Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Children and Adolescents With Increased Risk of Pneumococcal Disease.

This research study is looking at a new vaccine, called V116, for children and teenagers who have a higher chance of getting illnesses caused by a type of germ called pneumococcus. Pneumococcal disease can cause serious conditions like pneumonia, meningitis, and ear infections. The study wants to understand if V116 is safe and how well it helps the body fight off these germs compared to vaccines already in use. Researchers will be checking for any side effects and seeing how strong the immune response is after vaccination. This information will help doctors decide if V116 could be a good new option to protect vulnerable young people.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

215

Start

18 Mar 2024

Pneumococcal disease

What is this study about?

This study is about a new vaccine, called V116, designed to protect children and teenagers from infections caused by certain bacteria. These bacteria are known as 'pneumococcus' and can lead to serious illnesses like pneumonia (a lung infection), meningitis (an infection around the brain and spinal cord), and blood infections. Children and teens who are at a higher risk of getting these infections need effective ways to protect themselves.

The main goal of this study is to find out if the new V116 vaccine is safe and if it helps the body build up a good defense against pneumococcal bacteria. Researchers will be comparing V116 to vaccines that are already approved and widely used. This helps them understand if the new vaccine is just as good, or even better, at preventing these illnesses.

To do this, they will be looking at several things. They'll carefully record any side effects that people experience after getting the vaccine, whether they are minor (like a sore arm) or more serious. They will also take blood samples to see how well the body's immune system responds. This means checking for special protective substances (antibodies) that the body makes to fight off germs. Learning about these things will help ensure that new vaccines are both effective and safe for young people.

Key takeaways

This study is testing a new vaccine (V116) for pneumococcal disease.
It's for children and teenagers at higher risk of these infections.
The study compares V116 to existing vaccines.
Researchers will check for safety (side effects) and immune response (how the body fights germs).
Participation helps future medical treatments for young people.

Who may be eligible?

This study is looking for children and teenagers to take part, specifically those who are considered to have a higher chance of getting sick from pneumococcal bacteria. This might be due to certain health conditions that make them more vulnerable to infections.

There aren't any specific age limits or restrictions based on whether you are male or female, so anyone within the child and adolescent age range who meets the medical criteria for being at increased risk could potentially be suitable.

To find out if your child might be a good fit, a doctor involved in the study would need to review their full medical history and current health status. They will check for specific health details that make someone eligible or ineligible to ensure the study is safe and appropriate for all participants.

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 a child or teenager?
Does your child have a higher chance of getting pneumococcal disease (due to certain health conditions)?
Are you able to attend several clinic visits over time?
Are you comfortable with your child having blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, your child would receive one of the study vaccines. This could be the new V116 vaccine, or one of the existing vaccines (Pneumovax® 23 or Pneumococcal 21-valent Conjugate Vaccine) which are used for comparison. The specific vaccine your child receives will be decided randomly, like flipping a coin, and neither you nor the study doctors will know which one it is (this is called 'double-blind').

Throughout the study, there will be several visits to the clinic. During these visits, doctors and nurses will check your child's health and ask about any side effects they might be experiencing. These checks will include looking at the injection site for any redness or swelling, and asking about general feelings of being unwell like fever or headaches. Blood samples will also be taken at specific times to measure the body's immune response to the vaccine.

The study will follow your child for a certain period to make sure all information about safety and how well the vaccine works is collected. The exact number of visits, blood tests, and the total duration will be fully explained by the study team if your child is considered for participation.

Potential risks and benefits

Taking part in a clinical trial like this could offer potential benefits, such as receiving a new vaccine that might provide protection against serious pneumococcal diseases. It also helps advance medical knowledge, potentially leading to better health options for children and teens in the future. However, like any medicine, vaccines can have side effects, which could range from minor (like a sore arm, fever) to very rare, serious reactions. The study team will carefully monitor your child for any problems, and you always have the right to withdraw your child from the study at any time, for any reason, without it affecting their medical care.

Locations (5)

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

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Unverified
Sweden
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Unverified
Poland
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Unverified
France
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Unverified
Finland
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Unverified
Spain

Common questions

What is pneumococcal disease?

It's an illness caused by bacteria called pneumococcus. It can lead to serious conditions like pneumonia, meningitis, and ear infections.

What is a 'vaccine'?

A vaccine is a medicine that helps your body learn to fight off certain germs without actually getting sick from them. It helps build your natural defenses.

What does a 'Phase 3' study mean?

Phase 3 means the vaccine has already passed earlier safety checks and is now being tested on a larger group to confirm its effectiveness and safety before being widely used.

Will my child automatically get the new vaccine?

No, participants will be randomly chosen to receive either the new vaccine or a standard vaccine already in use. You won't know which one they received.

What are 'side effects'?

Side effects are any unintended reactions or problems that happen after receiving a vaccine or medicine. They can be mild, like a sore arm, or in rare cases, more serious.