GSK-444563/005 (rota-005)

Study Sponsor: GSK

Study Title

Phase II, double-blind, randomized, placebo-controlled study of 2 doses of GSK Bios’ live attenuated human rotavirus vaccine at different virus concentrations (10 5.2 and 10 6.4 ffu) in healthy infants following a 0, 2 month schedule and previously uninfected with human rotavirus

Medicine or Vaccine (generic name)

Rotavirus Vaccine

Sponsor Identification Number

444563/005 (rota-005)

Trial Registry Identification Number(#'s)

NCT00729001

Medical Condition

Infections, Rotavirus

Phase

Phase 2

Link to GSK Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=444563/005

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

http://clinicaltrials.gov/show/NCT00729001

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