Drugs Details

Drugs Info of Havrix, Vaqta
Drugs Details
  • Drugs Type  : FDA
  • Date : 31st Jan 2015 05:01 am
  • Brand Name : Havrix, Vaqta
  • Generic Name :  hepatitis A adult vaccine (Pronunciation: HEP a TYE tis)
Descriptions

VAQTA is an inactivated whole virus vaccine derived from hepatitis A virus grown in cell culture in human MRC-5 diploid fibroblasts. It contains inactivated virus of a strain which was originally derived by further serial passage of a proven attenuated strain. The virus is grown, harvested, purified by a combination of physical and high performance liquid chromatographic techniques developed at the Merck Research Laboratories, formalin inactivated, and then adsorbed onto amorphous aluminum hydroxyphosphate sulfate.

VAQTA is a sterile suspension for intramuscular injection. One milliliter of the vaccine contains approximately 50U of hepatitis A virus antigen, which is purified and formulated without a preservative. Within the limits of current assay variability, the 50U dose of VAQTA contains less than 0.1 mcg of nonviral protein, less than 4 x 10–6 mcg of DNA, less than 10–4 mcg of bovine albumin, and less than 0.8 mcg of formaldehyde. Other process chemical residuals are less than 10 parts per billion (ppb), including neomycin.

Each 0.5-mL pediatric dose contains 25U of hepatitis A virus antigen and adsorbed onto approximately 0.225 mg of aluminum provided as amorphous aluminum hydroxyphosphate sulfate, and 35 mcg of sodium borate as a pH stabilizer, in 0.9% sodium chloride.

Each 1-mL adult dose contains 50U of hepatitis A virus antigen and adsorbed onto approximately 0.45 mg of aluminum provided as amorphous aluminum hydroxyphosphate sulfate, and 70 mcg of sodium borate as a pH stabilizer, in 0.9% sodium chloride.

What are the possible side effects of hepatitis A vaccine (Havrix, Vaqta)?

You should not receive a booster vaccine if you have ever had a life-threatening allergic reaction after the first shot.

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

Becoming infected with hepatitis A is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Call your doctor at...

Read All Potential Side Effects and See Pictures of Vaqta »

What are the precautions when taking hepatitis a vaccine, inactivated (Vaqta)?

Before getting hepatitis A vaccine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as neomycin, formalin, latex in some vials/prefilled syringes), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems (such as hemophilia, low platelets, anticoagulant treatment), current illness with fever.

If you have decreased immune function from other medications (see also Drug Interactions) or other illness (such as HIV, leukemia, lymphoma, other cancer), your body may not make enough antibodies to protect you from hepatitis A...

Read All Potential Precautions of Vaqta »


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

Indications

Indications And Use

VAQTA® [Hepatitis A Vaccine, Inactivated] is indicated for the prevention of disease caused by hepatitis A virus (HAV) in persons 12 months of age and older. The primary dose should be given at least 2 weeks prior to expected exposure to HAV.

Dosage Administration

FOR INTRAMUSCULAR ADMINISTRATION ONLY.

Dosage And Schedule

Children/Adolescents (12 months through 18 years of age)

The vaccination schedule consists of a primary 0.5-mL dose administered intramuscularly, and a 0.5-mL booster dose administered intramuscularly 6 to 18 months later.

Adults (19 years of age and older)

The vaccination schedule consists of a primary 1-mL dose administered intramuscularly, and a 1-mL booster dose administered intramuscularly 6 to 18 months later.

Booster Immunization Following Another Manufacturer's Hepatitis A Vaccine

A booster dose of VAQTA may be given at 6 to 12 months following a primary dose of HAVRIX [see Clinical Studies].

Preparation And Administration

Shake the single-dose vial or single-dose prefilled syringe well to obtain a slightly opaque, white suspension before withdrawal and use. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard if the suspension does not appear homogenous or if extraneous particulate matter remains or discoloration is observed.

For single-dose vials, withdraw and administer entire dose of VAQTA intramuscularly using a sterile needle and syringe.

For single-dose prefilled syringes, securely attach a needle by twisting in a clockwise direction and administer dose of VAQTA intramuscularly.

For adults, adolescents, and children older than 2 years of age, the deltoid muscle is the preferred site for intramuscular injection. For children 12 through 23 months of age, the anterolateral area of the thigh is the preferred site for intramuscular injection.

How Supplied

Dosage Forms And Strengths

Suspension for injection available in four presentations:

  • 0.5-mL pediatric dose in single-dose vials and prefilled syringes
  • 1-mL adult dose in single-dose vials and prefilled syringes

[See DESCRIPTION for listing of vaccine components and Storage and Handling]

Storage And Handling

VAQTA is available in single-dose vials and prefilled Luer-Lok® syringes.

Pediatric/Adolescent Formulations

25U/0.5 mL in single-dose vials and prefilled Luer-Lok® syringes.

NDC 0006-4831-41 – box of ten 0.5-mL single dose vials.
NDC
0006-4095-02 – carton of ten 0.5-mL prefilled single-dose Luer-Lok® syringes with tip caps.
NDC 0006-4095-09 – carton of six 0.5-mL prefilled single-dose Luer-Lok® syringes with tip caps.

Adult Formulations

50U/1-mL in single-dose vials and prefilled Luer-Lok® syringes.

NDC 0006-4841-00 – 1-mL single dose vial.
NDC
0006-4841-41 – box of ten 1-mL single dose vials.
NDC
0006-4096-02 – carton of ten 1-mL prefilled single-dose Luer-Lok® syringes with tip caps.
NDC 0006-4096-09 – carton of six 1-mL prefilled single-dose Luer-Lok® syringes with tip caps.

Store vaccine at 2-8°C (36-46°F).

DO NOT FREEZE since freezing destroys potency.

Manuf. and Dist. by: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA. Revised: Feb 2014


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.

The safety of VAQTA has been evaluated in over 10,000 subjects 1 year to 85 years of age. Subjects were given one or two doses of the vaccine. The second (booster dose) was given 6 months or more after the first dose.

The most common local adverse reactions and systemic adverse events ( ≥ 15%) reported in different clinical trials across different age groups when VAQTA was administered alone or concomitantly were:

  • Children — 12 through 23 months of age: injection-site pain/tenderness (37.0%), injection-site erythema (21.2%), fever (16.4% when administered alone, and 27.0% when administered concomitantly).
  • Children/Adolescents — 2 through 18 years of age: injection-site pain (18.7%)
  • Adults — 19 years of age and older: injection-site pain, tenderness, or soreness (67.0%), injectionsite warmth (18.2%) and headache (16.1%)
Allergic Reactions

Local and/or systemic allergic reactions that occurred in < 1% of over 10,000 children/adolescents or adults in clinical trials regardless of causality included: injection-site pruritus and/or rash; bronchial constriction; asthma; wheezing; edema/swelling; rash; generalized erythema; urticaria; pruritus; eye irritation/itching; dermatitis [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS].

Children — 12 through 23 Months of Age

Across five clinical trials, 4374 children 12 to 23 months of age received one or two 25U doses of VAQTA, including 3885 children who received 2 doses of VAQTA and 1250 children who received VAQTA concomitantly with one or more other vaccines, including Measles, Mumps, and Rubella Virus Vaccine, Live (M-M-R II®), Varicella Vaccine, Live (VARIVAX®), Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine, Adsorbed (Tripedia or INFANRIX), Measles, Mumps, Rubella, and Varicella Vaccine, Live (ProQuad®), Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197, Prevnar), or

Haemophilus B Conjugate Vaccine (Meningococcal Protein Conjugate, PedvaxHIB®). Overall, the race distribution of study subjects was as follows: 64.7% Caucasian; 15.7% Hispanic-American; 12.3% Black; 4.8% other; 1.4% Asian; and 1.1% Native American. The distribution of subjects by gender was 51.8% male and 48.2% female.

