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Clinical Trials in the USA / NCT06740630
Recruiting Phase 3

A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine When Given to Healthy Children 12 to 15 Months of Age

NCT06740630 · tracked via the Priya Life Science USA tracker
Sponsor
GlaxoSmithKline
Phase
Phase 3
Started
2025-01-10
Last updated
2026-05-29

Condition(s) studied

Chickenpox

Investigational drug(s) / intervention(s)

Investigational varicella vaccine_Lot 1Investigational varicella vaccine_Lot 2Investigational varicella vaccine_Lot 3Marketed varicella vaccine_Lot 1Marketed varicella vaccine_Lot 2MMR vaccine →Hepatitis A vaccinePCV (pneumococcal conjugate vaccine) 13PCV 20Vaxneuvance

Investigational varicella vaccine_Lot 1: Investigational varicella vaccine of Lot 1 administered subcutaneously.

Investigational varicella vaccine_Lot 2: Investigational varicella vaccine of Lot 2 administered subcutaneously.

Investigational varicella vaccine_Lot 3: Investigational varicella vaccine of Lot 3 administered subcutaneously.

Marketed varicella vaccine_Lot 1: Marketed varicella vaccine of Lot 1 administered subcutaneously.

Marketed varicella vaccine_Lot 2: Marketed varicella vaccine of Lot 2 administered subcutaneously.

MMR vaccine: MMR vaccine co-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 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.

Study summary

The purpose of this study is to assess the consistency of immune response to three different lots of GSK's investigational varicella vaccine (VNS Vaccine), and to compare the safety and immune response of VNS vaccine to an already approved varicella vaccine (VV) known as Varivax. The study will be conducted in healthy children aged 12 to 15 months, who have neither contracted varicella nor received a varicella vaccination.

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 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. * Hypersensitivity to latex. * Major congenital defects, as assessed by the investigator. * 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. \*If emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is organized by public health authorities outside the routine immunization program, the time period described above can be reduced provided it is used according to the local governmental recommendations and sponsor is notified * 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.

Primary outcome measure(s)

Trial sites (97)

FacilityCityRegionStatus
GSK Investigational Site Mobile Alabama Recruiting
GSK Investigational Site Hot Springs Arkansas Recruiting
GSK Investigational Site Sherwood Arkansas Recruiting
GSK Investigational Site Canoga Park California Recruiting
GSK Investigational Site Covina California Recruiting
GSK Investigational Site Fullerton California Withdrawn
GSK Investigational Site Long Beach California Withdrawn
GSK Investigational Site Los Angeles California Recruiting
GSK Investigational Site Paramount California Withdrawn
GSK Investigational Site Sacramento California Recruiting
GSK Investigational Site Ventura California Recruiting
GSK Investigational Site Walnut Creek California Recruiting
GSK Investigational Site Winnetka California Recruiting
GSK Investigational Site Miami Florida Withdrawn
GSK Investigational Site Miami Florida Recruiting
GSK Investigational Site Miami Lakes Florida Recruiting
GSK Investigational Site Spring Hill Florida Recruiting
GSK Investigational Site Tampa Florida Recruiting
GSK Investigational Site Covington Georgia Recruiting
GSK Investigational Site Ammon Idaho Recruiting
GSK Investigational Site Moline Illinois Recruiting
GSK Investigational Site South Bend Indiana Recruiting
GSK Investigational Site Topeka Kansas Recruiting
GSK Investigational Site Bardstown Kentucky Recruiting
GSK Investigational Site Louisville Kentucky Recruiting
GSK Investigational Site Haughton Louisiana Recruiting
GSK Investigational Site Fall River Massachusetts Recruiting
GSK Investigational Site Bingham Farms Michigan Recruiting
GSK Investigational Site Jefferson City Missouri Recruiting
GSK Investigational Site Lincoln Nebraska Recruiting
GSK Investigational Site Lincoln Nebraska Withdrawn
GSK Investigational Site Lincoln Nebraska Recruiting
GSK Investigational Site The Bronx New York Recruiting
GSK Investigational Site Charlotte North Carolina Recruiting
GSK Investigational Site Monroe North Carolina Withdrawn
GSK Investigational Site Cleveland Ohio Recruiting
GSK Investigational Site Dayton Ohio Recruiting
GSK Investigational Site Chickasha Oklahoma Recruiting
GSK Investigational Site Tulsa Oklahoma Recruiting
GSK Investigational Site Gresham Oregon Recruiting

+ 57 more sites — see the full list on the official registry below.

More GlaxoSmithKline trials in the USA

Other trials for the same condition

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 NCT06740630 on ClinicalTrials.gov ↗ ← All trials in the USA