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 trial tests the immune response and safety of new chickenpox and MMR (measles, mumps, rubella) vaccines in young children. Researchers aim to compare these vaccines to existing chickenpox vaccines and assess their effectiveness with other childhood vaccines. It suits parents of healthy children aged 12 to 15 months who have not yet had chickenpox, measles, mumps, rubella, or certain vaccinations. As a Phase 3 trial, this study is the final step before potential FDA approval, allowing participants to contribute to the development of vaccines that could soon become widely available.

Will I have to stop taking my current medications?

The trial requires that participants do not use any investigational or non-registered products, immune-modifying drugs, or certain other medications for a specified period before and during the study. If your child is on such medications, they may need to stop them before joining the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that the chickenpox vaccine is generally safe and well-tolerated. Many vaccine safety monitoring systems and years of research support this. While some side effects, like rashes or mild reactions, can occur, serious problems are rare.

One study on a similar chickenpox vaccine found it to be safe, with no major safety issues reported.

In this trial, children will receive either the new chickenpox vaccine along with the MMR vaccine or an existing chickenpox vaccine. Both options have undergone previous testing, and evidence suggests they are generally safe. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the candidate varicella vaccine, VNS, because it offers a potentially improved approach to preventing chickenpox. Unlike standard varicella vaccines, VNS is being tested in combination with other vaccines like MMR, hepatitis A, and PCV, which could streamline immunization schedules and enhance protection. Additionally, the inclusion of VNS in this combination aims to boost immune response against chickenpox, which could result in better efficacy compared to existing vaccines. This innovative approach could simplify the vaccination process and provide more comprehensive protection in a single visit.

What evidence suggests that this trial's treatments could be effective for chickenpox?

This trial will compare the candidate varicella vaccine (VNS vaccine) with a marketed varicella vaccine (VV). Research has shown that the new chickenpox vaccine effectively prevents the disease. Studies indicate that one dose of the vaccine can protect against chickenpox in 82% to 97% of cases, depending on the situation. Additionally, two doses increase its effectiveness to 87%, offering even better protection. This suggests that the new vaccine could be a strong choice for preventing chickenpox in young children. ^{6 7 8 9 10}

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

**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)

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

Citations

1. cdc.gov cdc.gov/vaccines/vpd/varicella/hcp/about-vaccine.html

About the Varicella Vaccine A case-control study conducted from 1997 to 2003 showed that 1 dose of varicella vaccine was 97% effective in the first year after vaccination and 86% effective ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10611158/

Real-World Effectiveness of the Varicella Vaccine among ... The vaccine effectiveness of varicella vaccines was 56% and 87% for one- and two-dose regimens, respectively. Our findings showed that there ...

3. academic.oup.com academic.oup.com/jid/article/226/Supplement_4/S425/6764809

Effectiveness of Varicella Vaccine: 25 Years of Postlicensure ... One dose of varicella vaccine provided moderate protection (82%–85%) against varicella of any severity and high protection (100%) against severe varicella.

4. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2024.1320407/full

Effectiveness of two-dose vs. one-dose varicella vaccine in ... Our study demonstrated significant effectiveness of both the two-dose and one-dose VarV in preventing varicella infection, with an adjusted VE ...

5. nejm.org nejm.org/doi/full/10.1056/NEJM200103293441302

The Effectiveness of the Varicella Vaccine in Clinical Practice Of the 56 vaccinated children with chickenpox, 86 percent had mild disease, whereas only 48 percent of the 187 unvaccinated children with ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/22872734/

A phase 1/2 clinical trial evaluating safety and ... Conclusions: In this study, HZ/su adjuvanted subunit vaccine was well tolerated and more immunogenic than a live attenuated VZV vaccine. Clinical Trial ...

7. cdc.gov cdc.gov/vaccine-safety/vaccines/varicella.html

Chickenpox (Varicella) Vaccine Safety Chickenpox vaccine has been shown to be safe and well tolerated. The findings from many vaccine safety monitoring systems and years of studies ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0264410X23012124

Immunogenicity and safety of a live-attenuated varicella ... For different immunization schedules, the seroconversion rates in the test group ranged from 78.41 % to 83.22 % 4 weeks after the second dose ...

9. thelancet.com thelancet.com/journals/lanwpc/article/PIIS2666-6065(23)00025-1/fulltext

Safety and immunogenicity of a skin- and neuro-attenuated ... The candidate v7D vaccine has been preliminarily shown to be well-tolerated and immunogenic in humans. The data warrant further evaluation of ...

10. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/193060

Postlicensure Safety Surveillance for Varicella Vaccine Approximately 4% of reports described serious adverse events, including 14 deaths. The most frequently reported adverse events were rashes, possible vaccine ...