Status: marketed in Europe

Organizations involved:

GlaxoSmithKline Biologicals S.A. – Manuf.; R&D; Tech.; Europe mark.

GlaxoSmithKline plc – Parent

Cross ref.: See the entries for Diphtheria, Tetanus & Pertussis Vaccines (DTP/DTaP); DTaP Vaccine/GSK (Infanrix) and Hepatitis B Vaccine, rDNA/GSK (Engerix-B). See also the entries for Diphtheria Toxoid Products; Tetanus Toxoid Products; Pertussis Vaccines, Acellular; and Hepatitis B Virus Vaccine Products.

Description: Infanrix HepB is an aqueous formulation of a tetravalent combination vaccine containing diphtheria toxoid, tetanus toxoid, three acellular pertussis antigens [pertussis toxoid (PT); filamentous hemagglutinin (FHA); and pertactin], and recombinant Saccharomyces cerevisiae (yeast)-expressed hepatitis B virus surface antigen (HBsAg). It was developed as and is essentially the combination of Infanrix, a diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccine plus Engerix B recombinant HBsAg vaccine (with this component of Infanrix HepB adjuvanted with aluminum phosphate, while U.S.-approved Engerix-B uses aluminum hydroxide). The Infanrix component is an aqueous formulation containing adsorbed conventional diphtheria and tetanus toxoids (formaldehyde-inactivated toxins) plus an acellular Bordetella pertussis component including three antigens — pertussis toxoid (PT; formaldehyde inactivated pertussis toxin), filamentous hemagglutinin antigen (FHA), and pertactin (69 kDa outer membrane protein) — with each component vaccine individually adsorbed onto aluminum hydroxide adjuvant. The Engerix-B-like component contains recombinant nonglycosylated hepatitis B virus surface (s) antigen (HBsAg) from hepatitis B virus subtype adw2 produced by transformed Saccharomyces cerevisiae (yeast) strain DC5 (RT4376) as a suspension adsorbed onto aluminum phosphate adjuvant.

Each 0.5 mL dose contains diphtheria toxoid, ≥30 IU; tetanus toxoid, ≥40 IU; pertussis antigens [pertussis toxoid, 25 µg; filamentous hemagglutinin (FHA), 25 µg; and pertactin, 8 µg; each adsorbed on 0.5 mg aluminum hydroxide, 10 µg)]; and recombinant HBsAg adsorbed on aluminum phosphate (0.2 mg Al3+), 10 µg. Excipients include formaldehyde, 2-phenoxyethanol, sodium chloride and Water for Injection. The shelf life is 36 months when stored at 2-8˚C (refrigerated).

Nomenclature: DTaP-HBV, rDNA/GSK [BIO]; Infanrix HepB [TR]; Combined diphtheria, tetanus, acellular pertussis, and hepatitis B recombinant vaccine [EU common name]; Infanrix plus Engerix-B [SY]

Companies.: Infanrix HepB is manufactured and marketed in Europe by GlaxoSmithKline Biologicals S.A., a subsidiary of GlaxoSmithKline plc (GSK).

Status: European Union-wide approval was granted on July 30, 1997.

Indications: [European Union]: “for active immunization of all infants from the age of two months against diphtheria, tetanus, pertussis, and hepatitis B.”

Medical: Two primary vaccination regimens are approved for use in children and adolescents, a schedule starting at two months of age with two months between injections; and a schedule starting at three months with at least one month between doses. Currently, no booster regimen is recommended.