GSK-109810

Study Sponsor: GSK

Study Title

To assess long-term efficacy & safety of subjects approximately 3 years after priming with 2 doses of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated human rotavirus (HRV) vaccine (Rotarix) in the primary vaccination study (102247).

Medicine or Vaccine (generic name)

Rotavirus Vaccine

Sponsor Identification Number

109810

Trial Registry Identification Number(#'s)

NCT00420316

Medical Condition

Infections, Rotavirus

Phase

Phase 3

Link to GSK Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=109810

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

http://clinicaltrials.gov/show/NCT00420316

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

This is a follow-up study to 102247. A link to ClinicalTrials.gov and an NCTID number is not available for this study because the study is not in scope of regulatory requirements to register studies.

Date Added to this Site

January 2014