GSK-444563/033

Study Sponsor: GSK

Study Title

Study to assess the clinical consistency of three production lots of GSK Biologicals’ HRV vaccine in terms of immunogenicity and safety when given to healthy infants at 2 and 4 months of age

Medicine or Vaccine (generic name)

Rotavirus Vaccine

Sponsor Identification Number

444563/033

Trial Registry Identification Number(#'s)

NCT00757770

Medical Condition

Infections, Rotavirus

Phase

Phase 3

Link to GSK Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=444563/033

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

http://clinicaltrials.gov/show/NCT00757770

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

An annotated case report form is not available for this study. A blank case report form will be provided. 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