GSK-444563/002 (rota-002)

Study Sponsor: GSK

Study Title

A phase I, double-blind, randomized, placebo-controlled study of the safety and reactogenicity of GSK Biologicals’ live attenuated human rotavirus vaccine at 2 different virus concentrations in healthy seropositive children between 1 and 3 years of age, when given as a single oral administration

Medicine or Vaccine (generic name)

Rotavirus Vaccine

Sponsor Identification Number

444563/002 (rota-002)

Trial Registry Identification Number(#'s)

Medical Condition

Infections, Rotavirus

Phase

Phase 1

Link to GSK Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=444563/002

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

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 reporting and analysis plan is not available for this study. A link to ClinicalTrials.gov and an NCTID number are not available for this study because the study is not in scope of regulatory requirements to register studies.

Date Added to this Site

June 2015