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Study on the Effectiveness and Safety of OVX836 Vaccine for Preventing Influenza in Healthy Adults Aged 18-59

Fast replyRegistered 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 and safety of a new influenza vaccine called OVX836. The study is aimed at preventing Influenza Type A, a common viral infection that affects the respiratory system, causing symptoms like fever, cough, and body aches. The vaccine, OVX836, is being tested to see how well it works in preventing the flu compared to a placebo. The trial involves healthy adults aged 18 to 59 years.

Participants in the study will receive a single dose of the OVX836 vaccine through an injection. The study will monitor the occurrence of flu symptoms and any side effects after vaccination. The goal is to determine if the vaccine can effectively prevent the flu and to assess its safety. The study will also look at the body's immune response to the vaccine, which involves measuring specific immune cells and antibodies that help fight the flu virus.

The trial will take place over a period of time, with participants being observed for any flu symptoms or side effects. The study will also evaluate the severity and duration of any flu-like symptoms that occur. By comparing the results between those who receive the OVX836 vaccine and those who receive a placebo, researchers aim to gather important information about the vaccine's potential to protect against the flu.

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 you will be asked to provide written informed consent. This means you agree to participate after understanding the study details.

    During this visit, a medical history review and examination will be conducted to confirm your health status and eligibility for the study.

  2. Step 2

    Vaccination

    You will receive a single dose of the OVX836 influenza vaccine (480 micrograms) through an injection into your muscle. This is designed to help prevent influenza Type A.

    The vaccine administration is a one-time event during the study.

  3. Step 3

    Monitoring period

    For the first 7 days after receiving the vaccine, you will be asked to monitor and report any local or systemic signs and symptoms. This includes any reactions at the injection site or general symptoms like fever or tiredness.

    You will also report any unexpected medical events for 29 days following the vaccination.

  4. Step 4

    Follow-up assessments

    You will be required to complete an electronic diary and patient-reported outcomes to track your health status and any symptoms experienced.

    A subset of participants will have additional blood tests on Day 1 and Day 8 to measure immune responses.

  5. Step 5

    End of study

    The study will continue to monitor for any serious adverse events throughout its duration, which is estimated to end by May 17, 2026.

    Your participation will contribute to understanding the vaccine's effectiveness and safety in preventing influenza.

Who can join the trial?

8 criteria

  • Provide written informed consent, which means you agree to participate after being informed about the study.
  • Be a healthy male or female, as determined by your medical history and a medical examination.
  • Be between the ages of 18 and 59 years, inclusive.
  • Meet the reproductive criteria for male and female participants, which are specific guidelines related to reproductive health.
  • Be reliable and willing to be available for the entire duration of the study and follow the study procedures.
  • Be able to read, understand, and complete an electronic diary (eDiary) and electronic patient-reported outcome (ePRO), which are tools used to record your health information.
  • Be socially active, meaning you live with family or other household members, or have frequent social contacts at places like university, work, restaurants, theaters, or on public transportation.
  • Be able to read and sign the subject information sheet and informed consent form (ICF), which are documents that explain the study and confirm your agreement to participate.

Who cannot join the trial?

10 criteria

  • People who are not within the age range specified for the study.
  • Individuals who have a known allergy to any component of the vaccine.
  • Participants who have received another influenza vaccine within a certain period before the study.
  • Individuals with a history of severe allergic reactions, known as anaphylaxis, to any vaccine.
  • People with a weakened immune system, which means their body has a harder time fighting infections.
  • Participants who are currently experiencing a fever or any acute illness.
  • Individuals who are pregnant or breastfeeding.
  • People who have participated in another clinical trial recently.
  • Individuals with a history of drug or alcohol abuse.
  • Participants who have any other medical condition that the study doctors believe would make it unsafe for them to participate.
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Investigated drugs

OVX836 is an experimental vaccine designed to protect against the flu, specifically targeting influenza Type A. In this clinical trial, the vaccine is given as a single shot into the muscle. The main goal of using this vaccine is to see how well it can prevent people from getting the flu, as confirmed by a specific test called RT-PCR. The study also looks at how the body responds to the vaccine and checks for any side effects. This vaccine is being tested on healthy adults between the ages of 18 and 59 to see if it can effectively prevent flu symptoms compared to not receiving the vaccine.

What is already known about the treatment

OVX836 – OVX836 is an influenza vaccine administered as a single dose through an injection into the muscle, typically in the upper arm. It is currently being studied in clinical trials to assess its effectiveness, safety, and ability to trigger an immune response against influenza, specifically targeting Type A strains. The vaccine works by stimulating the body's immune system to recognize and fight the influenza virus, potentially preventing the onset of flu symptoms. It is classified as a vaccine, which is a type of medication designed to prevent infectious diseases by enhancing the body's natural defenses.

Investigated diseases

Influenza – Influenza, commonly known as the flu, is a contagious respiratory illness caused by influenza viruses. It primarily affects the nose, throat, and lungs. The disease typically begins suddenly and is characterized by symptoms such as fever, cough, sore throat, runny or stuffy nose, muscle or body aches, headaches, and fatigue. Influenza can lead to mild to severe illness, and symptoms usually appear one to four days after exposure to the virus. The virus spreads through droplets when an infected person coughs, sneezes, or talks. The progression of the disease can vary, with most people recovering within a few days to less than two weeks, although some may develop complications.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-520354-37-00Protocol codeOVX836-005Estimated enrolment2 850 patientsSponsorOsivax

sourced from the EU Clinical Trials Register and site verification

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