In an open-label clinical trial, 653 children 12 to 23 months of age were randomized to receive a first dose of VAQTA with ProQuad and Prevnar concomitantly (N=330) or a first dose of ProQuad and pneumococcal 7-valent conjugate vaccine concomitantly, followed by a first dose of VAQTA 6 weeks later (N=323). Approximately 6 months later, subjects received either the second doses of ProQuad and VAQTA concomitantly or the second doses of ProQuad and VAQTA separately. The race distribution of the study subjects was as follows: 60.3% Caucasian; 21.6% African-American; 9.5% Hispanic-American; 7.2% other; 1.1% Asian; and 0.3% Native American. The distribution of subjects by gender was 50.7% male and 49.3% female.

Table 1 presents rates of solicited local reactions at the VAQTA injection site and rates of elevated temperatures ( ≥ 100.4°F and ≥ 102.2°F) that occurred within 5 days following each dose of VAQTA and elevated temperatures > 98.6°F for a total of 14 days after vaccination; occurrences of these events were recorded daily on diary cards. Table 2 presents rates of unsolicited systemic adverse events that occurred within 14 days at ≥ 5% in any group following each dose of VAQTA.

Table 1: Incidences of Solicited Local Adverse Reactions at the VAQTA Injection Site and Elevated Temperatures Following Each Dose of VAQTA in Healthy Children 12-23 Months of Age Receiving VAQTA Alone or Concomitantly With ProQuad and PREVNAR*

Adverse reaction: Days 1-5 unless noted Dose 1 Dose 2
VAQTA alone VAQTA + ProQuad + Prevnar concomitantly VAQTA alone VAQTA + ProQuad concomitantly
Injection site adverse reactions N=274 N=311 N=251 N=263
  Injection site erythema 11.7% 9.6% 12.7% 9.5%
  Injection site pain/tenderness 15.3% 20.9% 20.3% 17.5%
  Injection site swelling 9.5% 6.8% 7.6% 6.1%
  Temperature > 98.6°F or feverish (Days 1-14) 12.4% 35.7% 10.8% 10.3%
  N=243 N=285 N=221 N=237
  Temperature ≥ 100.4°F 10.3% 16.8% 10% 4.2%
  Temperature ≥ 102.2 °F 2.1% 3.5% 2.3% 2.5%
*Pneumococcal 7-valent Conjugate Vaccine
N=number of subjects for whom data are available.

Table 2: Incidences of Unsolicited Systemic Adverse Events ≥ 5% in Any Group Following Each Dose of VAQTA in Healthy Children 12-23 Months of Age Receiving VAQTA Alone or Concomitantly With ProQuad and PREVNAR*

Adverse Event: Days 1-14 Dose 1 Dose 2  
VAQTA alone VAQTA + ProQuad + PREVNAR concomitantly VAQTA alone VAQTA + ProQuad concomitantly
  N=274 N=311 N=251 N=263
General Disorders and Administration Site Conditions
  Irritability 3.6% 6.1% 2.8% 2.7%
Infections and Infestations
  Upper respiratory tract infection 3.3% 6.1% 4.8% 5.7%
Skin and Subcutaneous Tissue Disorders
  Dermatitis diaper 1.1% 6.1% 2.4% 3.4%
*Pneumococcal 7-valent Conjugate Vaccine

In Stage I of an open, multicenter, randomized study, children 15 months of age were randomized to receive the first dose of VAQTA alone (N=151) or concomitantly with PedvaxHIB and INFANRIX (N=155); another group of children 15 months of age were randomized to receive the first dose of VAQTA alone (N=152) or concomitantly with PedvaxHIB (N=159). All groups received the second dose of VAQTA alone at least 6 months following the first dose. The race distribution of Stage I study subjects was: 63.9% Caucasian; 17.5% Hispanic-American; 14.7% Black; 2.6% other; and 1.3% Asian. The distribution of subjects by gender was 54.0% male and 46.0% female. In Stage II of this study, an additional 654 children 12-17 months of age received the first dose of VAQTA alone followed by the second dose of VAQTA 6 months later. The race distribution of Stage II of the study subjects was: 66.1% Caucasian; 10.6% Hispanic-American; 16.8% Black; 4.7% other; and 1.5% Asian. The distribution of subjects by gender was 51.2% male and 48.8% female.

Table 3 presents rates of solicited local reactions at the VAQTA injection-site and rates of elevated temperatures ( ≥ 100.4°F and ≥ 102.2°F) that occurred within 5 days following each dose of VAQTA and elevated temperatures > 98.6°F for a total of 14 days following each dose of VAQTA. Occurrences of these events were recorded daily on diary cards. Table 4 presents rates of unsolicited systemic adverse events that occurred within 14 days at ≥ 5% following each dose of VAQTA.

Table 3: Incidences of Solicited Local Adverse Reactions at the VAQTA Injection Site and Elevated Temperatures Following Each Dose of VAQTA in Healthy Children 12-23 Months of Age Receiving VAQTA Alone or Concomitantly with PedvaxHIB With or Without INFANRIX (Stage I) and those Receiving VAQTA Alone at Both Doses (Stage II)

Adverse Reaction: Days 1-5 unless noted Stage I Stage II
Dose 1 Dose 2 Dose 1 Dose 2
VAQTA alone VAQTA + PedvaxHIB and Infanrix or VAQTA + PedvaxHIB concomitantly VAQTA alone VAQTA alone VAQTA alone
Injection site adverse reactions N=256 N=302 N=503 N=647 N=599
  Injection site erythema 18.0% 19.9% 21.5% 11.7% 16.2%
  Injection site pain/tenderness 21.9% 36.4% 27.4% 20.1% 22.9%
  Injection site swelling 10.2% 14.2% 10.1% 7.1% 7.0%
  Temperature > 98.6°F or feverish (Days 114) 10.2% 17.2% 10.7% 10.0% 8.2%
  N=234 N=290 N=473 N=631 N=591
  Temperature ≥ 100.4°F 9.0% 16.9% 9.1% 9.4% 8.6%
  Temperature ≥ 102.2 °F 3.8% 3.1% 3.2% 2.9% 2.4%
N= number of subjects for whom data is available

Table 4: Incidences of Unsolicited Systemic Adverse Events ≥ 5% in Any Group Following Each Dose of VAQTA in Healthy Children 12-23 Months of Age Receiving VAQTA Alone or Concomitantly with PedvaxHIB With or Without INFANRIX (Stage and Those Receiving VAQTA Alone at Both Doses (Stage II)

Adverse Event: Days 1-14 Stage I Stage II
Dose 1 Dose 2 Dose 1 Dose 2
VAQTA alone VAQTA +PedvaxHIB and Infanrix or VAQTA + PedvaxHIB concomitantly VAQTA alone VAQTA alone VAQTA alone
  N=256 N=302 N=503 N=647 N=599
Gastrointestinal Disorders
  Diarrhea 3.9% 8.3% 3.8% 4.6% 3.8%
  Teething 3.1% 2.3% 1.4% 5.7% 4.3%
General Disorders and Administration Site Conditions
  Irritability 6.3% 9.6% 4.0% 8.8% 6.5%
Infections and Infestations
  Upper respiratory tract infection 2.3% 3.3% 3.0% 4.9% 5.2%
Respiratory, Thoracic and Mediastinal Disorders
  Rhinorrhea 2.0% 4.0% 3.8% 6.2% 3.8%

Data presented in Tables 1 through 4 on solicited local reactions, and solicited and unsolicited systemic adverse events with incidence ≥ 5% following each dose of VAQTA are representative of other clinical trials of VAQTA in children 12 through 23 months of age. Across the five studies conducted in children 12-23 months of age, ≥ 39.9% of subjects experienced local adverse reactions and ≥ 55.7% of subjects experienced systemic adverse events. The majority of local and systemic adverse events were mild to moderate in intensity.

The following additional unsolicited local adverse reactions and systemic adverse events were observed at a common frequency of ≥ 1% to < 10% in any individual clinical study. This listing includes only the adverse reactions not reported elsewhere in the label. These local adverse reactions and systemic adverse events occurred among recipients of VAQTA alone or VAQTA given concomitantly within 14 days following any dose of VAQTA across four clinical studies.

