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Cancer Vaccine

Investigational Vaccine for Chickenpox

Phase 3

Waitlist Available

Research Sponsored by GlaxoSmithKline

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

A male or female between, and including, 12 to 15 months of age at the time of the administration of study interventions

Be younger than 18 years old

Must not have

History of varicella disease

Previous vaccination against hepatitis A virus

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 (post-dose) to day 181 (study end)

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial aims to see how safe and well-tolerated a new varicella vaccine from GSK is compared to the already approved Varivax vaccine. It will involve healthy children aged 12

Who is the study for?

This trial is for healthy children aged 12 to 15 months who have never had chickenpox or the chickenpox vaccine. They must not have received any other vaccines within four weeks before the study starts and should not be planning to receive any during the study.

What is being tested?

The trial is testing a new investigational varicella (chickenpox) vaccine against an already approved one, Varivax. It will compare how well each vaccine works and how safe they are when given to young children.

What are the potential side effects?

Possible side effects from these vaccines may include pain at the injection site, fever, fatigue, rash, and loss of appetite. These are common reactions after vaccinations but can vary in intensity among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My child is between 12 to 15 months old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had chickenpox in the past.

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I have been vaccinated against hepatitis A.

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I have been vaccinated against chickenpox.

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I have uncontrolled neurological disorders or seizures.

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I have active, untreated tuberculosis.

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I am not on long-term immune-modifying drugs nor plan to use them during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 (post-dose) to day 181 (study end)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 (post-dose) to day 181 (study end)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (post-dose) to day 181 (study end) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of participants reporting each solicited administration site events

Percentage of participants reporting each solicited systemic event

Percentage of participants reporting each solicited systemic event in terms of fever

+4 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: VNS GroupExperimental Treatment6 Interventions

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

Group II: VV GroupActive Control6 Interventions

Participants receive 1 dose of a marketed VV, 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hepatitis A vaccine

2008

Completed Phase 4

~72490

PCV 20

2022

Completed Phase 1

~70