GSK-217744/086 (DTPa-HBV-IPV-086)

Single-blind, multicentre, phase IV clinical trial to assess and compare the immunogenicity and reactogenicity of GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) and Aventis Pasteur’s DTPa-HBV-IPV-Hib vaccine (Hexavac™) given as a primary vaccination course at 2, 4 and 6 months of age.
Combined Diphtheria, Tetanus, Acellular Pertussis, Hepatitis B, Inactivated Polio, Haemophilus influenzae Type b Vaccine
217744/086 (DTPa-HBV-IPV-086)
Acellular pertussis; Diphtheria; Haemophilus influenzae type b; Hepatitis B; Poliomyelitis; Tetanus
Phase 4
A booster study 217744/095 was conducted. An annotated case report form is not available for this study. A blank case report form will be provided. A reporting and analysis plan is not available for this study. A link to and a NCT ID number are not available for this study because the study was conducted before regulatory requirements to register studies.
September 2013