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

Summary

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.

Conditions

• Chickenpox

Interventions

BIOLOGICAL

Investigational varicella vaccine_Lot 1

Investigational varicella vaccine of Lot 1 administered subcutaneously.

BIOLOGICAL

Investigational varicella vaccine_Lot 2

Investigational varicella vaccine of Lot 2 administered subcutaneously.

BIOLOGICAL

Investigational varicella vaccine_Lot 3

Investigational varicella vaccine of Lot 3 administered subcutaneously.

BIOLOGICAL

Marketed varicella vaccine_Lot 1

Marketed varicella vaccine of Lot 1 administered subcutaneously.

BIOLOGICAL

Marketed varicella vaccine_Lot 2

Marketed varicella vaccine of Lot 2 administered subcutaneously.

BIOLOGICAL

MMR vaccine

MMR vaccine co-administered subcutaneously or intramuscularly.

BIOLOGICAL

Hepatitis A vaccine

Hepatitis A vaccine co-administered intramuscularly.

BIOLOGICAL

PCV (pneumococcal conjugate vaccine) 13

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.

BIOLOGICAL

PCV 20

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.

BIOLOGICAL

Vaxneuvance

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.

Sponsors & Collaborators

• GlaxoSmithKline

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

12 Months

Max Age

15 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-01-10

Primary Completion

2026-12-25

Completion

2027-05-13

FDA Drug

Yes

Countries

• United States

Study Locations