NCT06855160

Brief Summary

This study aims to assess the immune response and safety of GSK's candidate chickenpox and marketed MMR vaccines when given to children 12 to 15 months of age via a muscle injection. It compares the GSK vaccines to Merck's chickenpox vaccine, administered just under the skin. Additionally, the study will evaluate the immune response and safety of giving the GSK vaccines along with other childhood vaccines through a muscle injection.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for phase_3

Timeline
9mo left

Started Apr 2025

Geographic Reach
2 countries

12 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Apr 2025Feb 2027

First Submitted

Initial submission to the registry

February 25, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 3, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

April 17, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2027

Last Updated

December 4, 2025

Status Verified

November 1, 2025

Enrollment Period

1.4 years

First QC Date

February 25, 2025

Last Update Submit

November 27, 2025

Conditions

Chickenpox

Keywords

Chicken poxCandidate l varicella vaccine (VNS)VaricellaVarivaxHealthy Children

Outcome Measures

Primary Outcomes (6)

  • Percentage of participants with seroresponse to Varicella Zoster Virus (VZV) anti- glycoprotein E (gE) Immunoglobulin (IgG)

    The seroresponse rate is defined as the percentage of participants for whom the post-vaccination Day 43 anti VZV gE IgG concentration is above the seroresponse threshold.

    At Day 43

  • Geometric Mean Concentration (GMC) of anti-VZV gE IgG

    Concentrations of anti-VZV gE IgG are presented as GMC and expressed in milli-international units per milliliter (mIU/mL) for each group.

    At Day 43

  • Percentage of participants with seroresponse to MMR antigens

    The seroresponse rate is defined as the percentage of participants for whom the post-vaccination Day 43 anti-measles, mumps, and rubella antibody concentrations are above the seroresponse threshold.

    At Day 43

  • GMC of Anti-measles antibodies

    At Day 43

  • GMC of Anti-mumps antibodies

    At Day 43

  • GMC of Anti-rubella antibodies

    At Day 43

Secondary Outcomes (11)

  • Percentage of participants with seroresponse to demonstrate an acceptable immune response for IM administration of MMR vaccine

    At Day 43

  • Percentage of participants with seroresponse to MMR antigens with a reduced non-inferiority margin

    At Day 43

  • Percentage of participants reporting each solicited administration site events post-dose of investigational VNS vaccine or VV administration

    Day 1 (post-dose) to Day 4

  • Percentage of participants reporting each solicited administration site events post-dose of MMR vaccine administration

    Day 1 (post-dose) to Day 4

  • Percentage of participants reporting each solicited systemic events post-dose of study interventions administration

    Day 1 (post-dose) to Day 15

  • +6 more secondary outcomes

Study Arms (2)

VNS+ MMR Vaccine

EXPERIMENTAL

Participants receive 1 dose of the candidate varicella vaccine (VNS vaccine), 1 dose of a measles, mumps, and rubella (MMR) vaccine, 1 dose of a hepatitis A virus (HAV vaccine), and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.

Biological: Candidate varicella vaccineBiological: MMR vaccineBiological: Hepatitis A vaccineBiological: PCV (pneumococcal conjugate vaccine) 13Biological: PCV 20Biological: Vaxneuvance

VV+MMR Vaccine

ACTIVE COMPARATOR

Participants receive 1 dose of a Marketed varicella vaccine (VV), 1 dose of a MMR vaccine, 1 dose of a HAV vaccine, and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.

Biological: Marketed varicella vaccineBiological: MMR vaccineBiological: Hepatitis A vaccineBiological: PCV (pneumococcal conjugate vaccine) 13Biological: PCV 20Biological: Vaxneuvance

Interventions

Hepatitis A vaccineBIOLOGICAL

Hepatitis A vaccine co-administered intramuscularly.

VNS+ MMR VaccineVV+MMR Vaccine
PCV (pneumococcal conjugate vaccine) 13BIOLOGICAL

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.

VNS+ MMR VaccineVV+MMR Vaccine
PCV 20BIOLOGICAL

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.

VNS+ MMR VaccineVV+MMR Vaccine
Candidate varicella vaccineBIOLOGICAL

Investigational varicella vaccine administered intramuscularly.

VNS+ MMR Vaccine
MMR vaccineBIOLOGICAL

MMR vaccine administered subcutaneously or intramuscularly.

VNS+ MMR VaccineVV+MMR Vaccine
Marketed varicella vaccineBIOLOGICAL

Marketed varicella vaccine administered subcutaneously.

VV+MMR Vaccine
VaxneuvanceBIOLOGICAL

The Vaxneuvance (15-valent pneumococcal conjugate vaccine) co-administered intramuscularly. In some countries Vaxneuvancewill only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct.

VNS+ MMR VaccineVV+MMR Vaccine

Eligibility Criteria

Age12 Months - 15 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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 the administration of study intervention.

You may not qualify if:

  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions including hypersensitivity to neomycin or gelatin.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
  • Hypersensitivity to latex.
  • Major congenital defects, as assessed by the investigator.
  • Recurrent history of uncontrolled neurological disorders or seizures.
  • History of measles, mumps, rubella, or varicella disease.
  • Active untreated tuberculosis.
  • Participants with bleeding disorders (e.g., thrombocytopenia or any coagulation disorder).
  • Condition that in the judgment of the investigator would make intramuscular injection unsafe.
  • Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
  • Prior/Concomitant therapy
  • 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.
  • 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.
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

GSK Investigational Site

Tucson, Arizona, 85704, United States

RECRUITING

GSK Investigational Site

Huntington Park, California, 90255, United States

RECRUITING

GSK Investigational Site

Sherman Oaks, California, 91403, United States

RECRUITING

GSK Investigational Site

Coral Gables, Florida, 33134, United States

RECRUITING

GSK Investigational Site

Miami Lakes, Florida, 33014, United States

RECRUITING

GSK Investigational Site

Tampa, Florida, 33612, United States

RECRUITING

GSK Investigational Site

Idaho Falls, Idaho, 83404, United States

RECRUITING

GSK Investigational Site

Dayton, Ohio, 45414, United States

RECRUITING

GSK Investigational Site

Houston, Texas, 77584, United States

RECRUITING

GSK Investigational Site

Lewisville, Texas, 75067, United States

RECRUITING

GSK Investigational Site

Pharr, Texas, 78577, United States

RECRUITING

GSK Investigational Site

Alken, 3570, Belgium

RECRUITING

MeSH Terms

Conditions

Chickenpox

Interventions

Measles-Mumps-Rubella VaccineHepatitis A VaccinesPneumococcal Vaccines

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

Vaccines, CombinedVaccinesBiological ProductsComplex MixturesMeasles VaccineViral VaccinesMumps VaccineRubella VaccineViral Hepatitis VaccinesStreptococcal VaccinesBacterial Vaccines

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466GSKClinicalSupportHD@gsk.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This is an Open Label study.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2025

First Posted

March 3, 2025

Study Start

April 17, 2025

Primary Completion (Estimated)

September 10, 2026

Study Completion (Estimated)

February 2, 2027

Last Updated

December 4, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
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.
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.
More information

Locations

BE(1)US(11)