GSK-107072

Study Sponsor: GSK

Study Title

A phase III, double-blind, randomized, placebo-controlled, multi-country and multi-center study to assess the efficacy and safety of two doses of GSK Biologicals' oral live attenuated human rotavirus (HRV) vaccine in healthy infants.

Medicine or Vaccine (generic name)

Rotavirus Vaccine

Sponsor Identification Number

107072

Trial Registry Identification Number(#'s)

NCT00329745

Medical Condition

Infections, Rotavirus

Phase

Phase 3

Link to GSK Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=107070

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

http://clinicaltrials.gov/show/NCT00329745

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

The results of this study 107072 are summarised with studies 444563/028, 444563/029, 444563/030, 107070, and 107076 on the GSK Study Register. An annotated case report form is not available for this study. A blank case report form will be provided. A link to ClinicalTrials.gov and an NCTID number is 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