• Vaccine Name: Havrix
• Target Pathogen: Hepatitis A virus
• Target Disease: Hepatitis A
• Product Name: Hepatitis A Vaccine, Inactivated
• Tradename: Havrix
• Manufacturer: GlaxoSmithKline Biologicals
• Vaccine Ontology ID: VO_0000052
• CDC CVX code: 52, 83
• Type: Inactivated or "killed" vaccine
• Status: Licensed
• Location Licensed: USA (License #1617), Canada
• Host Species for Licensed Use: Human
• Antigen: Hepatitis A Vaccine, Inactivated
• Adjuvant:
  • Adjuvant name:
  • VO adjuvant ID: VO_0000884
  • Description: Aluminum hydroxide
• Preservative: 2 phenoxy ethanol (PE)
• Preparation: HAVRIX (Hepatitis A Vaccine) is a sterile suspension of inactivated virus for intramuscular administration. The virus (strain HM175) is propagated in MRC-5 human diploid cells. After removal of the cell culture medium, the cells are lysed to form a suspension. This suspension is purified through ultrafiltration and gel permeation chromatography procedures. Treatment of this lysate with formalin ensures viral inactivation. Viral antigen activity is detected by ELISA and expressed in terms of ELISA Units (EL.U.) (FDA: Havrix).
• Immunization Route: Intramuscular injection (i.m.)
• Storage: Store refrigerated between 2° and 8°C (36° and 46°F) (FDA: Havrix).
• Approved Age for Licensed Use: Ages greater than 12 months (FDA: Havrix).
• Contraindication: HAVRIX can cause a severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis A-containing vaccine, or to any component of HAVRIX, including neomycin. Hepatitis A vaccine may not prevent hepatitis A infection in individuals who have an unrecognized hepatitis A infection at the time of vaccination (FDA: Havrix).
• Description: Indication: To support lowering the age indication for Havrix from two years to 12 months of age (FDA: Havrix).

Human Response

• Vaccination Protocol: A double-blind, randomized controlled study was conducted in school children (age 1 to 16 years) in Thailand who were at high risk of Hepatitis A Virus (HAV) infection. A total of 40,119 children were vaccinated with either HAVRIX or ENGERIX-B at 0, 1, and 12 months. 19,037 children received a primary course (doses at 0 and 1 months) of HAVRIX and 19,120 children received a primary course (doses at 0 and 1 months) of ENGERIX-B (FDA: Havrix).
• Immune Response: In response to vaccination, 32 cases of clinical hepatitis A occurred in the control group. In the HAVRIX group, 2 cases were identified. These 2 cases were mild in terms of both biochemical and clinical indices of hepatitis A disease.
• Side Effects: Side Effects of HAVRIX included: injection site pain, redness and swelling, irratibility, loss of appetite, and drowsiness.
• Efficacy: In response to vaccination, 32 cases of clinical hepatitis A occurred in the control group. In the HAVRIX group, 2 cases were identified. These 2 cases were mild in terms of both biochemical and clinical indices of hepatitis A disease. Therefore, the efficacy rate for prevention of clinical hepatitis A was 94% (FDA: Havrix).

Human Response

• Vaccination Protocol: A multicenter study administered 720 EL.U./0.5mL of HAVRIX into infants 11 months and older. The same sample size and concentration was also administered in another study of infants 2 years of age and older (FDA: Havrix).
  
  In the 11 months and older study, each infant was administered either HAVRIX or were coadministered HAVRIX and INFANRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) and Haemophilus influenzae type b (Hib) conjugate vaccine (tetanus toxoid conjugate).
• Side Effects: The most common side effects recorded with this dosage concentration and amount were: injection site pain, redness, swelling, irritability, drowsiness, and loss of appetite

Human Response

• Vaccination Protocol: A clinical study of children 2 years and older administered HAVRIX at 360 EL.U, and were given the follow-up booster shots at 1 and 6 months after the initial shot (FDA: Havrix).
• Immune Response: After subjects were seropositive before each addtional booster was administered.
• Side Effects: Side effects recorded included: pain, and redness of the injection site, swelling, irritability, drowsiness and loss of appetite.