Investigational Vaccine for Chickenpox

Recruiting at 34 trial locations

Overseen By EU GSK Clinical Trials Call Center

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: GlaxoSmithKline

Must not be taking: Immune-modifying drugs

Disqualifiers: Immunosuppressive conditions, Neurological disorders, Tuberculosis, 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

1840 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new chickenpox vaccine to evaluate its efficacy and safety compared to an already approved vaccine. Researchers seek to determine if different batches of the new vaccine produce a consistent immune response in children. The trial is open to healthy children aged 12 to 15 months who have not had chickenpox or been vaccinated for it. Participants will receive either the investigational varicella vaccine (new chickenpox vaccine) or the standard vaccine, along with other routine vaccines. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking vaccine.

Will I have to stop taking my current medications?

The trial does not specify if participants must stop taking their current medications. However, it excludes those using immune-modifying drugs for more than 14 days or planning to use them during the study. If your child is on such medications, they may need to stop before joining the trial.

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

Research has shown that GSK's new chickenpox vaccine (VNS Vaccine) was generally well-tolerated in earlier studies. Healthy children aged 12 to 15 months who received the vaccine demonstrated positive safety results. These studies did not find any serious side effects directly caused by the vaccine. They evaluated the vaccine's ability to trigger a strong immune response without causing major side effects. Now in a late-stage clinical trial, the vaccine has already passed earlier safety tests, suggesting it is considered safe enough for testing on a larger group of children. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

The investigational VNS vaccine for chickenpox is unique because it introduces a new approach to preventing this common viral infection. Unlike standard vaccines, which typically rely on well-established formulations, the VNS vaccine could potentially offer improved efficacy or safety profiles. Researchers are excited about the possibility that this vaccine might work better or have fewer side effects than current options, which include widely used varicella vaccines like Varivax. By comparing multiple lots of the VNS vaccine to existing vaccines, scientists hope to identify a superior option for protecting against chickenpox.

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

This trial will compare the investigational VNS vaccine with marketed varicella vaccines. Research has shown that varicella vaccines, like the investigational VNS vaccine in this trial, are highly effective. Studies indicate that a single dose of similar varicella vaccines can provide moderate protection, about 82% to 85%, against chickenpox of any severity, and complete protection against severe cases. One study found that a single dose of a varicella vaccine was 97% effective in the first year and 86% effective in subsequent years. Additionally, most vaccinated children who contracted chickenpox experienced only mild symptoms. This evidence suggests that the investigational VNS vaccine could effectively prevent chickenpox in children. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for healthy children aged 12 to 15 months who have never had chickenpox or the chickenpox vaccine. They should not have any known allergies to vaccine components.

Inclusion Criteria

Written or witnessed/thumb printed informed consent obtained from the participant's parent(s)/LAR(s) prior to performance of any study-specific procedure

I am between 12 to 15 months old.

Participant's parent(s) or Legally Acceptable Representatives (LARs) 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)

Exclusion Criteria

I am scheduled to receive a vaccine soon, with some exceptions.

Previous vaccination against measles, mumps, and rubella

Participants with high-risk individuals in their household

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 investigational or marketed varicella vaccine, along with MMR, HAV, and PCV vaccines on Day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for immune response and safety, including seroresponse and adverse events

43 days

Multiple visits (in-person and virtual)

Extended Follow-up

Participants are monitored for serious adverse events and medically attended adverse events

181 days

What Are the Treatments Tested in This Trial?

Interventions

• Investigational varicella vaccine

Trial Overview The study tests three different lots of a new varicella (chickenpox) vaccine against an approved one, Varivax. It also looks at how well these vaccines work with other common childhood vaccinations like PCV and MMR.

How Is the Trial Designed?

Group I: VNS_Lot 3 Group Experimental Treatment 6 Interventions

Participants receive 1 dose of the investigational VNS vaccine of Lot 3, 1 dose of MMR vaccine, 1 dose of HAV vaccine, and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.

Group II: VNS_Lot 2 Group Experimental Treatment 6 Interventions

Participants receive 1 dose of the investigational VNS vaccine of Lot 2, 1 dose of MMR vaccine, 1 dose of HAV vaccine, and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.

Group III: VNS_Lot 1 Group Experimental Treatment 6 Interventions

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

Group IV: VV_Lot 1 Group Active Control 6 Interventions

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

Group V: VV_Lot 2 Group Active Control 6 Interventions

Participants receive 1 dose of a marketed VV of Lot 2, 1 dose of MMR vaccine, 1 dose of 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

Published Research Related to This Trial

The Advisory Committee on Immunization Practices (ACIP) has issued its first recommendations for the use of the live, attenuated varicella virus vaccine (VARIVAX), which is approved for healthy individuals aged 12 months and older.

