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

May 27, 2026 updated by: GlaxoSmithKline

A Phase 3a, Observer-blind, Randomized, Controlled Study to Demonstrate Lot-to-lot Consistency and Evaluate the Immunogenicity and Safety of an Investigational Varicella Vaccine Compared With Varivax, Administered as a First Dose to Healthy Children 12 to 15 Months of Age

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1840

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Xavier STEPHENNE
      • Ghent, Belgium, 9000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Levi Hoste
      • Gozée, Belgium, 6534
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marc De Meulemeester
      • Leuven, Belgium, 3000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • François Vermeulen
      • Liège, Belgium, 4000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Annabelle Lefevre
  • Colombia
      • Cali, Colombia, 760042
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Viviana Marquez
      • Medellín, Colombia, 050021
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maria Carolina Ortega Maffla
  • Czechia
      • Jindřichův Hradec, Czechia, 377 01
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Daniela Verdanova
      • Jindřichův Hradec, Czechia, 37701
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Daniel Drazan
      • Jinočany, Czechia, 530 12
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jirina Dvorakova
      • Ostrava, Czechia, 708 00
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • David Zeman
      • Prague, Czechia, 160 00
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Renata Adamovska
  • Dominican Republic
      • Santo Domingo, Dominican Republic, 10201
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sonia Mazara
      • Santo Domingo, Dominican Republic, 10205
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sorivel Sosa Hilario
      • Santo Domingo Oeste, Dominican Republic, 11114
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dania Torres
  • Estonia
      • Paide, Estonia, 72713
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ingrid Alt
      • Tartu, Estonia, 50106
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Airi Poder
  • Mexico
      • Acapulco, Mexico, 39670
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ilya Angelica Rochin-Kobachi
      • Hidalgo, Mexico, 42000
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Joselito Hernandez Pichardo
        • Contact:
        • Contact:
      • Mexico City, Mexico, 6750
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ana Estela Gamiño Arroyo
      • Mexico City, Mexico
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Miguel Angel Rodriguez-Weber
      • Veracruz, Mexico, 91900
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Francisco Salazar Martinez
  • Poland
      • Bydgoszcz, Poland, 85-048
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Piotr Korbal
        • Contact:
        • Contact:
      • Częstochowa, Poland, 42-217
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Elzbieta Janusik
      • Krakow, Poland, 30-363
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Agnieszka Swiat
      • Siemianowice Śląskie, Poland, 41103
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Barbara Pajek
        • Contact:
        • Contact:
      • Torun, Poland, 87-100
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Elzbieta Kopińska
        • Contact:
        • Contact:
  • Puerto Rico
      • Caguas, Puerto Rico, 00725
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Fernando Ysern-Borras
      • Ponce, Puerto Rico, 00716
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Elizabeth Barranco Santana
      • San Juan, Puerto Rico, 00918
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Carmen Deseda
        • Contact:
        • Contact:
      • San Juan, Puerto Rico, 907
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yareri Soto Mendoza
  • Thailand
      • Bangkok, Thailand, 10700
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Orasri Wittawatmongkol
      • Rajathevee, Thailand, 10400
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Veerachai Watanaveeradej
  • United Arab Emirates
      • Abu Dhabi, United Arab Emirates
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Majed Abulhassan
      • Al Ain City, United Arab Emirates
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ghassan Ghatash
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Paul Matherne
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jon Robert
      • Sherwood, Arkansas, United States, 72120
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kimberly Clinton
    • California
      • Canoga Park, California, United States, 91304
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • James Saunders
      • Covina, California, United States, 91723
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Holly Lim
        • Contact:
        • Contact:
      • Fullerton, California, United States, 92835
        • Withdrawn
        • GSK Investigational Site
      • Long Beach, California, United States, 90807
        • Withdrawn
        • GSK Investigational Site
      • Los Angeles, California, United States, 90057
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Peyman Banooni
      • Paramount, California, United States, 90723
        • Withdrawn
        • GSK Investigational Site
      • Sacramento, California, United States, 95823
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marita Biag
      • Ventura, California, United States, 93003
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Carey Chronis
        • Contact:
        • Contact:
      • Walnut Creek, California, United States, 94598
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Timothy Ryschon
      • Winnetka, California, United States, 91306
