Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on the V116 Vaccine for Adults Aged 18-64 at Increased Risk of Pneumococcal Infection

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a disease called Pneumococcal infection, which is caused by bacteria that can lead to serious illnesses like pneumonia, meningitis, and bloodstream infections. The study is testing a new vaccine called V116, which is designed to protect against this infection. The trial will also compare the effects of V116 with other vaccines, specifically PCV15 and PPSV23. Participants in the study will receive either the new vaccine or a placebo, which is a substance with no active ingredients, to help researchers understand the vaccine's safety and effectiveness.

The purpose of the study is to evaluate how safe and well-tolerated the V116 vaccine is, as well as how well it works in producing an immune response in adults aged 18 to 64 who are at increased risk for pneumococcal disease. This includes individuals with conditions like diabetes, chronic liver disease, chronic obstructive pulmonary disease (COPD), asthma, chronic heart disease, and chronic kidney disease. The study will monitor participants for any side effects and measure their immune response to the vaccine over a period of time.

Participants will be randomly assigned to receive either the V116 vaccine or the other vaccines being studied. They will receive the vaccine through an injection into the muscle. The study will track any reactions at the injection site, as well as any other side effects, for a few days after vaccination. Additionally, the study will measure the levels of specific antibodies in the blood, which are proteins that help fight infections, to see how well the vaccine works in boosting the immune system. The study aims to provide valuable information on the potential benefits of the V116 vaccine for preventing pneumococcal infections in people who are more vulnerable to this disease.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    Upon joining the study, you will attend an initial visit. During this visit, your eligibility will be confirmed based on specific health conditions such as diabetes, chronic liver disease, or chronic heart disease.

    Your medical history will be reviewed, and you will be asked to provide informed consent to participate in the study.

  2. Step 2

    First vaccination

    You will receive the first dose of the V116 vaccine through an intramuscular injection. This means the vaccine will be injected into a muscle.

    You will be monitored for any immediate reactions to the vaccine.

  3. Step 3

    Monitoring period

    For the first five days after vaccination, you will be asked to report any side effects, such as pain at the injection site or other symptoms.

    You will be required to attend follow-up visits to monitor your health and the vaccine's effects.

  4. Step 4

    Second vaccination

    Approximately 12 weeks after the first vaccination, you will receive a second dose, which may be a different vaccine called PCV15 + PPSV23.

    This dose will also be administered via intramuscular injection.

  5. Step 5

    Final monitoring

    You will continue to be monitored for any side effects or reactions for a specified period after the second vaccination.

    Your immune response to the vaccines will be evaluated through blood tests to measure specific antibodies.

  6. Step 6

    Study completion

    Once all follow-up visits and evaluations are completed, your participation in the study will conclude.

    You will receive information about the study's findings and any relevant health advice.

Who can join the trial?

9 criteria

  • The patient must have at least one of the following risk conditions for **pneumococcal disease**:
    • **Diabetes mellitus**: A condition where the body has trouble managing blood sugar levels. The patient should be on at least one approved diabetes medication, and all blood sugar tests (Hemoglobin A1c) should be 9% or lower in the last 6 months.
    • **Compensated chronic liver disease**: A liver condition that is stable and managed.
    • **Chronic obstructive pulmonary disease (COPD)**: A lung condition that makes it hard to breathe, managed according to local guidelines.
    • **Mild or moderate persistent asthma**: A lung condition causing breathing difficulties, managed according to local guidelines.
    • **Chronic heart disease**: A heart condition that is confirmed and managed according to local guidelines.
    • **Chronic kidney disease**: A kidney condition lasting more than 3 months.
    • The patient must be receiving stable medical treatment for the above conditions for at least 3 months, with no major changes in treatment expected during the study, and no more than one hospital stay related to the condition.
    • The patient must be between 18 and 64 years old at the time of giving consent to participate in the study.
    • If the patient is a female who can have children, she must use an acceptable method of birth control or choose not to have vaginal intercourse as a regular lifestyle choice. Her medical and menstrual history, as well as recent sexual activity, should be reviewed by the study investigator.

Who cannot join the trial?

9 criteria

  • Participants who have had a severe allergic reaction to any vaccine in the past.
  • Individuals with a weakened immune system, which means their body has a harder time fighting infections.
  • People who are currently receiving treatment that affects the immune system, such as chemotherapy for cancer.
  • Participants who have received any other vaccine within the last 30 days.
  • Individuals with a history of bleeding disorders, which are conditions that affect the way blood clots.
  • Pregnant or breastfeeding women.
  • Anyone who has participated in another clinical trial within the last 30 days.
  • Individuals with a history of drug or alcohol abuse within the past year.
  • People with any other medical condition that the study doctors believe would make it unsafe for them to participate.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • V116

    is a new vaccine being tested in this clinical trial. It is designed to protect against pneumococcal disease, which is an infection caused by bacteria that can lead to serious illnesses like pneumonia, meningitis, and bloodstream infections. The trial is focused on understanding how safe and well-tolerated this vaccine is for adults who have never received a pneumococcal vaccine before and are at increased risk for these infections. The study also looks at how well the vaccine works by measuring the body's immune response to it.

  • PCV15

    is a pneumococcal conjugate vaccine that is already used to protect against pneumococcal disease. It works by helping the immune system recognize and fight off the bacteria that cause these infections. In this trial, PCV15 is used as a comparison to see how the new vaccine, V116, performs in terms of safety and immune response.

  • PPSV23

    is another type of pneumococcal vaccine that is used to protect against a broader range of pneumococcal bacteria. It is often given to adults to help prevent serious infections. In this study, PPSV23 is used in combination with PCV15 to compare the immune response and safety of the new vaccine, V116, against this established vaccination regimen.

What is already known about the treatment

V116 – V116 is a vaccine administered through an injection to help protect against pneumococcal infections, which are caused by bacteria that can lead to serious illnesses like pneumonia. Currently, V116 is being studied in clinical trials to assess its safety and effectiveness in adults aged 18 to 64 who are at increased risk for pneumococcal disease. The vaccine works by stimulating the body's immune system to produce antibodies that can recognize and fight off the bacteria. It is classified as a pneumococcal vaccine, and its main goal is to prevent infections by enhancing the body's natural defense mechanisms.

Investigated diseases

Pneumococcal infection – Pneumococcal infection is caused by the bacterium Streptococcus pneumoniae. It can lead to various illnesses, including pneumonia, meningitis, and bacteremia. The infection typically begins when the bacteria colonize the upper respiratory tract. From there, it can spread to other parts of the body, causing more severe diseases. The progression of the infection depends on the site affected and the individual's immune response. Symptoms can range from mild respiratory issues to severe complications affecting the brain or bloodstream.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502791-22-01Protocol codeV116-008Estimated enrolment500 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).