Initial U.S. Approval: 1995
HAVRIX is a vaccine indicated for active immunization against disease caused by hepatitis A virus…
Clinical Trials Experience
Incidence <1% of Injections
– Pharyngitis, upper respiratory tract infections.
– Lymphadenopathy.
– Insomnia.
– Dysgeusia, hypertonia.
– Photophobia.
– Vertigo.
– Abdominal pain, diarrhea, vomiting.
– Pruritus, rash, urticaria.
– Arthralgia, myalgia.
– Injection site hematoma.
– Creatine phosphokinase increased.
Serious Adverse Events
Among subjects administered HAVRIX alone 1.0%… reported a serious adverse event.
[T]here were 4 reports of seizure within 31 days post-vaccination: these occurred 2, 9, and 27 days following the first dose of HAVRIX administered alone and 12 days following the second dose of HAVRIX. In 1 subject who received INFANRIX… and Hib conjugate vaccine followed by HAVRIX 6 weeks later, bronchial hyperreactivity and respiratory distress were reported on the day of administration of HAVRIX alone.
Postmarketing Experience
– Rhinitis.
– Thrombocytopenia.
– Anaphylactic reaction, anaphylactoid reaction, serum sickness–like syndrome.
– Convulsion, dizziness, encephalopathy, Guillain-Barré syndrome, hypoesthesia, multiple sclerosis, myelitis, neuropathy, paresthesia, somnolence, syncope.
– Vasculitis.
– Dyspnea.
– Hepatitis, jaundice.
– Angioedema, erythema multiforme, hyperhidrosis.
– Congenital anomaly.
– Musculoskeletal stiffness.
– Chills, influenza-like symptoms, injection site reaction, local swelling.
The virus… is propagated in MRC-5 human diploid cells.
Each 1-mL adult dose of vaccine contains… 0.5 mg of aluminum as aluminum hydroxide.
Each 0.5-mL pediatric dose of vaccine contains… 0.25 mg of aluminum as aluminum hydroxide.
HAVRIX also contains residual MRC-5 cellular proteins…
HAVRIX has not been evaluated for its carcinogenic potential, mutagenic potential, or potential for impairment of fertility.