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Parisa Arman Khorsandi
    • Florida
      • Miami, Florida, United States, 33184
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Lilia Roque Guerrero
        • Contact:
        • Contact:
      • Miami, Florida, United States, 33176
        • Withdrawn
        • GSK Investigational Site
      • Miami Lakes, Florida, United States, 33014
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ihosvani Barroso
      • Spring Hill, Florida, United States, 34609
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Imad Jandali
      • Tampa, Florida, United States, 33613
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Teena Hughes
        • Contact:
        • Contact:
    • Georgia
      • Covington, Georgia, United States, 70433
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Sherri Casey
        • Contact:
        • Contact:
    • Idaho
      • Ammon, Idaho, United States, 83406
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joseph Moore
    • Illinois
      • Moline, Illinois, United States, 61265
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nafees Khan
    • Indiana
      • South Bend, Indiana, United States, 46617
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alicia Wilson
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Randall Schumacher
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Daniel Finn
        • Contact:
        • Contact:
      • Louisville, Kentucky, United States, 40202-1822
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Gary Marshall
        • Contact:
        • Contact:
    • Louisiana
      • Haughton, Louisiana, United States, 71037
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Stacey Sparks
        • Contact:
        • Contact:
    • Massachusetts
      • Fall River, Massachusetts, United States, 02721-1735
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Walter Rok
    • Michigan
      • Bingham Farms, Michigan, United States, 48025
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Martin Levinson
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alfred Johnson
    • Nebraska
      • Lincoln, Nebraska, United States, 68505
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Theodore Pham
      • Lincoln, Nebraska, United States, 68516
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alexander Ryan
      • Lincoln, Nebraska, United States, 68510
        • Withdrawn
        • GSK Investigational Site
    • New York
      • The Bronx, New York, United States, 10456
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ruby Hussain
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christine Turley
      • Monroe, North Carolina, United States, 28112
        • Withdrawn
        • GSK Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44121
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Shelly Senders
        • Contact:
        • Contact:
      • Dayton, Ohio, United States, 45424
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Steve Choi
    • Oklahoma
      • Chickasha, Oklahoma, United States, 73018
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ahmad Musa
      • Tulsa, Oklahoma, United States, 74137
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Erin Latimer
    • Oregon
      • Gresham, Oregon, United States, 97030
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Frank Calcagno
        • Contact:
        • Contact:
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Robert Clifford
        • Contact:
        • Contact:
      • Charleston, South Carolina, United States, 29407
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • John Traynham
      • Greenville, South Carolina, United States, 29607
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Scott Dobson
      • Simpsonville, South Carolina, United States, 29681
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Stephen Jones
    • Texas
      • Beaumont, Texas, United States, 77701
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Derick Young
      • Burleson, Texas, United States, 76028
        • Withdrawn
        • GSK Investigational Site
      • Corpus Christi, Texas, United States, 78404
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Wieslaw Jakubowski
      • Dallas, Texas, United States, 75230-2571
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Benjamin Marcum
      • Dallas, Texas, United States, 75251
        • Withdrawn
        • GSK Investigational Site
      • Houston, Texas, United States, 77030
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gloria Heresi
      • Houston, Texas, United States, 77087
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Martin Yudovich
        • Contact:
        • Contact:
      • McAllen, Texas, United States, 78504
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Ashley Bose
        • Contact:
        • Contact:
      • Mesquite, Texas, United States, 75149
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Salma Saiger
    • Utah
      • Layton, Utah, United States, 84041
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Brent Eberhard
        • Contact:
        • Contact:
      • Layton, Utah, United States, 84041
        • Completed
        • GSK Investigational Site
      • Murray, Utah, United States, 84107
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jake Jones
      • Pleasant View, Utah, United States, 84404
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jason Church
      • South Jordan, Utah, United States, 84095
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kathy Garcia
      • West Jordan, Utah, United States, 84088
        • Withdrawn
        • GSK Investigational Site
    • Virginia
      • Richmond, Virginia, United States, 23226
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Richard Bennett

