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Study on the Effectiveness and Safety of IVX-A12 Vaccine for Preventing Respiratory Infections in Adults Aged 60 and Older

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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 two respiratory diseases: Respiratory Syncytial Virus (RSV) and Human Metapneumovirus (hMPV). These viruses can cause lung infections, especially in older adults. The study will test a new vaccine called IVX-A12, which is designed to protect against both RSV and hMPV. The vaccine is given as a solution for injection into the muscle.

The purpose of the study is to see how well the IVX-A12 vaccine works in preventing lung infections caused by RSV and hMPV in adults aged 60 and older. Participants in the study will receive either the IVX-A12 vaccine or a placebo, which is a substance that looks like the vaccine but does not contain the active ingredients. The study will monitor participants over a period of time to check for any signs of these infections and to assess the safety of the vaccine.

Participants will be followed through different seasons to observe the occurrence of infections. The study aims to gather information on how effective the vaccine is in preventing these infections and to ensure it is safe for use in older adults. This research is important for developing new ways to protect against these common respiratory viruses.

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

    Initial visit and consent

    Upon joining the study, you will attend an initial visit where the study team will explain the trial in detail. You will be asked to sign an informed consent form, confirming your understanding and agreement to participate.

    During this visit, your medical history will be reviewed to ensure you meet the study's eligibility criteria, which includes being 60 years of age or older and medically stable.

  2. Step 2

    Vaccination

    You will receive a single intramuscular injection. This injection will either be the study vaccine, IVX-A12, or a placebo (a saltwater solution). The injection is given in the muscle of your upper arm.

    The purpose of the vaccine is to help prevent respiratory illnesses caused by the respiratory syncytial virus (RSV) and human metapneumovirus (hMPV).

  3. Step 3

    Monitoring period

    After the vaccination, you will be monitored for any immediate reactions. This is a standard procedure to ensure your safety.

    You will be asked to report any symptoms or health changes you experience during the study period. This helps the study team assess the vaccine's safety and effectiveness.

  4. Step 4

    Follow-up visits

    You will have scheduled follow-up visits with the study team. These visits are important for monitoring your health and collecting data on the vaccine's effects.

    During these visits, you may undergo physical examinations and provide blood samples. These samples help measure your body's response to the vaccine.

  5. Step 5

    End of study

    The study is expected to continue until September 2027. At the end of the study, you will have a final visit to assess your health and discuss your experience.

    The information collected during the study will contribute to understanding the vaccine's ability to prevent illnesses caused by RSV and hMPV.

Who can join the trial?

3 criteria

  • Participant must be 60 years of age or older at the time of signing the informed consent.
  • Participants must be medically stable in the opinion of the study doctor. This means that if you have a long-term health condition like diabetes, high blood pressure, or heart disease, it should be under control and not causing major problems.
  • Participants must be able to understand and follow the study requirements. This includes attending all scheduled study visits. If needed, you can have help from a caregiver or a legally authorized representative.

Who cannot join the trial?

7 criteria

  • Participants must not have any serious health conditions that could interfere with the study.
  • Participants should not have a history of severe allergic reactions to vaccines.
  • Participants must not be currently participating in another clinical trial.
  • Participants should not have received any other vaccine within 30 days before the study starts.
  • Participants must not have a weakened immune system, which means their body has trouble fighting infections.
  • Participants should not be pregnant or planning to become pregnant during the study.
  • Participants must not have any condition that, in the opinion of the study doctor, makes them unsuitable for the study.
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Investigated drugs

IVX-A12 is a vaccine designed to protect against two viruses: the Respiratory Syncytial Virus (RSV) and the Human Metapneumovirus (hMPV). These viruses can cause lung infections, especially in older adults. The vaccine works by using particles that look like the viruses to help the body recognize and fight them off if exposed in the future. This study is testing how well the vaccine works, how safe it is, and how the body responds to it in people aged 60 and older.

What is already known about the treatment

IVX-A12 – This medication is administered as a single injection into the muscle (intramuscularly) and is currently being studied in a Phase 3 clinical trial. It is designed to protect older adults, specifically those aged 60 and above, from respiratory illnesses caused by the Respiratory Syncytial Virus (RSV) and Human Metapneumovirus (hMPV). The vaccine works by using virus-like particles to stimulate the body's immune system to recognize and fight these viruses. IVX-A12 falls under the category of vaccines, which are substances used to prevent diseases by enhancing the body's natural defenses.

Investigated diseases

  • Respiratory Syncytial Virus Infection

    Respiratory Syncytial Virus (RSV) infection is a common respiratory virus that affects the lungs and breathing passages. It typically begins with symptoms similar to a mild cold, such as a runny nose, cough, and fever. As the infection progresses, it can lead to more severe respiratory issues, especially in older adults and those with weakened immune systems. The virus can cause inflammation of the small airways in the lungs, leading to wheezing and difficulty breathing. In some cases, it can progress to bronchiolitis or pneumonia, which are more serious conditions. The infection is highly contagious and spreads through respiratory droplets.

  • Human Metapneumovirus Infection

    Human Metapneumovirus (hMPV) infection is a respiratory virus that causes symptoms similar to those of the common cold. It often starts with a runny nose, cough, and sore throat. As the infection develops, it can lead to more severe respiratory problems, particularly in older adults and individuals with compromised immune systems. The virus can cause inflammation in the airways, resulting in wheezing and difficulty breathing. In some cases, it can lead to bronchiolitis or pneumonia, which are more severe respiratory conditions. The virus is spread through close contact with an infected person or contaminated surfaces.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513740-28-00Protocol codeD8610C00001Estimated enrolment29 450 patientsSponsorAstraZeneca AB

sourced from the EU Clinical Trials Register and site verification

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