Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A parallel-group, prevention, Phase III, modified double-blind, 2-arm, study to investigate the immunogenicity and describe the safety of a quadrivalent meningococcal conjugate vaccine (MenACYW conjugate vaccine) compared with Nimenrix® when administered in a 1+1 schedule in healthy infants and toddlers at 6 and 12 months of age

This study is for healthy babies and young children in the UK to compare a new vaccine called MenQuadfi with an existing vaccine, Nimenrix. Both vaccines aim to protect against meningococcal disease, a serious infection. Researchers want to see how well the new vaccine helps the body build protection (this is called 'immunogenicity') and to check for any side effects. Children will receive two doses of either the new vaccine or Nimenrix, one at 6 months old and another at 12 months old. This is a very common type of study (Phase III) to confirm a vaccine's effectiveness and safety before it can be widely used.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Sanofi Pasteur

Enrolment target

840

Start

13 Feb 2024

Healthy volunteers (Meningococcal infection)

What is this study about?

Meningococcal disease is a serious illness, and vaccines are really important in helping to protect children from it. This study is testing a new vaccine called MenQuadfi against a vaccine that’s already in use, called Nimenrix. Both vaccines protect against four specific types of meningococcal bacteria (A, C, W, and Y).

The main aim of this study is to see how well the new vaccine helps a child's body create antibodies. Antibodies are like little soldiers in your immune system that fight off infections. We also want to carefully record any side effects that children might experience, comparing them between the new vaccine and Nimenrix. This helps us ensure that any new vaccine is not only effective but also safe for children.

This is a 'Phase III' study, which means it’s one of the final steps in vaccine development. Thousands of people typically take part in these studies to confirm that the vaccine works well and is safe across a larger group before it can be approved for wider public use. The information gathered from this study is vital for helping doctors and health authorities make decisions about future vaccinations.

Key takeaways

Compares a new meningococcal vaccine (MenQuadfi) with an existing one (Nimenrix).
Aims to check how well the new vaccine builds protection and its safety in babies.
Children receive two vaccine doses, at 6 and 12 months of age.
Participation involves clinic visits, health checks, and blood samples.
This 'Phase III' study is crucial for future vaccine approval.
You can withdraw your child at any time.

Who may be eligible?

This study is looking for healthy babies and young children to take part. There are no specific age limits mentioned beyond being a 'healthy infant and toddler', but detailed checks will be done by the study team.

To be eligible, children generally need to be in good health. This means they shouldn't have any serious ongoing medical conditions that might affect how the vaccine works or how safe it is for them. The study team will review your child's medical history to make sure they are a good fit.

It's important that your child hasn't received certain other vaccines recently or had meningococcal disease before. The study staff will explain all the specific requirements in detail to help you understand if your child can take part.

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 a healthy baby or toddler?
Does my child have any serious ongoing medical conditions?
Has my child recently received other vaccines?
Has my child ever had meningococcal disease?
Am I able to attend clinic visits at 6 and 12 months for vaccinations and follow-ups?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, they will receive two doses of a vaccine. One dose will be given when they are 6 months old, and the second dose when they are 12 months old. They will receive either the new vaccine (MenQuadfi) or the currently used vaccine (Nimenrix). You won't know which vaccine your child receives until after the study is complete, as this is a 'blinded' study to make sure the results are fair.

Throughout the study, your child will have several visits to the clinic for health checks and to provide blood samples. These samples help the researchers measure how well the vaccines are working by checking for antibodies. You will also be asked to keep track of any side effects your child might experience, especially in the days immediately following each vaccination. The total duration of your child's involvement in the study will be around 7-8 months, from the first vaccine dose until a final check-up after the second dose.

Potential risks and benefits

Taking part in this study could potentially help advance our understanding of new ways to protect children from meningococcal disease. While there's no direct benefit to your child from receiving the new vaccine over the existing one, the information gained will contribute to public health. As with any vaccine, there's a possibility of side effects, such as soreness or redness where the injection was given, or a mild fever. The study team will closely monitor your child for any health changes. You are free to withdraw your child from the study at any time, for any reason, without it affecting their regular medical care.

Locations (6)

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

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Unverified
Finland
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Unverified
Poland
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Unverified
Germany
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Unverified
Romania
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Unverified
Denmark
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Unverified
Czechia

Common questions

What is meningococcal disease?

Meningococcal disease is a serious bacterial infection that can cause meningitis (inflammation of the lining of the brain and spinal cord) or septicaemia (blood poisoning). It can be very serious, especially for babies and young children.

What does 'immunogenicity' mean?

Immunogenicity is a scientific word for how well a vaccine helps your body build protection, like making antibodies, to fight off an infection.

Will I know which vaccine my child receives?

No, during the study, neither you nor the study doctors will know if your child received the new vaccine or the existing one. This is to ensure the study results are unbiased. You will be informed after the study is completed.

How many injections will my child get?

Your child will receive two injections. One at 6 months of age and another at 12 months of age.

What if my child gets sick during the study?

The study team will closely monitor your child's health throughout the study. If your child gets sick, you should contact the study team immediately. They will guide you on the next steps and ensure your child receives appropriate care.