GSK-115461 (Rota-081)

Study Sponsor: GSK

Study Title

Immunogenicity and safety study of two formulations of GlaxoSmithKline (GSK) Biologicals’ human rotavirus (HRV) vaccine (444563), in healthy infants starting at age 6-12 weeks

Medicine or Vaccine (generic name)

Rotavirus Vaccine

Sponsor Identification Number

115461 (Rota-081)

Trial Registry Identification Number(#'s)

NCT02914184 2016-000598-19

Medical Condition

Infections, Rotavirus

Phase

Phase 3

Link to study details on the GSK Clinical Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=115461

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

http://clinicaltrials.gov/show/NCT02914184

Link to study details on EudraCT (if available)

https://www.clinicaltrialsregister.eu/ctr-search/search?query=/2016-000598-19

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

Date Added to this Site

June 2020