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NCT Number: NCT06855160

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

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.

Recruiting

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Key information

Age range

12 month–15 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Alken, Belgium

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Candidate varicella vaccine

Biological

Investigational varicella vaccine administered intramuscularly.

Marketed varicella vaccine

Biological

Marketed varicella vaccine administered subcutaneously.

MMR Vaccine

Biological

MMR vaccine administered subcutaneously or intramuscularly.

Hepatitis A Vaccine

Biological

Hepatitis A vaccine co-administered intramuscularly.

PCV (pneumococcal conjugate vaccine) 13

Biological

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

Biological

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

Biological

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.

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

  3. Percentage of participants with seroresponse to MMR antigens

    Time frame: 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.

  4. GMC of Anti-measles antibodies

    Time frame: At Day 43

  5. GMC of Anti-mumps antibodies

    Time frame: At Day 43

  6. GMC of Anti-rubella antibodies

    Time frame: At Day 43

Secondary outcomes

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

    Time frame: At Day 43

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

    Time frame: At Day 43

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

    Time frame: Day 1 (post-dose) to Day 4

    Solicited administration site events include injection site redness, pain, and swelling.

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

    Time frame: Day 1 (post-dose) to Day 4

    Solicited administration site events include injection site redness, pain and swelling.

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

    Time frame: Day 1 (post-dose) to Day 15

    Solicited systemic events include drowsiness, loss of appetite and irritability.

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

    Time frame: Day 1 (post-dose) to Day 22

    Fever is defined as temperature greater than or equal (>=) 38.0 degrees Celsius (°C) regardless of the location of measurement (the preferred location for measuring temperature is the axilla).

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

    Time frame: Day 1 (post-dose) to Day 43

    Solicited administration site events include injection site varicella-like rash.

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

    Time frame: Day 1 (post-dose) to Day 43

    Solicited systemic events includes varicella-like rash (non-injection site), measles/rubella-like rash, and general rash (not varicella like and not measles/rubella-like).

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

    Time frame: Day 1 (post-dose) to Day 43

    Unsolicited AEs include any AE reported in addition to solicited events during the study, or any "solicited" symptoms with onset outside of the specified period of follow-up for solicited symptoms, are assessed for each group after the administration of all vaccines. Unsolicited AEs include nonserious and serious AEs.

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

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

    A MAAE is an AE for which the participant received medical attention including any symptom or illness requiring hospitalization, or an emergency room visit, or visit to/by a healthcare professional.

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

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

    A SAE is an AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or other situations that are considered serious per medical or scientific judgment.

Study contacts

Contact information is provided by the study sponsor or research team.

EU GSK Clinical Trials Call Center

CONTACT

[email protected]

+44 (0) 20 89904466

US GSK Clinical Trials Call Center

CONTACT

[email protected]

877-379-3718

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 3, 2025
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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