CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 1,259 enrolled
Drug / intervention
GSK Biological's investigational vaccine 209762 +4 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00861744
NCT00861744Phase 2Completed

A Phase II, Randomized, Observer Blind, Controlled, Multicenter Study to Assess Immunogenicity and Antibody Persistence Following Vaccination With GSK's Candidate Combined Measles, Mumps, and Rubella Vaccine (MMR) Versus M-M-R® II as a First Dose, Both Administered Subcutaneously at 12-15 Months of Age, Concomitantly With Hepatitis A Vaccine (HAV), Varicella Vaccine (VV) and Pneumococcal Conjugate Vaccine (PCV) But at Separate Sites.

GlaxoSmithKline·interventional·Posted Mar 13, 2009·Updated Jan 3, 2020

In Brief

A Phase 2 clinical trial evaluating GSK Biological's investigational vaccine 209762, M-M-R® II (Merck and Co), and 3 other interventions for Rubella and 3 related conditions. Completed, enrolled 1,259 participants across 48 sites in 2 countries.

Detailed Summary

The purpose of this study is to compare two measles, mumps and rubella conjugate vaccines (manufactured by GSK and Merck and Company ) in terms of the immune response elicited and safety with a six month follow-up after first vaccination. Additionally, antibody persistence will be assessed one and two years after administration of MMR vaccine. The Protocol Posting has been updated following Protocol amendment 1 and 2, Oct 2009.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 13, 2009
Enrollment StartJun 3, 2009
Primary CompletionJul 21, 2010
Study CompletionJun 18, 2012
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 17.3 years ago

Interventions

GSK Biological's investigational vaccine 209762biological

Subcutaneous injection, one dose

M-M-R® II (Merck and Co)biological

Subcutaneous injection, one dose

Varivax®biological

Subcutaneous injection, one dose

Havrix®biological

Intramuscular injection, one dose

Prevnar®biological

Intramuscular injection, one dose