Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on the Effectiveness of an MF59-Adjuvanted Influenza Vaccine Compared to a Non-Adjuvanted Vaccine in Adults Aged 65 and Older

Fast replyRegistered drug
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 the effectiveness and safety of vaccines designed to protect against the influenza virus, commonly known as the flu. The study involves two types of vaccines: the Adjuvanted Trivalent Influenza Vaccine (aTIV) and the FLUARIX (Influenza Vaccine). Both vaccines are given as a shot in the muscle and are designed to protect against different strains of the flu virus, including the Influenza Virus B/Austria/1359417/2021-like strain, A/Victoria/4897/2022 (H1N1)pdm09-like strain, and Influenza Virus A/Thailand/8/2022 (H3N2) IVR-237-like strain.

The purpose of this study is to compare how well the MF59-adjuvanted influenza vaccine works in preventing the flu compared to a non-adjuvanted vaccine in adults aged 65 and older. An adjuvant is a substance added to a vaccine to help boost the body's immune response to the vaccine. Participants in the study will receive one of the two vaccines and will be monitored to see if they develop the flu, confirmed by a test called RT-PCR, which detects the presence of the virus in the body.

The study will take place over the course of the flu season, starting 14 days after vaccination. Participants will be observed for any side effects and the occurrence of flu symptoms. The study aims to provide valuable information on the safety and effectiveness of these vaccines in older adults, helping to improve flu prevention strategies for this age group.

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, you will be required to provide written informed consent. This means you agree to participate after understanding the study's nature and procedures.

  2. Step 2

    Vaccination

    You will receive a vaccination. The vaccine is administered as a suspension for injection and is given intramuscularly, which means it is injected into a muscle.

    There are two types of vaccines being compared in this study: the MF59-adjuvanted influenza vaccine and a non-adjuvanted influenza vaccine. The specific vaccine you receive will be determined randomly.

  3. Step 3

    Monitoring period

    After receiving the vaccine, you will be monitored for any immediate reactions for 30 minutes.

    You will be asked to report any adverse events, which are any unexpected medical issues, throughout the study period. This includes any serious adverse events or those that lead to withdrawal from the study.

  4. Step 4

    Follow-up

    You will be followed up from 14 days after vaccination until the end of the influenza season. This is to check for any occurrence of influenza confirmed by specific tests.

    The study aims to evaluate the effectiveness of the vaccine in preventing influenza, as well as its safety and ability to trigger an immune response.

  5. Step 5

    End of study

    The study is expected to conclude by May 31, 2026. Your participation will help determine the efficacy and safety of the vaccines being tested.

Who can join the trial?

3 criteria

  • Adults who are 65 years of age or older on the day they receive the vaccine.
  • Individuals who have voluntarily given written informed consent. This means they have agreed to participate in the study after it has been explained to them, following local rules and regulations.
  • Individuals who have the ability to follow the study procedures, including attending follow-up appointments.

Who cannot join the trial?

9 criteria

  • Participants must not have any severe allergies, especially to components of the vaccine.
  • Participants should not have a history of severe reactions to previous influenza vaccines.
  • Participants must not have any acute illness or fever at the time of vaccination.
  • Participants should not be receiving any treatment that affects the immune system, such as chemotherapy or high-dose steroids.
  • Participants must not have any chronic diseases that are not well controlled, such as uncontrolled diabetes or heart disease.
  • Participants should not be pregnant or planning to become pregnant during the study period.
  • Participants must not have participated in another clinical trial within the last 30 days.
  • Participants should not have received any other influenza vaccine within the last 6 months.
  • Participants must not have any condition that, in the opinion of the study doctor, would make participation unsafe or affect the results of the study.
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

  • MF59-adjuvanted influenza vaccine

    is a type of flu shot designed to help protect against the influenza virus. This vaccine contains an ingredient called MF59, which is an adjuvant. An adjuvant is a substance that helps boost the body's immune response to the vaccine, making it more effective. This means that when you receive this vaccine, your body is better prepared to fight off the flu if you are exposed to the virus. This vaccine is specifically being tested in people aged 65 and older to see how well it works in preventing the flu.

  • Non-adjuvanted influenza vaccine

    is another type of flu shot that is being compared to the MF59-adjuvanted vaccine in this study. Unlike the MF59-adjuvanted vaccine, this one does not contain an adjuvant. It is a standard flu vaccine that aims to protect against the influenza virus by helping your body recognize and fight the virus if you come into contact with it. This vaccine is also being tested in people aged 65 and older to evaluate its effectiveness in preventing the flu.

What is already known about the treatment

MF59-Adjuvanted Influenza Vaccine – This vaccine is given as an injection to help protect against the flu, specifically in adults aged 65 and older. It is currently being studied in clinical trials to compare its effectiveness and safety against a standard flu vaccine without the MF59 adjuvant. The main purpose of this vaccine is to prevent flu caused by any strain of the influenza virus. The MF59 adjuvant works by boosting the body's immune response to the vaccine, making it more effective in producing antibodies that fight the flu virus. This vaccine is classified as an inactivated subunit vaccine, meaning it contains parts of the virus that cannot cause disease but can still trigger an immune response.

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 sometimes the lungs. The disease typically begins suddenly and can include symptoms such as fever, cough, sore throat, runny or stuffy nose, muscle or body aches, headaches, and fatigue. Influenza can spread through droplets when an infected person coughs, sneezes, or talks. The virus can also be transmitted by touching surfaces or objects that have the virus on them and then touching the mouth, nose, or eyes. The progression of the disease can vary, with some individuals recovering in a few days, while others may experience more severe symptoms.
Trial detailsLast updated 2 Oct 2026
Age65+ yearsPhasePhase IIITrial ID2022-503004-24-00Protocol codeV118_24Estimated enrolment57 925 patientsSponsorSeqirus UK Limited

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).