CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 4,011 enrolled
Drug / intervention
Priorix +3 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/NCT01621802
NCT01621802Phase 3Completed
CompareCT.gov

Immunogenicity and Safety Study of GSK Biologicals' Combined Measles-mumps-rubella Vaccine in Subjects Four to Six Years of Age (209762)

GlaxoSmithKline·interventional·Posted Jun 18, 2012·Updated Nov 25, 2019

In Brief

A Phase 3 clinical trial evaluating Priorix, M-M-R II, and 2 other interventions for Measles-Mumps-Rubella. Completed, enrolled 4,011 participants across 67 sites in 3 countries.

Detailed Summary

The purpose of this study is to support licensure of GSK Biologicals' MMR vaccine (Priorix®) in the US by generating immunogenicity and safety data in contrast to the US standard of care, Merck's MMR vaccine (M-M-R®II), when given as a second dose to children four to six years of age.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeasles-Mumps-Rubella
CountriesSouth Korea, Taiwan, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 18, 2012
Enrollment StartJun 21, 2012
Primary CompletionJul 6, 2015
Study CompletionNov 9, 2015
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 14.0 years ago

Interventions

Priorixbiological

One dose administered subcutaneously in the triceps region of the right arm.

M-M-R IIbiological

One dose administered subcutaneously in the triceps region of the right arm.

Kinrixbiological

One dose administered by deep intramuscular injection in the upper left deltoid.

ProQuadbiological

One dose administered subcutaneously in the triceps region of the left arm.