NCT01681992

Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Children in Their Second Year of Life

Immunogenicity and Safety Study of GSK Biologicals' Priorix Vaccine (209762) at an End of Shelf-life Potency Compared to Merck & Co., Inc.'s Measles-mumps-rubella (MMR) Vaccine When Both Are Given on a 2-dose Schedule to Healthy Children in Their 2nd Year of Life

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4,538 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 12 Months – 15 Months
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate end of shelf-life potency in terms of the immunogenicity and safety of GSK Biologicals' trivalent MMR vaccine, by comparing it to Merck \& Co., Inc.'s MMR vaccine, which is approved for use in the United States (US).

Detailed description

This trial is a Phase IIIA, randomized, observer-blind, controlled, multi-center, multi-country study with four parallel groups. This study will evaluate the immunogenicity and safety of GSK Biologicals' trivalent investigational MMR vaccine (referred to as Inv\_MMR vaccine, throughout this document) in contrast to the US standard of care comparator vaccine (M-M-R II, Merck and Co., Inc., referred to as Com\_MMR throughout this document) in children during their second year of life. The first dose of this two-dose study is designed to establish the end of shelf-life potency of Inv\_MMR vaccine. The Inv\_MMR vaccine will be given as one of two lots; one of a minimum potency, designated Inv\_MMR\_Min; and the other at a mid-range or medium potency designated Inv\_MMR\_Med to two groups. The second dose for both of these Inv\_MMR groups will have a potency within the release range of the marketed vaccine. The Com\_MMR vaccine will consist of two lots designated Com\_MMR\_L1 and Com\_MMR\_L2 and will be analyzed as pooled lots within the study. The first MMR vaccine dose will be co-administered with Varivax, Havrix and (in the US sub-cohort only) Prevnar 13 which are routinely administered to children of this age in the US.

Conditions

• Measles
• Mumps
• Rubella
• Measles-Mumps-Rubella Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	Priorix	Subjects receive one dose of either minimum (Inv\_MMR\_Min) or medium (Inv\_MMR\_Med) potency lot at Day 0 and a dose of separate potency lot (Inv\_MMR\_Release) at Day 42, administered subcutaneously in the triceps region of the left arm.
BIOLOGICAL	M-M-R II	Subjects receive two doses of either Lot 1 or Lot 2, one at Day 0 and one at Day 42, administered subcutaneously in the triceps region of the left arm.
BIOLOGICAL	Varivax	Subjects receive one dose co-administered subcutaneously with the study vaccines (Priorix and M-M-R II), in the triceps region of right arm, at Day 0.
BIOLOGICAL	Havrix	Subjects receive one dose co-administered intramuscularly with the study vaccines (Priorix and M-M-R II), in the anterolateral region of the right thigh, at Day 0.
BIOLOGICAL	Prevnar 13	US Subjects receive one dose co-administered intramuscularly with the study vaccines (Priorix and M-M-R II), in the anterolateral region of the left thigh, at Day 0.

Timeline

• Start date: 2012-10-10
• Primary completion: 2015-02-03
• Completion: 2015-08-18
• First posted: 2012-09-10
• Last updated: 2021-01-07
• Results posted: 2018-08-17

Locations

81 sites across 7 countries: United States, Czechia, Finland, Malaysia, Puerto Rico, Spain, Thailand