GSK-217744/077 (DTPa-HBV-IPV-077)

Study Sponsor: GSK

Study Title

A phase III, double-blind, randomized, multicenter primary vaccination study to bridge the DTPa-HBV-IPV vaccine manufactured according to the large scale manufacturing process with the DTPa-HBV-IPV vaccine manufactured by the small scale manufacturing process when administered intramuscularly to infants at 2, 4 and 6 months of age, co-administered with Merck's Hib conjugate vaccine (Liquid PedvaxHIB®) in a separate injection at 2 and 4 months of age

Medicine or Vaccine (generic name)

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

Sponsor Identification Number

217744/077 (DTPa-HBV-IPV-077)

Trial Registry Identification Number(#'s)

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=217744/077

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

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

An annotated case report form is not available for this study. A blank case report form will be provided. A link to ClinicalTrials.gov and an NCTID number are not available for this study because the study is not in scope of regulatory requirements to register studies.

Date Added to this Site

September 2013