GSK-106786

Study Sponsor: GSK

Study Title

A study to evaluate the immunogenicity and safety of a new formulation of GSK Biologicals' DTPa-HBV-IPV/Hib vaccine as compared to the currently licensed Infanrix hexa in healthy infants (2,3,4 M)

Medicine or Vaccine (generic name)

Combined Diphtheria, Tetanus, Acellular Pertussis, Hepatitis B, Inactivated Polio, Haemophilus influenzae Type b Vaccine

Sponsor Identification Number

106786

Trial Registry Identification Number(#'s)

NCT00376779 2006-000554-46

Medical Condition

Acellular pertussis; Diphtheria; Haemophilus influenzae type b; Hepatitis B; Poliomyelitis; Tetanus

Phase

Phase 2

Link to GSK Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=106786

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

http://clinicaltrials.gov/show/NCT00376779

Link to study details on EudraCT (if available)

https://www.clinicaltrialsregister.eu/ctr-search/search?query=2006-000554-46

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

September 2013