Eye disorders: Conjunctivitis

Gastrointestinal disorders: Constipation; vomiting

General disorders and administration site conditions: Injection-site bruising; injection-site ecchymosis

Infections and infestations: Otitis media; nasopharyngitis; rhinitis; viral infection; croup; pharyngitis streptococcal; laryngotracheobronchitis; viral exanthema; gastroenteritis viral; roseola

Metabolism and nutrition disorders: Anorexia

Psychiatric disorders: Insomnia; crying

Respiratory, thoracic and mediastinal disorders: Cough; nasal congestion; respiratory congestion

Skin and subcutaneous tissue disorders: Rash vesicular; measles-like/rubella-like rash; varicellalike rash; rash morbilliform

Serious Adverse Events (Children 12 through 23 Months of Age)

Across the five studies conducted in subjects 12-23 months of age, 0.7% (32/4374) of subjects reported a serious adverse event following any dose of VAQTA, and 0.1% (5/4374) of subjects reported a serious adverse event judged to be vaccine related by the study investigator. The serious adverse events were collected over the period defined in each protocol (14, 28, or 42 days). Vaccine-related serious adverse events which occurred following any dose of VAQTA with or without concomitant vaccines included febrile seizure (0.05%), dehydration (0.02%), gastroenteritis (0.02%), and cellulitis (0.02%).

Children/Adolescents — 2 Years through 18 Years of Age

In 11 clinical trials, 2615 healthy children 2 years through 18 years of age received at least one dose of VAQTA. These studies included administration of VAQTA in varying doses and regimens (1377 children received one or more 25U doses). The race distribution of the study subjects who received at least one dose of VAQTA in these studies was as follows: 84.7% Caucasian; 10.6% American Indian; 2.3% African- American; 1.5% Hispanic-American; 0.6% other; 0.2% Oriental. The distribution of subjects by gender was 51.2% male and 48.8% female.

In a double-blind, placebo-controlled efficacy trial (i.e. The Monroe Efficacy Study), 1037 healthy children and adolescents 2 through 16 years of age were randomized to receive a primary dose of 25U of VAQTA and a booster dose of VAQTA 6, 12, or 18 months later, or placebo (alum diluent). All study subjects were Caucasian: 51.5% were male and 48.5% were female. Subjects were followed days 1 to 5 postvaccination for fever and local adverse reactions and days 1 to 14 for systemic adverse events. The most common adverse events/reactions were injection-site reactions, reported by 6.4% of subjects. Table 5 summarizes local adverse reactions and systemic adverse events reported in ≥ 1% of subjects. There were no significant differences in the rates of any adverse events or adverse reactions between vaccine and placebo recipients after Dose 1.

Table 5: Local Adverse Reactions and Systemic Adverse Events ( ≥ 1%) in Healthy Children and Adolescents from the Monroe Efficacy Study

Adverse Event VAQTA (N=519) Placebo (Alum Diluent)*†,‡
(N=518)
Rate (Percent)
Dose 1* Rate (Percent) Booster Rate (Percent)
 
Injection Site§ n=515 n=475 n=510
Pain 6.4% 3.4% 6.3%
Tenderness 4.9% 1.7% 6.1%
Erythema 1.9% 0.8% 1.8%
Swelling 1.7% 1.5% 1.6%
Warmth 1.7% 0.6% 1.6%
Systemic1 n=519 n=475 n=518
Abdominal pain 1.2% 1.1% 1.0%
Pharyngitis 1.2% 0% 0.8%
Headache 0.4% 0.8% 1.0%
N=Number of subjects enrolled/randomized.
Percent=percentage of subjects for whom data are available with adverse event
n=number of subjects for whom adverse events available
* No statistically significant differences between the two groups.
† Second injection of placebo not administered because code for the trial was broken.
‡ Placebo (Alum diluent) = amorphous aluminum hydroxyphosphate sulfate.
§ Adverse Reactions at the injection site (VAQTA) Days 1-5 after vaccination with VAQTA
para; Systemic adverse events reported Days 1-15 after vaccination, regardless of causality.
Adults — 19 Years of Age and Older

In an open-label clinical trial, 240 healthy adults 18 to 54 years of age were randomized to receive either VAQTA (50U/1-mL) with Typhim Vi (Typhoid Vi polysaccharide vaccine) and YF-Vax (yellow fever vaccine) concomitantly (N=80), typhoid Vi polysaccharide and yellow fever vaccines concomitantly (N=80), or VAQTA alone (N=80). Approximately 6 months later, subjects who received VAQTA were administered a second dose of VAQTA. The race distribution of the study subjects who received VAQTA with or without typhoid Vi polysaccharide and yellow fever vaccine was as follows: 78.3% Caucasian; 14.2% Oriental; 3.3% other; 2.1% African-American; 1.7% Indian; 0.4% Hispanic-American. The distribution of subjects by gender was 40.8% male and 59.2% female. Subjects were monitored for local adverse reactions and fever for 5 days and systemic adverse events for 14 days after each vaccination. In the 14 days after the first dose of VAQTA, the proportion of subjects with adverse events was similar between recipients of VAQTA given concomitantly with typhoid Vi polysaccharide and yellow fever vaccines compared to recipients of typhoid Vi polysaccharide and yellow fever vaccines without VAQTA. Table 6 summarizes solicited local adverse reactions and Table 7 summarizes unsolicited systemic adverse events reported in ≥ 5% in adults who received one or two doses of VAQTA alone and for subjects who received VAQTA concomitantly with typhoid Vi polysaccharide and yellow fever vaccines. There were no solicited systemic complaints reported at a rate ≥ 5%. Fever ≥ 101°F occurred in 1.3% of subjects in each group.

Table 6: Incidences of Solicited Local Adverse Reactions in Healthy Adults ≥ 19 Years of Age Occurring at ≥ 5% After Any Dose

Adverse Event VAQTA administered alone
(N=80)
VAQTA + ViCPS* and Yellow Fever vaccines administered concomitantly†
(N=80)
Rate Percent)
Injection-site*
Pain/tenderness/soreness 78.8% 70.3%
Warmth 23.7% 23.7%
Swelling 16.2% 8.8%
Erythema 17.5% 6.3%
N=Number of subjects enrolled/randomized.
Percent=percentage of subjects with adverse event.
*ViCPS=Typhoid Vi polysaccharide vaccine.
†VAQTA administered concomitantly with typhoid Vi polysaccharide (ViCPS) and yellow fever vaccines.
‡ Adverse Reactions at the injection site (VAQTA) Days 1-5 after vaccination

Table 7: Incidences of Unsolicited Systemic Adverse Events in Adults ≥ 19 Years of Age Occurring at ≥ 5% After Any Dose

Body System
Adverse Event
VAQTA administered alone
(N=80)
VAQTA + ViCPS* and Yellow Fever vaccines administered concomitantly†,
(N=80)
Rate (Percent)
General disorders and administration site reactions‡
  Asthenia/fatigue 7.5% 11.3%
  Chills 1.3% 7.5%
Gastrointestinal disorders‡
  Nausea 7.5% 12.5%
Musculoskeletal and connective tissue disorders‡
  Myalgia 5.0% 10.0%
  Arm pain 0.0% 6.3%
Nervous system disorders‡
  Headache 23.8% 26.3%
Infections and infestations‡
  Upper respiratory infection 7.5% 3.8%
  Pharyngitis 2.5% 6.3%
N=Number of subjects enrolled/randomized with data available.
Percent=percentage of subjects with adverse event for whom data are available.
*ViCPS=Typhoid Vi polysaccharide vaccine.
†VAQTA administered concomitantly with typhoid Vi polysaccharide (ViCPS) and yellow fever vaccines.
‡Systemic Adverse Events reported Days 1-15 after vaccination, regardless of causality.

