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Ongoing Clinical Trials for Varicella (Chickenpox)

Currently, there are 4 ongoing clinical trials studying new vaccines for varicella (chickenpox) in healthy children. These trials are being conducted across multiple European countries and focus on comparing new investigational vaccines with existing chickenpox vaccines. The studies aim to evaluate the safety and immune response of these vaccines in children aged 12 to 15 months. (Also known as: chickenpox)

Clinical trial locations

Study on the Immune Response and Safety of a New Varicella Vaccine (GSKVX000000025896) Compared to Varicella Virus Oka/Merck Strain in Healthy Children Aged 12-15 Months

This trial is testing a new chickenpox vaccine called VNS vaccine and comparing it with an existing vaccine called Varivax in healthy children aged 12 to 15 months. The main goal is to determine whether the new vaccine produces a similar immune response and is as safe as the current vaccine.

Inclusion criteria: Children must be between 12 and 15 months old and in good health. Parents or legal guardians must be able to complete electronic diaries and attend follow-up visits. Written consent is required before joining the study. In countries where the pneumococcal vaccine is recommended at this age, children must have already received their primary vaccination series, with the last dose given at least 60 days before the study starts.

Exclusion criteria: Children who have had chickenpox in the past or have received other chickenpox vaccines recently cannot participate. Those with weakened immune systems, severe allergic reactions to vaccines, pregnant women or those planning pregnancy during the study, and individuals currently participating in another clinical trial are also excluded. Any significant health issues that could interfere with the study results will prevent participation.

Focus: The study involves giving children either the new VNS vaccine or Varivax as a single injection under the skin. After vaccination, children will be monitored for several months to check their immune response, which will be measured through blood tests taken 43 days after vaccination. Parents will record any side effects in electronic diaries for the first 43 days, including reactions at the injection site, fever, irritability, and loss of appetite. The study will continue monitoring for any health issues for up to 181 days.

Investigational drugs: The trial uses the VNS vaccine, which is a live attenuated vaccine designed to help the body build immunity against the virus that causes chickenpox. Varivax serves as the comparison vaccine, as it is already approved and widely used to prevent chickenpox in children.

Study on the Safety of a New Chickenpox Vaccine (GSKVX000000025896) Compared to Varicella Virus Oka/Merck Strain in Healthy Children Aged 12-15 Months

This trial focuses on evaluating the safety of a new chickenpox vaccine in healthy children aged 12 to 15 months. The study will compare the investigational vaccine with Varivax, while also looking at how well these vaccines work when given alongside other routine childhood vaccines.

Inclusion criteria: Children must be between 12 and 15 months old and in good health, confirmed through medical history and physical examination. Parents or legal guardians must provide written consent and be able to complete electronic diaries and attend follow-up visits. In countries where the pneumococcal vaccine is recommended at this age and included in the study, children must have completed their primary vaccination series in the first year of life, with the last dose given at least 60 days before starting the study.

Exclusion criteria: Children with current or past chickenpox infection cannot participate. Those who have received any other vaccines within 4 weeks prior to the study, have known allergies to vaccine components, have weakened immune systems, or are taking medications that affect the immune system are excluded. Pregnant or breastfeeding mothers, individuals with a history of severe vaccine reactions, those with serious chronic illnesses, participants in other clinical trials within the last 30 days, and anyone with a history of alcohol or drug abuse in the past year cannot join.

Focus: The study involves administering either the VNS vaccine or Varivax as an injection under the skin. Other routine vaccines including MMR (measles, mumps, and rubella), HAV (hepatitis A), and PCV (pneumococcal) may also be given during the study. Children will be monitored for reactions at the injection site for up to 4 days and for general symptoms affecting the whole body for up to 15 days. Fever will be monitored for 22 days, and rashes for 43 days. Any health issues requiring medical attention will be tracked until day 181.

Investigational drugs: The trial tests the VNS vaccine, a live attenuated vaccine that stimulates the immune system to protect against chickenpox. Varivax serves as the comparison vaccine. The study also includes the MMR vaccine (Priorix), which protects against measles, mumps, and rubella; the HAV vaccine for hepatitis A protection; and the PCV vaccine, which protects against bacterial infections that can cause pneumonia and other serious illnesses.

Study of new chickenpox vaccine and measles-mumps-rubella vaccine given by intramuscular injection in healthy children aged 12 to 15 months

This trial evaluates whether a new chickenpox vaccine and the Priorix vaccine (which protects against measles, mumps, and rubella) work equally well when injected into a muscle compared to the standard method of injecting under the skin.

Inclusion criteria: Children must be between 12 and 15 months old (from their first birthday until the day before they turn 16 months) and be in good health as confirmed by medical history and examination. Parents or legal guardians must provide written consent before any study procedures begin and must be able to complete electronic diaries and attend follow-up visits. In countries where the pneumococcal vaccine is recommended at 12-15 months, children must have received the primary vaccination series in their first year of life, with the last dose given at least 60 days before starting the study. Both male and female children can participate.

