NCT01702428

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 5,016 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 12 Months – 15 Months
• Healthy volunteers: Accepted

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).

Detailed description

This study will evaluate the consistency of the immune response to three different lots of GSK Biologicals' trivalent investigational MMR vaccine (referred to as INV\_MMR vaccine, throughout this document) and compare its immunogenicity 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 INV\_MMR vaccine will be given as one of three consistency lots manufactured to target potencies designated as INV\_MMR\_L1, INV\_MMR\_L2 and INV\_MMR\_L3. The COM\_MMR vaccine will be given as one of two lots designated COM\_MMR\_L1 and COM\_MMR\_L2 and will be analysed as pooled lots within the study. The MMR vaccine will be co-administered with Varivax (VV), Havrix (HAV) and (in the US sub-cohort only) Prevnar 13 (PCV-13) which are routinely administered to children of this age in the US.

Conditions

• Rubella
• Measles
• Mumps

Interventions

Type	Name	Description
BIOLOGICAL	Priorix	Subjects receive 1 dose of MMR vaccine which is administered subcutaneously in the triceps region of the left arm.
BIOLOGICAL	M-M-R II	Subjects receive 1 dose of MMR vaccine which is administered subcutaneously in the triceps region of the left arm.
BIOLOGICAL	Varivax	Subjects receive 1 dose of VV vaccine which is administered subcutaneously in the triceps region of the right arm.
BIOLOGICAL	Havrix	Subjects receive 1 dose of HAV vaccine which is administered intramuscularly in the anterolateral region of the right thigh.
BIOLOGICAL	Prevnar 13	US subjects receive 1 dose of PCV-13 vaccine which is administered intramuscularly in the anterolateral region of the left thigh.

Timeline

• Start date: 2012-11-09
• Primary completion: 2014-11-25
• Completion: 2015-04-16
• First posted: 2012-10-08
• Last updated: 2019-11-25
• Results posted: 2018-06-28

Locations

90 sites across 6 countries: United States, Estonia, Finland, Mexico, Puerto Rico, Spain

Regulatory

• FDA-regulated drug study