GSK-104489

Study Sponsor: GSK

Study Title

Study to assess immunogenicity and safety of GlaxoSmithKline Biologicals' Kft’s DTPw-HBV/Hib vs DTPwCSL-HBV/Hib Kft and vs concomitant administration of CSL’s Triple Antigen and GlaxoSmithKline Biologicals’ Hiberix, to infants at 2, 4, 6 months of age, after a birth dose of hepatitis B

Medicine or Vaccine (generic name)

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

Sponsor Identification Number

104489

Trial Registry Identification Number(#'s)

NCT00316680 2011-003880-31

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=104489

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

http://clinicaltrials.gov/show/NCT00316680

Link to study details on EudraCT (if available)

https://www.clinicaltrialsregister.eu/ctr-search/search?query=2011-003880-31

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