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

NCT06693895 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 750

Last updated 2025-01-20

No results posted yet for this study

Summary

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.

Conditions

  • Chickenpox

Interventions

BIOLOGICAL

Investigational varicella vaccine

1 dose of investigational varicella vaccine administered subcutaneously.

BIOLOGICAL

Marketed varicella vaccine

1 dose of marketed varicella vaccine administered subcutaneously.

BIOLOGICAL

Measles, mumps, and rubella vaccine

1 dose of measles, mumps, and rubella vaccine co-administered subcutaneously or intramuscularly.

BIOLOGICAL

Hepatitis A vaccine

1 dose of hepatitis A vaccine co-administered intramuscularly.

BIOLOGICAL

PCV (pneumococcal conjugate vaccine) 13

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.

BIOLOGICAL

PCV 20

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.

BIOLOGICAL

Vaxneuvance

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.

Sponsors & Collaborators

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
2024-11-26
Primary Completion
2026-07-01
Completion
2026-11-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06693895 on ClinicalTrials.gov