In four clinical trials involving 1645 healthy adults 19 years of age and older who received one or more 50U doses of hepatitis A vaccine, subjects were followed for fever and local adverse reactions 1 to 5 days postvaccination and for systemic adverse events 1 to 14 days postvaccination. One single-blind study evaluated doses of VAQTA with varying amounts of viral antigen and/or alum content in healthy adults ≥ 170 pounds and ≥ 30 years of age (N=210 adults administered 50U/1-mL dose). One open-label study evaluated VAQTA given with immune globulin (IG) or alone (N=164 adults who received VAQTA alone). A third study was single-blind and evaluated 3 different lots of VAQTA (N=1112). The fourth study that was also single-blind evaluated doses of VAQTA with varying amounts of viral antigen in healthy adults ≥ 170 pounds and ≥ 30 years of age (N=159 adults administered the 50U/1-mL dose). Overall, the race distribution of the study subjects who received at least one dose of VAQTA was as follows: 94.2% Caucasian; 2.2% Black; 1.5% Hispanic; 1.5% Oriental; 0.4% other; 0.2% American Indian. 47.6% of subjects were male and 52.4% were female. The most common adverse event/reaction was injection-site pain/soreness/tenderness reported by 67.0% of subjects. Of all reported injection-site reactions 99.8% were mild (i.e., easily tolerated with no medical intervention) or moderate (i.e., minimally interfered with usual activity possibly requiring little medical intervention). Listed below in Table 8 are the local adverse reactions and systemic adverse events reported by ≥ 5% of subjects, in decreasing order of frequency within each body system.

Table 8: Incidences of Local Adverse Reactions and Systemic Adverse Events ≥ 5% in Adults 19 Years of Age and Older

Body System
Adverse Events
VAQTA (Any Dose)
(N=1645)
Rate (n/total n)
Nervous system disorders* n=1641
  Headache 16.1%
General disorders and administration site reactions† n=1640
  Injection-site pain/tenderness/soreness 67.0%
  Injection-site warmth 18.2%
  Injection-site swelling 14.7%
  Injection-site erythema 13.7%
N=Number of subjects enrolled/randomized.
n=Number of subjects in each category with data available.
Percent=percentage of subjects for whom data are available with adverse event.
*Systemic Adverse Events reported Days 1 to 14 after vaccination, regardless of causality.
†Adverse Reactions at the injection site (VAQTA) and measured fever Days 1 to 5 after vaccination.

The following additional unsolicited systemic adverse events were observed among recipients of VAQTA that occurred within 14 days at a common frequency of ≥ 1% to < 10% following any dose not reported elsewhere in the label. These adverse reactions have been reported across 4 clinical studies.

Musculoskeletal and connective tissue disorders: Back pain; stiffness

Reproductive system and breast disorders: Menstruation disorders

Post-Marketing Experience

The following additional adverse events have been reported with use of the marketed vaccine. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to a vaccine exposure.

Blood and lymphatic disorders: Thrombocytopenia.

Nervous system disorders: Guillain-Barré syndrome; cerebellar ataxia; encephalitis.

Post-Marketing Observational Safety Study

In a post-marketing, 60-day safety surveillance study, conducted at a large health maintenance organization in the United States, a total of 42,110 individuals ≥ 2 years of age received 1 or 2 doses of VAQTA (13,735 children/adolescents and 28,375 adult subjects). Safety was passively monitored by electronic search of the automated medical records database for emergency room and outpatient visits, hospitalizations, and deaths. Medical charts were reviewed when an event was considered to be possibly vaccine-related by the investigator. None of the serious adverse events identified were assessed as being related to vaccine by the investigator. Diarrhea/gastroenteritis, resulting in outpatient visits, was determined by the investigator to be the only vaccine-related nonserious adverse reaction in the study. There was no vaccine-related adverse reaction identified that had not been reported in earlier clinical trials with VAQTA.

Read the Vaqta (hepatitis a vaccine, inactivated) Side Effects Center for a complete guide to possible side effects

Interactions

Use With Other Vaccines

Do not mix VAQTA with any other vaccine in the same syringe or vial. Use separate injection sites and syringes for each vaccine. Please refer to package inserts of coadministered vaccines.

In clinical trials in children, VAQTA was concomitantly administered with one or more of the following US licensed vaccines: Measles, Mumps, and Rubella Virus Vaccine, Live; Varicella Vaccine, Live; Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine, Adsorbed; Measles, Mumps, Rubella, and Varicella Vaccine, Live; Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197); and Haemophilus B Conjugate Vaccine (Meningococcal Protein Conjugate). Safety and immunogenicity were similar for concomitantly administered vaccines compared to separately administered vaccines. In clinical trials in adults, VAQTA was concomitantly administered with typhoid Vi polysaccharide and yellow fever vaccines [see ADVERSE REACTIONS and Clinical Studies]. Safety and immunogenicity were similar for concomitantly administered vaccines compared to separately administered vaccines.

Use With Immune Globulin

VAQTA may be administered concomitantly with Immune Globulin, human, using separate sites and syringes. The recommended vaccination regimen for VAQTA should be followed. Consult the manufacturer's product circular for the appropriate dosage of Immune Globulin. A booster dose of VAQTA should be administered at the appropriate time as outlined in the recommended regimen for VAQTA [see Clinical Studies].

Immunosuppressive Therapy

If VAQTA is administered to a person receiving immunosuppressive therapy, an adequate immunologic response may not be obtained.

Read the Vaqta Drug Interactions Center for a complete guide to possible interactions

Learn More »


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

Warnings

Included as part of the PRECAUTIONS section.

Precautions

Prevention And Management Of Allergic Vaccine Reactions

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine [see CONTRAINDICATIONS].

Hypersensitivity To Latex

The vial stopper and the syringe plunger stopper and tip cap contain dry natural latex rubber that may cause allergic reactions in latex-sensitive individuals [see HOW SUPPLIED/Storage and Handling].

Altered Immunocompetence

Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished immune response to VAQTA and may not be protected against HAV infection after vaccination [see Use in Specific Populations].

Limitations Of Vaccine Effectiveness

Hepatitis A virus has a relatively long incubation period (approximately 20 to 50 days). VAQTA may not prevent hepatitis A infection in individuals who have an unrecognized hepatitis A infection at the time of vaccination. Vaccination with VAQTA may not result in a protective response in all susceptible vaccinees.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

VAQTA has not been evaluated for its carcinogenic or mutagenic potential, or its potential to impair fertility.

Use In Specific Populations

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with VAQTA. It is also not known whether VAQTA can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. VAQTA should be given to a pregnant woman only if clearly needed.

Nursing Mothers

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

Pediatric Use

The safety of VAQTA has been evaluated in 4374 children 12 through 23 months of age, and 2615 children/adolescents 2 through 18 years of age who received at least one 25U dose of VAQTA [see ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION].

Safety and effectiveness in infants below 12 months of age have not been established.

Geriatric Use

In the post-marketing observational safety study which included 42,110 persons who received VAQTA [see ADVERSE REACTIONS], 4769 persons were 65 years of age or older and 1073 persons were 75 years of age or older. There were no adverse events judged by the investigator to be vaccine-related in the geriatric study population. In other clinical studies, 68 subjects 65 years of age or older were vaccinated with VAQTA, 10 of whom were 75 years of age or older. No overall differences in safety and immunogenicity were observed between these subjects and younger subjects; however, greater sensitivity of some older individuals cannot be ruled out. Other reported clinical experience has not identified differences in responses between the elderly and younger subjects.

Immunocompromised Individuals

Immunocompromised persons may have a diminished immune response to VAQTA and may not be protected against HAV infection.


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

OverDose

No information provided.

ContrainDications

Do not administer VAQTA to individuals with a history of immediate and/or severe allergic or hypersensitivity reactions (e.g., anaphylaxis) after a previous dose of any hepatitis A vaccine, or to individuals who have had an anaphylactic reaction to any component of VAQTA, including neomycin [see DESCRIPTION].


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

Clinical Pharamacology

Mechanism Of Action

VAQTA has been shown to elicit antibodies to hepatitis A as measured by ELISA.

Protection from hepatitis A disease has been shown to be related to the presence of antibody. However, the lowest titer needed to confer protection has not been determined.

