GSK-104567

Study Sponsor: GSK

Study Title

Phase IIIb, multicentre study to assess safety & immunogenicity of GSK Biologicals’ combined DTPa/Hib (Infanrix/Hib) vaccine vs separate administration of DTPa (Infanrix) & Hib (Hiberix) vaccines in healthy infants 3,4,&5 months of age as compared with the separate administration of DTPa and Hib vaccines at different injection sites.

Medicine or Vaccine (generic name)

Diphtheria, Tetanus, Acellular Pertussis Vaccine Adsorbed

Sponsor Identification Number

104567

Trial Registry Identification Number(#'s)

NCT00412854

Medical Condition

Acellular pertussis; Diphtheria; Tetanus

Phase

Phase 3

Link to GSK Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=104567

Link to study details on ClinicalTrials.gov (if available)

http://clinicaltrials.gov/show/NCT00412854

Link to study details on EudraCT (if available)

Datasets and Documents Available for this Study

Raw dataset	Annotated case report form	Dataset specifications	Protocol with any amendments
Analysis-ready dataset	Reporting and analysis plan	Clinical study report	Ready to Share

Additional information about the data and documents available for this study

Date Added to this Site

May 2013