaccine) Side Effects Center for a complete guide to possible side effects

Learn More »
 

PRECAUTIONS: Before receiving this vaccine, tell your doctor or pharmacist if you are allergic to it; or to latex; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before receiving this vaccination, tell your doctor or pharmacist your medical history, especially of: current fever/illness, a certain nerve disease (Guillain-Barre syndrome), bleeding disorders (such as hemophilia, thrombocytopenia).

During pregnancy, this vaccine should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: "blood thinners" (such as warfarin), chemotherapy, corticosteroids (such as prednisone, dexamethasone), drugs that weaken the immune system (such as cyclosporine, efalizumab, tacrolimus).

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: As with any vaccine, this vaccine may not fully protect everyone who receives it.

Keep vaccine records for yourself and all of your children, and after your children are grown provide their records to them and their doctors. This will prevent unnecessary re-vaccinations.

 

MISSED DOSE: It is important that you or your child receive each vaccination as scheduled. Be sure to ask when each dose should be received, and make a note on a calendar to help you remember.

 

STORAGE: Not applicable. This vaccine is given in a doctor's office and will not be stored at home.

 

Information last revised September 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Menactra, Menveo

Generic Name: meningococcal conjugate vaccine (Pronunciation: me NIN je KOK al KON je gate vax EEN)

  • What is meningococcal conjugate vaccine (Menactra)?
  • What are the possible side effects of meningococcal conjugate vaccine (Menactra)?
  • What is the most important information I should know about meningococcal conjugate vaccine (Menactra)?
  • What should I discuss with my healthcare provider before receiving meningococcal conjugate vaccine (Menactra)?
  • How is meningococcal conjugate vaccine given (Menactra)?
  • What happens if I miss a dose (Menactra)?
  • What happens if I overdose (Menactra)?
  • What should I avoid before or after getting meningococcal conjugate vaccine (Menactra)?
  • What other drugs will affect meningococcal conjugate vaccine (Menactra)?
  • Where can I get more information?

What is meningococcal conjugate vaccine (Menactra)?

 

Meningococcal disease is a serious infection caused by a bacteria. Meningococcal bacteria can infect the blood, spinal cord, and brain. These conditions can be fatal.

Meningococcal disease can spread from one person to another through small droplets of saliva that are expelled into the air when an infected person coughs or sneezes. The bacteria can also be passed through contact with objects the infected person has touched, such as a door handle, or other surface. The bacteria can also be passed through kissing, or sharing a drinking glass or eating utensil with an infected person.

Meningococcal conjugate vaccine is used to prevent infection caused by meningococcal bacteria. The vaccine contains four of the most common types of meningococcal bacteria.

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

Meningococcal conjugate vaccine is for use in children and adults between the ages of 9 months and 55 years old.

Like any vaccine, meningococcal conjugate vaccine may not provide protection from disease in every person.

Becoming infected with meningitis (infection of the spinal cord and lining of the brain) is much more dangerous to your health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

What are the possible side effects of meningococcal conjugate vaccine (Menactra)?

 

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

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

You may feel faint after receiving this vaccine. Some people have had seizure-like reactions after receiving this vaccine. Your doctor may want you to remain under observation during the first 15 minutes after the injection.

Call your doctor at once if you have a serious side effect such as:

  • severe weakness or unusual feeling in your arms and legs (may occur 2 to 4 weeks after you receive the vaccine);
  • high fever; or
  • unusual bleeding.

Less serious side effects may include:

  • low fever;
  • redness, pain, swelling, or a lump where the vaccine was injected;
  • headache, tired feeling;
  • joint or muscle pain;
  • diarrhea;
  • nausea, vomiting, loss of appetite; or
  • fussiness, irritability, crying for an hour or longer.

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 Menactra (polysaccharide diphtheria toxoid conjugate vaccine) Side Effects Center for a complete guide to possible side effects

Learn More »
 

What is the most important information I should know about meningococcal conjugate vaccine (Menactra)?

