GSK-103992

Study Sponsor: GSK

Study Title

Evaluate immunogenicity, reactogenicity & safety of 2 doses of GSK Biologicals’ oral live attenuated HRV vaccine (RIX4414 at 106.5 CCID50) when given concomitantly with OPV versus given alone (HRV vaccine dose given 15 days after the OPV dose) in healthy infants in Bangladesh

Medicine or Vaccine (generic name)

Rotavirus Vaccine

Sponsor Identification Number

103992

Trial Registry Identification Number(#'s)

NCT00139334 2011-004060-30

Medical Condition

Infections, Rotavirus

Phase

Phase 2

Link to GSK Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=103992

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

http://clinicaltrials.gov/show/NCT00139334

Link to study details on EudraCT (if available)

https://www.clinicaltrialsregister.eu/ctr-search/search?query=2011-004060-30

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

January 2014