Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase II, single-blind, randomized, controlled study to evaluate the immunogenicity and safety of a measles, mumps, rubella, varicella vaccine compared with ProQuad, administered in healthy children 4 to 6 years of age

This research is looking into a new vaccine designed to protect children from measles, mumps, rubella, and chickenpox. It involves healthy children between 4 and 6 years old. Scientists will compare this new vaccine to an existing one called ProQuad. The main aim is to check how well the new vaccine helps children's bodies build protection (immunity) against these diseases. They will also be carefully checking for any side effects to make sure the vaccine is safe. This type of study, called a Phase II trial, helps us understand early on if a new treatment or vaccine is promising before it goes into larger studies. It's a key step in developing safe and effective ways to keep children healthy.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

GlaxoSmithKline Biologicals, GlaxoSmithKline Biologicals

Enrolment target

110

Start

19 Apr 2023

Healthy volunteers (prevention of measles mumps rubella and varicella infections)

What is this study about?

This study is all about finding out more about a new combined vaccine for four common childhood illnesses: measles, mumps, rubella (German measles), and varicella (chickenpox). We already have vaccines that protect against these, but scientists are always working to improve them or find new options. This particular study focuses on healthy children aged 4 to 6 years old.

The main goal is to see how well this new vaccine helps children's immune systems create protective antibodies against these four diseases, compared to a vaccine already in use called ProQuad. Antibodies are like little soldiers in your body that fight off germs. Researchers will measure these antibodies about six weeks after the vaccine is given. This helps them understand how strong the protection might be.

Another very important part of the study is to carefully monitor for any side effects. Safety is always the top priority in vaccine research. By comparing the new vaccine to an existing one, they can gather valuable information on both its effectiveness and how well children tolerate it. This trial is an important step in the process of developing new vaccinations.

Key takeaways

Tests a new vaccine for measles, mumps, rubella, and chickenpox.
Involves healthy children aged 4-6 years old.
Compares the new vaccine to an existing one (ProQuad).
Checks how well the vaccine helps the body create protective antibodies.
Carefully monitors for any potential side effects or safety issues.
The study lasts for about 6 months.

Who may be eligible?

This study is looking for healthy children to take part. The children must be between 4 and 6 years old.

There aren't any specific rules about gender, so both boys and girls are welcome to be considered.

The main idea is to evaluate a vaccine for prevention, so children must be in good general health.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is my child generally healthy?
Is my child between 4 and 6 years old?
Are we able to attend regular clinic appointments?
Am I comfortable with my child receiving an experimental vaccine or an existing vaccine?
Am I willing to keep a diary of my child's health for a period after vaccination?

Answer every question to see your result.

What does participation involve?

If a child takes part in this study, they will receive either the new combined vaccine or the existing ProQuad vaccine, given as an injection. Neither you nor the study team will know which one they receive during the main part of the study, to keep the results fair. This is called 'single-blind'.

There will be several visits to the clinic, and blood samples will be taken to measure antibody levels. You will also need to keep a diary for a short period after the vaccination to note any reactions or side effects, both at the injection site and anywhere else in the body, like tiredness or fever. Serious side effects will be monitored throughout the entire study period. The full study will last for about 6 months.

Potential risks and benefits

Participating in research always involves potential benefits and risks. The potential benefit of taking part in this study is contributing to our understanding of new vaccines that could protect children from serious diseases. There's also a small chance your child could receive a new vaccine that may offer effective protection. Potential risks include discomfort from injections, and possible mild side effects like fever, soreness at the injection site, or a rash, similar to those seen with existing vaccines. More serious side effects are rare but possible. You have the right to withdraw your child from the study at any time, for any reason, without it affecting their future medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Latvia
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Unverified
Spain

Common questions

What diseases does this study's vaccine aim to prevent?

It aims to prevent measles, mumps, rubella (German measles), and chickenpox (varicella).

Who can take part in this study?

Healthy children aged 4 to 6 years old can be considered for this study.

What is the purpose of comparing the new vaccine to ProQuad?

It helps scientists understand if the new vaccine works as well or better than an existing vaccine, and to compare their safety.

How long will my child need to be involved in the study?

The study will involve monitoring and follow-up over about 6 months.

What does a 'Phase II' study mean?

It means it's an early-stage study to see if a new treatment or vaccine is effective and safe, involving a relatively small number of people, before larger studies begin.