For active immunization of persons 12 months and 15y/o children against disease caused by hepatitis A virus (HAV).

Vaccine; Vaccine, Inactivated (Viral)

Onset of action: Protective antibodies develop in 95% of adults after the first dose and in 100% of adults after the second dose of the vaccine; ?97% of children and adolescents will be seropositive within 1 month of the first dose and 100% will develop protective antibodies after receiving two doses. The efficacy of preventing hepatitis A disease in children living in highly infected areas is 94% to 100% (CDC 2015). Duration: Protective antibodies induced by the vaccine may persist for ?17 years (CDC 2015).

Immediate and/or severe allergic or hypersensitivity reaction to hepatitis A containing vaccines or any component of the formulation, including neomycin.

C

It is not known if this vaccine is excreted into breast milk. The manufacturer recommends that caution be used if administered to breastfeeding women. Administration does not affect the safety of breastfeeding for the mother or the infant. Breastfeeding infants should be vaccinated according to the recommended schedules (ACIP [Kroger 2017]).

Common Dermatologic: Erythema (20% to 23.9%), Injection site induration (1% to 10% ), Injection site pain (21% to 56% ), Swelling (8.7% to 10.2%) Gastrointestinal: Loss of appetite (1% to 26.1% ), Nausea (1% to 10% ) Neurologic: Headache (less than 9% to 14%), Irritability (27.2% to 43.9% ), Somnolence (20.8% to 35.3% ) Other: Fatigue (1% to 10% ), Fever (0.4% to 10% ), Malaise (1% to 10% ) Serious Dermatologic: Erythema multiforme Hematologic: Thrombocytopenia Hepatic: Hepatitis, Jaundice Immunologic: Anaphylactoid reaction, Anaphylaxis Neurologic: Encephalopathy, Guillain-Barr? syndrome, Seizure Other: Angioedema, Transfusion reaction due to serum protein reaction

IM: 0.5 mL per dose for a total of two doses. The series should be initiated at 12 months to 15 y/o children of age; the two doses should be separated by 6 to 36 months

There are no dosage adjustments provided in the manufacturer's labeling.

There are no dosage adjustments provided in the manufacturer's labeling; however, data suggest patients with chronic liver disease have a lower antibody response to Havrix product than healthy subjects.

store between 2-8 degree C