Safety, reactogenicity and immunogenicity of a combined hexavalent tetanus, diphtheria, acellular pertussis, hepatitis B, inactivated poliovirus vaccine and Haemophilus influenzae type b conjugate vaccine, for primary immunization of infants

Abstract

Safety, reactogenicity and immunogenicity of GSK Biologicals’ hexavalent DTPa–HBV–IPV/Hib vaccine (Infanrix ®hexa) was assessed when used for primary vaccination at 3, 4 and 5 months of age ( N=2163), compared to the separate administration of DTPa–IPV/Hib and HBV vaccines ( N=720). A similar safety and reactogenicity profile was demonstrated for both vaccine regimens, as well as a good immune response for all antigen components. By offering protection against six diseases in a series of single injections, the hexavalent DTPa–HBV–IPV/Hib vaccine was shown to be a safe, well tolerated and immunogenic alternative to primary immunization with licensed separately administered vaccines.