RECRUITING

A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine and a Marketed Measles, Mumps and Rubella Vaccine When Administered as Intramuscular Injection to Healthy Children 12 to 15 Months of Age

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 3a, Open-Label, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of Intramuscular Administration of an Investigational Varicella Vaccine and Priorix Compared With Subcutaneous Administration of Varivax and Priorix, When Given as a First Dose to Healthy Children 12 to 15 Months of Age

Quick Facts

Study Start:2025-04-17

Study Completion:2026-12-24

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06855160

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.

Ages Eligible for Study:12 Months to 15 Months

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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.	* 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. * 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. * 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. * 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. * 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

Inclusion Criteria

Exclusion 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.

* 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.
* 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.
* 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.
* 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.
* 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

Contacts and Locations

Study Contact

US GSK Clinical Trials Call Center

CONTACT

877-379-3718

GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466

GSKClinicalSupportHD@gsk.com

Study Locations (Sites)

GSK Investigational Site

Tucson, Arizona, 85704

United States

GSK Investigational Site

Huntington Park, California, 90255

United States

GSK Investigational Site

Sherman Oaks, California, 91403

United States

GSK Investigational Site

Coral Gables, Florida, 33134

United States

GSK Investigational Site

Idaho Falls, Idaho, 83404

United States

GSK Investigational Site

Houston, Texas, 77584

United States

Collaborators and Investigators

Sponsor: 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 Registration Dates

Study Start Date2025-04-17

Study Completion Date2026-12-24

Study Record Updates

Study Start Date2025-04-17

Study Completion Date2026-12-24

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Chickenpox