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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.

Author(s): Zepp F, Knuf M, Heininger U, Jahn K, Collard A, Habermehl P, Schuerman L, Sanger R

Affiliation(s): Children's Hospital, Johannes-Gutenberg-University, Langenbeckstrasse 1, 55101 Mainz, Germany. zepp@kinder.klinik.uni-mainz.de

Publication date & source: 2004-06-02, Vaccine., 22(17-18):2226-33.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

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.

Page last updated: 2006-01-31

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