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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Krakowskie Centrum Medyczne Sp. z o.o. Cracow Poland
Centrul Medical Sana S.R.L. Bucharest Romania
AOMPFPC “Zaprin Pepelov” Plovdiv Bulgaria
Stichting European Clinical Research Alliance on Infectious Diseases Utrecht The Netherlands
Rokotetutkimuskeskus Finvac Oy Tampere Finland
Clintrial Medical Center S.R.L. Resca Romania
Nova-Clin Medical Research Center S.R.L. Timisoara Romania
Zdravi-fit s.r.o. Protivin Czechia
FVR Suomen rokotetutkimus Oy Oulu Finland
Ko-Med Centra Kliniczne Sp. z o.o. Staszow Poland
Futuremeds Łódź Lodz Poland
Futuremeds Sp. z o.o. Wroclaw Poland
Ames Research Center S.R.L. Călărași Romania
MUDr. Jakub Strincl s.r.o. Liberec (Neclenene Mesto) Czechia
Diagnostic And Consulting Center 2-Sliven EOOD Sliven Bulgaria

Other Sites

Site Name City Country Status
Academisch Ziekenhuis Leiden Leiden The Netherlands
Alessandro Manzoni Hospital Lecco Italy
Multiprofile Hospital For Active Treatment Dr. Tota Venkova AD Gabrovo Bulgaria
Diagnostics And Consultancy Center Pulmed EOOD Plovdiv Bulgaria
Spitalul Municipal Caracal Caracal Romania
Medical Center Hera EOOD Sofia Bulgaria
Diagnostic-Consultative Center 22 Sofia EOOD Sofia Bulgaria
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
Jan Yperman Ziekenhuis Ieper Belgium
Medical Center Zdrave-1 OOD Kozloduy Bulgaria
Universitair Ziekenhuis Gent Gent Belgium
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos Kaunas Lithuania
Multi-Profile Hospital For Active Treatment Dr. Stamen Iliev AD Montana Bulgaria
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k. Cracow Poland
Rcmed Oddzial Sochaczew Sochaczew Poland
Pratia Brno s.r.o. Brno-Stred Czechia
Medif Thuin Belgium
CCR Ostrava s.r.o. Moravska Ostrava A Privoz Czechia
Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov-Ruse Ruse Bulgaria
Equip D’assistencia Primaria Vic S.L.P. Vic Spain
Etg Neuroscience Sp. z o.o. Warsaw Poland
Medical Center Excelsior OOD Sofia Bulgaria
Diagnostic Consultative Centre Ascendent OOD Sofia Bulgaria
Universidade De Santiago De Compostela Santiago De Compostela Spain
University Multiprofile Hospital For Active Treatment Eurohospital Plovdiv Ltd. Plovdiv Bulgaria
Servei De Salut De Les Illes Balears Palma Spain
Medical Center Teodora EOOD Ruse Bulgaria
Saules seimos medicinos centras UAB Kaunas Lithuania
Ko-Med Centra Kliniczne Sp. z o.o. Zamosc Poland
ASST Fatebenefratelli Sacco Milan Italy
Medical Center Intermedica Ltd. Sofia Bulgaria
Medical Center Lovech EOOD Lovech Bulgaria
University Hospital Consorziale Policlinico Bari Italy
Medical Center 1 Sevlievo EOOD Sevlievo Bulgaria
Ordinace Hradebni s.r.o. Ceske Budejovice Czechia
Ohyiyyenwf Cagnzm Fjy Iwonzycznm Poqmsnao Fpj Pkftaqo Mfxlcgq Cnfi Dlx Vfelj Vgjdnqiqsrsdlrllb Emwr Pazardzhik Bulgaria
Ituwzggf Ugr Kaunas Lithuania
Ec Byjpqc Aofcff Bnud Almere The Netherlands
Aqdyuhbzch Ftb Iuawjlerja Psbqzddh Fyu Ptkucno Mymaacx Aki Atpxcb Daj Zvqnogu Dkgzdiic Entw Stamboliyski Bulgaria
Hyiaxgjz Pcyhbh Sdpi Vigo Spain
Qedtwacqi Byim Rotterdam The Netherlands
Dtvjod srpdet Prestice Czechia
Fjz Semfdu ragcqotlggfhfd Ou Turku Finland
Msuzfva Cagwaj Hugk Ekng Montana Bulgaria
Mwskwcl Caatjm Plpvcf Cjrudk Ewnh Lovech Bulgaria
Pclem Mdvsm Jjzy Bykpl Csln smzfou Hradec Kralove Czechia
Auntl szholm Ceske Budejovice Czechia
Morwzse Czzycr Myfkuvzdpa Pzmicr Ozt Pleven Bulgaria

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
02.10.2023
Bulgaria Bulgaria
Not recruiting
02.10.2023
Czechia Czechia
Not recruiting
02.10.2023
Finland Finland
Not recruiting
02.10.2023
Italy Italy
Not recruiting
02.10.2023
Lithuania Lithuania
Not recruiting
02.10.2023
Poland Poland
Not recruiting
02.10.2023
Romania Romania
Not recruiting
02.10.2023
Spain Spain
Not recruiting
02.10.2023
The Netherlands The Netherlands
Not recruiting
02.10.2023

Trial locations

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.

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 ID:
2022-503004-24-00
Protocol code:
V118_24
NCT ID:
NCT06087640
Trial Phase:
Therapeutic confirmatory (Phase III)

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