A Study on the Immune Response and Safety of an Investigational Combined Measles, Mumps, Rubella and Varicella Vaccine, When Given to Healthy Children 4 to 6 Years of Age

Conditions

• Measles
• Measles-Mumps-Rubella+Chickenpox Vaccine
• Mumps
• Rubella
• Varicella (Chickenpox)

Eligibility Criteria

Sex

ALL

Age

4 Years - 6 Years

Healthy Volunteers

Accepted

Interventions

• MMRVNS vaccine — BIOLOGICAL
  MMRVNS vaccine will be administered on Day 1.
• MMRV vaccine — BIOLOGICAL
  MMRV vaccine will be administered on Day 1.
• DTaP-IPV vaccine — BIOLOGICAL
  DTaP-IPV vaccine will be administered on Day 1.

Study Details

The purpose of this study is to evaluate how consistently 3 different manufacturing lots of the GSK's investigational measles, mumps, rubella, and varicella (MMRVNS) vaccine will produce an immune response. It will also compare the overall immune response to the MMRVNS vaccine with that of the Merck licensed measles, mumps, rubella, and varicella (MMRV) vaccine. The vaccines will be given as a second dose to children aged 4 to 6 years who have previously received a first dose of any combination of measles, mumps, rubella, and varicella-containing vaccine(s). The study will also assess the immune response and safety of the MMRVNS and MMRV vaccines when given at the same time as a diphtheria, tetanus, acellular pertussis, and inactivated poliovirus (DTaP-IPV) vaccine. The DTaP-IPV vaccine used is licensed as Kinrix in the United States.

Key Dates

First listed

Aug 3, 2026

Start date

Aug 11, 2026

Status verified

Jul 2026

Primary completion

Jun 27, 2028

Completion

Nov 21, 2028

Study Design

Enrollment

1,860 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: MMRVNS_Lot 1 group
  Participants will receive a single dose of the Lot 1 MMRVNS vaccine and a single dose of the DTaP-IPV vaccine on Day 1.
• Experimental: MMRVNS_Lot 2 group
  Participants will receive a single dose of the Lot 2 MMRVNS vaccine and a single dose of the DTaP-IPV vaccine on Day 1.
• Experimental: MMRVNS_Lot 3 group
  Participants will receive a single dose of the Lot 3 MMRVNS vaccine and a single dose of the DTaP-IPV vaccine on Day 1.
• Active Comparator: MMRV group
  Participants will receive a single dose of MMRV vaccine and a single dose of DTaP-IPV vaccine on Day 1.

Primary Outcome Measure

Geometric mean concentrations (GMCs) of immunoglobulin G (IgG) antibodies against measles, mumps, rubella, and varicella zoster virus (VZV) glycoprotein E (gE) after MMRVNS vaccine administration [ 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 (38)

Find similar trials in Jonesboro, AR

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