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Study on the Safety and Immune Response of V116 Vaccine in Children and Adolescents at Higher Risk for Pneumococcal Disease

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What is this trial about?

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

This clinical trial is focused on studying the safety and effectiveness of a new vaccine called V116 in children and adolescents who are at increased risk of developing pneumococcal disease. Pneumococcal disease is an infection caused by the bacteria Streptococcus pneumoniae, which can lead to serious illnesses like pneumonia, meningitis, and bloodstream infections. The study will compare the new vaccine, V116, with an existing vaccine known as Pneumovax® 23, which is also used to prevent pneumococcal disease.

The purpose of the study is to evaluate how safe and well-tolerated the new vaccine is, as well as how well it works in producing an immune response. Participants in the study will receive either the new vaccine, V116, or the existing vaccine, Pneumovax® 23, or a placebo. The study will monitor participants for any side effects and measure their immune response to the vaccine. This will help determine if the new vaccine is as effective or more effective than the existing one.

Participants will be followed for a period of time to observe any reactions to the vaccine and to measure the levels of antibodies, which are proteins in the blood that help fight infections. The study aims to provide valuable information on the potential benefits of the new vaccine for those at higher risk of pneumococcal disease, such as individuals with conditions like diabetes, chronic lung disease, or chronic heart disease. The results of this study could lead to improved prevention strategies for pneumococcal disease in vulnerable populations.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific health conditions such as diabetes, chronic liver, lung, heart, or kidney disease. Stable management of these conditions for at least three months is required.

    Participants should not have received more than one dose of the 23-valent pneumococcal vaccine in the last five years.

  2. Step 2

    Initial vaccination

    The first step involves receiving the V116 vaccine. This is administered as a solution for injection into the muscle.

    The purpose of this vaccine is to help protect against pneumococcal disease, which can cause serious infections.

  3. Step 3

    Monitoring for adverse events

    After vaccination, monitoring for any adverse events at the injection site or systemic reactions is conducted.

    This includes tracking any serious adverse events that may be related to the vaccine.

  4. Step 4

    Follow-up assessments

    Follow-up assessments are conducted to measure the immune response to the vaccine. This involves checking the levels of specific antibodies in the blood.

    The assessments help determine the effectiveness of the vaccine in producing an immune response.

  5. Step 5

    Final evaluation

    A final evaluation is conducted to compare the immune response to the V116 vaccine with the response to the previously used 23-valent vaccine.

    This includes measuring the geometric mean titers of antibodies and assessing any significant increases from baseline levels.

Who can join the trial?

8 criteria

  • The patient must have one or more of the following risk conditions for **pneumococcal disease**:
    • **Diabetes mellitus**: A condition where the body has trouble controlling blood sugar levels, and the patient is receiving treatment with medication for diabetes.
    • **Chronic compensated liver disease**: A long-term liver condition where the liver is still able to function.
    • **Chronic lung disease**: A long-term condition affecting the lungs.
    • **Chronic heart disease**: A long-term condition affecting the heart.
    • **Chronic kidney disease**: A long-term condition affecting the kidneys, with ongoing kidney problems.
    • The patient must be receiving stable medical management for the risk conditions listed above for at least 3 months.
    • The patient must not have received the **pneumococcal vaccine, polyvalent (23-valent) (PPSV23)**, or must have received no more than 1 dose of PPSV23 at least 5 years before the study vaccination.
    • The study is open to both male and female participants.

Who cannot join the trial?

9 criteria

  • Individuals who have a known allergy to any component of the vaccine cannot participate. An allergy is when your body reacts negatively to something, causing symptoms like itching or swelling.
  • People who have had a severe allergic reaction to a previous dose of a pneumococcal vaccine are excluded. A severe allergic reaction can include difficulty breathing or a drop in blood pressure.
  • Participants with a weakened immune system are not eligible. The immune system is the body's defense against infections, and if it's weakened, it may not respond well to the vaccine.
  • Those who are currently receiving treatment that affects the immune system, such as chemotherapy, cannot join. Chemotherapy is a treatment often used for cancer that can lower the body's ability to fight infections.
  • Individuals with a history of certain blood disorders are excluded. Blood disorders can affect how blood cells work, which might impact the vaccine's effectiveness.
  • Pregnant women are not allowed to participate. Pregnancy is the period when a woman is carrying a baby, and certain vaccines may not be safe during this time.
  • People who have received another vaccine within a certain time frame before the study starts are not eligible. This is to ensure that other vaccines do not interfere with the study vaccine.
  • Anyone with a current illness that includes a fever is excluded. A fever is a temporary increase in body temperature, often due to an infection.
  • Participants who have been involved in another clinical trial recently are not allowed to join. This is to prevent any overlap that could affect the study results.
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Investigated drugs

V116 is a vaccine being studied to see how safe and well-tolerated it is in children and adolescents who are at higher risk of getting pneumococcal disease. The trial aims to understand how the body responds to this vaccine and whether it causes any side effects. The study also compares the immune response generated by V116 to that of another vaccine called PPSV23, focusing on specific types of bacteria that can cause pneumococcal disease.

What is already known about the treatment

V116 – This medication is administered as an injection and is currently being studied in clinical trials for its safety and effectiveness in children and adolescents at increased risk of pneumococcal disease. It is in the phase 3 stage of clinical trials, which means it is being tested for safety and how well it works in larger groups of people. The main therapeutic use of V116 is to prevent pneumococcal disease, which can cause serious infections like pneumonia. V116 works by stimulating the immune system to produce antibodies against specific strains of the pneumococcus bacteria, helping the body to fight off infections. It is classified as a vaccine, which is a type of medication that helps prevent diseases by boosting the body's natural defenses.

Investigated diseases

Pneumococcal disease – Pneumococcal disease is an infection caused by the bacterium Streptococcus pneumoniae. It can lead to various illnesses, including pneumonia, meningitis, and bloodstream infections. The disease often begins with symptoms like fever, cough, and difficulty breathing. In some cases, it can progress to more severe conditions, such as inflammation of the brain or spinal cord. The bacteria can spread from person to person through respiratory droplets. It is more common in young children, older adults, and individuals with weakened immune systems.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2023-506236-32-00Protocol codeV116-013Estimated enrolment820 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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