GSK-444563/024

Study Sponsor: GSK

Study Title

A multi-country & multi-center study to assess the efficacy, immunogenicity & safety of two doses of GSK Biologicals' oral live attenuated HRV vaccine given concomitantly with routine EPI vaccinations including OPV in healthy infants

Medicine or Vaccine (generic name)

Rotavirus Vaccine

Sponsor Identification Number

444563/024

Trial Registry Identification Number(#'s)

NCT00139347

Medical Condition

Infections, Rotavirus

Phase

Phase 3

Link to GSK Study Register

http://www.gsk-clinicalstudyregister.com/study/444563/024

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

http://clinicaltrials.gov/show/NCT00139347

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

Additional information about the data and documents available for this study

A link to Clinicaltrials.gov and a NCT ID number is not available for this study because the study was conducted before regulatory requirements to register studies.

Date Added to this Site

January 2014