GSK-106602

Study Sponsor: GSK

Study Title

Immunogenicity, Reactogenicity & Safety of a Booster Dose of GSK Biologicals’ DTPw-HBV/Hib Kft Vaccine Vs GSK Biologicals’ DTPw-HBV/Hib Vaccine, in Infants Who Received a 3-Dose Primary Vaccination Course With the Same Vaccines.

Medicine or Vaccine (generic name)

Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine (KFT)

Sponsor Identification Number

106602

Trial Registry Identification Number(#'s)

NCT00332566

Medical Condition

Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis

Phase

Phase 3

Link to GSK Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=106602

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

http://clinicaltrials.gov/show/NCT00332566

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

October 2014