GSK-112269

Study Sponsor: GSK

Study Title

Immunogenicity, reactogenicity and safety study to evaluate two doses of the lyophilised formulation of the human rotavirus (HRV) vaccine when administered to healthy Korean infants previously uninfected with HRV

Medicine or Vaccine (generic name)

Rotavirus Vaccine

Sponsor Identification Number

112269

Trial Registry Identification Number(#'s)

NCT00969228 2015-001545-81

Medical Condition

Infections, Rotavirus

Phase

Phase 4

Link to study details on the GSK Clinical Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=112269

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

http://clinicaltrials.gov/show/NCT00969228

Link to study details on EudraCT (if available)

https://www.clinicaltrialsregister.eu/ctr-search/search?query=2015-001545-81

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

May 2013