DESCRIPTION
HAVRIX (Hepatitis A Vaccine, Inactivated) is a noninfectious hepatitis A vaccine developed and manufactured by GlaxoSmithKline Biologicals. The virus (strain HM175) is propagated in MRC5 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. HAVRIX contains a sterile suspension of inactivated virus; viral antigen activity is referenced to a standard using an enzyme linked immunosorbent assay (ELISA), and is therefore expressed in terms of ELISA Units (EL.U.).
HAVRIX is supplied as a sterile suspension for intramuscular administration. The vaccine is ready for use without reconstitution; it must be shaken before administration since a fine white deposit with a clear colorless supernatant may form on storage. After shaking, the vaccine is a slightly turbid white suspension.
Each 1-mL adult dose of vaccine consists of not less than 1440 EL.U. of viral antigen, adsorbed on 0.5 mg of aluminum as aluminum hydroxide.
There are 2 pediatric dose formulations, each with its own dosing schedule (see DOSAGE AND ADMINISTRATION). The formulations are: Not less than 360 EL.U. of viral antigen/0.5 mL; not less than 720 EL.U. of viral antigen/0.5 mL. Each dose is adsorbed onto 0.25 mg of aluminum as aluminum hydroxide.
The vaccine preparations also contain 0.5% (w/v) of 2-phenoxyethanol as a preservative. Other excipients are: Amino acid supplement (0.3% w/v) in a phosphate-buffered saline solution and polysorbate 20 (0.05 mg/mL). Residual MRC5 cellular proteins (not more than 5 mcg/mL) and traces of formalin (not more than 0.1 mg/mL) are present. Neomycin sulfate, an aminoglycoside antibiotic, is included in the cell growth media; only trace amounts (not more than 40 ng/mL) remain following purification.
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