CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 5,016 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/NCT01702428
NCT01702428Phase 3Completed
CompareCT.gov

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

GlaxoSmithKline·interventional·Posted Oct 8, 2012·Updated Nov 25, 2019

In Brief

A Phase 3 clinical trial evaluating Priorix, M-M-R II, and 3 other interventions for Rubella and 2 related conditions. Completed, enrolled 5,016 participants across 90 sites in 6 countries.

Detailed Summary

The purpose of this study is to evaluate consistency in terms of the immune response to three different lots of GSK Biologicals' trivalent MMR vaccine manufactured to target potencies, and compare its immunogenicity to Merck \& Co., Inc.'s MMR vaccine, which is approved for use in the United States (US).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRubella, Measles, Mumps
CountriesEstonia, Finland, Mexico, Puerto Rico, Spain, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 8, 2012
Enrollment StartNov 9, 2012
Primary CompletionNov 25, 2014
Study CompletionApr 16, 2015
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 13.7 years ago

Interventions

Priorixbiological

Subjects receive 1 dose of MMR vaccine which is administered subcutaneously in the triceps region of the left arm.

M-M-R IIbiological

Subjects receive 1 dose of MMR vaccine which is administered subcutaneously in the triceps region of the left arm.

Varivaxbiological

Subjects receive 1 dose of VV vaccine which is administered subcutaneously in the triceps region of the right arm.

Havrixbiological

Subjects receive 1 dose of HAV vaccine which is administered intramuscularly in the anterolateral region of the right thigh.

Prevnar 13biological

US subjects receive 1 dose of PCV-13 vaccine which is administered intramuscularly in the anterolateral region of the left thigh.