 

You should not receive this vaccine if you have ever had an allergic reaction to a meningococcal or a diphtheria vaccine, if you are allergic to latex, or if you have a history of Guillain-Barre syndrome.

Before receiving meningococcal conjugate vaccine, tell your doctor if you have a bleeding or blood clotting disorder, a weak immune system, or if you are receiving steroids, chemotherapy, or radiation treatment. If you have any of these conditions, your vaccine may need to be postponed or not given at all.

You may feel faint after receiving this vaccine. Some people have had seizure-like reactions after receiving this vaccine. Your doctor may want you to remain under observation during the first 15 minutes after the injection.

Keep track of any and all side effects you have after receiving this vaccine. If you ever need to receive a booster dose, you will need to tell your doctor if the previous shot caused any side effects.

You can still receive a vaccine if you have a minor cold. In the case of a more severe illness with a fever or any type of infection, wait until you recover before receiving this vaccine.

Becoming infected with meningitis (infection of the spinal cord and lining of the brain) is much more dangerous to your health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

Like any vaccine, meningococcal conjugate vaccine may not provide protection from disease in every person.

Side Effects Centers
  • Menactra

Patient Detailed How Take

What should I discuss with my healthcare provider before receiving meningococcal conjugate vaccine (Menactra)?

 

You should not receive this vaccine if you have ever had an allergic reaction to a meningococcal or a diphtheria vaccine, if you are allergic to latex, or if you have a history of Guillain-Barre syndrome.

To make sure you can safely receive this vaccine, tell your doctor if you have any of these other conditions:

  • a bleeding or blood clotting disorder, such as hemophilia;
  • any condition that weakens the immune system (such as HIV, AIDS, or cancer); or
  • if you are receiving steroids, chemotherapy, or radiation treatments.

If you have any of these conditions,you may not be able to receive meningococcal conjugate vaccine, or you may need to wait until your condition changes or you have completed your treatments.

FDA pregnancy category C. It is not known whether meningococcal conjugate vaccine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant soon after receiving this vaccine.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of meningococcal conjugate vaccine on the baby.

It is not known whether this vaccine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

The Menactra brand of this vaccine should not be given to anyone younger than 9 months or older than 55 years of age. The Menveo brand should not be given to anyone younger than 2 years or older than 55 years of age.

How is meningococcal conjugate vaccine given (Menactra)?

 

This vaccine is injected into a muscle. You will receive this injection in a doctor's office or clinic setting.

Meningococcal conjugate vaccine is recommended in the following situations:

  • for all children 9 months to 18 years old;
  • for people who are in the military;
  • for laboratory workers who are routinely exposed to meningococcal bacteria;
  • for people who live in dormitories or other group housing; and
  • for people who travel or live among certain populations where meningococcal outbreak is common.

This vaccine is usually given as a one-time injection to adults and children who are at least 2 years old. Unless your doctor's tells you otherwise, you will not need a booster vaccine.

In children younger than 2 years old, meningococcal conjugate vaccine is given in two doses. The first shot is usually given when the child is 9 months old. The booster shot is then given 3 months later.

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

You can still receive a vaccine if you have a minor cold. In the case of a more severe illness with a fever or any type of infection, wait until you recover before receiving this vaccine.

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.

Side Effects Centers
  • Menactra

Patient Detailed Avoid Taking

What happens if I miss a dose (Menactra)?

 

Contact your doctor if you 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.

What happens if I overdose (Menactra)?

 

An overdose of this vaccine is not likely to occur.

What should I avoid before or after getting meningococcal conjugate vaccine (Menactra)?

 

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What other drugs will affect meningococcal conjugate vaccine (Menactra)?

 

Before receiving this vaccine, tell your doctor about all other vaccines you have recently received.

Also tell the doctor if you are using a blood thinner (warfarin, Coumadin, Jantoven), or if you have recently received drugs or treatments 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), 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).

This list is not complete and other drugs may interact with meningococcal conjugate vaccine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

 

Your doctor or pharmacist can provide more information about this vaccine. Additional information is available 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.

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