TABLE 1.

Clinical trials with DTPa/Hib and DTPw/Hib vaccinesa

Study (study date [day-mo-yr])SchedulePrimary vaccinationBooster vaccinationStudy objective
United States, DTPa-HBV-IPV-Hib-001 (245917/001) (24-07-1996 to 28-04-1998)2, 4, 6 mo; booster, 15-18 moDTPa-HBV-IPV/Hib (Infanrix HeXa)DTPa/Hib (Infanrix/Hib)Comparison of the immune responses to a combination of components and immune responses to the components injected separately
DTPa + HBV + OPV + Hib (Hib: OmniHIB)DTPa + Hib (Hib: OmniHIB)
Germany A, Hib-006 (208108/006) (20-08-1993 to 28-08-1995)3, 4, 5 mo; booster, 15-27 moDTPa/Hib (Hib: Hiberix)DTPa/HibComparison of the immune responses against Hib whether combined or coadministered with DTPa
DTPa + Hib (Hib: Hiberix)DTPa + Hib (Hib: Hiberix)
Germany B, Hib-026 (208108/026) (09-06-1994 to 02-04-1996)3, 4, 5 mo; booster, 18-24 moDTPa-HBV + Hib (Hib: Hiberix)dtpa-HBV + PRP (plain polysaccharide)Comparison of the immune responses against Hib when coadministered or combined with DTPa-HBV and to evaluate immunological priming with plain polysaccharide booster
DTPa-HBV/Hib (Hib: Hiberix)dtpa-HBV/PRP (plain polysaccharide)
Myanmar, Hib-052 (208108/052) (16-01-1998 to 11-10-1999)6, 10, 14 wk; booster, 15-19 moDTPw-HBV/Hib2.5DTPw-HBV/Hib2.5 + MMRComparison of two different doses of Hib in combination with DTPw-HBV
DTPw-HBV/Hib (TritanrixHepB/Hiberix)DTPw-HBV/Hib (TritanrixHepB/Hiberix) + MMR
  • a dtpa, experimental DTPa vaccine with reduced antigen content; Hib2.5, Hib vaccine containing 2.5 μg PRP conjugated to TT; MMR, combined measles mumps rubella vaccine; OPV, oral poliovirus vaccine. All vaccines were manufactured by GSK Biologicals, with the exception of OmniHIB (Sanofi Pasteur). All Hib vaccines were conjugated to TT. In the vaccine formulations, a hyphen indicates the components of a solution, a slash indicates the reconstitution of a lyophilisate, and a plus indicates coadministration.