Ireland
--:--IST
Recruiting Phase 3

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

NCT06855160 · tracked via the Priya Life Science Poland tracker
Phase
Phase 3
Started
2025-04-17
Last updated
2026-05-29

Condition(s) studied

Chickenpox

Investigational drug(s) / intervention(s)

Candidate varicella vaccineMarketed varicella vaccine →MMR vaccine →Hepatitis A vaccine →PCV (pneumococcal conjugate vaccine) 13 →PCV 20 →Vaxneuvance →

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.

Study 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.

Eligibility

Sex
ALL
Min age
12 Months
Max age
15 Months
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

Primary outcome measure(s)

  • Percentage of participants with seroresponse to Varicella Zoster Virus (VZV) anti- glycoprotein E (gE) Immunoglobulin (IgG) — At Day 43
    The seroresponse rate is defined as the percentage of participants for whom the post-vaccination Day 43 anti VZV gE IgG concentration is above the seroresponse threshold.
  • Geometric Mean Concentration (GMC) of anti-VZV gE IgG — At Day 43
    Concentrations of anti-VZV gE IgG are presented as GMC and expressed in milli-international units per milliliter (mIU/mL) for each group.
  • Percentage of participants with seroresponse to MMR antigens — At Day 43
    The seroresponse rate is defined as the percentage of participants for whom the post-vaccination Day 43 anti-measles, mumps, and rubella antibody concentrations are above the seroresponse threshold.
  • GMC of Anti-measles antibodies — At Day 43
  • GMC of Anti-mumps antibodies — At Day 43
  • GMC of Anti-rubella antibodies — At Day 43

Trial sites (22)

FacilityCityRegionStatus
GSK Investigational Site Tucson Arizona Recruiting
GSK Investigational Site Huntington Park California Recruiting
GSK Investigational Site Sherman Oaks California Recruiting
GSK Investigational Site Coral Gables Florida Recruiting
GSK Investigational Site Miami Lakes Florida Recruiting
GSK Investigational Site Tampa Florida Recruiting
GSK Investigational Site Idaho Falls Idaho Recruiting
GSK Investigational Site Dayton Ohio Recruiting
GSK Investigational Site Houston Texas Recruiting
GSK Investigational Site Lewisville Texas Recruiting
GSK Investigational Site Mansfield Texas Recruiting
GSK Investigational Site Pharr Texas Recruiting
GSK Investigational Site Richmond Virginia Recruiting
GSK Investigational Site Alken Belgium Recruiting
GSK Investigational Site Tartu Estonia Recruiting
GSK Investigational Site Athens Greece Withdrawn
GSK Investigational Site Athens Greece Recruiting
GSK Investigational Site Thessaloniki Greece Recruiting
GSK Investigational Site Trzebnica Poland Recruiting
GSK Investigational Site Brasov Romania Recruiting
GSK Investigational Site Calarasi Romania Recruiting
GSK Investigational Site Chiang Mai Thailand Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06855160 on ClinicalTrials.gov ↗ ← All trials in Poland