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Participant's parent(s) Legally acceptable representatives /(LAR[s]), who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiaries, return for follow-up visits).
  • Written or witnessed/thumb printed informed consent obtained from the participant's parent(s)/LAR(s) prior to performance of any study-specific procedure.
  • Healthy participants as established by medical history and clinical examination before entering into the study.
  • A male or female between, and including, 12 to 15 months of age (i.e., from the day of 1-year birthday until the day before 16 months of age) at the time of the administration of study interventions.

  • Only for children in countries where PCV is recommended at 12 to 15 months of age as per national immunization schedule and provided as part of the study interventions:

    • Participant who previously received the primary series of PCV in the first year of life with last dose at least 60 days prior to study entry.

Exclusion Criteria:

  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Hypersensitivity to latex.
  • Major congenital defects, as assessed by the investigator.
  • Recurrent history of uncontrolled neurological disorders or seizures.
  • History of varicella disease.
  • Active untreated tuberculosis.
  • Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
  • Use of any investigational or non-registered product (drug, vaccine or invasive medical device) other than the study interventions during the period beginning 30 days before the dose of study interventions administration (Day -29 to Day 1), or their planned use during the study period.
  • Planned administration of a vaccine in the period starting 30 days before the dose and ending 43 days after the dose of study interventions administration* (Visit 2) with the exception of inactivated influenza vaccine which may be given at any time during the study and administered at a different location than the study interventions.

Any other age-appropriate vaccine may be given starting at Visit 2 and anytime thereafter.

*If emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is organized by public health authorities outside the routine immunization program, the time period described above can be reduced provided it is used according to the local governmental recommendations and sponsor is notified

  • Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune modifying treatments at any time up to the end of the study.

    • Up to 90 days prior to the study intervention administration:
    • For corticosteroids, this will mean prednisone equivalent >=0.5 mg/kg/day with maximum of 20 mg/day for pediatric participants. Inhaled and topical steroids are allowed.
    • Administration of immunoglobulins and/or any blood products or plasma derivatives.
    • Up to 180 days prior to study interventions administration: long acting immune-modifying drugs including among others immunotherapy (e.g., tumor necrosis factor-inhibitors), monoclonal antibodies (except the ones not interfering with the immune response to the study vaccines, e.g., nirsevimab), antitumoral medication.
  • Previous vaccination against measles, mumps, and rubella.
  • Previous vaccination against hepatitis A virus.
  • Previous vaccination against varicella virus.
  • Only for children in countries where PCV is recommended at 12 to 15 months of age as per national immunization schedule and provided as part of the study interventions, participant who previously received a booster dose of any PCV.
  • Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/invasive medical device).
  • Child in care.
  • Any study personnel's immediate dependents, family, or household members.

  • Participants with the following high-risk individuals in their household:

    • Immunocompromised individuals.
    • Pregnant women without documented history of varicella.
    • Newborn infants of mothers without documented history of varicella.
    • Newborn infants born less than (<) 28 weeks of gestation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Biological: Investigational varicella vaccine_Lot 1
Investigational varicella vaccine of Lot 1 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.
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.
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.
Biological: Investigational varicella vaccine_Lot 2
Investigational varicella vaccine of Lot 2 administered subcutaneously.
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.
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.
Biological: Investigational varicella vaccine_Lot 3
Investigational varicella vaccine of Lot 3 administered subcutaneously.
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.
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.
Biological: Marketed varicella vaccine_Lot 1
Marketed varicella vaccine of Lot 1 administered subcutaneously.
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.
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.
Biological: Marketed varicella vaccine_Lot 2
Marketed varicella vaccine of Lot 2 administered subcutaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Seroresponse is defined as post-vaccination (Day 43) anti-VZV gE IgG antibody concentration greater than or equal to (>=) 300 milli-international units per milliliter (mIU/mL) among participants who were seronegative [(antibody concentration less than (<) LLOQ (Lower limit of quantification)] before vaccination. A seronegative participant is a participant whose antibody concentration is below the LLOQ of the assay. A seropositive participant is a participant whose antibody concentration is greater than or equal to the LLOQ of the assay.
At Day 43
Geometric Mean Concentration (GMC) of anti-VZV gE IgG for the 3 lots of VNS vaccine groups
Time Frame: At Day 43
Concentrations of anti-VZV gE IgG presented as GMCs and expressed in mIU/mL for each group.
At Day 43
Percentage of participants with seroresponse to anti-VZV gE IgG for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups
Time Frame: At Day 43
Seroresponse is defined as post-vaccination (Day 43) anti-VZV gE IgG concentration >= 300 mIU/mL among participants who were seronegative (antibody concentration < LLOQ) before vaccination. A seronegative participant is a participant whose antibody concentration is below the LLOQ of the assay. A seropositive participant is a participant whose antibody concentration is greater than or equal to the LLOQ of the assay.
At Day 43
GMCs of anti-VZV gE IgG for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups
Time Frame: At Day 43
Concentrations of anti-VZV gE IgG are presented as GMCs and expressed in mIU/mL for each group.
At Day 43

