Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruiting

Study on Immune Response and Safety of Measles, Mumps, Rubella, and Varicella Vaccine in Healthy Children Aged 4 to 6 Years

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the immune response and safety of a new vaccine for preventing infections caused by the measles, mumps, rubella, and varicella (chickenpox) viruses. The study involves healthy children aged 4 to 6 years. The new vaccine is being compared to an existing vaccine called ProQuad, which is already available on the market. The new vaccine contains live, weakened strains of the viruses that cause these diseases, similar to the ProQuad vaccine.

The purpose of the study is to evaluate how well the new vaccine works in generating an immune response, which is the body's way of defending against infections. The study will also assess the safety of the vaccine by monitoring any side effects that may occur. Children participating in the study will receive either the new vaccine or the ProQuad vaccine. The vaccines are given as a single injection under the skin, and the study will follow the children for several months to observe their immune response and any side effects.

Throughout the study, researchers will measure the levels of antibodies, which are proteins made by the immune system to fight infections, in the children's blood. These measurements will help determine how effectively the vaccines protect against the viruses. The study will also track any common side effects, such as fever or rash, and any serious adverse events that might occur. The goal is to ensure that the new vaccine is both effective and safe for use in children.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit and vaccine administration

    Upon joining the study, the child will attend an initial visit. During this visit, a healthcare professional will conduct a brief health check to ensure the child is healthy and eligible to participate.

    The child will receive a vaccine called ProQuad, which is a combination vaccine for measles, mumps, rubella, and chickenpox. This vaccine is given as a single injection under the skin, known as subcutaneous use.

  2. Step 2

    Monitoring period

    After the vaccine is administered, the child will be monitored for any immediate reactions. Parents or guardians will be asked to observe the child for any side effects over the next 43 days.

    During the first 4 days, parents or guardians should pay attention to any reactions at the injection site, such as redness or swelling, and any general symptoms like drowsiness or loss of appetite.

    Over the entire 43-day period, it is important to watch for symptoms such as fever, rashes, or any other unusual signs. Any serious health issues should be reported immediately.

  3. Step 3

    Follow-up visit

    A follow-up visit will be scheduled around Day 43. During this visit, healthcare professionals will assess the child's health and check for the presence of antibodies against measles, mumps, rubella, and chickenpox.

    The child's immune response to the vaccine will be evaluated by measuring the concentration of antibodies in the blood.

  4. Step 4

    Final assessment

    The study will continue to monitor the child's health until Day 181. Any serious adverse events should be reported throughout this period.

    At the end of the study, a final assessment will be conducted to ensure the child's well-being and to gather any remaining data needed for the study.

Who can join the trial?

6 criteria

  • Participants must be healthy, as determined by their medical history and a clinical examination before joining the study.
  • Participants must be between 4 and 6 years old. This means they should be at least 4 years old but not yet 7 years old at the time they receive the study vaccine.
  • Participants must have received their first dose of a varicella (chickenpox) vaccine when they were in their second year of life.
  • Participants must have received a single dose of a measles, mumps, and rubella (MMR) vaccine when they were in their second year of life.
  • Written informed consent must be obtained from the participant's parent(s) or legally acceptable representative(s) before any study-specific procedures are performed. This means the parents or guardians agree to let their child participate in the study after being informed about it. Additionally, the child will be asked for their agreement to participate, according to local rules.
  • The participant's parent(s) or legally acceptable representative(s) must be able and willing, in the opinion of the study investigator, to follow the study requirements. This includes tasks like completing electronic diaries and attending follow-up visits.

Who cannot join the trial?

9 criteria

  • Participants must not have any **serious health conditions**. This means they should be generally healthy without any major illnesses.
  • Participants should not have a **weakened immune system**. This can happen due to certain diseases or medications that affect the body's ability to fight infections.
  • Participants must not be **pregnant or breastfeeding**. This is to ensure the safety of both the mother and the baby.
  • Participants should not have a history of **allergic reactions** to vaccines. This includes any severe reactions to previous vaccinations.
  • Participants must not have received any other **vaccines** within a certain period before the study. This is to avoid interference with the study vaccine.
  • Participants should not be taking any **medications** that might affect the immune system. This includes drugs that suppress the immune response.
  • Participants must not have any **chronic illnesses** that are not well controlled. This means any long-term health conditions should be stable and managed.
  • Participants should not have a history of **substance abuse**. This includes excessive use of alcohol or drugs.
  • Participants must not have participated in another **clinical trial** recently. This is to ensure that previous studies do not affect the results of this one.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruitingNot recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • MMRVNS Vaccine

    is a new vaccine being tested in this study. It is designed to protect against four common childhood diseases: measles, mumps, rubella, and varicella (also known as chickenpox). The vaccine works by helping the body build up its defense system, known as the immune system, to fight off these viruses if the person is exposed to them in the future. This vaccine is being compared to another vaccine to see how well it works and how safe it is for children.

  • MMRV Vaccine

    is a combination vaccine that is already used to protect children against measles, mumps, rubella, and varicella. It combines the vaccines for these four diseases into one shot, making it easier for children to get protected with fewer injections. In this study, the MMRV vaccine is used as a comparison to see how the new MMRVNS vaccine performs in terms of safety and effectiveness.

What is already known about the treatment

Measles, Mumps, Rubella, Varicella Vaccine (MMRV) – This vaccine is administered as an injection to healthy children aged 4 to 6 years to prevent infections caused by measles, mumps, rubella, and varicella (chickenpox) viruses. Currently, it is being studied in clinical trials to compare its immune response and safety with an existing vaccine called ProQuad. The vaccine works by stimulating the body's immune system to produce antibodies against these viruses, providing protection if exposed in the future. It is classified as a live attenuated vaccine, meaning it contains weakened forms of the viruses that do not cause disease in healthy individuals.

Investigated diseases

  • Measles

    Measles is a highly contagious viral infection caused by the measles virus. It begins with symptoms such as fever, cough, runny nose, and red eyes. After a few days, a red rash appears, starting on the face and spreading to the rest of the body. The rash typically lasts for about a week. Measles can lead to complications, especially in young children and adults. The virus spreads through respiratory droplets from coughs and sneezes.

  • Mumps

    Mumps is a viral infection primarily affecting the salivary glands, particularly the parotid glands located near the ears. It starts with symptoms like fever, headache, muscle aches, and fatigue. Swelling of the salivary glands follows, causing puffy cheeks and a tender, swollen jaw. The swelling usually lasts for about a week. Mumps is spread through infected respiratory droplets or direct contact with an infected person. It can lead to complications, especially in adults.

  • Rubella

    Rubella, also known as German measles, is a contagious viral infection characterized by a red rash. It begins with mild fever and swollen lymph nodes, followed by a rash that starts on the face and spreads to the rest of the body. The rash typically lasts for about three days. Rubella is generally mild in children but can be more severe in adults. It spreads through respiratory droplets from coughs and sneezes. Rubella is particularly concerning during pregnancy due to potential effects on the developing fetus.

  • Varicella

    Varicella, commonly known as chickenpox, is a highly contagious viral infection caused by the varicella-zoster virus. It starts with fever, fatigue, and a characteristic itchy rash that turns into fluid-filled blisters. The blisters eventually crust over and heal. The rash usually appears first on the chest, back, and face, then spreads to the rest of the body. Varicella is spread through direct contact with the rash or through respiratory droplets. It is more severe in adults and can lead to complications.

Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IITrial ID2022-501564-18-00Protocol code217715Estimated enrolment890 patientsSponsorGlaxoSmithKline Biologicals

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).