Clinical Studies

Efficacy Of VAQTA: The Monroe Clinical Study

The immunogenicity and protective efficacy of VAQTA were evaluated in a randomized, double-blind, placebo-controlled study involving 1037 susceptible healthy children and adolescents 2 through 16 years of age in a U.S. community with recurrent outbreaks of hepatitis A (The Monroe Efficacy Study). All of these children were Caucasian, and there were 51.5% male and 48.5% female. Each child received an intramuscular dose of VAQTA (25U) (N=519) or placebo (alum diluent) (N=518). Among those individuals who were initially seronegative (measured by a modification of the HAVAB radioimmunoassay [RIA]), seroconversion was achieved in > 99% of vaccine recipients within 4 weeks after vaccination. The onset of seroconversion following a single dose of VAQTA was shown to parallel the onset of protection against clinical hepatitis A disease.

Because of the long incubation period of the disease (approximately 20 to 50 days, or longer in children), clinical efficacy was based on confirmed cases1 of hepatitis A occurring ≥ 50 days after vaccination in order to exclude any children incubating the infection before vaccination. In subjects who were initially seronegative, the protective efficacy of a single dose of VAQTA was observed to be 100% with 21 cases of clinically confirmed hepatitis A occurring in the placebo group and none in the vaccine group (p < 0.001). The number of clinically confirmed cases of hepatitis A ≥ 30 days after vaccination were also compared. In this analysis, 28 cases of clinically confirmed hepatitis A occurred in the placebo group while none occurred in the vaccine group ≥ 30 days after vaccination. In addition, it was observed in this trial that no cases of clinically confirmed hepatitis A occurred in the vaccine group after day 16.2 Following demonstration of protection with a single dose and termination of the study, a booster dose was administered to a subset of vaccinees 6, 12, or 18 months after the primary dose.

No cases of clinically confirmed hepatitis A disease ≥ 50 days after vaccination have occurred in those vaccinees from The Monroe Efficacy Study monitored for up to 9 years.

Other Clinical Studies

The efficacy of VAQTA in other age groups was based upon immunogenicity measured 4 to 6 weeks following vaccination. VAQTA was found to be immunogenic in all age groups.

Children — 12 through 23 Months of Age

In a clinical trial, children 12 through 23 months of age were randomized to receive the first dose of VAQTA with or without M-M-R II and VARIVAX (N=617) and the second dose of VAQTA with or without Tripedia and optionally either oral poliovirus vaccine (no longer licensed in the US) or IPOL (N=555). The race distribution of study subjects who received at least one dose of VAQTA was as follows: 56.7% Caucasian; 17.5% Hispanic-American; 14.3% African-American; 7.0% Native American; 3.4% other; 0.8% Oriental; 0.2% Asian; and 0.2% Indian. The distribution of subjects by gender was 53.6% male and 46.4% female. In the analysis population, there were 471 initially seronegative children 12 through 23 months of age, who received the first dose of VAQTA with (N=237) or without (N=234) M-M-R II and VARIVAX of whom 96% (95% CI: 93.7%, 97.5%) seroconverted (defined as having an anti-HAV titer ≥ 10 mIU/mL) post dose 1 with an anti-HAV geometric mean titer (GMT) of 48 mIU/mL (95% CI: 44.7, 51.6). There were 343 children in the analysis population who received the second dose of VAQTA with (N=168) or without (N=175) Tripedia and optional oral poliovirus vaccine or IPOL of whom 100% (95% CI: 99.3%, 100%) seroconverted post dose 2 with an anti-HAV GMT of 6920 mIU/mL (95% CI: 6136, 7801). Of children who received only VAQTA at both visits, 100% (n=97) seroconverted after the second dose of VAQTA. In a clinical trial involving 653 healthy children 12 to 15 months of age, 330 were randomized to receive VAQTA, ProQuad, and pneumococcal 7-valent conjugate vaccine concomitantly, and 323 were randomized to receive ProQuad and pneumococcal 7-valent conjugate vaccine concomitantly followed by VAQTA 6 weeks later. The race distribution of the study subjects was as follows: 60.3% Caucasian; 21.6% African-American; 9.5% Hispanic-American; 7.2% other; 1.1% Asian/Pacific; and 0.3% Native American. The distribution of subjects by gender was 50.7% male and 49.3% female. In the analysis population, the seropositivity rate for hepatitis A antibody (defined as the percent of subjects with an anti- HAV titer ≥ 10 mIU/mL) was 100% (n=182; 95% CI: 98.0%, 100%) post dose 2 with an anti-HAV GMT of 4977 mIU/mL (95% CI: 4068, 6089) when VAQTA was given with ProQuad and pneumococcal 7-valent conjugate vaccine and 99.4% (n=159, 95% CI: 96.5%, 100%) post dose 2 with an anti-HAV GMT of 6123 mIU/mL (95% CI: 4826, 7770) when VAQTA alone was given. These seropositivity rates were similar whether VAQTA was administered with or without ProQuad and pneumococcal 7-valent conjugate vaccine.

In an open, multicenter, randomized study involving 617 children 15 months of age, 306 were randomized to receive VAQTA with or without PedvaxHIB and INFANRIX, and 311 were randomized to receive VAQTA with or without PedvaxHIB. The race distribution of the study subjects was as follows: 63.9% Caucasian; 17.5% Hispanic-American; 14.7% Black; 2.6% other; and 1.3% Asian. The distribution of subjects by gender was 54.0% male and 46.0% female. The seropositivity rate for hepatitis A antibody (defined as the percent of subjects with an anti-HAV titer ≥ 10 mIU/mL) 4 weeks post dose 2 was 100% (n=208, 95% CI: 98.2%, 100.0%) in those who received VAQTA concomitantly with PedvaxHIB and INFANRIX or concomitantly with PedvaxHIB. In those subjects who received VAQTA alone, the seropositivity rate for hepatitis A antibody was 100% (n=183, 95% CI: 98.0%, 100.0%), regardless of baseline hepatitis A serostatus. Overall, the anti-HAV GMT in the concomitant groups was 3616.5 mIU/mL (95% CI: 3084.5, 4240.2). The anti-HAV GMT in the nonconcomitant groups was 4712.6 mIU/Ml (95% CI: 3996.8, 5556.8). Comparable responses were observed in both the initially seronegative and seropositive subjects.

In three combined clinical studies 1022 initially seronegative subjects received 2 doses of VAQTA alone or concomitantly with other vaccines. Of the seronegative subjects, 99.9% achieved an anti-HAV titer ≥ 10 mIU/mL (95% CI: 99.5%, 100%) and an anti-HAV GMT of 5392.1 mIU/mL (95% CI: 4996.5, 5819.0) 4 weeks following dose 2 of VAQTA.

Children/Adolescents — 2 Years through 18 Years of Age

Immunogenicity data were combined from eleven randomized clinical studies in children and adolescents 2 through 18 years of age who received VAQTA (25U/0.5 mL). These included administration of VAQTA in varying doses and regimens (N=404 received 25U/0.5 mL), the Monroe Efficacy Study (N=973), and comparison studies for process and formulation changes (N=1238). The race distribution of the study subjects who received at least one dose of VAQTA in these studies was as follows: 84.8% Caucasian; 10.6% American Indian; 2.3% African-American; 1.5% Hispanic-American; 0.6% other; 0.2% Oriental. The distribution of subjects by gender was 51.2% male and 48.8% female. The proportions of subjects who seroconverted 4 weeks after the first and second doses administered 6 months apart were 97% (n=1230; 95% CI: 96%, 98%) and 100% (n=1057; 95% CI: 99.5%, 100%) of subjects with anti-HAV GMTs of 43 mIU/mL (95% CI: 40, 45) and 10,077 mIU/mL (95% CI: 9394, 10,810), respectively.

