NCT05630846

A Study on the Immune Response and Safety of a Combined Measles, Mumps, Rubella, Chickenpox Vaccine Compared to a Marketed Combined Vaccine, Given to Healthy Children 4 to 6 Years of Age

A Phase II, Single-blind, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of a Measles, Mumps, Rubella, Varicella Vaccine Compared With ProQuad, Administered in Healthy Children 4-6 Years of Age

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 801 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 4 Years – 6 Years
• Healthy volunteers: Accepted

Summary

The main purpose of this study is to assess immune response and safety of various potencies of a measles, mumps, rubella, and varicella (MMRVNS) vaccines given to healthy children of 4 to 6 years of age.

Detailed description

This study is designed to evaluate the immunogenicity and safety of the investigational measles, mumps, rubella, varicella vaccine (referred to as the MMRVNS vaccine) compared with the licensed measles, mumps, rubella, varicella vaccine, ProQuad (referred to as the MMRV vaccine), when given as a second dose to children 4 to 6 years of age who were previously primed with a first dose of any combination of measles, mumps, rubella, and varicella-containing vaccine(s). This study will evaluate immunogenicity and safety using 3 MMRVNS formulations which vary for some or all the individual virus potencies. The 3 MMRVNS formulations (designated as MMRV(H)NS vaccine, MM(H)RVNS vaccine and M(L)M(L)R(L)V(L)NS vaccine) will be compared with the MMRV vaccine. To ensure representative data on the comparator, participants enrolled in the MMRV group will be randomized to two different lots (designated as MMRV\_Lot 1 and MMRV\_Lot 2). Throughout the study, the two lots will be analyzed as a pooled group.

Conditions

• Measles; Mumps; Rubella; Chickenpox
• Measles

Interventions

Type	Name	Description
BIOLOGICAL	Investigational MMRV(H)NS vaccine	1 dose of a measles, mumps, and rubella at release potency and VNS at high (H) potency vaccine administered subcutaneously.
BIOLOGICAL	Investigational MM(H)RVNS vaccine	1 dose of a measles, rubella, and varicella at release potency and mumps at high (H) potency vaccine administered subcutaneously.
BIOLOGICAL	Investigational M(L)M(L)R(L)V(L)NS vaccine	1 dose of measles, mumps, rubella, and varicella, all at low (L) potency vaccine administered subcutaneously.
BIOLOGICAL	Marketed MMRV_Lot 1 and Lot 2 vaccine	1 dose of a marketed measles, mumps, rubella, and varicella of Lot 1 or 1 dose of a marketed measles, mumps, rubella, and varicella of Lot 2 vaccine administered subcutaneously.

Timeline

• Start date: 2022-12-14
• Primary completion: 2024-06-07
• Completion: 2024-10-14
• First posted: 2022-11-30
• Last updated: 2025-06-22
• Results posted: 2025-06-22

Locations

47 sites across 5 countries: United States, Colombia, Latvia, Puerto Rico, Taiwan

Regulatory

• FDA-regulated drug study