Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 3, Randomized, Double-blind, Active Comparator-controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 50 Years of Age or Older

This study is looking at a new vaccine, called V116, for pneumonia. We are inviting adults aged 50 and older who haven't had a pneumonia vaccine before to take part. The main goals are to check how safe the vaccine is, if people have any side effects, and how well it helps their bodies build protection against the germs that cause pneumonia. We're comparing V116 to a vaccine that's already in use to understand if it works as well or better. By doing this research, we hope to find new ways to prevent pneumonia and keep older adults healthy.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

300

Start

21 Jun 2023

Pneumococcal disease

What is this study about?

This clinical trial is designed to investigate a new vaccine, known as V116, which is intended to protect against pneumococcal disease. Pneumococcal disease is a common type of infection that can lead to serious illnesses like pneumonia, especially in older adults. The study focuses on adults who are 50 years of age or older and who have not previously received a pneumonia vaccine.

The main purpose of this research is to see if the V116 vaccine is safe and if it helps the body produce a strong immune response against the specific types of germs that cause pneumococcal disease. We will be comparing V116 to a pneumonia vaccine that is already approved and used. This comparison will help us understand if V116 can offer similar or better protection, and if it's well-tolerated by patients.

By carefully studying these aspects, we aim to gather important information that could lead to new and improved ways to prevent pneumococcal infections. This research is crucial for providing effective protection for older adults, who are often more vulnerable to severe forms of this disease.

Key takeaways

This study is testing a new pneumonia vaccine (V116) for adults over 50.
The main goals are to check vaccine safety, common side effects, and how well it boosts your immune system.
You must not have had a pneumonia vaccine before to join this study.
Participation involves clinic visits, blood tests, and monitoring for side effects.
You will receive either the new vaccine or an existing one; you won't know which during the study.
Your medical care will not be affected if you choose to withdraw at any time.

Who may be eligible?

The study is looking for adults who are 50 years old or older. You can be any gender to take part.

Crucially, you should not have received any pneumonia vaccine before. This helps us to get a clear picture of how the new vaccine works in people who haven't had prior protection.

There will be other health checks to make sure the study is right for you, but these are the main starting points to consider.

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.

Are you 50 years old or older?
Have you never had any pneumonia vaccine before?
Are you generally in good health?
Are you willing to attend several clinic visits for check-ups and blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will receive either the new V116 vaccine or an existing pneumonia vaccine. You won't know which one you're getting, nor will the study team, until after the study is complete. This helps ensure fair results. You will need to attend several appointments at the study clinic throughout the trial. These visits will involve blood tests to check your immune response and discussions about any side effects you might experience. We'll monitor how you're feeling and any reactions you have after the vaccination. The team will provide a detailed schedule of visits and what to expect at each one. The overall duration of your involvement will be clearly explained before you agree to join.

Potential risks and benefits

Taking part in this study could potentially help advance medical understanding and lead to better ways to prevent pneumonia. You might also gain some protection from pneumonia. However, like all vaccines, there's a chance of side effects, such as soreness or redness at the injection site, or feeling generally unwell for a short period. More serious side effects are rare but possible. You are free to withdraw from the study at any time, for any reason, without it affecting your 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
Spain
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Unverified
Germany

Common questions

What is pneumococcal disease?

It's an infection caused by bacteria that can lead to serious illnesses like pneumonia, which affects your lungs, and sometimes can cause ear infections or even more severe conditions.

Why is this study only for people aged 50 and over?

Older adults are more likely to get severe pneumonia and other pneumococcal diseases, so this study focuses on understanding how well the vaccine works in this age group.

What does a 'new vaccine' mean?

It means this vaccine, V116, is still being tested to see if it's safe and effective before it can be made widely available to the public.

Will I know if I get the new vaccine or the existing one?

No, neither you nor the study team will know which vaccine you receive until the study is finished. This helps to make the study results fair and unbiased.

What kind of side effects might I experience?

Common side effects from vaccines can include soreness, redness, or swelling where you got the injection. You might also feel a bit tired or have a headache, but these are usually mild and don't last long.