A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine When Given to Healthy Children 12 to 15 Months of Age

Conditions

• Chickenpox

Eligibility Criteria

Sex

ALL

Age

12 Months - 15 Months

Healthy Volunteers

Accepted

Interventions

• Investigational varicella vaccine_Lot 1 — BIOLOGICAL
  Investigational varicella vaccine of Lot 1 administered subcutaneously.
• Investigational varicella vaccine_Lot 2 — BIOLOGICAL
  Investigational varicella vaccine of Lot 2 administered subcutaneously.
• Investigational varicella vaccine_Lot 3 — BIOLOGICAL
  Investigational varicella vaccine of Lot 3 administered subcutaneously.
• Marketed varicella vaccine_Lot 1 — BIOLOGICAL
  Marketed varicella vaccine of Lot 1 administered subcutaneously.
• Marketed varicella vaccine_Lot 2 — BIOLOGICAL
  Marketed varicella vaccine of Lot 2 administered subcutaneously.
• MMR vaccine — BIOLOGICAL
  MMR vaccine co-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 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.

Study Details

The purpose of this study is to assess the consistency of immune response to three different lots of GSK's investigational varicella vaccine (VNS Vaccine), and to compare the safety and immune response of VNS vaccine to an already approved varicella vaccine (VV) known as Varivax. The study will be conducted in healthy children aged 12 to 15 months, who have neither contracted varicella nor received a varicella vaccination.

Key Dates

Start date

Jan 10, 2025

Status verified

May 2026

Primary completion

Dec 25, 2026

Completion

May 17, 2027

Study Design

Enrollment

1,840 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: VNS_Lot 1 Group
  Participants receive 1 dose of the investigational VNS vaccine of Lot 1, 1 dose of measles, mumps, and rubella (MMR) vaccine, 1 dose of hepatitis A vaccine (HAV), and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.
• Experimental: VNS_Lot 2 Group
  Participants receive 1 dose of the investigational VNS vaccine of Lot 2, 1 dose of MMR vaccine, 1 dose of HAV vaccine, and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.
• Experimental: VNS_Lot 3 Group
  Participants receive 1 dose of the investigational VNS vaccine of Lot 3, 1 dose of MMR vaccine, 1 dose of HAV vaccine, and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.
• Active Comparator: VV_Lot 1 Group
  Participants receive 1 dose of a marketed varicella vaccine (VV) of Lot 1, 1 dose of MMR vaccine, 1 dose of HAV vaccine, and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.
• Active Comparator: VV_Lot 2 Group
  Participants receive 1 dose of a marketed VV of Lot 2, 1 dose of MMR vaccine, 1 dose of 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) for the 3 lots of VNS vaccine groups [ 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 (60)

Find similar trials in Mobile, AL

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