Adults — 19 Years of Age and Older

Immunogenicity data were combined from five randomized clinical studies in adults 19 years of age and older who received VAQTA (50U/1-mL). One single-blind study evaluated doses of VAQTA with varying amounts of viral antigen and/or alum content in healthy adults ≥ 170 pounds and ≥ 30 years of age (N=208 adults administered 50U/1-mL dose). One open-label study evaluated VAQTA given with immune globulin or alone (N=164 adults who received VAQTA alone). A third study was single-blind and evaluated 3 different lots of VAQTA (N=1112). The fourth study was single-blind and evaluated doses of VAQTA with varying amounts of viral antigen in healthy adults ≥ 170 pounds and ≥ 30 years of age (N=159 adults administered the 50U/1-mL dose). The fifth study was an open-label study to evaluate various regimens for time of administration of the booster dose of VAQTA (6, 12, and 18 months post dose 1, N=354). The race distribution of the study subjects who received at least one dose of VAQTA in these studies was as follows: 93.2% Caucasian; 2.5% African-American; 2.1% Hispanic-American; 1.4% Oriental; 0.5% other; 0.3% American Indian. The distribution of subjects by gender was 44.8% male and 55.2% female. The proportion of subjects who seroconverted 4 weeks after the first and second doses administered 6 months apart was 95% (n=1411; 95% CI: 94%, 96%) and 99.9% (n=1244; 95% CI: 99.4%, 100%) with GMTs of 37 mIU/mL (95% CI: 35, 38) and 6013 mIU/mL (95% CI: 5592, 6467), respectively. Furthermore, at 2 weeks postvaccination, 69.2% (n=744; 95% CI: 65.7%, 72.5%) of adults seroconverted with an anti- HAV GMT of 16 mIU/mL after a single dose of VAQTA.

Timing Of Booster Dose Administration

Children/Adolescents — 2 through 18 Years of Age

In the Monroe Efficacy Study, children were administered a second dose of VAQTA (25U/0.5 mL) 6, 12, or 18 months following the initial dose. For subjects who received both doses of VAQTA, the GMTs and proportions of subjects who seroconverted 4 weeks after the booster dose administered 6, 12, and 18 months after the first dose are presented in Table 9.

Table 9: Children/Adolescents from the Monroe Efficacy Study Seroconversion Rates (%) and Geometric Mean Titers (GMT) for Cohorts of Initially Seronegative Vaccinees at the Time of the Booster(25U) and 4 Weeks Later

Months Following Initial 25U Dose Cohort* (n=960) 0 and 6 Months Cohort* (n=35) 0 and 12 Months Cohort* (n=39) 0 and 18 Months
  Seroconversion Rate GMT (mIU/mL) (95% CI)
6 97% 107 (98, 117) __
7 100% 10433 (9681, 11243) __
12 91% 48 (33, 71)
13 100% 12308 (9337, 16226)
18 __ 90% 50 (28, 89)
19 __ 100% 9591 (7613, 12082)
* Blood samples were taken at prebooster and postbooster time points.
Adults — 19 years of age and older

Among the 5 randomized clinical studies in adults 19 years of age and older described in Section 14.2, there were additional data in which a booster dose of VAQTA (50U/1-mL) was administered 12 or 18 months after the first dose. For subjects in these studies who received both doses of VAQTA, the proportions who seroconverted 4 weeks after the booster dose administered 6, 12, and 18 months after the first dose were 100% of 1201 subjects, 98% of 91 subjects, and 100% of 84 subjects, respectively. GMTs in mIU/mL one month after the subjects received the booster dose at 6, 12, or 18 months after the primary dose were 5987 mIU/mL (95% CI: 5561, 6445), 4896 mIU/mL (95% CI: 3589, 6679), and 6043 mIU/mL (95% CI: 4687, 7793), respectively.

Duration Of Immune Response

In follow-up of subjects in The Monroe Efficacy Study, in children ( ≥ 2 years of age) and adolescents who received two doses (25U) of VAQTA, detectable levels of anti-HAV antibodies ( ≥ 10 mIU/mL) were present in 100% of subjects for at least 10 years postvaccination. In subjects who received VAQTA at 0 and 6 months, the GMT was 819 mIU/mL (n=175) at 2.5 to 3.5 years and 505 mIU/mL (n=174) at 5 to 6 years, and 574 mIU/mL (n=114) at 10 years postvaccination. In subjects who received VAQTA at 0 and 12 months, the GMT was 2224 mIU/mL (n=49) at 2.5 to 3.5 years, 1191 mIU/mL (n=47) at 5 to 6 years, and 1005 mIU/mL (n=36) at 10 years postvaccination. In subjects who received VAQTA at 0 and 18 months, the GMT was 2501 mIU/mL (n=53) at 2.5 to 3.5 years, 1614 mIU/mL (n=56) at 5 to 6 years, and 1507 mIU/mL (n=41) at 10 years postvaccination.

In adults that were administered VAQTA at 0 and 6 months, the hepatitis A antibody response to date has been shown to persist at least 6 years. Detectable levels of anti-HAV antibodies ( ≥ 10 mIU/mL) were present in 100% (378/378) of subjects with a GMT of 1734 mIU/mL at 1 year, 99.2% (252/254) of subjects with a GMT of 687 mIU/mL at 2 to 3 years, 99.1% (219/221) of subjects with a GMT of 605 mIU/mL at 4 years, and 99.4% (170/171) of subjects with a GMT of 684 mIU/mL at 6 years postvaccination.

The total duration of the protective effect of VAQTA in healthy vaccinees is unknown at present.

Concomitant Administration Of VAQTA And Immune Globulin

The concurrent use of VAQTA (50U) and immune globulin (IG, 0.06 mL/kg) was evaluated in an openlabel, randomized clinical study involving 294 healthy adults 18 to 39 years of age. Adults were randomized to receive 2 doses of VAQTA 24 weeks apart (N=129), the first dose of VAQTA concomitant with a dose of IG followed by the second dose of VAQTA alone 24 weeks later (N=135), or IG alone (N=30). The race distribution of the study subjects who received at least one dose of VAQTA or IG in this study was as follows: 92.3% Caucasian; 4.0% Hispanic-American; 3.0% African-American; 0.3% Native American; 0.3% Asian/Pacific. The distribution of subjects by gender was 28.7% male and 71.3% female. Table 10 provides seroconversion rates and GMTs at 4 and 24 weeks after the first dose in each treatment group and at one month after a booster dose of VAQTA (administered at 24 weeks) [see DRUG INTERACTIONS].

Table 10: Seroconversion Rates (%) and Geometric Mean Titers (GMT) After Vaccination with VAQTA Plus IG, VAQTA Alone, and IG Alone

  VAQTA plus IG VAQTA IG
Weeks Seroconversion Rate GMT (mIU/mL) (95% CI)
4 100% 96% 87%
42 (39, 45) 38 (33, 42) 19 (15, 23)
(n=129) (n=135) (n=30)
24 92% 97%* 0%
83 (65, 105) 137* (112, 169) Undetectable†
(n=125) (n=132) (n=28)
28 100% 100% N/A
4872 (3716, 6388) (n=114) 6498 (5111,8261) (n=128)  
*The seroconversion rate and the GMT in the group receiving VAQTA alone were significantly higher than in the group receiving VAQTA plus IG (p=0.05, p < 0.001, respectively).
†Undetectable is defined as < 10mIU/mL.
N/A = Not Applicable.

Interchangeability Of The Booster Dose

A randomized, double-blind clinical study in 537 healthy adults, 18 to 83 years of age, evaluated the immune response to a booster dose of VAQTA and HAVRIX given at 6 or 12 months following an initial dose of HAVRIX. Subjects were randomized to receive VAQTA (50U) as a booster dose 6 months (N=232) or 12 months (N=124) following an initial dose of HAVRIX or HAVRIX (1440 EL. U) as a booster dose 6 months (N=118) or 12 months (N=63) following an initial dose of HAVRIX. The race distribution of the study subjects who received the booster dose of VAQTA or HAVRIX in this study was as follows: 87.2% Caucasian; 8.0% African-American; 1.9% Hispanic-American; 1.3% Oriental; 0.9% Asian; 0.4% Indian; 0.4% other. The distribution of subjects by gender was 44.9% male and 55.1% female. When VAQTA was given as a booster dose following HAVRIX, the vaccine produced an adequate immune response (see Table 11) [see DOSAGE AND ADMINISTRATION].

