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Study on the Effectiveness of 20-Valent Pneumococcal Conjugate Vaccine for Preventing Pneumonia in Adults Aged 65 and Older

Verified siteRegistered drugNo placebo
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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 effectiveness of a vaccine called Apexxnar, which is a 20-valent pneumococcal conjugate vaccine. This vaccine is designed to protect against a type of lung infection known as community-acquired pneumonia in adults aged 65 and older. Community-acquired pneumonia is a lung infection that people can get outside of a hospital setting, and it can be confirmed through imaging tests like X-rays.

The purpose of the study is to determine how well the Apexxnar vaccine works in preventing pneumonia caused by specific types of bacteria that the vaccine targets. Participants in the study will receive either the vaccine or a placebo. The study will monitor participants to see if they develop pneumonia and will use this information to assess the vaccine's effectiveness. The vaccine is given as an injection into the muscle, similar to a flu shot.

Throughout the study, participants will be observed for any signs of pneumonia, such as fever, cough, or difficulty breathing. The study will also consider factors like age, sex, and previous vaccinations to understand how these might affect the vaccine's performance. The trial is expected to continue until 2027, providing valuable data on the vaccine's ability to prevent pneumonia in older adults.

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

    Joining the study

    Upon joining the study, the participant is required to provide informed consent. This involves understanding the study's requirements and agreeing to participate.

  2. Step 2

    Initial assessment

    The participant undergoes an initial assessment to confirm eligibility. This includes verifying age (65 years or older) and confirming hospitalization with symptoms of pneumonia, such as fever, chills, or cough.

    A radiographic examination is conducted to confirm pneumonia, looking for signs like pleural effusion or increased lung density.

  3. Step 3

    Vaccine administration

    The participant receives the Apexxnar vaccine, which is a pneumococcal polysaccharide conjugate vaccine. It is administered as a suspension for injection using a pre-filled syringe.

    The vaccine is given intramuscularly, meaning it is injected into a muscle.

  4. Step 4

    Monitoring and follow-up

    After receiving the vaccine, the participant is monitored for any immediate reactions to the injection.

    Follow-up assessments are conducted to evaluate the effectiveness of the vaccine in preventing pneumonia. This involves comparing the health outcomes of vaccinated participants with those who are not vaccinated.

  5. Step 5

    Data collection and analysis

    Data is collected throughout the study to assess the vaccine's effectiveness. This includes monitoring for any cases of pneumonia and analyzing the results based on age, sex, and other factors.

    The study aims to determine the vaccine's effectiveness by calculating the reduction in pneumonia cases among vaccinated participants compared to those who are not vaccinated.

  6. Step 6

    Study completion

    The study is expected to conclude by May 31, 2027. At this point, all data will be analyzed to draw conclusions about the vaccine's effectiveness.

Who can join the trial?

13 criteria

  • Participants must be **male or female** and **65 years of age or older**.
  • Participants must be **hospitalized** with a doctor's suspicion of **community-acquired pneumonia (CAP)**, showing at least **two** of the following symptoms:
    • **Fever**: High body temperature measured orally or in the ear.
    • **Hypothermia**: Low body temperature measured by a healthcare provider.
    • **Chills or rigors**: Feeling cold and shivering.
    • **Pleuritic chest pain**: Sharp pain in the chest that worsens with breathing.
    • **New or worsening cough**.
    • **Sputum production**: Coughing up mucus.
    • **Dyspnea**: Shortness of breath.
    • **Tachypnea**: Breathing faster than normal.
    • **Malaise**: General feeling of discomfort or illness.
    • **Abnormal auscultatory findings**: Unusual sounds in the lungs heard with a stethoscope, suggesting pneumonia.
    • Participants must have a **radiographic finding** (like an X-ray) that shows signs of pneumonia, such as fluid in the lungs or increased lung density due to infection.
    • Participants must be able to **give signed informed consent**, meaning they understand and agree to the study's requirements and restrictions.
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Investigated drugs

20vPnC is a 20-valent pneumococcal conjugate vaccine. It is designed to protect against pneumonia caused by 20 different types of pneumococcal bacteria. This vaccine is being studied to see how well it works in preventing pneumonia in adults aged 65 and older.

What is already known about the treatment

20-Valent Pneumococcal Conjugate Vaccine – This vaccine is administered via injection and is currently being evaluated in a Phase 4 clinical trial. It is designed to protect against community-acquired pneumonia in adults aged 65 and older. The vaccine works by stimulating the immune system to recognize and fight against 20 different serotypes of the bacteria that cause pneumonia. It falls under the pharmacological classification of vaccines, specifically targeting pneumococcal infections.

Investigated diseases

Community-Acquired Pneumonia – This is an infection of the lungs that is acquired outside of a hospital or healthcare setting. It is caused by bacteria, viruses, or fungi, leading to inflammation in the air sacs of the lungs. Symptoms often include cough, fever, chest pain, and difficulty breathing. The disease can vary in severity, from mild to severe, depending on the individual's age, health status, and the specific pathogen involved. It is more common in older adults and those with weakened immune systems. The progression of the disease can lead to complications if not managed properly.
Trial detailsLast updated 7 Oct 2026
Age65+ yearsPhasePhase IIITrial ID2023-507293-40-00Protocol codeB7471015Estimated enrolment17 500 patientsSponsorPfizer Inc.

sourced from the EU Clinical Trials Register and site verification

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