GSK-217744/097 (DTPa-HBV-IPV-097)

Study Sponsor: GSK

Study Title

Study to assess immunogenicity and reactogenicity of three doses of GSK Bio’s combined Hib-MenC vaccine co-admind with GSK Bio’s DTPa-HBV-IPV vaccine and of two doses of Baxters meningococcal C conjugate vaccine co-admind with GSK Bio’s DTPa-HBV-IPV/Hib vaccine

Medicine or Vaccine (generic name)

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

Sponsor Identification Number

217744/097 (DTPa-HBV-IPV-097)

Trial Registry Identification Number(#'s)

NCT00352963

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=217744/097

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

http://clinicaltrials.gov/show/NCT00352963

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

Follow-on studies 106672, 106673, 106675, 106679 and 106680 were conducted. 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