GSK-107531

Study Sponsor: GSK

Study Title

Assess the immunogenicity of 3 doses of Pediarix®, Prevnar® & ActHIB® given to healthy infants when administered with GSK Biologicals’ 2 dose oral live attenuated human rotavirus vaccine given during the same vaccination visit or separately

Medicine or Vaccine (generic name)

Rotavirus Vaccine

Sponsor Identification Number

107531

Trial Registry Identification Number(#'s)

NCT00334607 2011-004061-32

Medical Condition

Infections, Rotavirus

Phase

Phase 3

Link to GSK Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=107531

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

http://clinicaltrials.gov/show/NCT00334607

Link to study details on EudraCT (if available)

https://www.clinicaltrialsregister.eu/ctr-search/search?query=2011-004061-32

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

January 2014