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 DTaP Vaccine/GSK (Infanrix); Poliovirus Vaccine (IPV)/GSK; Hepatitis B Vaccine, rDNA/GSK (Engerix-B); and Haemophilus b Vaccine/GSK (OmniHIB). See also the entries for Diphtheria Toxoid Products; Tetanus Toxoid Products; Pertussis Vaccines, Acellular; Polio Vaccine Products; Hepatitis B Virus Vaccine Products; and Haemophilus b Vaccine Products. See also DTaP-Hib-HBV, rDNA-IPV/Sanofi (HEXAVAX), another vaccine with the same basic components.

Description: Infanrix Hexa refers to lyophilized (freeze-dried) and aqueous formulations of a hexavalent (six component) combination vaccine containing diphtheria toxoid, tetanus toxoid, three acellular pertussis antigens [pertussis toxoid (PT); filamentous hemagglutinin (FHA); and pertactin], recombinant Saccharomyces cerevisiae (yeast)-expressed hepatitis B virus surface antigen (HBsAg); three strains of inactivated poliovirus (IPV); and Haemophilus influenzae type b capsular polysaccharide–tetanus toxoid (PRP-T) conjugate vaccine. This vaccine is essentially a combination of trivalent Infanrix (DTaP); inactivated poliovirus vaccine (IPV); Engerix-B (recombinant HBsAg vaccine); and OmniHIB [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)]. The diphtheria, tetanus, pertussis, Haemophilus B, and hepatitis B antigens are separately adsorbed onto aluminum hydroxide or aluminum phosphate adjuvant.

Infanrix Hexa is packaged as a suspension in prefilled syringes and as powder in vials. Each 0.5 mL dose for intramuscular injection contains diphtheria toxoid, adsorbed, ≥30 IU; tetanus toxoid, adsorbed, ≥40 IU; pertussis antigens [pertussis toxoid, 25 µg; filamentous hemagglutinin (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; inactivated polioviruses [type 1, 40 DU; type 2, 8 DU, and type 3, 32 DU); and Haemophilus influenzae type b capsular polysaccharide (PRP; 10 µg) conjugated to tetanus toxoid (PRT-T), 20-40 µg. Excipients include 2-phenoxyethanol, 2.5 mg; sodium chloride; Medium 199; and Water for Injection. The vaccine contains a total of 0.82 mg aluminum, including 0.5 mg 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 (refrigerated).

Nomenclature: DTaP-Hib-HBV, rDNA-IPV/GSK [BIO]; Infanrix Hexa [TR]; Combined Diphtheria, Tetanus, acellular Pertussis, Hepatitis B, inactivated Poliovirus and Haemophilus influenzae type b vaccine [EU common name]

Companies.: Infanrix Hexa 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, poliomyelitis and disease caused by Haemophilus influenzae type b.

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 starting at least six months of age and at least 6 months after completion of primary vaccination.

Market: In Sept. 2005, the European Union suspended sales of Hexavac (see entry below) due to concerns it may not offer adequate protection to its hepatitis B component. GlaxoSmithKline responded by increasing production of Infanrix hexa.