A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine and a Marketed Measles, Mumps and Rubella Vaccine When Administered as Intramuscular Injection to Healthy Children 12 to 15 Months of Age

Conditions

• Chickenpox

Eligibility Criteria

Sex

ALL

Age

12 Months - 15 Months

Healthy Volunteers

Accepted

Interventions

• Candidate varicella vaccine — BIOLOGICAL
  Investigational varicella vaccine administered intramuscularly.
• Marketed varicella vaccine — BIOLOGICAL
  Marketed varicella vaccine administered subcutaneously.
• MMR vaccine — BIOLOGICAL
  MMR vaccine administered subcutaneously or intramuscularly.
• Hepatitis A vaccine — BIOLOGICAL
  Hepatitis A vaccine co-administered intramuscularly.
• PCV (pneumococcal conjugate vaccine) 13 — BIOLOGICAL
  The 13-valent pneumococcal conjugate vaccine co-administered intramuscularly. In some countries PCV will only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct.
• PCV 20 — BIOLOGICAL
  The 20-valent pneumococcal conjugate vaccine co-administered intramuscularly. In some countries PCV will only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct.
• Vaxneuvance — BIOLOGICAL
  The Vaxneuvance (15-valent pneumococcal conjugate vaccine) co-administered intramuscularly. In some countries Vaxneuvancewill only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct.

Study Details

This study aims to assess the immune response and safety of GSK's candidate chickenpox and marketed MMR vaccines when given to children 12 to 15 months of age via a muscle injection. It compares the GSK vaccines to Merck's chickenpox vaccine, administered just under the skin. Additionally, the study will evaluate the immune response and safety of giving the GSK vaccines along with other childhood vaccines through a muscle injection.

Key Dates

Start date

Apr 17, 2025

Status verified

May 2026

Primary completion

Sep 10, 2026

Completion

Feb 2, 2027

Study Design

Enrollment

911 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: VNS+ MMR Vaccine
  Participants receive 1 dose of the candidate varicella vaccine (VNS vaccine), 1 dose of a measles, mumps, and rubella (MMR) vaccine, 1 dose of a hepatitis A virus (HAV vaccine), and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.
• Active Comparator: VV+MMR Vaccine
  Participants receive 1 dose of a Marketed varicella vaccine (VV), 1 dose of a MMR vaccine, 1 dose of a HAV vaccine, and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.

Primary Outcome Measure

Percentage of participants with seroresponse to Varicella Zoster Virus (VZV) anti- glycoprotein E (gE) Immunoglobulin (IgG) [ 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 (13)

Find similar trials in Tucson, AZ

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