GSK-105910

Study Sponsor: GSK

Study Title

Compare immunogenicity & reactogenicity of 2 formulations of GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine (new vs current) given in healthy infants. The DTPa-HBV-IPV vaccine (new formulation) will also be assessed in a 3rd group of subjects

Medicine or Vaccine (generic name)

Combined Diphtheria, Tetanus, Acellular Pertussis Adsorbed, Hepatitis B (Recombinant), Inactivated Polio Vaccine

Sponsor Identification Number

105910

Trial Registry Identification Number(#'s)

NCT00320463 2012-002427-15

Medical Condition

Acellular pertussis; Diphtheria; Hepatitis B; Poliomyelitis; Tetanus

Phase

Phase 3

Link to GSK Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=105910

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

http://clinicaltrials.gov/show/NCT00320463

Link to study details on EudraCT (if available)

https://www.clinicaltrialsregister.eu/ctr-search/search?query=2012-002427-15

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

An annotated case report form is not available for this study. A blank case report form will be provided.

Date Added to this Site

September 2013