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants reporting each solicited systemic event
Time Frame: Day 1 (post-dose) to Day 15
Solicited systemic events include drowsiness, loss of appetite and irritability.
Day 1 (post-dose) to Day 15
Percentage of participants reporting medically attended AEs (MAAE)
Time Frame: Day 1 (post-dose) to Day 181 (study end)
A MAAE is an AE for which the participant received medical attention including any symptom or illness requiring hospitalization, or an emergency room visit, or visit to/by a healthcare professional.
Day 1 (post-dose) to Day 181 (study end)
Percentage of participants reporting serious adverse events (SAEs)
Time Frame: Day 1 (post-dose) to Day 181 (study end)
A SAE is an AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or other situations that are considered serious per medical or scientific judgment.
Day 1 (post-dose) to Day 181 (study end)
Anti-measles antibodies GMCs for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups
Time Frame: At Day 43
At Day 43
Anti-mumps antibodies GMCs for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups
Time Frame: At Day 43
At Day 43
Anti-rubella antibodies GMCs for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups
Time Frame: At Day 43
At Day 43
Percentage of participants with seroresponse to anti-measles for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups
Time Frame: At Day 43

Seroresponse is defined as post-vaccination (Day 43) anti-measles antibody concentration >= cut-off value among participants who were seronegative (antibody concentration < cut-off value) before vaccination.

The assay cut-off values for anti-measles will be defined by the laboratory before the analysis.
At Day 43
Percentage of participants with seroresponse to anti-mumps for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups
Time Frame: At Day 43

Seroresponse is defined as post-vaccination (Day 43) anti-mumps antibody concentration >= cut-off value among participants who were seronegative (antibody concentration < cut-off value) before vaccination.

The assay cut-off values for anti-mumps will be defined by the laboratory before the analysis.
At Day 43
Percentage of participants with seroresponse to anti-rubella for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups
Time Frame: At Day 43

Seroresponse is defined as post-vaccination (Day 43) anti-rubella antibody concentration >= cut-off value among participants who were seronegative (antibody concentration < cut-off value) before vaccination.

The assay cut-off values for anti-rubella will be defined by the laboratory before the analysis.
At Day 43
Anti-Hepatitis A antibodies GMCs for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups in Hepatitis A virus (HAV) subset
Time Frame: At Day 43
At Day 43
Percentage of participants with seroresponse to anti-HAV for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups in HAV subset
Time Frame: At Day 43

Seroresponse is defined as post-vaccination (Day 43) anti-HAV antibody concentration >= cut-off value among participants who were seronegative (antibody concentration < cut-off value) before vaccination.

The assay cut-off values for anti-HAV antibodies will be defined by the laboratory before the analysis.
At Day 43
Anti-S. pneumoniae serotype specific Polysaccharide IgG antibody concentrations for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups in PCV subset
Time Frame: At Day 43
S. pneumoniae polysaccharides to be tested: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F.
At Day 43
Percentage of participants in the VNS vaccine pooled group with anti-VZV gE antibody concentrations above the adaptive seroresponse threshold
Time Frame: At Day 43
The adaptive seroresponse threshold is the anti-VZV gE IgG antibody concentration for which the response rate in the VV group is 95% or higher.
At Day 43
Percentage of participants reporting each solicited administration site event
Time Frame: Day 1 (post-dose) to Day 4
Solicited administration site events include injection site redness, pain and swelling.
Day 1 (post-dose) to Day 4
Percentage of participants reporting each solicited systemic event in terms of fever
Time Frame: Day 1 (post-dose) to Day 22
Fever is defined as temperature greater than or equal to (>=)38.0 degrees Celsius (°C) by any route (the preferred location for measuring temperature is the axilla).
Day 1 (post-dose) to Day 22
Percentage of participants reporting each solicited administration site event
Time Frame: Day 1 (post-dose) to Day 43
Solicited administration site events include injection site varicella-like rash.
Day 1 (post-dose) to Day 43
Percentage of participants reporting each solicited systemic event
Time Frame: Day 1 (post-dose) to Day 43
Solicited systemic events include varicella-like rash (non-injection site) and general rash (not varicella-like).
Day 1 (post-dose) to Day 43
Percentage of participants reporting unsolicited adverse events (AEs)
Time Frame: Day 1 (post-dose) to Day 43
Unsolicited AEs include any AE reported in addition to solicited events during the study, or any "solicited" symptoms with onset outside of the specified period of follow-up for solicited symptoms, are assessed for each group after the administration of all vaccines.
Day 1 (post-dose) to Day 43

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2025

Primary Completion (Estimated)

December 25, 2026

Study Completion (Estimated)

May 17, 2027

Study Registration Dates

First Submitted

December 12, 2024

First Submitted That Met QC Criteria

December 12, 2024

First Posted (Actual)

December 18, 2024

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 213998
  • 2024-515869-33-00 (Other Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf

IPD Sharing Time Frame

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.

IPD Sharing Access Criteria

Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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