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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

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What is this study about?

This clinical trial is focused on studying a disease known as , commonly referred to as chickenpox. The study involves testing a new vaccine designed to protect against this disease. The vaccine being tested is called , and it is produced by a company named MSD Sharp & Dohme GmbH. Another vaccine, known as , will also be used in the study for comparison. Additionally, a vaccine with the code name from GlaxoSmithKline Biologicals S.A. will be part of the study.

The purpose of the study is to evaluate the immune response and safety of the new chickenpox vaccine when given to healthy children aged 12 to 15 months. The study will compare the new vaccine with the existing VARIVAX® vaccine to see if it produces a similar immune response. The study will also look at the safety of the vaccines by monitoring any side effects that may occur after vaccination.

Participants in the study will receive either the new vaccine or the VARIVAX® vaccine. The study will last for several months, during which time the children will be monitored for their immune response to the vaccine and any side effects. The study aims to ensure that the new vaccine is safe and effective in preventing chickenpox in young children.

1 initial visit and consent

Upon joining the study, the parent or legally acceptable representative will provide written or witnessed consent for the child’s participation. This consent is necessary before any study-specific procedures can begin.

A medical history review and clinical examination will be conducted to confirm the child’s health status and eligibility for the study.

2 vaccine administration

The child will receive a dose of the investigational varicella vaccine or the comparator vaccine, Varivax, as a subcutaneous injection. This means the vaccine will be injected under the skin.

The vaccine is administered as a single dose to healthy children aged 12 to 15 months.

3 monitoring and follow-up

After the vaccine is administered, the child will be monitored for any immediate reactions at the injection site or systemic reactions such as fever, irritability, or loss of appetite.

Parents or guardians will be required to complete electronic diaries (eDiaries) to record any symptoms or reactions observed in the child from Day 1 to Day 43.

4 follow-up visits

The child will return for follow-up visits to assess the immune response to the vaccine. Blood samples may be taken to measure the concentration of antibodies against the varicella zoster virus.

The primary assessment of the immune response will occur on Day 43 after the vaccine administration.

5 long-term safety monitoring

The study will continue to monitor the child for any adverse events or serious adverse events up to Day 181. This includes any medical attention required due to symptoms or illnesses.

Parents or guardians will be informed of any significant findings related to the child’s health during this period.

Who Can Join the Study?

  • The participant’s parent(s) or legally acceptable representative(s) must be able to follow the study requirements, like filling out electronic diaries and attending follow-up visits.
  • Written or witnessed/thumb-printed informed consent must be obtained from the participant’s parent(s) or legally acceptable representative(s) before any study-specific procedures are done.
  • The participant must be healthy as determined by their medical history and a physical examination before joining the study.
  • The participant must be a male or female between 12 to 15 months of age, which means from their first birthday until the day before they turn 16 months old, at the time of receiving the study interventions.
  • For children in countries where the Pneumococcal Conjugate Vaccine (PCV) is recommended at 12 to 15 months of age as part of the national immunization schedule and provided as part of the study interventions: The participant must have previously received the primary series of PCV in the first year of life, with the last dose given at least 60 days before entering the study.

Who Cannot Join the Study?

  • People who have had a recent infection with the Varicella virus, which is the virus that causes chickenpox, cannot participate.
  • Individuals who have received any other Varicella vaccine recently are not eligible.
  • Participants with a weakened immune system, which means their body has a harder time fighting infections, are excluded.
  • Pregnant women or those planning to become pregnant during the study period cannot take part.
  • Anyone with a history of severe allergic reactions to vaccines or any component of the study vaccine is not allowed to join.
  • People currently participating in another clinical trial are not eligible.
  • Individuals with any other significant health issues that the study doctors believe could interfere with the study results are excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
MUDr. David Zeman s.r.o. Poruba Czechia
Zdravotnicke stredisko Dubina v.o.s. Pardubice Czechia
Katholieke Universiteit te Leuven Leuven Belgium
Vee Perearstikeskus OÜ Paide Estonia

Other Sites

Site Name City Country Status
Universitair Ziekenhuis Gent Gent Belgium
Centre Hospitalier Regional De La Citadelle Liege Belgium
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k. Cracow Poland
Medif Thuin Belgium
Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice Rybarczyk I Partnerzy Spolka Lekarska sp.p. Siemianowice Slaskie Poland
Kliiniliste Uuringute Keskus OÜ Tartu Estonia
Pratia S.A. Skorzewo Poland
In Vivo Sp. z o.o. Bydgoszcz Poland
Cdphqfdou Uuhnxlflvrjgki Soptppmuf Woluwe-Saint-Lambert Belgium
Df oglkkgbp schfto Jindřichův Hradec Czechia
Mlshcjlki Icuxbegyht Cdxfbfya Srvdxciu Sdk z oudj Warsaw Poland
Malauwsclxo 6 slgqxn Praha 6 – Vokovice Czechia
Mjaul Dumoxhm Vonresbskt Mto Jindřichův Hradec Czechia

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
14.07.2025
Czechia Czechia
Recruiting
14.07.2025
Estonia Estonia
Recruiting
14.07.2025
Poland Poland
Recruiting
14.07.2025

Trial locations

Investigated drugs:

VNS vaccine is an investigational vaccine being tested to protect against the varicella zoster virus, which causes chickenpox. The study aims to see if different batches of this vaccine produce a consistent immune response in children aged 12 to 15 months. The vaccine is given as a first dose to help the body build protection against the virus.

Varivax is an existing vaccine used to prevent chickenpox. In this study, it serves as a comparison to the investigational VNS vaccine. By comparing the immune response and safety of Varivax with the new vaccine, researchers can determine if the new vaccine is as effective and safe as the established one. Varivax is also given as a first dose to healthy children aged 12 to 15 months.

Investigated diseases:

Varicella – Varicella, commonly known as chickenpox, is a highly contagious viral infection caused by the varicella-zoster virus. It typically begins with a fever, fatigue, and a characteristic itchy rash that progresses from red spots to fluid-filled blisters, and eventually to scabs. The rash usually starts on the face, chest, and back before spreading to the rest of the body. The disease is most common in children, but it can affect individuals of any age. After the initial infection, the virus can remain dormant in the body and may reactivate later in life as shingles. The progression of the rash and symptoms usually occurs over a period of about one to two weeks.

Trial ID:
2024-515869-33-00
Protocol code:
213998 (VNS 20-002)
NCT ID:
NCT06740630
Trial Phase:
Therapeutic confirmatory (Phase III)

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