Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

C4801002 - A Phase 2, Randomized, Open-Label Trial to Describe the Safety and Immunogenicity of A Monovalent Pneumococcal Conjugate Candidate Administered As a 2-Dose Series in Healthy Toddlers 12 Through 15 Months of Age Who Previously Received PCV10 Primary Series in the European Union

This research study is testing a new vaccine designed to protect against pneumonia, a common lung infection. It's for toddlers between 12 and 15 months old in the European Union who have already received an earlier pneumonia vaccine (called PCV10). The main goal is to understand how safe this new vaccine is and how effectively it helps the body build protection against specific types of bacteria that cause pneumonia. Researchers are carefully watching for any reactions to the vaccine, both at the injection site and general body responses like fever. They are also measuring the children's immune system response to see how well it works. This study helps doctors learn more about new ways to keep children healthy.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Pfizer Inc.

Enrolment target

100

Start

19 Oct 2023

Pneumococcal Infections

What is this study about?

This study is all about trying out a new vaccine to protect young children from serious infections, often called pneumonia. Pneumonia is an infection that can make children very poorly, especially affecting their lungs. This new vaccine is for toddlers aged 12 to 15 months in the European Union who have already had a course of another pneumonia vaccine called PCV10 when they were babies.

The main aim of the study is to see two things: first, how safe the new vaccine is, and second, how well it helps a child's body create defences (what we call immunity) against the specific types of bacteria that cause pneumonia. Think of it like giving their immune system a practice run so it's ready to fight if it ever meets the real thing.

This kind of research is really important because it helps doctors and scientists understand if new vaccines work well and are safe for children. It's a key step in developing better ways to protect toddlers from these serious infections in the future.

Key takeaways

This study is testing a new pneumonia vaccine for toddlers.
It's for children aged 12 to 15 months who've already had a different pneumonia vaccine.
The main goals are to check the vaccine's safety and how well it helps build immunity.
Your child would receive two doses of the new vaccine.
Researchers will monitor for side effects and check immune responses.
This research helps improve future protection against pneumonia in children.

Who may be eligible?

This study is looking for young children between 12 months and 15 months old. Both boys and girls can take part.

To be considered for this study, your child must have already received a full course of a different pneumonia vaccine called PCV10 when they were younger babies. This means they've already had their basic protection against some types of pneumonia.

The research team will have more specific requirements to ensure the study is safe and effective for all participants. These will be discussed with you in detail if you are interested in your child taking 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 your child between 12 and 15 months old?
Has your child already had their full course of the PCV10 pneumonia vaccine?
Is your child generally healthy?
Are you able to attend regular appointments for your child's vaccination and check-ups?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, they would receive a new pneumonia vaccine. This vaccine is given as an injection, just like other routine childhood vaccines. The study involves giving two doses of the vaccine. The researchers will be checking your child carefully for any side effects after the injection, both at the injection site (like redness or swelling) and general effects (like fever or changes in sleep).

You would need to attend appointments with your child for the vaccine doses and follow-up checks. They might also take small blood samples to see how their body is responding to the vaccine and building protection. The medical team will explain everything fully, including how long you'll need to be involved and what each visit will include.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as helping researchers learn more about how to protect children better against pneumonia in the future. Your child might receive a new vaccine that could offer protection. However, as with any medical treatment, there are potential risks, such as common vaccine side effects like soreness, redness, or swelling at the injection site, or a mild fever. More serious reactions 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 usual 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
Finland
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Unverified
Poland

Common questions

What is pneumonia?

Pneumonia is a common infection that affects the lungs and can make children very unwell. Vaccines can help protect against some types of it.

What does 'Phase 2' mean?

Phase 2 means this is an early stage of testing for a new medicine or vaccine. It focuses on checking if it's safe and if it works as expected in a small group of people.

Will my child get a real vaccine or a dummy one?

This particular study involves participants receiving one of the active study vaccines, not a dummy or placebo. This is clearly explained in the study information.

What does 'immunogenicity' mean?

Immunogenicity means how well a vaccine helps a person's body create protection (immunity) against a disease. Researchers measure this by looking at levels of certain protective substances in the blood.

How long will my child be in the study?

The full length of the study's involvement for your child will be explained by the study team, including how many visits are needed and for how long.