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The safety of VAQTA (hepatitis a vaccine, inactivated) has been evaluated in over 10,000 subjects ages 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. As with any vaccine, there is the possibility that use of VAQTA (hepatitis a vaccine, inactivated) in very large populations might reveal adverse experiences not observed in clinical trials.

VAQTA (hepatitis a vaccine, inactivated) should not be mixed with any other vaccine in the same syringe or vial.

If VAQTA (hepatitis a vaccine, inactivated) is administered to a person receiving immunosuppressive therapy, or who has an immunodeficiency disorder, an adequate immunologic response may not be obtained.⁹

Clinical Studies

Children —12 Through 23 Months of Age

In combined clinical trials involving 706 healthy children 12 through 23 months of age who received one or more ~25U dose, subjects were monitored for local adverse events and fever for 5 days after each vaccination and systemic adverse events for 14 days after each vaccination by diary cards. Some of these children received VAQTA (hepatitis a vaccine, inactivated) in combination with other routinely recommended pediatric vaccines. Listed below are the complaints (with 95% CI) for all solicited events and for unsolicited events reported at ≥ 1.0% without regard to causality in decreasing order of frequency within each body system.

Table 4 : All Incidences of Solicited Local and Systemic Complaints in Healthy Infants 12 to 23 Months of Age

 Unsolicited adverse events ≥ 1% (95% CI)

Localized Injection-Site Reactions

Ecchymosis 1.0% (0.4%, 2.2%).

Digestive system

Diarrhea 5.9% (4.3%, 8.0%); vomiting 4.0% (2.7%, 5.8%); anorexia 1.2% (0.6%, 2.4%).

Nervous System/Psychiatric

Irritability 10.8% (8.6%, 13.4%); crying 1.8% (1.0%, 3.2%).

Respiratory system

Upper respiratory infection 10.1% (8.0%, 12.7%); rhinorrhea 5.7% (4.1%, 7.8%); cough 5.1% (3.6%, 7.1%); respiratory congestion 1.6% (0.8%, 2.9%); nasal congestion 1.2% (0.6%, 2.4%); laryngotracheobronchitis 1.2% (0.6%, 2.4%).

Skin And Skin Appendages

Rash 4.5% (3.1%, 6.4%); viral exanthema 1.0% (0.4%, 2.2%).

Special Senses – Ear

Otitis media 7.6% (5.8%, 9.9%); otitis: 1.8% (1.0%, 3.2%).

Special Senses – Eye

Conjunctivitis 1.3% (0.6%, 2.6%).

Serious Adverse Events: There were 7 children who experienced 9 seizures during the entire study period. Seizures were reported between 9 days and 81 days following the administration of VAQTA (hepatitis a vaccine, inactivated) . Some subjects had received concomitant or nonconcomitant immunization with M-M-R II and VARIVAX. None of the events were considered to be related to VAQTA (hepatitis a vaccine, inactivated) by the investigator. Other serious events that occurred during the study included bronchiolitis, dehydration, RLL (Right Lower Lobe) pneumonia, asthma, and asthma exacerbation, which were also considered by the investigator to be unrelated to VAQTA (hepatitis a vaccine, inactivated) . These events occurred 9 days to 46 days following the administration of VAQTA (hepatitis a vaccine, inactivated) . Some subjects received concomitant or nonconcomitant immunization with M-M-R II, and VARIVAX or TRIPEDIA, and/or oral or inactivated polio vaccine.

Children/Adolescents — 2 Through 18 Years of Age

Safety Data Gathered from Monroe Efficacy Study

In The Monroe Efficacy Study, 1037 healthy children and adolescents, 2 through 16 years of age, received a primary dose of ~25U of hepatitis A vaccine and a booster 6, 12, or 18 months later, or placebo. Subjects were followed during a 5-day period for fever and local complaints and during a 14-day period for systemic complaints. Injection-site complaints, generally mild and transient³, were the most frequently reported complaints. Table 5 summarizes the local and systemic complaints ( ≥ 1%) reported in this study, without regard to causality. There were no significant differences in the rates of any complaints between vaccine and placebo recipients after Dose 1.

