What side effects are associated with this type of intervention?

The most common side effects of chickenpox vaccines, which stimulate the immune system to produce antibodies against the varicella-zoster virus, include mild reactions such as pain, redness, and swelling at the injection site. Some individuals may experience fever, fatigue, or a mild rash. Serious side effects are rare but can include allergic reactions. These side effects are generally consistent with those observed in prelicensure clinical trials and postlicensure surveillance studies.

What prior FDA approvals exist?

The FDA has approved several vaccines for the prevention of chickenpox (varicella), which work by stimulating the immune system to produce antibodies against the varicella-zoster virus. The most commonly known vaccine is the Varivax (varicella vaccine), which is a live attenuated virus vaccine. Another combination vaccine, ProQuad, includes measles, mumps, rubella, and varicella (MMRV) components. These vaccines are typically administered to children between 12 to 15 months of age, with a second dose given later to ensure immunity. These vaccines have been shown to be effective in preventing chickenpox and are part of the routine immunization schedule for children in the United States.

What other types of research exist?

Promising novel alternatives to the traditional chickenpox vaccine for 2024 include DNA vaccines, recombinant subunit vaccines, and inactivated vaccines. These approaches have shown potential in other viral infections and could offer enhanced safety and efficacy. Additionally, the use of immune-modulating adjuvants and the development of cost-effective subunit vaccines are promising strategies.

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Virus Vaccine

Investigational Chickenpox Vaccine for Chickenpox

Q: What is the mechanism of action of this treatment?

The most common treatments for Chickenpox include vaccines and antiviral medications. Vaccines work by stimulating the immune system to produce antibodies against the varicella-zoster virus, thereby providing immunity and preventing infection. Antiviral medications, such as acyclovir, inhibit the replication of the virus, which helps to reduce the severity and duration of symptoms. These treatments are important for Chickenpox patients as they help prevent complications, reduce the spread of the virus, and improve overall patient outcomes.

Phase 2

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 and 15 months of age (i.e., from his/her 1 year birthday until the day before age of 16 months) at the time of the administration of the study interventions.

Be younger than 18 years old

Must not have

- Newborn infants born <28 weeks of gestation.

Chronic administration (defined as more than 14 days in total) of immunosuppressants, or other immune-modifying drugs during the period starting 90 days prior to the study interventions administration. For corticosteroids, this will mean prednisone equivalent ≥ 0.5 mg/kg/day or 20 mg/day whichever is the maximum dose for pediatric participants, or equivalent. Inhaled and topical steroids are allowed.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up throughout the entire study period (from day 1 to day 181)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new chickenpox vaccine in healthy young children to see how well it works and if it is safe. The vaccine helps the body build defenses against chickenpox by creating protective antibodies. An existing chickenpox vaccine has a well-established safety and efficacy profile.

Who is the study for?

This trial is for healthy children aged 12 to 15 months who have received their primary series of pneumococcal conjugate vaccine. They must not have a history of severe allergies, immune conditions, or recent immunosuppressant use. Children with certain household members at risk (like pregnant women without chickenpox immunity) are excluded.

What is being tested?

The study tests different potencies of an investigational chickenpox vaccine against a marketed one in young children. It also includes other routine vaccines like MMR and Hepatitis A to assess the immune response and safety profile of the new varicella vaccine.

What are the potential side effects?

Potential side effects may include typical reactions at the injection site such as redness, swelling, pain, fever, rash similar to mild chickenpox, irritability or crying more than usual. Severe allergic reactions are rare but possible.

Eligibility Criteria

Inclusion Criteria

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

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I am between 12 and 15 months old.

Exclusion Criteria

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

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My newborn was born before 28 weeks of pregnancy.

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I haven't taken long-term immune system drugs or high-dose steroids recently.

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I am not taking long-acting immune-modifying drugs during the study.

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I do not have uncontrolled seizures or neurological disorders.

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I still have symptoms from a past COVID-19 infection.

