GSK-444563/006

Study Sponsor: GSK

Study Title

To assess the efficacy, immuno & safety of 2 doses of GSK HRV vaccine at different virus concentrations in healthy infants aged 2 months & previously uninfected with HRV, concurrently given with DTPw-HBV, Hib.

Medicine or Vaccine (generic name)

Rotavirus Vaccine

Sponsor Identification Number

444563/006

Trial Registry Identification Number(#'s)

NCT00385320

Medical Condition

Infections, Rotavirus

Phase

Phase 2

Link to GSK Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=444563/006

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

http://clinicaltrials.gov/show/NCT00385320

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

An annotated case report form is not available for this study. A blank case report form will be provided.

Date Added to this Site

June 2015