GSK-217744/070 (DTPa-HBV-IPV-070)

Study Sponsor: GSK

Study Title

An open clinical study to assess the immunogenicity and safety of GSK Bio’s DTPa-HBV-IPV vaccine mixed in one syringe with Hib vaccine, as a primary vaccination course to pre-term infants(

Medicine or Vaccine (generic name)

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

Sponsor Identification Number

217744/070 (DTPa-HBV-IPV-070)

Trial Registry Identification Number(#'s)

NCT00366366

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=217744/070

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

http://clinicaltrials.gov/show/NCT00366366

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.

Date Added to this Site

June 2015