These recommendations also update previous guidelines on the use of varicella zoster immune globulin (VZIG) for preventing chickenpox, highlighting the importance of vaccination in managing varicella outbreaks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of varicella: Recommendations of the Advisory Committee on Immunization Practices (ACIP). Centers for Disease Control and Prevention. [2017]

Between 1995 and 2005, nearly 48 million doses of the varicella vaccine were distributed, with 25,306 adverse events reported, indicating a low incidence of serious adverse events at 2.6 per 100,000 doses.

While some adverse events, such as meningitis, were linked to the vaccine strain of varicella-zoster virus, serious complications remain rare and are outweighed by the significant benefits of vaccination, highlighting the importance of ongoing safety monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of varicella vaccine after licensure in the United States: experience from reports to the vaccine adverse event reporting system, 1995-2005. Chaves, SS., Haber, P., Walton, K., et al.[2022]

The live attenuated varicella vaccine demonstrated an efficacy of 87.1% in preventing varicella in a study of 5997 children aged 1 to 12 years, with only six cases in the vaccine group compared to 46 in the placebo group.

The vaccine was found to be safe, with no significant difference in adverse reactions between the vaccine and placebo groups, and a high seroconversion rate of 97.1%, indicating strong immune response in vaccinated children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, safety and immunogenicity of live attenuated varicella vaccine in healthy children in China: double-blind, randomized, placebo-controlled clinical trial. Hao, B., Chen, Z., Zeng, G., et al.[2019]

Children who experienced breakthrough varicella after being vaccinated had significantly fewer total and vesicular lesions compared to those with natural varicella, indicating a milder form of the disease.

Breakthrough varicella was associated with a lower incidence of fever and a shorter duration of illness, suggesting that the live attenuated vaccine effectively modifies the clinical severity of chickenpox.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical survey of natural varicella compared with breakthrough varicella after immunization with live attenuated Oka/Merck varicella vaccine. Bernstein, HH., Rothstein, EP., Watson, BM., et al.[2010]

The live-virus varicella vaccine (Varivax) was licensed in 1995 and initially showed minimal adverse events, but rare risks have been identified since its widespread use.

A case study of an HIV-infected boy revealed that he developed a severe reaction, including dissemination of the vaccine strain of varicella zoster, highlighting potential risks in immunocompromised individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disseminated vaccine strain varicella as the acquired immunodeficiency syndrome-defining illness in a previously undiagnosed child. Kramer, JM., LaRussa, P., Tsai, WC., et al.[2019]

The VAR-PE process for the varicella vaccine demonstrated 100% seroconversion in healthy children aged 12 to 23 months, showing that it is as effective as the commercial varicella vaccine (VAR) in inducing an immune response.

While both vaccines had similar rates of injection-site adverse events, VAR-PE was associated with higher instances of pyrexia and otitis media, indicating some differences in safety profiles, but overall, the incidence of adverse events decreased after the second dose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A double-blind, randomized, multicenter, controlled study to evaluate the immunogenicity, safety, and tolerability of varicella vaccine (VARIVAX™) passage extension 34 (PE34) process administered concomitantly with measles, mumps, and rubella vaccine (M-M-R™ II). Silas, PE., Zissman, EN., Gardner, J., et al.[2021]

The varicella vaccine (Varivax) is 84.5% effective in preventing all cases of chickenpox when given before exposure, and it is 100% effective in preventing severe cases, based on a review of 19 studies.

When given after exposure to the virus, the varicella vaccine is also highly effective in preventing or reducing the severity of the disease, but a two-dose schedule is now recommended to improve effectiveness and prevent outbreaks in high-contact environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Varicella vaccine effectiveness in the US vaccination program: a review. Seward, JF., Marin, M., Vázquez, M.[2022]

In a study of 181 healthy children vaccinated with a reformulated varicella vaccine, the overall seroconversion rate was 99%, indicating high efficacy of the vaccine.

Risk factors for breakthrough varicella included being vaccinated at 14 months or younger, having household contact with varicella, and receiving a low titre vaccine, which suggests that vaccination strategies may need to be adjusted to reduce these risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors for breakthrough varicella in healthy children. Lim, YJ., Chew, FT., Tan, AY., et al.[2019]

In a study of 505 healthy children aged 1 to 12 years, the thermostable varicella vaccine was found to be well tolerated, with most side effects being mild and temporary, resolving within the follow-up period.

