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General Information
Havrix (Hepatitis A Vaccine) is a sterile suspension of inactivated virus for intramuscular administration.
Havrix is specifically indicated for r active immunization against disease caused by hepatitis A virus (HAV). Havrix is approved for use in persons 12 months of age and older. Primary immunization should be administered at least 2 weeks prior to expected exposure to HAV.
Havrix is administered by intramuscular injection.
Children and adolescents: A single 0.5-mL dose and a 0.5-mL booster dose administered between 6 to 12 months later.
Adults: A single 1-mL dose and a 1-mL booster dose administered between 6 to 12 months later
Mechanism of Action
Havrix (Hepatitis A Vaccine) is a sterile suspension of inactivated virus for intramuscular administration. The hepatitis A virus belongs to the picornavirus family. It is 1 of several hepatitis viruses that cause systemic disease with pathology in the liver. The incubation period for hepatitis A averages 28 days (range: 15 to 50 days).1 The course of hepatitis A infection is extremely variable, ranging from asymptomatic infection to icteric hepatitis and death. The presence of antibodies to HAV confers protection against hepatitis A infection. However, the lowest titer needed to confer protection has not been determined.
Side Effects
The most common adverse events in clinical trials were injection site soreness and headache.
Clinical Trial Results
Vaccination induced production of antibodies in up to 98% of adults and in up to 96% of children and adolescents within 15 days of the primary injection.
Approval Date: 1996-03-01
Company Name: GlaxoSmithKline