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 2015-001540-10

Medical Condition

Infections, Rotavirus

Phase

Phase 3

Link to GSK Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=444563/024

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

http://clinicaltrials.gov/show/NCT00139347

Link to study details on EudraCT (if available)

https://www.clinicaltrialsregister.eu/ctr-search/search?query=2015-001540-10

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

A link to ClinicalTrials.gov and an NCTID number are not available for this study because the study is not in scope of regulatory requirements to register studies.

Date Added to this Site

January 2014