Exclusion criteria: Children with a history of allergic reactions to any vaccine components, especially neomycin (an antibiotic), cannot participate. Those who have had previous severe reactions to measles, mumps, rubella, or chickenpox vaccines, have active untreated tuberculosis, are currently taking medications that suppress the immune system, have blood disorders or recent blood transfusions within the past 3 months, have current fever or active infection, or have pregnancy plans within 3 months of vaccination are excluded. Children with immunodeficiency disorders, who have received other vaccines within 30 days before the study, participated in another clinical trial within the past 3 months, have any serious chronic medical condition, have known or suspected cancer, or have a history of seizures or neurological disorders cannot join.

Focus: The study compares giving the chickenpox vaccine and Priorix as injections into the muscle versus under the skin. Children will receive both vaccines during their first visit. For the first 4 days after vaccination, parents will monitor and record any injection site reactions such as redness, pain, and swelling. For 15 days, they will watch for drowsiness, loss of appetite, or irritability. Temperature will be monitored for 22 days, and any rashes for 43 days. On day 43, children will return for a blood test to check how well their immune system has responded to the vaccines. Health monitoring continues for a total of 181 days (approximately 6 months), with a final visit on day 181.

Investigational drugs: The trial uses the VNS vaccine, an investigational chickenpox vaccine being tested for intramuscular administration. Varivax, an approved chickenpox vaccine, is administered subcutaneously as a comparison. Priorix, the combination MMR vaccine, is being tested for both intramuscular and subcutaneous administration.

Study on the Immune Response and Safety of a Second Dose of Investigational Varicella Vaccine (GSKVX000000025896) Compared to Varicella Virus Oka/Merck Strain in Healthy Children

This trial studies how well a second dose of an investigational chickenpox vaccine works compared to the existing Varivax vaccine. The study involves healthy children who have already received their first vaccine dose between 12 and 15 months of age.

Inclusion criteria: Parents or legally acceptable representatives must be able and willing to follow study requirements according to the study investigator. Written or witnessed consent must be obtained before any study-specific procedures are performed. Children must be healthy, as determined by medical history and clinical examination before joining the study. Participants must be male or female between 12 to 15 months of age (from the day they turn 1 year old until the day before they turn 16 months old) at the time of the first vaccination. In countries where the pneumococcal vaccine is recommended at 12 to 15 months of age as part of the national immunization schedule, children must have previously received the primary vaccination series in the first year of life, with the last dose given at least 60 days before entering the study.

Exclusion criteria: Children with current or past chickenpox infection cannot participate. Those who have received any other vaccines within 4 weeks before the first dose, have a known allergy to any component of the study vaccine, have a weakened immune system, are pregnant or planning to become pregnant during the study period, are breastfeeding, are participating in another clinical trial at the same time, have a history of severe reactions to vaccines in the past, or have any other medical condition that study doctors think might make it unsafe to participate are excluded.

Focus: The study involves giving children their first dose of either the investigational vaccine or Varivax at 12 to 15 months of age. After the first dose, children are monitored for injection site reactions for days 1 to 4, for general symptoms including fever for days 1 to 22, and for any unexpected reactions for days 1 to 43. Three months after the first dose, children receive a second dose. Following the second dose, monitoring occurs for injection site reactions from days 91 to 94, for general symptoms including fever from days 91 to 112, and for any unexpected reactions from days 91 to 133. The primary evaluation of the immune response is conducted 43 days after the second dose (on day 133), and the study continues to monitor for any health issues until day 271.

Investigational drugs: The trial tests the Investigational Varicella Vaccine (VNS), a live attenuated vaccine containing a weakened form of the virus that safely builds immunity without causing the disease. Varivax is used as a comparison to see if the new vaccine is as effective or better in boosting the immune system’s response to the virus when given as a second dose.

Summary

All four trials focus on evaluating new approaches to chickenpox vaccination in young children aged 12 to 15 months. Three trials concentrate on comparing the new VNS vaccine with the established Varivax vaccine, examining both first doses and second doses given three months apart. The trials are concentrated primarily in Northern and Eastern European countries, with Poland, Estonia, Denmark, and Bulgaria hosting the most studies.

A notable aspect of these trials is the investigation of different administration methods, with one study specifically examining whether intramuscular injection (into the muscle) works as well as the standard subcutaneous injection (under the skin). Several trials also assess how the chickenpox vaccine works when given alongside other routine childhood vaccines such as MMR, hepatitis A, and pneumococcal vaccines.

The studies follow similar monitoring protocols, typically tracking children for several months after vaccination to assess both immediate reactions and longer-term safety. Most trials require blood tests to measure immune response and use electronic diaries for parents to record any symptoms or reactions their children experience.

Ongoing Clinical Trials on Varicella

  • Study of new chickenpox vaccine and measles-mumps-rubella vaccine given by intramuscular injection in healthy children aged 12 to 15 months

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Bulgaria Denmark Estonia Greece Lithuania +2

  • Study on the Safety of a New Chickenpox Vaccine (GSKVX000000025896) Compared to Varicella Virus Oka/Merck Strain in Healthy Children Aged 12-15 Months

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Denmark Estonia Lithuania Poland

  • Study on the Immune Response and Safety of a New Varicella Vaccine (GSKVX000000025896) Compared to Varicella Virus Oka/Merck Strain in Healthy Children Aged 12-15 Months

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Czechia Estonia Poland

  • Study on the Immune Response and Safety of a Second Dose of Investigational Varicella Vaccine (GSKVX000000025896) Compared to Varicella Virus Oka/Merck Strain in Healthy Children

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark Norway

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