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
NCT05630846 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 801
Last updated 2025-06-22
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.
Conditions
- Measles; Mumps; Rubella; Chickenpox
- Measles
Interventions
- 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.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
GSK Clinical Trials · GlaxoSmithKline
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 4 Years
- Max Age
- 6 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-12-14
- Primary Completion
- 2024-06-07
- Completion
- 2024-10-14
- FDA Drug
- Yes
Countries
- United States
- Colombia
- Latvia
- Puerto Rico
- Taiwan
Study Locations
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