GSK-208136/040

Study Sponsor: GSK

Study Title

Study to evaluate immunogenicity and safety of three production lots of GSK Biologicals' combined MeMuRu-OKA candidate vaccine given on a two-dose schedule to healthy children, as compared to separate administration of GSK Biologicals' Priorix® and Varilrix® vaccines

Medicine or Vaccine (generic name)

Combined Measles, Mumps, Rubella, Varicella Vaccine

Sponsor Identification Number

208136/040

Trial Registry Identification Number(#'s)

Medical Condition

Measles; Mumps; Rubella; Varicella

Phase

Phase 3

Link to GSK Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=208136/040

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

This is a Year 2 follow-up study to 208136/038. 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 are not available for this study because the study is not in scope of regulatory requirements to register studies.

Date Added to this Site

February 2015