Recruiting
Phase 3

Chickenpox Vaccine

Sponsor:

GlaxoSmithKline

Code:

NCT06693895

Conditions

Chickenpox

Eligibility Criteria

Sex: All

Age: 1

Healthy Volunteers: Accepted

Interventions

Investigational varicella vaccine

Marketed varicella vaccine

Measles, mumps, and rubella vaccine

Hepatitis A vaccine

PCV (pneumococcal conjugate vaccine) 13

Study Details

Brief summary:

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.

Conditions

Chickenpox

Study ID

NCT06693895

Start date

Nov 26, 2024

Status verified date

May, 2026

Completion date

Nov 23, 2026

Anticipated

Primary completion date

Nov 23, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1

Healthy Volunteers: Accepted

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 Design

Enrollment

750 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Investigational varicella vaccine

1 dose of investigational varicella vaccine administered subcutaneously.

Marketed varicella vaccine

1 dose of marketed varicella vaccine administered subcutaneously.

Measles, mumps, and rubella vaccine

1 dose of measles, mumps, and rubella vaccine co-administered subcutaneously or intramuscularly.

Hepatitis A vaccine

1 dose of hepatitis A vaccine co-administered intramuscularly.

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.

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.

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.

Primary outcome measure

  • Percentage of participants reporting each solicited administration site events [ Time Frame: Day 1 (post-dose) to Day 4 ]
  • Percentage of participants reporting each solicited systemic event [ Time Frame: 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 ]
  • Percentage of participants reporting each solicited administration site events [ Time Frame: Day 1 (post-dose) to Day 43 ]
  • Percentage of participants reporting solicited systemic events [ Time Frame: Day 1 (post-dose) to Day 43 ]
  • Percentage of participants reporting unsolicited adverse events (AEs) [ Time Frame: 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) ]
  • Percentage of participants reporting serious adverse events (SAEs) [ Time Frame: Day 1 (post-dose) to Day 181 (study end) ]

Central Contacts and Locations

Central contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

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

Locations

GSK Investigational Site

Recruiting

Huntington Park, California, United States, 90057

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Jose Diaz

GSK Investigational Site

Recruiting

National City, California, United States, 91950

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Mohammed Bailony

GSK Investigational Site

Recruiting

West Covina, California, United States, 91790

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Holly Lim

GSK Investigational Site

Recruiting

Hialeah, Florida, United States, 33012

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Jorge Alsina

GSK Investigational Site

Recruiting

Miami, Florida, United States, 33142

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Giselle Deiros

GSK Investigational Site

Recruiting

Chicago, Illinois, United States, 60621

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Ayoade Akere

GSK Investigational Site

Recruiting

Lafayette, Louisiana, United States, 70508

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Jibran Atwi

GSK Investigational Site

Recruiting

Mankato, Minnesota, United States, 56002

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Mary Kathryn Smentek

GSK Investigational Site

Recruiting

Lincoln, Nebraska, United States, 68516

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Luke Anschutz

GSK Investigational Site

Recruiting

Cincinnati, Ohio, United States, 45245

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Christopher Peltier

GSK Investigational Site

Recruiting

Dallas, Texas, United States, 75230-2571

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Ronald Blair

GSK Investigational Site

Recruiting

Houston, Texas, United States, 77065

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Kashif Ali

GSK Investigational Site

Recruiting

Richmond, Texas, United States, 77469

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Fabiana Farinetti

GSK Investigational Site

Recruiting

Richmond, Texas, United States, 77469

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Michael Bornstein

GSK Investigational Site

Recruiting

Syracuse, Utah, United States, 84075

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Peter Silas

GSK Investigational Site

Recruiting

Richmond, Virginia, United States, 23294

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

John Scott

More Information

Sponsor

GlaxoSmithKline

Last update posted

May 29, 2026

Last verified

May, 2026

Keywords

  • Chickenpox
  • Investigational varicella vaccine (VNS) Varicella

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by GlaxoSmithKline on 2026-05-29.