Last updated: 11/27/2025 15:40:13

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

GSK study ID
223105
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Trial status
Recruiting
Recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Percentage of participants with seroresponse to Varicella Zoster Virus (VZV) anti- glycoprotein E (gE) Immunoglobulin (IgG)

Timeframe: At Day 43

Geometric Mean Concentration (GMC) of anti-VZV gE IgG

Timeframe: At Day 43

Percentage of participants with seroresponse to MMR antigens

Timeframe: At Day 43

GMC of Anti-measles antibodies

Timeframe: At Day 43

GMC of Anti-mumps antibodies

Timeframe: At Day 43

GMC of Anti-rubella antibodies

Timeframe: At Day 43

Secondary outcomes:

Percentage of participants with seroresponse to demonstrate an acceptable immune response for IM administration of MMR vaccine

Timeframe: At Day 43

Percentage of participants with seroresponse to MMR antigens with a reduced non-inferiority margin

Timeframe: At Day 43

Percentage of participants reporting each solicited administration site events post-dose of investigational VNS vaccine or VV administration

Timeframe: Day 1 (post-dose) to Day 4

Percentage of participants reporting each solicited administration site events post-dose of MMR vaccine administration

Timeframe: Day 1 (post-dose) to Day 4

Percentage of participants reporting each solicited systemic events post-dose of study interventions administration

Timeframe: Day 1 (post-dose) to Day 15

Percentage of participants reporting each solicited systemic event in terms of fever post-dose of study interventions administration

Timeframe: Day 1 (post-dose) to Day 22

Percentage of participants reporting each solicited administration site events post-dose of study interventions administration

Timeframe: Day 1 (post-dose) to Day 43

Percentage of participants reporting each solicited systemic events post-dose of study interventions administration

Timeframe: Day 1 (post-dose) to Day 43

Percentage of participants reporting unsolicited Adverse Events (AEs) post-dose of study interventions administration

Timeframe: Day 1 (post-dose) to Day 43

Percentage of participants reporting medically attended AEs (MAAE) post-dose of study interventions administration

Timeframe: Day 1 (post-dose) to Day 181 (Study end)

Percentage of participants reporting Serious AEs (SAEs) post-dose of study interventions administration

Timeframe: Day 1 (post-dose) to Day 181 (Study end)

Interventions:
  • Biological/vaccine: Candidate varicella vaccine
  • Biological/vaccine: Marketed varicella vaccine
  • Biological/vaccine: MMR vaccine
  • Biological/vaccine: Hepatitis A vaccine
  • Biological/vaccine: PCV (pneumococcal conjugate vaccine) 13
  • Biological/vaccine: PCV 20
  • Biological/vaccine: Vaxneuvance
  • Enrollment:
    900
    Primary completion date:
    2026-10-09
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Chickenpox
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    April 2025 to February 2027
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    12 - 15 Months
    Accepts healthy volunteers
    Yes
    • 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.
    • 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).

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Coral Gables, FL, United States, 33134
    Status
    Recruiting
    Location
    GSK Investigational Site
    Houston, TX, United States, 77584
    Status
    Recruiting
    Location
    GSK Investigational Site
    Huntington Park, CA, United States, 90255
    Status
    Recruiting
    Location
    GSK Investigational Site
    Idaho Falls, ID, United States, 83404
    Status
    Recruiting
    Location
    GSK Investigational Site
    Sherman Oaks, CA, United States, 91403
    Status
    Recruiting
    Location
    GSK Investigational Site
    Tucson, AZ, United States, 85704
    Status
    Recruiting
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    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Recruiting
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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