GSK-444563/023

Study Sponsor: GSK

Study Title

A placebo-controlled, multi-country & multi-center study to assess the efficacy, safety & immunogenicity of 2 doses of GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine in healthy infants

Medicine or Vaccine (generic name)

Rotavirus Vaccine

Sponsor Identification Number

444563/023

Trial Registry Identification Number(#'s)

NCT00140673

Medical Condition

Infections, Rotavirus

Phase

Phase 3

Link to study details on the GSK Clinical Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=444563/023

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

http://clinicaltrials.gov/show/NCT00140673

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	Ready to Share

Additional information about the data and documents available for this study

Date Added to this Site

September 2013