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I have received a booster dose of a pneumococcal vaccine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ throughout the entire study period (from day 1 to day 181)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~throughout the entire study period (from day 1 to day 181)

This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout the entire study period (from day 1 to day 181) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Concentrations of anti-varicella zoster virus (VZV) glycoprotein E (gE) antibodies

Secondary study objectives

Percentage of participants reporting serious adverse events (SAEs)

Percentage of participants reporting solicited administration site events

Percentage of participants reporting solicited systemic events

+2 more

Side effects data

From 2014 Phase 3 trial • 720 Patients • NCT01411241

47%

Irritability; Post-injection 1

36%

Crying abnormal; Post-injection 1

35%

Nasopharyngitis

32%

Appetite lost; Post-injection 1

30%

Injection site Tenderness; Post-injection 1

25%

Fever; Post-injection 1

24%

Drowsiness; Post-injection 1

19%

Vomiting; Post-injection 1

18%

Gastroenteritis

16%

Pharyngitis

14%

Injection site Erythema; Post-injection 1

11%

Diarrhoea

Pharyngotonsillitis

Rhinitis

Injection site Swelling; Post-injection 1

Febrile convulsion

Asthmatic crisis

100%

80%

60%

40%

20%

Study treatment Arm

CYD Dengue Vaccine Group 1

CYD Dengue Vaccine Group 2

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: VNS_Med GroupExperimental Treatment7 Interventions

Healthy children aged 12 to 15 months of age receive 1 dose of an investigational varicella vaccine (VNS) of medium potency, 1 dose of a measles, mumps, and rubella vaccine, 1 dose of a hepatitis A vaccine, and 1 dose of a 13-valent pneumococcal conjugate vaccine on Day 1. The 13 valent pneumococcal conjugate vaccine will only be administered to participants enrolled in the US and in countries where pneumococcal conjugate vaccine is recommended at 12-15 months as per national immunization schedule.

Group II: VNS_Low GroupExperimental Treatment8 Interventions

Healthy children aged 12 to 15 months of age receive 1 dose of an investigational varicella vaccine (VNS) of low potency 1 dose of a measles, mumps, and rubella vaccine, 1 dose of a hepatitis A vaccine and 1 dose of a13 valent pneumococcal conjugate vaccine on Day 1. The 13 valent pneumococcal conjugate vaccine will only be administered to participants enrolled in the US and in countries where pneumococcal conjugate vaccine is recommended at 12-15 months as per national immunization schedule.

Group III: VNS_High GroupExperimental Treatment7 Interventions

Healthy children aged 12 to 15 months of age receive 1 dose of an investigational varicella vaccine (VNS) of high potency 1 dose of a measles, mumps, and rubella vaccine, 1 dose of a hepatitis A vaccine, and 1 dose a 13-valent pneumococcal conjugate vaccine on Day 1. The 13 valent pneumococcal conjugate vaccine will only be administered to participants enrolled in the US and in countries where pneumococcal conjugate vaccine is recommended at 12-15 months as per national immunization schedule.

Group IV: VV_Lot1 and Lot2 Pooled GroupActive Control5 Interventions

Healthy children aged 12 to 15 months of age receive 1 dose of a marketed varicella vaccine (VV) of Lot 1 or 1 dose of a marketed varicella vaccine (VV) of Lot 2, 1 dose of a measles, mumps, and rubella vaccine, 1 dose of a hepatitis A vaccine, and a 1 dose of a 13-valent pneumococcal conjugate vaccine on Day 1. The 13 valent pneumococcal conjugate vaccine will only be administered to participants enrolled in the US and in countries where pneumococcal conjugate vaccine is recommended at 12-15 months as per national immunization schedule.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Marketed varicella vaccine Lot 2

2022

Completed Phase 2

~800

Investigational varicella vaccine low potency

2022

Completed Phase 2

~800

Investigational varicella vaccine high potency

2022

Completed Phase 2

~800

Marketed varicella vaccine Lot 1

2022

Completed Phase 2

~800

Measles, mumps, and rubella vaccine

2011

Completed Phase 3

~2320

Hepatitis A vaccine

2008

Completed Phase 4

~72490

13-valent pneumococcal conjugate vaccine

2010

Completed Phase 4

~12980

Investigational varicella vaccine medium potency

2022

Completed Phase 2

~800

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Chickenpox include vaccines and antiviral medications. Vaccines work by stimulating the immune system to produce antibodies against the varicella-zoster virus, thereby providing immunity and preventing infection. Antiviral medications, such as acyclovir, inhibit the replication of the virus, which helps to reduce the severity and duration of symptoms. These treatments are important for Chickenpox patients as they help prevent complications, reduce the spread of the virus, and improve overall patient outcomes.