Table 11: Seropositivity Rate, Booster Response Rate* and Geometric Mean Titer 4 Weeks Following a Booster Dose of VAQTA or HAVRIX Administered 6 to 12 Months After First Dose of HAVRIX†

First Dose Booster Dose Seropositivity Rate Booster Response Rate* Geometric Mean Titer
HAVRIX 1440 EL.U. VAQTA 50 U 99.7% (n=313) 86.1% (n=310) 3272 (n=313)
HAVRIX 1440 EL.U. HAVRIX 1440 EL.U. 99.3% (n=151) 80.1% (n=151) 2423 (n=151)
*Booster Response Rate is defined as greater than or equal to a tenfold rise from prebooster to postbooster titer and postbooster titer ≥ 100 mIU/mL.
†Study conducted in adults 18 years of age and older.

Immune Response To Concomitantly Administered Vaccines

Clinical Studies of VAQTA with M-M-R II, VARIVAX, and Tripedia

In the clinical trial in which children 12 months of age received the first dose of VAQTA concomitantly with M-M-R II and VARIVAX described in Section 14.2, rates of seroprotection to hepatitis A were similar between the two groups who received VAQTA with or without M-M-R II and VARIVAX. Measles, mumps, and rubella immune responses were tested in 241 subjects, 263 subjects, and 270 subjects, respectively. Seropositivity rates were 98.8% [95% CI: 96.4%, 99.7%] for measles, 99.6% [95% CI: 97.9%, 100%] for mumps, and 100% [95% CI: 98.6%, 100%] for rubella, which were similar to observed historical rates (seropositivity rates 99% for all three antigens, with lower bound of the 95% CI > 89%) following vaccination with a first dose of M-M-R II in this age group. Data from this study were insufficient to adequately assess the immune response to VARIVAX administered concomitantly with VAQTA. In this same study, the second dose of VAQTA at 18 months of age was given with or without Tripedia (DTaP). Seropositivity rates for diphtheria and tetanus were similar to those in historical controls. However, data from this study were insufficient to assess the pertussis response of DTaP when administered with VAQTA. Rates of seroprotection to hepatitis A were similar between the two groups who received VAQTA with or without M-M-R II and VARIVAX, and between the two groups who received VAQTA with or without DTaP.

Clinical Studies of VAQTA with ProQuad and Prevnar

In the clinical trial of concomitant use of VAQTA with ProQuad and pneumococcal 7-valent conjugate vaccine in children 12 to 15 months of age described in Section 14.2, the antibody GMTs for S. pneumoniae types 4, 6B, 9V, 14, 18C, 19F, and 23F 6 weeks after vaccination with pneumococcal 7-valent conjugate vaccine administered concomitantly with ProQuad and VAQTA were non-inferior as compared to GMTs observed in the group given pneumococcal 7-valent conjugate vaccine with ProQuad alone (the lower bounds of the 95% CI around the fold-difference for the 7 serotypes excluded 0.5). For the varicella component of ProQuad, in subjects with baseline antibody titers < 1.25 gpELISA units/mL, the proportion with a titer ≥ 5 gpELISA units/mL 6 weeks after their first dose of ProQuad was non-inferior (defined as -10 percentage point change) when ProQuad was administered with VAQTA and pneumococcal 7-valent conjugate vaccine as compared to the proportion with a titer ≥ 5 gpELISA units/mL when ProQuad was administered with pneumococcal 7-valent conjugate vaccine alone (difference in seroprotection rate -5.1% [95% CI: -9.3, -1.4%]). Hepatitis A responses were similar when compared between the two groups who received VAQTA with or without ProQuad and pneumococcal 7-valent conjugate vaccine. Seroconversion rates and antibody titers for varicella and S. pneumoniae types 4, 6B, 9V, 14, 18C, 19F, and 23F were similar between groups at 6 weeks postvaccination.

Clinical Studies of VAQTA with INFANRIX and PedvaxHIB

In the clinical trial of concomitant administration of VAQTA with INFANRIX and PedvaxHIB in children 15 months of age, described in Section 14.2, when the first dose of VAQTA was administered concomitantly with either INFANRIX and PedvaxHIB or PedvaxHIB, there was no interference in immune response to hepatitis A as measured by seropositivity rates after dose 2 of VAQTA compared to administration of both doses of VAQTA alone. When dose 1 of VAQTA was administered concomitantly with either PedvaxHIB and INFANRIX or PedvaxHIB, there was no interference in immune response to Haemophilus influenza b (as measured by the proportion of subjects who attained an anti-polyribosylribitol phosphate antibody titer > 1.0 mcg/mL at 4 weeks after vaccination), compared to subjects receiving either PedvaxHIB and INFANRIX or PedvaxHIB. When VAQTA was administered concomitantly with INFANRIX and PedvaxHIB, there was no interference in immune responses at 4 weeks after vaccination to the pertussis antigens (PT, FHA, or pertactin, as measured by GMTs) and no interference in immune responses to diphtheria toxoid or tetanus toxoid (as measured by the proportion of subjects achieving an antibody titer > 0.1 IU/mL) compared to administration of INFANRIX and PedvaxHIB.

Clinical Studies of VAQTA with Typhoid Vi Polysaccharide Vaccine and Yellow Fever Vaccine, Live Attenuated

In the clinical trial of concomitant use of VAQTA with typhoid Vi polysaccharide and yellow fever vaccines in adults 18-54 years of age described in Section 6.1, the antibody response rates for typhoid Vi polysaccharide and yellow fever were adequate when typhoid Vi polysaccharide and yellow fever vaccines were administered concomitantly with (N=80) and nonconcomitantly without VAQTA (N=80). The seropositivity rate for hepatitis A when VAQTA, typhoid Vi polysaccharide, and yellow fever vaccines were administered concomitantly was generally similar to when VAQTA was given alone [see DRUG INTERACTIONS].

Data are insufficient to assess the immune response to VAQTA and poliovirus vaccine when administered concomitantly.

REFERENCES

1 The clinical case definition included all of the following occurring at the same time: 1) one or more typical clinical signs or symptoms of hepatitis A (e.g., jaundice, malaise, fever ≥ 38.3°C); 2) elevation of hepatitis A IgM antibody (HAVAB-M); 3) elevation of alanine transferase (ALT) ≥ 2 times the upper limit of normal.

2 One vaccinee did not meet the pre-defined criteria for clinically confirmed hepatitis A but did have positive hepatitis A IgM and borderline liver enzyme (ALT) elevations on days 34, 50, and 58 after vaccination with mild clinical symptoms observed on days 49 and 50.


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

  • Inform the patient, parent or guardian of the potential benefits and risks of the vaccine.
  • Question the vaccine recipient, parent, or guardian about the occurrence of any symptoms and/or signs of an adverse reaction after a previous dose of hepatitis A vaccine.
  • Inform the patient, parent, or guardian about the potential for adverse events that have been temporally associated with administration of VAQTA.
  • Tell the patient, parent, or guardian accompanying the recipient, to report adverse events to the physician or clinic where the vaccine was administered.
  • Prior to vaccination, give the patient, parent, or guardian the Vaccine Information Statements which are required by the National Childhood Vaccine Injury Act of 1986. These materials are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines).
  • Tell the patient, parent, or guardian that 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. The VAERS tollfree number is 1-800-822-7967. Reporting forms may also be obtained at the VAERS website at (www.vaers.hhs.gov).


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.

 

HEPATITIS A VACCINE - INJECTION

 

(hep-uh-TIE-tuss A)

 

COMMON BRAND NAME(S): Havrix, Vaqta

 

USES: This medication is used to help prevent infection from the hepatitis A virus. Hepatitis A infection can be mild with no symptoms or a severe illness that can rarely cause liver failure and death. Preventing infection can prevent these problems.

