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

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.

Conditions

Study Overview

Study Details

Study overview

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.

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

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

Condition
Chickenpox
Intervention / Treatment

-

Contacts and Locations

Tucson

GSK Investigational Site, Tucson, Arizona, United States, 85704

Huntington Park

GSK Investigational Site, Huntington Park, California, United States, 90255

Sherman Oaks

GSK Investigational Site, Sherman Oaks, California, United States, 91403

Coral Gables

GSK Investigational Site, Coral Gables, Florida, United States, 33134

Idaho Falls

GSK Investigational Site, Idaho Falls, Idaho, United States, 83404

Houston

GSK Investigational Site, Houston, Texas, United States, 77584

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

12 Months to 15 Months

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

GlaxoSmithKline,

Study Record Dates

2026-12-24