Recruiting
Phase 3

GSK & Merck

Sponsor:

GlaxoSmithKline

Code:

NCT06855160

Conditions

Chickenpox

Eligibility Criteria

Sex: All

Age: 1

Healthy Volunteers: Accepted

Interventions

Candidate varicella vaccine

Marketed varicella vaccine

MMR vaccine

Hepatitis A vaccine

PCV (pneumococcal conjugate vaccine) 13

Study Details

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.

Conditions

Chickenpox

Study ID

NCT06855160

Start date

Apr 17, 2025

Status verified date

May, 2026

Completion date

Feb 2, 2027

Anticipated

Primary completion date

Sep 10, 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 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.

Exclusion Criteria:

  • 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.
  • 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 varicella virus.
  • Previous vaccination against hepatitis A 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.

Prior/Concurrent clinical study experience

• 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).

Other exclusion criteria

  • Any study personnel or their immediate dependents, family, or household members.
  • Child in care.
  • 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 <28 weeks of gestation

Study Design

Enrollment

911 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: VNS+ MMR Vaccine

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.

active comparator: VV+MMR Vaccine

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.

Interventions

Candidate varicella vaccine

Investigational varicella vaccine administered intramuscularly.

Marketed varicella vaccine

Marketed varicella vaccine administered subcutaneously.

MMR vaccine

MMR vaccine administered subcutaneously or intramuscularly.

Hepatitis A vaccine

Hepatitis A vaccine co-administered intramuscularly.

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.

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.

Vaxneuvance

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.

Primary outcome measure

  • Percentage of participants with seroresponse to Varicella Zoster Virus (VZV) anti- glycoprotein E (gE) Immunoglobulin (IgG) [ Time Frame: At Day 43 ]
  • Geometric Mean Concentration (GMC) of anti-VZV gE IgG [ Time Frame: At Day 43 ]
  • Percentage of participants with seroresponse to MMR antigens [ Time Frame: At Day 43 ]
  • GMC of Anti-measles antibodies [ Time Frame: At Day 43 ]
  • GMC of Anti-mumps antibodies [ Time Frame: At Day 43 ]
  • GMC of Anti-rubella antibodies [ Time Frame: At Day 43 ]

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

Tucson, Arizona, United States, 85704

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:

Dena Petersen

GSK Investigational Site

Recruiting

Huntington Park, California, United States, 90255

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:

Albert Nassir

GSK Investigational Site

Recruiting

Sherman Oaks, California, United States, 91403

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:

Dmitriy Romanenko

GSK Investigational Site

Recruiting

Coral Gables, Florida, United States, 33134

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:

Ivo Alonso

GSK Investigational Site

Recruiting

Miami Lakes, Florida, United States, 33014

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:

Angel Rico

GSK Investigational Site

Recruiting

Tampa, Florida, United States, 33612

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:

Michele Johnson Towson

GSK Investigational Site

Recruiting

Idaho Falls, Idaho, United States, 83404

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:

Boyd Southwick

GSK Investigational Site

Recruiting

Dayton, Ohio, United States, 45414

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:

Julie Shepard

GSK Investigational Site

Recruiting

Houston, Texas, United States, 77584

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:

Yvette Poindexter

GSK Investigational Site

Recruiting

Lewisville, Texas, United States, 75067

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:

Asgar Dudhbhai

GSK Investigational Site

Recruiting

Mansfield, Texas, United States, 76063

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:

Keithlee Dolinta

GSK Investigational Site

Recruiting

Pharr, Texas, United States, 78577

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:

Belinda Jordan

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

  • Chicken pox
  • Candidate l varicella vaccine (VNS)
  • Varicella
  • Varivax
  • Healthy Children

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by GlaxoSmithKline on 2026-05-29.