Active not recruitingPHASE3INTERVENTIONAL

Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age

This research is looking into a new pneumonia-fighting vaccine called PCV21. We want to find out if it's safe and good at helping healthy babies, about 2 to 4 months old, build up their protection against specific germs. We're comparing PCV21 with a vaccine already in use (Vaxneuvance), giving them along with babies' other routine vaccinations. The study will last around 20 months for each baby and involves several visits to check on their health. This is a "Phase 3" study, meaning it's one of the final steps before a new medicine might be approved for wider use.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Sanofi

Enrolment target

1,092

Start

22 May 2025

Estimated completion

25 Aug 2027

Pneumococcal Immunization Healthy Volunteers

What is this study about?

This study is a research project designed to test a new vaccine called PCV21. This vaccine is meant to protect babies from pneumococcal disease, which can cause serious infections like pneumonia, meningitis, and blood infections. We want to see if PCV21 is safe for babies and if it helps their bodies produce important germ-fighting agents called "antibodies." These antibodies are crucial for protecting against illnesses.

We're comparing this new PCV21 vaccine to another vaccine called Vaxneuvance, which is already approved and used. Babies in the study will receive either PCV21 or Vaxneuvance, administered at the same time as their usual childhood vaccinations. This helps us understand how well the new vaccine works alongside their routine immunisations and whether it offers similar or better protection.

Finding effective and safe vaccines for children is really important for protecting their health from serious diseases. This study aims to gather important information that could help provide more options for preventing pneumococcal infections in infants in the future.

Key takeaways

This study is testing a new vaccine (PCV21) for pneumonia and other serious infections in babies.
It's comparing a new vaccine to one already in use.
Babies aged 2-4 months at the start can join.
Study vaccines are given with routine childhood jabs.
Participation involves several visits over about 20 months.
It aims to find out if the new vaccine is safe and effective.

Who may be eligible?

For your baby to take part in this study, they need to be generally healthy and between 42 and 112 days old (about 2 to 4 months old) on the day they join. They also need to have been born at full term (37 weeks or more) with a birth weight of at least 2.5 kg, or, if born a little early (between 28 and 36 weeks), they need to have weighed at least 1.5 kg at birth and be stable and healthy according to the study doctor.

Babies unfortunately can't join if they have certain health conditions. This includes known problems with their immune system, a history of serious pneumococcal infections, or severe allergic reactions to vaccines. If your baby has certain long-term illnesses, clotting problems, or active serious infections, or a history of seizures, they also wouldn't be able to participate. The study doctor will carefully review your baby's health to make sure it's safe for them to 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 baby between 2 and 4 months old (42 to 112 days)?
Is my baby generally healthy?
Was my baby born at full term (37 weeks or more) and at least 2.5 kg, or, if a little early (28-36 weeks), at least 1.5 kg and healthy?
Does my baby have any serious immune system problems or previous severe reactions to vaccines?
Does my baby have a history of serious pneumococcal infections or uncontrolled long-term health issues?
Does my baby have any bleeding problems or significant neurological conditions like seizures?

Answer every question to see your result.

What does participation involve?

If your baby joins the study, they will receive either the PCV21 vaccine or the Vaxneuvance vaccine. These will be given alongside their other routine childhood vaccinations, just as they normally would receive them. Full-term babies will have their study vaccines at around 2, 4, and 11-15 months of age. Babies born a bit early will have theirs at around 2, 3, 4, and 11-15 months of age.

The study involves about 5 visits for full-term babies or 6 visits for babies born early. These visits will be spread out over roughly 20 months. During these visits, the study team will monitor your baby's health, check how they are reacting to the vaccines, and ensure everything is progressing as expected. They'll also perform any necessary health assessments.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as contributing to medical knowledge that might help protect future generations from pneumococcal disease. Your baby would also receive careful monitoring of their health throughout the study. However, as with any vaccine, there's always a chance of side effects, which are usually mild, like soreness at the injection site or a fever. There might also be other unknown risks with a new vaccine. You are free to withdraw your baby from the study at any time, for any reason, without affecting their future medical care.

Locations (49)

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

Investigational Site Number : 0560004
Verified postcode
Alken, Belgium
Investigational Site Number : 0560001
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Bruges, Belgium
Investigational Site Number : 0560002
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Edegem, Belgium
Investigational Site Number : 0560005
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Gozée, Belgium
Investigational Site Number : 0560007
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Leuven, Belgium
Investigational Site Number : 0560003
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Roeselare, Belgium
Investigational Site Number : 2030001
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Jindřichův Hradec, Czechia
Investigational Site Number : 2030009
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Krnov, Czechia
Investigational Site Number : 2030006
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Pilsen, Czechia
Investigational Site Number : 2030008
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Prague, Czechia
Investigational Site Number : 2330001
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Paide, Estonia
Investigational Site Number : 2330004
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Tallinn, Estonia

Common questions

What is pneumococcal disease?

Pneumococcal disease is an infection caused by bacteria that can lead to serious conditions like pneumonia (lung infection), meningitis (brain and spinal cord infection), and blood poisoning.

What's the difference between PCV21 and Vaxneuvance?

PCV21 is a new vaccine being tested, designed to protect against 21 types of pneumococcal bacteria. Vaxneuvance is an existing, approved vaccine that protects against 15 types.

Will my baby get their other routine vaccinations?

Yes, your baby will receive their standard childhood vaccinations at the same time as the study vaccines, following the usual schedule for babies in the UK.

How long will my baby be in the study?

Each baby will be in the study for up to approximately 20 months from when they start, attending around 5 or 6 visits during that time.

Will I know which vaccine my baby gets?

This is a "double-blind" study, meaning neither you nor the study doctors will know which of the two study vaccines your baby receives until the end of the research. This helps ensure fair results.