CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,742 enrolled
Drug / intervention
Priorix +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/NCT02184572
NCT02184572Phase 3Completed
CompareCT.gov

Safety and Immunogenicity Study of GSK Biologicals' Measles-mumps-rubella (MMR) Vaccine (209762) Comparing Immunogenicity and Safety to Merck & Co., Inc.'s MMR Vaccine, in Healthy Children 12 to 15 Months of Age

GlaxoSmithKline·interventional·Posted Jul 9, 2014·Updated Jan 7, 2021

In Brief

A Phase 3 clinical trial evaluating Priorix, M-M-R II, and 3 other interventions for Measles; Mumps; Rubella and Measles-Mumps-Rubella Vaccine. Completed, enrolled 1,742 participants across 95 sites in 5 countries.

Detailed Summary

The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' trivalent MMR (Priorix), comparing it to Merck's MMR vaccine (M-M-R II), which is approved for use in the US in healthy children 12 to 15 months of age.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeasles; Mumps; Rubella, Measles-Mumps-Rubella Vaccine
CountriesEstonia, Finland, Puerto Rico, Taiwan, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 9, 2014
Enrollment StartAug 25, 2014
Primary CompletionAug 14, 2015
Study CompletionDec 22, 2015
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 12.0 years ago

Interventions

Priorixbiological

1 dose administered subcutaneously in the triceps region of left arm at Day 0

M-M-R IIbiological

1 dose administered subcutaneously in the triceps region of left arm at Day 0

Varivaxbiological

1 dose administered subcutaneously in the triceps region of right arm at Day 0

Havrixbiological

1 dose administered intramuscularly in the anterolateral region of the right thigh at Day 0

Prevnar 13biological

1 dose administered intramuscularly in the anterolateral region of the left thigh at Day 0 to subjects recruited in US