Status: marketed in Europe, not U.S.

Organizations involved:

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

GlaxoSmithKline plc – Parent

Cross ref.: See the entries for DTaP Vaccine/GSK (Infanrix), Poliovirus Vaccine (IPV)/GSK, and Hepatitis B Vaccine, rDNA/GSK (Engerix-B). See the entry above for Pediarix, the comparable vaccine from GSK marketed in the U.S. See also the entries for Diphtheria Toxoid Products; Tetanus Toxoid Products; Pertussis Vaccines, Acellular; Poliovaccine Products; and Hepatitis B Virus Vaccine Products. See the entry for DTaP & Hepatitis B & Polio Vaccine, which is substantially similar to this vaccine.

Description: Infanrix penta is an aqueous formulation of a pentavalent combination vaccine containing diphtheria toxoid, tetanus toxoid, three acellular pertussis antigens [pertussis toxoid (PT); filamentous hemagglutiniin (FHA); and pertactin], recombinant Saccharomyces cerevisiae (yeast) strain DC5 (RT4376)-expressed hepatitis B virus surface antigen (HBsAg); and three strains of inactivated poliovirus (IPV). This vaccine is essentially a combination of trivalent Infanrix (DTaP); inactivated poliovirus vaccine (IPV); and Engerix-B (recombinant HBsAg vaccine), but with some differences in antigen composition. The diptheria, tetanus, pertussis antigens are adsorbed onto aluminum hydroxide (total 0.95 mg), and the recombinant HBsAg is adsorbed on aluminum phosphate (total 0.90 mg) adjuvant.

Infanrix penta is packaged as a suspension in prefilled syringes. Each 0.5 mL dose for intramuscular injection contains diptheria toxoid, adsorbed, ≥30 IU; tetanus toxoid, adsorbed, ≥40 IU; pertussis antigens [pertussis toxoid, 25 µg; filamentous hemaglutinin (FHA), adsorbed, 25 µg; and pertactin, adsorbed, 8 µg (each adsorbed on aluminum hydroxide)]; recombinant HBsAg adsorbed on aluminum phosphate (0.2 mg Al3+), 10 µg; and inactivated polioviruses [type 1, 40 DU; type 2, 8 DU, and type 3, 32 DU). Excipients include 2-phenoxyethanol, 2.5 mg; sodium chloride, 2.5 mg; Medium 199, 1.15 mg (containing 0.09 mg amino acids); lactose, 12.6 mg; and Water for Injection. The vaccine contains a total of 0.92 mg aluminum, including 0.5 mg as aluminum hydroxide and 0.32 mg aluminum phosphate (including 01.2 mg from the Haemophilus b component). The shelf life is 36 months when stored at 2-8˚C (refrigerated). 2-Phenoxyethanol is used as an antimicrobial preservative, because the use of aluminum gel adjuvants does allow final sterilization by filtration. Shelf life is 36 months when stored at 2-8˚C (refrigeated).

Nomenclature: DTaP-HBV, rDNA-IPV/EU [BIO]; Infanrix penta [TR]; Diphtheria, Tetanus, acellular Pertussis, Hepatitis B recombinant (adsorbed), inactivated Poliomyelitis vaccine [EU common name]; DTPa-HepB-IPV [SY];

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

Status: European Union approval was granted on Oct. 23, 2000.

Indications: [European Union]: “for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis B and poliomyelitis”

Medical: Primary vaccination involves three intramuscular doses one or more months apart within the first six months of life (with modification, if a hepatitis B vaccine was given at birth). Booster vaccination involves two doses at least one month apart startin at at least six months of age and at least 6 months after completion of primary vaccination.