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 18 to 64 years of Age With Increased Risk for Pneumococcal Disease

This important study is looking at a new vaccine, called V116, designed to protect against pneumonia caused by pneumococcal bacteria. We are inviting adults aged 18 to 64 who have a higher chance of getting this type of pneumonia to take part. The main goals are to check how safe V116 is, if people experience any side effects, and how well it helps your body build protection against the infection. We'll be comparing V116 with current pneumonia vaccines to see if it works as well, or even better. Understanding these things helps us decide if V116 could be a valuable new option for preventing pneumonia in the future.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

100

Start

11 Apr 2023

Pneumococcal infection

What is this study about?

Imagine your body as a castle and germs as attackers. Vaccines are like training your castle's guards (your immune system) to recognise and fight off specific attackers before they can make you seriously ill. This study is about a new vaccine, called V116, which aims to protect you from a type of germ called pneumococcus. This germ can cause serious infections like pneumonia, which affects your lungs, and even other conditions like meningitis or blood poisoning.

We are looking for adults between 18 and 64 years old who are at a higher risk of getting sick from pneumococcal infection. This might be due to certain health conditions they have. The main purpose of this study is to carefully check if this new vaccine, V116, is safe to use and if it helps your body build up a good defence against these germs. We also want to understand if it works as well as, or better than, the pneumonia vaccines that are already available.

By taking part, you would be helping doctors and scientists learn more about new ways to prevent serious illnesses. The information we gather will help us know if V116 could be a helpful new tool in protecting people's health in the future.

Key takeaways

This study tests a new pneumonia vaccine (V116) for adults at higher risk.
It compares V116 to existing vaccines or a saline injection.
We're checking safety, side effects, and how well it helps your body fight infection.
Participation involves vaccine administration, follow-up visits, and blood tests.
The study helps develop new ways to prevent serious pneumococcal diseases.

Who may be eligible?

This study is looking for adults who are aged 18 years or older. There is no upper age limit for joining.

Both men and women are welcome to take part in this study. The most important thing is that you are in good general health and haven't had a pneumococcal vaccine before, or if you have, it was more than a certain amount of time ago (the study team will check this).

You also need to be at a higher risk of getting a pneumococcal infection. The study team will discuss what this means and check if your health conditions or circumstances meet the specific requirements for the study.

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 18 years old or older?
Have you never received a pneumonia vaccine before, or was your last one a long time ago?
Do you have a health condition that puts you at higher risk for pneumococcal infection?
Are you able to attend regular follow-up appointments?
Are you comfortable with blood tests during the study visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be given either the new V116 vaccine or one of the existing pneumonia vaccines. Some people might also receive a saline (saltwater) injection, which acts as a comparison. You won't know which one you receive, nor will the study team, until the end (this is called 'double-blind').

After getting the vaccine, you would need to attend several follow-up visits over a period of time. During these visits, the study team will check for any side effects and take blood samples to see how your body is responding to the vaccine. They will be looking at how well your immune system is building protection against pneumococcal germs. The total time you would be involved in the study would be for a number of months, and the team will explain the exact schedule of visits and what each involves.

Potential risks and benefits

Taking part in a study like this could mean you receive a new vaccine that might offer good protection against pneumonia. However, like all medicines, vaccines can have side effects. These are usually mild, like soreness where you had the injection, but there's a chance of more serious side effects too, though these are rare. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

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Unverified
Poland

Common questions

What is pneumococcal pneumonia?

It's a serious lung infection caused by a common germ called pneumococcus, which can also cause other serious illnesses.

What is the new vaccine, V116?

V116 is a new vaccine being tested to see if it can protect people from pneumococcal infections.

Will I definitely get the new vaccine if I join?

No, you might receive the new vaccine, or a standard vaccine, or a saline injection. The study is set up so neither you nor the doctors know which one you get.

What kind of side effects might I experience?

Common side effects are usually mild, like soreness or redness at the injection site. Serious side effects are rare, but the study team will monitor you closely.

How long will I be in the study?

You'll be involved for several months, with different visits and check-ups over that time. The team will tell you the exact schedule.