Hepatitis A vaccine is made from whole, killed hepatitis A virus. It does not contain live virus, so you cannot get hepatitis from the vaccine. This vaccine works by helping the body produce immunity (through antibody production) that will prevent you from getting infection from hepatitis A virus. Hepatitis A vaccine does not protect you from other virus infections (such as HIV virus, which causes AIDS; hepatitis B, hepatitis C or hepatitis E; HPV virus, which causes genital warts and other problems).

The vaccine is recommended for people aged 12 months and older, especially those at an increased risk of getting the infection. Those at an increased risk include people who live with or spend much time with people with hepatitis A infections, institutional or daycare workers, lab workers, people with multiple sex partners, men who have sex with men, sex workers, injecting and non-injecting drug abusers, and people traveling to high-risk areas.

 

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.

Depending on your age, this vaccine is usually given by injection into a shoulder or thigh muscle by a health care professional.

A series of 2 injections is usually given over a 6- to 18-month period. Your doctor will give you a vaccination schedule, which must be followed closely for best effectiveness. If you have an illness with fever at the time a vaccination is scheduled, your doctor may choose to delay the injection until you are better.

The dosage is based on your age. Different brands of hepatitis A vaccine are available and may be given differently. Make sure that you receive the same brand for each injection.

If you are receiving the first hepatitis A vaccine injection at a time when your doctor feels you may have been exposed to hepatitis A, you will also receive an injection of immune globulin (IG). IG contains antibodies against the hepatitis A virus and will immediately help protect you from developing an infection. These antibodies only last a few months. For long-term protection, it is important to follow your vaccination schedule for the hepatitis A vaccine exactly.

Consumer Overview Side Effect

SIDE EFFECTS: Pain/redness/swelling at the injection site, fever, tiredness, headache, nausea, and loss of appetite 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. Report all side effects to your doctor before you receive the next injection.

Tell your doctor immediately if this rare but serious side effect occurs: seizures.

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 Vaqta (hepatitis a vaccine, inactivated) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before getting hepatitis A vaccine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as neomycin, formalin, latex in some vials/prefilled syringes), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems (such as hemophilia, low platelets, anticoagulant treatment), current illness with fever.

If you have decreased immune function from other medications (see also Drug Interactions) or other illness (such as HIV, leukemia, lymphoma, other cancer), your body may not make enough antibodies to protect you from hepatitis A infection. Antibody levels should be checked after the vaccine series.

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

It is unknown whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor or pharmacist give you the best care, be sure to tell your doctor or pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

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

Other vaccines may be given at the same time as hepatitis A vaccine, but should be given with separate syringes and at different injection sites.

This document does not contain all possible interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

 

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.

Hepatitis A spreads very easily, often through contaminated food or water, infected food handlers, sexual contact with an infected individual, eating raw shellfish from contaminated water, poor sanitary conditions, and rarely by blood transfusions or sharing needles with actively infected people.

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 to 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 March 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Havrix, Vaqta

Generic Name: hepatitis A adult vaccine (Pronunciation: HEP a TYE tis)

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

What is hepatitis A vaccine (Vaqta)?

Hepatitis is a serious disease caused by a virus. Hepatitis A is spread through contact with the stool (bowel movements) of a person infected with the hepatitis A virus. This usually occurs by eating food or drinking water that has become contaminated as a result of handling by an infected person.

Hepatitis causes inflammation of the liver, vomiting, and jaundice (yellowing of the skin or eyes). Hepatitis can lead to liver cancer, cirrhosis, or death.

The hepatitis A adult vaccine is used to help prevent this disease in adults. The vaccine works by exposing you to a small amount of the virus, 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.

Vaccination with hepatitis A adult vaccine is recommended for all adults who travel in certain areas of the world where hepatitis A is a common disease.

Other risk factors for hepatitis include: being a homosexual male; having chronic liver disease; using intravenous (IV) drugs; receiving treatment for hemophilia or other bleeding disorders; working in a research laboratory or around animals (especially monkeys) where you may be exposed to the hepatitis A virus; or being in an area where there has been an outbreak of hepatitis A.

Like any vaccine, the hepatitis A vaccine may not provide protection from disease in every person.

What are the possible side effects of hepatitis A vaccine (Vaqta)?

You should not receive a booster vaccine if you have ever had a life-threatening allergic reaction after the first shot.

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

Becoming infected with hepatitis A is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Call your doctor at once if you have any of these serious side effects:

  • high fever;
  • fast or uneven heartbeats; or
  • behavior changes.

Less serious side effects include:

  • low fever;
  • headache;
  • dizziness, tired feeling;
  • nausea, vomiting, stomach pain, diarrhea, loss of appetite;
  • joint pain;
  • sore throat; or
  • swelling, redness, or a hard lump where the shot was given.

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 Vaqta (hepatitis a vaccine, inactivated) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about hepatitis A vaccine (Vaqta)?

Hepatitis A vaccine will not protect you against infection with hepatitis B, C, and E, or other viruses that affect the liver. It may also not protect you from hepatitis A if you are already infected with the virus, even if you do not yet show symptoms.

You will most likely receive 2 separate injections of the hepatitis A vaccine at 6 months apart, depending on your exposure or risk of infection. Children should receive their first hepatitis A vaccine between 12 months and 23 months of age.

Your 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.

Vaccination with hepatitis A adult vaccine is recommended for all adults who travel in certain areas of the world where hepatitis A is a common disease.

Other risk factors for hepatitis include: being a homosexual male; having chronic liver disease; using intravenous (IV) drugs; receiving treatment for hemophilia or other bleeding disorders; working in a research laboratory or around animals (especially monkeys) where you may be exposed to the hepatitis A virus; or being in an area where there has been an outbreak of hepatitis A.

Be sure you receive all recommended doses of this vaccine. If you do not receive the full series of vaccines, you may not be fully protected against the disease.

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

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

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

Becoming infected with hepatitis A is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Side Effects Centers
  • Havrix
  • Vaqta

Patient Detailed How Take

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

Hepatitis A vaccine will not protect you against infection with hepatitis B, C, and E, or other viruses that affect the liver. It may also not protect you from hepatitis A if you are already infected with the virus, even if you do not yet show symptoms.

You should not receive this vaccine if you have ever had a life-threatening allergic reaction to any vaccine containing hepatitis A, or if you have received cancer chemotherapy or radiation treatment in the past 3 months.

Before receiving this vaccine, tell your doctor if you have:

  • a bleeding or blood clotting disorder such as hemophilia or easy bruising;
  • a history of seizures;
  • a neurologic disorder or disease affecting the brain;
  • an allergy to latex rubber;
  • a weak immune system caused by disease, bone marrow transplant, or by using certain medicines or receiving cancer treatments; or
  • if you are taking a blood thinner such as warfarin (Coumadin).

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

Before receiving the hepatitis A vaccine, tell your doctor if you are pregnant.

It is not known if hepatitis A vaccine passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How is this vaccine given (Vaqta)?

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

You will most likely receive 2 separate injections of the hepatitis A vaccine at 6 months apart, depending on your exposure or risk of infection.

To prevent hepatitis A while traveling, you should receive this vaccine at least 2 weeks before your trip. Your healthcare provider will determine the best dosing schedule for your situation.

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 take.

It is especially important to prevent fever from occurring if you have a seizure disorder such as epilepsy.

Side Effects Centers
  • Havrix
  • Vaqta

Patient Detailed Avoid Taking

What happens if I miss a dose (Vaqta)?

Contact your doctor if you will miss a hepatitis A vaccine 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 to receive all recommended doses of this vaccine. If you do not receive the full series of vaccines, you may not be fully protected against the disease.

What happens if I overdose (Vaqta)?

An overdose of hepatitis A vaccine is unlikely to occur.

What should I avoid before or after getting this vaccine (Vaqta)?

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

What other drugs will affect hepatitis A vaccine (Vaqta)?

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

Also tell the doctor 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), 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 you are using any of these medications, you may not be able to receive the vaccine, or may need to wait until the other treatments are finished.

There may be other drugs that can affect this vaccine. Tell your doctor about all the prescription and over-the-counter medications you have received. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your 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: 1.08. Revision date: 12/15/2010.

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Side Effects Centers
  • Havrix
  • Vaqta

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