Only two subjects experienced severe symptoms, but no serious adverse events were reported, indicating a strong safety profile for the vaccine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reactogenicity to a live attenuated varicella vaccine in Canadian children. Diaz-Mitoma, F., Halperin, SA., Scheifele, D.[2020]

In a study of over 1.1 million children who received the varicella vaccine, there was no significant increase in the risk of serious adverse events like idiopathic thrombocytopenic purpura (ITP), meningitis, encephalitis, or ischemic stroke following vaccination.

A slight increase in the risk of pneumonia was observed during the 6th week post-vaccination, but this was not seen for other serious conditions, indicating that the varicella vaccine is generally safe with minimal risk of severe side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of pre-specified adverse events following varicella vaccine: A population-based self-controlled risk interval study. Liu, CH., Yeh, YC., Huang, WT., et al.[2021]

In a trial involving 37 leukemic children, the live attenuated OKA varicella vaccine successfully fully immunized all 20 seronegative patients, demonstrating its efficacy in this vulnerable population.

The vaccine was well-tolerated with only a few side effects and no cases of generalized vaccinal infection, suggesting it is a safe option for immunocompromised patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study of tolerance and effectiveness of a varicella vaccine in leukemic children. Bancillon, A., Leblanc, T., Baruchel, A., et al.[2007]

The varicella vaccine used as post-exposure prophylaxis (PEP) for chickenpox in pediatric patients is cost-effective, saving an average of USD 611 per patient while also reducing the quality-adjusted life-year (QALY) loss compared to not using the vaccine.

In a decision analysis involving local epidemiology and medical literature, the study found that PEP with the varicella vaccine resulted in lower costs (USD 320 vs USD 731) and less QALY loss (0.00423 vs 0.01122) when compared to no PEP, demonstrating its effectiveness in preventing chickenpox after exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-effectiveness analysis of varicella vaccine as post-exposure prophylaxis in Hong Kong. Chui, KS., Wu, HL., You, JH.[2013]

The varicella vaccine is effective in preventing chickenpox in immunocompromised children, such as those with acute leukemia or solid tumors, and also benefits healthy seronegative siblings.

Acyclovir, an antiviral drug, effectively reduces severe complications from chickenpox in at-risk groups, and the use of zoster hyperimmunoglobulin provides additional protection during the incubation period, suggesting that with these interventions, chickenpox will become less of a medical concern even for vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Results of virostatic treatment of varicella with various severity]. Stary, A.[2013]

Varilrix, the first refrigerator-stable varicella vaccine, has been used safely and effectively in over 10,000 individuals across clinical trials and mass vaccination programs, demonstrating its immunogenicity and efficacy against chickenpox.

With 16 years of clinical and postmarketing experience, Varilrix is indicated for high-risk groups and healthy individuals, highlighting its importance in preventing varicella in various populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sixteen years of global experience with the first refrigerator-stable varicella vaccine (Varilrix). Kreth, HW., Lee, BW., Kosuwon, P., et al.[2019]

Citations

1. 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.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06693895

NCT06693895 | A Study on the Safety of an Investigational ... The purpose of this study is to assess how well-tolerated GSK's investigational varicella vaccine (VNS Vaccine) is, in comparison to an already approved ...

3. 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 ...

4. 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.

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. clinicaltrials.gov clinicaltrials.gov/study/NCT05084508

NCT05084508 | A Study on the Immune Response and ... The purpose of this study is to assess immune response and safety of various potencies of an investigational chickenpox vaccine given to healthy children 12 to ...

7. ctv.veeva.com ctv.veeva.com/study/a-study-on-the-safety-of-an-investigational-chickenpox-vaccine-when-given-to-healthy-children-12-t

A Study on the Safety of an Investigational Chickenpox ... The purpose of this study is to assess how well-tolerated GSK's investigational varicella vaccine (VNS Vaccine) is, in comparison to an already approved ...

8. clinicaltrialsregister.eu clinicaltrialsregister.eu/ctr-search/trial/2022-001910-21/3rd

Clinical Trials Register A study on the immune response and safety of various potencies of an investigational chickenpox vaccine compared with a marketed chickenpox vaccine, given ...

9. clinicalresearch.com clinicalresearch.com/en/find-trials/Study/NCT06693895

NCT06693895 A Study on the Safety of an Investigational Chickenpox Vaccine, When Given to Healthy Children, 12 to 15 Months of Age.