Chickenpox + MMR Vaccines for Chickenpox

Recruiting at 5 trial locations

Overseen By US GSK Clinical Trials Call Center

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: GlaxoSmithKline

Must not be taking: Immune-modifying drugs, Corticosteroids

Disqualifiers: Immunosuppressive conditions, Neurological disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

900 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for healthy children aged 12 to 15 months who have already completed their primary series of pneumococcal conjugate vaccine (PCV). Parents or legal guardians must consent and be able to follow the study's protocol. Children with health issues that could interfere with the study, or those not within the age range, cannot participate.

Inclusion Criteria

My parent or legal guardian can meet the study's requirements.

My parent or legal guardian has given consent for me to participate.

I am between 12 to 15 months old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 1 dose of the candidate varicella vaccine, MMR vaccine, HAV vaccine, and PCV on Day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of immune response and adverse events

26 weeks

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Candidate varicella vaccine

Trial Overview The trial is testing GSK's investigational chickenpox vaccine and a marketed MMR vaccine given by muscle injection. It compares these to Merck's chickenpox vaccine administered under the skin. The study also looks at how well these vaccines work alongside other childhood vaccines when given via muscle injection.

How Is the Trial Designed?

Group I: VNS+ MMR Vaccine Experimental Treatment 6 Interventions

Participants receive 1 dose of the candidate varicella vaccine (VNS vaccine), 1 dose of a measles, mumps, and rubella (MMR) vaccine, 1 dose of a hepatitis A virus (HAV vaccine), and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.

Group II: VV+MMR Vaccine Active Control 6 Interventions

Participants receive 1 dose of a Marketed varicella vaccine (VV), 1 dose of a MMR vaccine, 1 dose of a HAV vaccine, and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

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Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School