NCT02184572

Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' Measles, Mumps and Rubella (MMR) Vaccine (209762) Compared to Merck & Co., Inc.'s MMR Vaccine in Healthy Children 12 to 15 Months of Age

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,742 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 12 Months – 15 Months
• Healthy volunteers: Accepted

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.

Detailed description

This study will evaluate the safety of GSK's trivalent MMR vaccine (referred to as INV\_MMR vaccine) at a potency that will be used to define maximum release limits for the INV\_MMR in comparison to the US standard of care (M-M-R II/ M-M-R VaxPro vaccine referred to as COM\_MMR vaccine). In order to obtain more representative data on the comparator vaccine, the COM\_MMR used in this study will consist of two lots designated COM\_MMR\_L1 and COM\_MMR\_L2. Throughout the study COM\_MMR\_L1 and COM\_MMR\_L2 will be analyzed as pooled lots. This study is intended to support licensure of GSK's MMR vaccine in the US. All children will receive Varivax and Havrix vaccines, concomitantly with MMR containing vaccine at 12 to 15 months of age. Prevnar 13 will be administered only to US children. At the end of the study, GSK will provide a second dose of Havrix and/or varicella vaccine to participants enrolled in selected non-US countries if local health departments do not routinely provide hepatitis A and varicella vaccination. The second dose of Havrix and varicella vaccine is not part of the study procedures.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	Priorix	1 dose administered subcutaneously in the triceps region of left arm at Day 0
BIOLOGICAL	M-M-R II	1 dose administered subcutaneously in the triceps region of left arm at Day 0
BIOLOGICAL	Varivax	1 dose administered subcutaneously in the triceps region of right arm at Day 0
BIOLOGICAL	Havrix	1 dose administered intramuscularly in the anterolateral region of the right thigh at Day 0
BIOLOGICAL	Prevnar 13	1 dose administered intramuscularly in the anterolateral region of the left thigh at Day 0 to subjects recruited in US

Timeline

• Start date: 2014-08-25
• Primary completion: 2015-08-14
• Completion: 2015-12-22
• First posted: 2014-07-09
• Last updated: 2021-01-07
• Results posted: 2018-07-03

Locations

95 sites across 5 countries: United States, Estonia, Finland, Puerto Rico, Taiwan