A Study on the 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 Evaluate the 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 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
750

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Bulgaria
      • Burgas, Bulgaria, 8008
        • Withdrawn
        • GSK Investigational Site
      • Gabrovo, Bulgaria, 5300
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Svetla Pashova-Mihova
      • Kyustendil, Bulgaria, 2500
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Iliana Gogeva
      • Plovdiv, Bulgaria, 4002
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Miroslava Bosheva
      • Rousse, Bulgaria, 7000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Svetoslav Dachev
      • Sevlievo, Bulgaria, 5400
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Stanka Kalcheva
      • Yambol, Bulgaria, 8600
        • Withdrawn
        • GSK Investigational Site
  • Denmark
      • Aarhus N, Denmark, 8200
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nina Breinholt Staerke
      • Copenhagen, Denmark, DK-2100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anja Poulsen
      • Hvidovre, Denmark, 2650
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Thomas Benfield
      • Odense C, Denmark, DK-5000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Isik Johansen
  • Estonia
      • Tallinn, Estonia, 10617
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kaia Kiiroja
      • Tallinn, Estonia, 10615
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Eve Kivistik
  • Hong Kong
      • Hong Kong, Hong Kong, 00852
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Wing Shan Queenie See
      • Shatin, Hong Kong
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Agnes Sze-Yin Leung
  • Lithuania
      • Kaunas, Lithuania, 47116
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Giedra Leviniene
      • Kaunas, Lithuania, LT-48259
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alina Kucinskiene
  • Mexico
      • Durango, Mexico, 34000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Juan Carlos Tinoco-Favila
      • Tlalpan, Mexico, 14340
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Guadalupe Maldonado-Colin
  • Poland
      • Bydgoszcz, Poland, 85-796
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Oleg Warszalewski
      • Trzebnica, Poland, 55-100
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Henryk Szymanski
        • Contact:
        • Contact:
      • Warsaw, Poland, 02-172
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Damian Okrucinski
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Withdrawn
        • GSK Investigational Site
      • Tucson, Arizona, United States, 85741
        • Withdrawn
        • GSK Investigational Site
    • California
      • Huntington Park, California, United States, 90057
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jose Diaz
        • Contact:
        • Contact:
      • National City, California, United States, 91950
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mohammed Bailony
      • West Covina, California, United States, 91790
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Holly Lim
        • Contact:
        • Contact:
    • Florida
      • Hialeah, Florida, United States, 33012
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jorge Alsina
      • Miami, Florida, United States, 33142
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Giselle Deiros
    • Illinois
      • Chicago, Illinois, United States, 60621
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ayoade Akere
    • Kansas
      • El Dorado, Kansas, United States, 67042
        • Withdrawn
        • GSK Investigational Site
    • Louisiana
      • Lafayette, Louisiana, United States, 70508
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jibran Atwi
        • Contact:
        • Contact:
    • Minnesota
      • Mankato, Minnesota, United States, 56002
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mary Kathryn Smentek
    • Nebraska
      • Lincoln, Nebraska, United States, 68516
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Luke Anschutz
        • Contact:
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States, 45245
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christopher Peltier
    • Texas
      • Dallas, Texas, United States, 75230-2571
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Ronald Blair
        • Contact:
        • Contact:
      • Dallas, Texas, United States, 75235
        • Withdrawn
        • GSK Investigational Site
      • Houston, Texas, United States, 77065
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Kashif Ali
        • Contact:
        • Contact:
      • Richmond, Texas, United States, 77469
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Michael Bornstein
        • Contact:
        • Contact:
      • San Antonio, Texas, United States, 78244
        • Withdrawn
        • GSK Investigational Site
    • Utah
      • Roy, Utah, United States, 84067
        • Completed
        • GSK Investigational Site
      • Syracuse, Utah, United States, 84075
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Peter Silas
    • Virginia
      • Richmond, Virginia, United States, 23294
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • John Scott
        • Contact:
        • Contact:
      • Vienna, Virginia, United States, 22180
        • Withdrawn
        • GSK Investigational Site

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 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 (no laboratory testing required).
  • Hypersensitivity to latex.
  • 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.

  • 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: VNS Group
Participants receive 1 dose of a VNS vaccine, 1 dose of measles, mumps, and rubella (MMR) vaccine, 1 dose of hepatitis A (HAV) vaccine, and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.
Biological: Investigational varicella vaccine
1 dose of investigational 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.
Active Comparator: VV Group
Participants receive 1 dose of a marketed VV, 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: 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.
Biological: Marketed varicella vaccine
1 dose of marketed varicella vaccine administered subcutaneously.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of participants reporting each solicited administration site events
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
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 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°C (100.4°F) 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 events
Time Frame: Day 1 (post-dose) to Day 43
Solicited administration site include injection site varicella-like rash.
Day 1 (post-dose) to Day 43
Percentage of participants reporting solicited systemic events
Time Frame: Day 1 (post-dose) to Day 43
Solicited systemic events includes 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
An unsolicited AE is an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.
Day 1 (post-dose) to Day 43
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)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 26, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 23, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 23, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 15, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 213997
  • 2024-515868-31-00 (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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