Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

A Phase II, Randomized, Partially Blinded Study to Assess the Safety, Tolerability and Immunogenicity of Meningococcal Combined ABCWY Vaccine when Administered to Healthy Infants

This research is looking at a new vaccine designed to protect babies from severe infections, particularly meningococcal disease. We want to understand how safe the vaccine is for young children and if they tolerate it well, meaning if they have many side effects. We're also checking how effectively the vaccine helps their immune system build up defences against the germs that cause these illnesses. By giving different routine vaccines together, the study hopes to find the best way to protect babies from several serious diseases at once, making sure a combined approach is both safe and effective.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

GlaxoSmithKline Biologicals

Enrolment target

497

Start

19 Jan 2024

Infections Meningococcal

What is this study about?

This study is a medical research project focused on keeping babies healthy. Doctors are trying out a new vaccine that combines protection against several types of meningococcal disease (A, C, W, Y, and B) into one shot. Meningococcal disease is a serious infection that can cause meningitis (swelling around the brain and spinal cord) and septicaemia (blood poisoning), which can be very dangerous, especially for young children.

The main purpose of this study is to see if this combined vaccine is safe for babies. They will be looking closely for any side effects or reactions. The study also wants to find out how well babies' bodies respond to the vaccine by measuring the protective substances their immune system makes. This tells us if the vaccine is doing its job in helping babies fight off these infections.

By including other routine childhood vaccines in the trial, like those for pneumococcal disease, rotavirus, and the 6-in-1 vaccine (for diphtheria, tetanus, pertussis, hepatitis B, polio, and Hib) researchers are trying to see how all these vaccines work together when given at the same time. This helps doctors figure out the best vaccination schedule to protect children from many serious diseases efficiently and safely.

Key takeaways

Tests a new combined vaccine for meningococcal disease (ABCWY).
Aims to check safety and how well babies tolerate it.
Measures how well babies' immune systems respond to the vaccine.
Involves other routine childhood vaccines to see how they work together.
Participation lasts about 11 months with clinic visits.
Helps improve future childhood vaccination programmes.

Who may be eligible?

This study is looking for healthy babies to take part. The research team will check if your baby is suitable based on their health history and other factors. There are no specific age limits mentioned, but it's designed for infants, usually meaning babies under one year old.

Both baby boys and girls can take part in this study. The medical team will ask you questions about your baby's health to make sure it's safe for them to participate. They'll confirm that your baby doesn't have any medical conditions or allergies that might make it unsafe to receive the vaccines.

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 baby generally healthy?
Is my baby an infant (under one year old)?
Does my baby have any known serious allergies?
Am I able to commit to several clinic visits over about 11 months?
Am I comfortable with my baby having blood samples taken?

Answer every question to see your result.

What does participation involve?

If your baby takes part in this study, they will receive several vaccines, including the new combined meningococcal vaccine, along with other standard childhood vaccinations. These will be given as injections and some may be given by mouth. The study involves several visits to the clinic over a period of about 11 months. During these visits, doctors and nurses will monitor your baby's health carefully, look for any side effects, and take small blood samples to see how their immune system is responding to the vaccines. You'll be asked to keep a record of any symptoms your baby has for about a week after each vaccination. There will be checks at 1 month after the second vaccination, before the third vaccination (around 10 months into the study), and 1 month after the third vaccination (around 11 months into the study). The total duration of your baby's involvement in the study will be approximately 11 months.

Potential risks and benefits

Taking part in a clinical trial might offer your baby early access to a new vaccine that could protect against serious infections. It also helps contribute to medical knowledge that can benefit many other children in the future. However, like all medicines, vaccines can have side effects, such as pain or swelling at the injection site, fever, or fussiness. More serious side effects, though rare, are also possible. Your baby's health will be closely monitored throughout the study. Remember, you can choose to withdraw your baby from the study at any time, for any reason, without it affecting their future medical care.

Locations (3)

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

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Unverified
Poland
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Unverified
Spain
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Unverified
Germany

Common questions

What is meningococcal disease?

It's a serious bacterial infection that can cause meningitis (brain and spinal cord swelling) and blood poisoning, which can be life-threatening.

What is the 'combined ABCWY vaccine'?

It's a new vaccine being tested that aims to protect against five different types of meningococcal bacteria (A, B, C, W, and Y) in one vaccine.

Will my baby still get their routine vaccinations?

Yes, other standard childhood vaccines will be part of this study, helping researchers see how they work with the new vaccine.

How long will my baby be in the study?

Your baby's involvement in the study will last for about 11 months, with several clinic visits during that time.

What kind of tests will my baby have?

Your baby will receive vaccinations, have regular health checks, and a few small blood samples will be taken to see how their body reacts to the vaccines.