Table 5 : Local and Systemic Complaints ( ≥ 1%) in Healthy Children and Adolescents From the Monroe Efficacy Study

Children/Adolescents — 2 Through 18 Years of Age - Combined Clinical Trials

In combined clinical trials (including Monroe Efficacy Study participants) involving 2615 healthy children ( ≥ 2 years of age) and adolescents who received one or more ~25U doses of hepatitis A vaccine, subjects were followed for fever and local complaints during a 5-day period postvaccination and systemic complaints during a 14-day period postvaccination. Injection-site complaints, generally mild and transient, were the most frequently reported complaints. Listed below are the complaints reported by 1% of subjects, without regard to causality, in decreasing order of frequency within each body system.

Localized Injection-Site Reactions

Pain (18.7%); tenderness (16.9%); warmth (8.6%); erythema (7.5%); swelling (7.3%); ecchymosis (1.3%).

Body As AWhole

Fever ( ≥ 102°F, Oral) (3.1%); abdominal pain (1.6%).

Digestive system

Diarrhea (1.0%); vomiting (1.0%).

Nervous System/Psychiatric

Headache (2.3%).

Respiratory system

Pharyngitis (1.5%); upper respiratory infection (1.1%); cough (1.0%).

Laboratory Findings

Very few laboratory abnormalities were reported and included isolated reports of elevated liver function tests, eosinophilia, and increased urine protein.

Adults — 19 Years of Age and Older

In combined clinical trials involving 1512 healthy adults who received one or more ~50U doses of hepatitis A vaccine, subjects were followed for fever and local complaints during a 5-day period postvaccination and systemic complaints during a 14-day period postvaccination. Injection-site complaints, generally mild and transient, were the most frequently reported complaints. Listed below are the complaints reported by ≥ 1% of subjects, without regard to causality, in decreasing order of frequency within each body system.

Localized Injection-Site Reactions

Tenderness (52.7%); pain (51.1%); warmth (17.4%); swelling (13.8%); erythema (13.1%); ecchymosis (1.5%); pain/soreness (1.2%).

Body As a whole

Asthenia/fatigue (3.9%); fever (2.7%); abdominal pain (1.3%).

Digestive system

Diarrhea (2.5%); nausea (2.3%).

Musculoskeletal System

Myalgia (1.9%); arm pain (1.3%); back pain (1.1%); stiffness (1.0%).

Nervous System/Psychiatric

Headache (16.0%).

Respiratory System

Pharyngitis (2.7%); upper respiratory infection (2.7%); nasal congestion (1.1%).

Urogenital System

Menstruation disorder (1.1%).

Allergic Reactions

Local and/or systemic allergic reactions that occurred in < 1% of children/adolescents or adults in clinical trials regardless of causality included:

Local

Injection site pruritus and/or rash.

Systemic

Bronchial constriction; asthma; wheezing; edema/swelling; rash; generalized erythema; urticaria; pruritus; eye irritation/itching; dermatitis. (See CONTRAINDICATIONS and WARNINGS.)

Marketed Experience

The following additional adverse reactions have been reported with use of the marketed vaccine.

Hemic And Lymphatic System

Very rarely, thrombocytopenia.

Nervous System

Very rarely, Guillain-Barré syndrome, cerebellar ataxia, encephalitis.

Post-marketing Safety Study

In a post-marketing, short-term 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 (hepatitis a vaccine, inactivated) ¹⁰ (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 indicated. There was no serious, vaccine-related, adverse event identified among the 42,110 vaccine recipients in this study. Diarrhea/gastroenteritis, resulting in outpatient visits, was determined by the investigator to be the only vaccine-related nonserious adverse event in the study. There was no vaccine-related adverse event identified that had not been reported in earlier clinical trials with VAQTA (hepatitis a vaccine, inactivated) .

REFERENCES

3. Werzberger, A., et al: A Controlled trial of a formalin-inactivated hepatitis A vaccine in healthy children, NEJM 327(7): 453-457, 1992.

9. Recommendations of the Advisory Committee on Immunization Practices (ACIP); Prevention of Hepatitis A Through Active or Passive Immunization, MMWR 42(RR-4): 1-18, 1993.

10.Black, S., et al: A postlicensure evaluation of the safety of inactivated hepatitis A vaccine (VAQTA® (hepatitis a vaccine, inactivated) , Merck) in children and adults, Vaccine 22: 766-772, 2004.

Last reviewed on RxList: 3/5/2009
This monograph has been modified to include the generic and brand name in many instances.