GSK-109995

Study Sponsor: GSK

Study Title

A phase IIIb, open, randomised, multicentre, primary study in healthy children, to establish the non-inferiority of GlaxoSmithKline (GSK) Biologicals’ MeMuRu-OKA vaccine (administered at 9 and 15 months of age) versus Priorix™ (9 months of age) and Priorix™ co-administered with Varilrix™ at 15 months of age (comparator) and also to evaluate the non-inferiority of Priorix™ (9 months of age) and MeMuRu-OKA vaccine (15 months of age) versus the comparator, all administered subcutaneously as two-dose primary vaccination course

Medicine or Vaccine (generic name)

Combined Measles, Mumps, Rubella, Varicella Vaccine

Sponsor Identification Number

109995

Trial Registry Identification Number(#'s)

NCT00969436 2011-005882-19

Medical Condition

Measles; Mumps; Rubella; Varicella

Phase

Phase 3

Link to GSK Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=109995

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

http://clinicaltrials.gov/show/NCT00969436

Link to study details on EudraCT (if available)

https://www.clinicaltrialsregister.eu/ctr-search/search?query=2011-005882-19

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

September 2015