A Study on the Immune Response and Safety of an Investigational Combined Measles, Mumps, Rubella and Varicella Vaccine, When Administered as Intramuscular Injection to Healthy Children 15 Months to 6 Years of Age

Conditions

• Measles
• Measles-Mumps-Rubella+Chickenpox Vaccine

Eligibility Criteria

Sex

ALL

Age

15 Months - 6 Years

Healthy Volunteers

Accepted

Interventions

• MMRVNS — BIOLOGICAL
  One dose of MMRVNS administered intramuscularly.
• MMRV — BIOLOGICAL
  One dose of MMRV administered intramuscularly.

Study Details

This study is evaluating the immunogenicity and safety of intramuscular administration of the investigational MMRVNS vaccine compared to intramuscular administration of the MMRV (Merck's measles, mumps, rubella and varicella) vaccine (ProQuad) that is already licensed for this route, when administered as a second dose in children 15 months 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).

Key Dates

First listed

Feb 12, 2026

Start date

May 11, 2026

Status verified

Jul 2026

Primary completion

Feb 28, 2028

Completion

Jul 20, 2028

Study Design

Enrollment

1,209 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: MMRVNS Group
  Children, 15 months to 6 years old, who will receive one dose of MMRVNS on Day 1.
• Active Comparator: MMRV Group
  Children, 15 months to 6 years old, who will receive one dose of MMRV on Day 1.

Primary Outcome Measure

Seroresponse of Immunoglobulin G (IgG) concentrations against measles [ Time Frame: At Day 43 ]

Central Contacts

• US GSK Clinical Trials Call Center
  877-379-3718
  [email protected]
• EU GSK Clinical Trials Call Center
  +44 (0) 20 89904466
  [email protected]

Locations (17)

Find similar trials in Birmingham, AL