A Study on the 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 — BIOLOGICAL
  1 dose of investigational varicella vaccine administered subcutaneously.
• Marketed varicella vaccine — BIOLOGICAL
  1 dose of marketed varicella vaccine administered subcutaneously.
• Measles, mumps, and rubella vaccine — BIOLOGICAL
  1 dose of measles, mumps, and rubella vaccine co-administered subcutaneously or intramuscularly.
• Hepatitis A vaccine — BIOLOGICAL
  1 dose of hepatitis A vaccine co-administered intramuscularly.
• PCV (pneumococcal conjugate vaccine) 13 — BIOLOGICAL
  1 dose of 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
  1 dose of 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
  1 dose of 15-valent pneumococcal conjugate (Vaxneuvance) 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 how well-tolerated GSK's investigational varicella vaccine (VNS Vaccine) is, in comparison to an already approved varicella vaccine (VV) known as Varivax. The study will be conducted on healthy children aged 12 to 15 months, and who have neither contracted varicella nor received a varicella vaccination.

Key Dates

Start date

Nov 26, 2024

Status verified

May 2026

Primary completion

Nov 23, 2026

Completion

Nov 23, 2026

Study Design

Enrollment

750 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: VNS Group
  Participants receive 1 dose of a VNS vaccine, 1 dose of measles, mumps, and rubella (MMR) vaccine, 1 dose of hepatitis A (HAV) vaccine, and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.
• Active Comparator: VV Group
  Participants receive 1 dose of a marketed VV, 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 reporting each solicited administration site events [ Time Frame: Day 1 (post-dose) to Day 4 ]

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 (23)

Find similar trials in Phoenix, AZ

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