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RECRUITING
NCT06806137
PHASE3

A Study on the Immune Response and Safety of the Second Dose of an Investigational Chickenpox Vaccine When Given to Healthy Children 3 Months After a First Dose at 12 to 15 Months of Age

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the immune response and safety of GSKs investigational varicella vaccine (VNS Vaccine) compared to an already approved varicella vaccine, Varivax (VV), when administered as second dose to healthy children. 3 months after first dose at 12 to 15 months. The study will be conducted in children who have not previously contracted varicella or received a varicella vaccination.

Official title: A Phase 3a, Observer-blind, Randomized, Controlled, Study to Evaluate the Immunogenicity and Safety of an Investigational Varicella Vaccine Compared With Varivax, When Given as a Second Dose to Healthy Children, 3 Months After the Administration of a First Dose at 12 to 15 Months of Age

Key Details

Gender

All

Age Range

12 Months - 15 Months

Study Type

INTERVENTIONAL

Enrollment

600

Start Date

2025-05-15

Completion Date

2027-05-03

Last Updated

2025-12-04

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

Investigational varicella vaccine

Investigational varicella vaccine administered subcutaneously.

BIOLOGICAL

Marketed varicella vaccine

Marketed varicella vaccine 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.

Locations (3)

GSK Investigational Site

Salvaleón de Higüey, La Altagracia Province, Dominican Republic

GSK Investigational Site

Constanza, Dominican Republic

GSK Investigational Site

Santo Domingo Oeste, Dominican Republic