NCT06806137

Brief 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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for phase_3

Timeline
11mo left

Started May 2025

Geographic Reach
2 countries

6 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 Progress55%
May 2025May 2027

First Submitted

Initial submission to the registry

January 31, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 3, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

May 15, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2027

Last Updated

May 29, 2026

Status Verified

May 1, 2026

Enrollment Period

1.6 years

First QC Date

January 31, 2025

Last Update Submit

May 27, 2026

Conditions

Chickenpox

Keywords

Chicken poxInvestigational varicella vaccine (VNS) VaricellaVarivax (VV)Healthy Children

Outcome Measures

Primary Outcomes (2)

  • Percentage of participants with seroresponse to Varicella Zoster Virus (VZV) anti- glycoprotein E (gE) IgG for 2 doses of VNS vaccine compared to 2 doses of VV

    Seroresponse is defined as post-vaccination (Day 43 post Dose 2) anti VZV gE Immunoglobulin (IgG) concentration greater than equal to (\>=) 300 milli-international units per milliliter (mIU/mL).

    At Day 133 (43 days post-dose 2)

  • Geometric Mean Concentration (GMC) of anti-VZV gE IgG for 2 doses of VNS vaccine compared to 2 doses of VV

    Concentrations of anti-VZV gE IgG are presented as GMC and expressed in mIU/mL for each group.

    At Day 133 (within 43 days post-dose 2)

Secondary Outcomes (16)

  • Percentage of participants with seroresponse to anti-VZV gE IgG for VV-VNS group

    At Day 133 (within 43 days post-dose 2)

  • GMC of anti-VZV gE IgG for VV-VNS group

    At Day 133 (within 43 days post-dose 2)

  • Percentage of participants reporting each solicited administration site event

    Day 1 (post-dose 1) to Day 4

  • Percentage of participants reporting each solicited administration site event

    Day 91 (post-dose 2) to Day 94

  • Percentage of participants reporting each solicited systemic event

    Day 1 (post-dose 1) to Day 15

  • +11 more secondary outcomes

Study Arms (3)

VV-VV Group

ACTIVE COMPARATOR

Participants receive 2 doses of a VV vaccine on Day 1 and Day 91. 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. A second dose of MMR vaccine will be co-administered to the participants in countries where a second dose of MMR is recommended at 15 to 18 months of age, as per national immunization schedule.

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

VNS-VNS Group

EXPERIMENTAL

Participants receive 2 doses of a VNS vaccine on Day 1 and Day 91. 1 doses of MMR vaccine, 1 dose of HAV vaccine, and 1 dose of PCV (either PCV 13, Vaxneuvance or PCV 20) on Day 1. A second dose of MMR vaccine will be co-administered to the participants in countries where second dose of MMR is recommended at 15 to 18 months of age, as per national immunization schedule.

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

VV-VNS Group

EXPERIMENTAL

Participants receive 1 dose of VV vaccine on Day 1, 1 dose of VNS Vaccine on Day 91. 1 doses of MMR vaccine, 1 dose of HAV, and 1 dose of PCV (either PCV 13, Vaxneuvance or PCV 20) on Day 1. A second dose of MMR vaccine will be co-administered to the participants in countries where second dose of MMR is recommended at 15 to 18 months of age, as per national immunization schedule.

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

Interventions

MMR vaccineBIOLOGICAL

MMR vaccine co-administered subcutaneously or intramuscularly.

VNS-VNS GroupVV-VNS GroupVV-VV Group
Investigational varicella vaccineBIOLOGICAL

Investigational varicella vaccine administered subcutaneously.

VNS-VNS GroupVV-VNS Group
Marketed varicella vaccineBIOLOGICAL

Marketed varicella vaccine administered subcutaneously.

VV-VNS GroupVV-VV Group
Hepatitis A vaccineBIOLOGICAL

Hepatitis A vaccine co-administered intramuscularly.

VNS-VNS GroupVV-VNS GroupVV-VV Group
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-VNS GroupVV-VNS GroupVV-VV Group
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-VNS GroupVV-VNS GroupVV-VV Group
VaxneuvanceBIOLOGICAL

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.

VNS-VNS GroupVV-VNS GroupVV-VV Group

Eligibility Criteria

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

You may qualify if:

  • Participant's parent(s)/Legally acceptable representative (LAR)(s), who, in the opinion of the investigator, can and will comply with the requirements of the protocol
  • 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 the first 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.

You may not qualify if:

  • 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 first dose of study interventions (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 first dose and ending 43 days after the second dose of study interventions administration (Visit 3), 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.
  • 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:
  • i) 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.
  • ii) 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 vaccinese.g., nirsevimab), antitumoral medication.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

GSK Investigational Site

Salvaleón de Higüey, La Altagracia Province, 23000, Dominican Republic

RECRUITING

GSK Investigational Site

Constanza, 11201, Dominican Republic

RECRUITING

GSK Investigational Site

Santo Domingo Oeste, 11906, Dominican Republic

RECRUITING

GSK Investigational Site

San Pedro Sula, 21104, Honduras

RECRUITING

GSK Investigational Site

Tegucigalpa, 11101, Honduras

RECRUITING

GSK Investigational Site

Tegucigalpa, 2449, Honduras

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
SINGLE
Who Masked
PARTICIPANT
Masking Details
Observer-blind study.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2025

First Posted

February 3, 2025

Study Start

May 15, 2025

Primary Completion (Estimated)

December 14, 2026

Study Completion (Estimated)

May 3, 2027

Last Updated

May 29, 2026

Record last verified: 2026-05

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

HO(3)DO(3)