GSK-102247

Study Sponsor: GSK

Study Title

A 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 in co-administration with specific childhood vaccines

Medicine or Vaccine (generic name)

Rotavirus Vaccine

Sponsor Identification Number

102247

Trial Registry Identification Number(#'s)

NCT00140686 2004-001175-19

Medical Condition

Infections, Rotavirus

Phase

Phase 3

Link to GSK Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=102247/036

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

http://clinicaltrials.gov/show/NCT00140686

Link to study details on EudraCT (if available)

https://www.clinicaltrialsregister.eu/ctr-search/search?query=2004-001175-19

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 follow-on study 109810 was conducted.

Date Added to this Site

January 2014