Study on the Safety and Immune Response of a High-Dose Influenza Vaccine in Adults Aged 60 and Over, Comparing Trivalent Influenza Vaccine with a Drug Combination

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What is this study about?

This clinical trial is focused on studying the effectiveness and safety of a new high-dose vaccine for influenza, commonly known as the flu, in adults aged 60 and older. The study will compare Abbott’s candidate high-dose vaccine, known as Trivalent Influenza Vaccine – High Dose (TIV-HD), with an existing vaccine called Efluelda. Both vaccines are designed to protect against three different strains of the influenza virus, which are updated regularly to match the most common strains circulating each flu season.

The purpose of the study is to determine if the new high-dose vaccine is at least as effective as the existing vaccine in producing an immune response. Participants will receive either the new vaccine or the existing one through an injection. The study will monitor the immune response by measuring specific antibodies in the blood 28 days after vaccination. Participants will also be observed for any side effects or adverse reactions following the vaccination.

The study will take place over several months, with participants being followed up to six months after receiving the vaccine. This will help researchers gather comprehensive data on the vaccine’s safety and its ability to trigger a strong immune response. The ultimate goal is to ensure that the new high-dose vaccine provides effective protection against influenza in older adults, who are at higher risk for complications from the flu.

1 initial vaccination

Upon joining the study, you will receive your first dose of the high-dose influenza vaccine. This vaccine is designed to help your body build protection against the flu.

The vaccine will be given as an intramuscular injection, which means it will be injected into a muscle, usually in your upper arm.

After receiving the vaccine, you will be asked to stay for a short period to ensure there are no immediate reactions.

2 recording reactions

For the first 7 days after your vaccination, you will need to record any reactions you experience. This includes reactions at the injection site, such as redness or swelling, and general reactions like fever or headache.

You will use an application on your personal device, such as a smartphone or tablet, to record these reactions. If you do not have a device, one will be provided to you.

3 follow-up visit

28 days after your first vaccination, you will return for a follow-up visit. During this visit, your health will be assessed, and any reactions you recorded will be reviewed.

This visit is important to ensure your safety and to gather information on how well the vaccine is working.

4 revaccination

At the follow-up visit, you will receive a second dose of the high-dose influenza vaccine.

This second dose is given to boost your immune response and provide better protection against the flu.

5 second recording period

After the second vaccination, you will again record any reactions for 7 days using the application on your device.

This helps in monitoring your response to the second dose and ensures your continued safety.

6 long-term follow-up

You will have additional follow-up visits over the next 6 months. These visits are to monitor your health and any long-term effects of the vaccine.

During these visits, you will be asked about any health changes and may undergo some routine health checks.

Who Can Join the Study?

Willing and able to give informed consent, which means you understand the study and agree to participate.
Adults who are 60 years of age or older and are generally healthy, as judged by the study doctor based on your medical history and a health check-up. You can have other health conditions as long as they are under control. If you take regular medication, the dose must not have changed in the last 3 months before getting the study vaccine.
If you are a female participant, you must be postmenopausal. This means you have not had a menstrual period for at least 1 year, or you have hormone levels that show your ovaries are not active.
Able to follow the study requirements, including using an app on a personal device like a smartphone or tablet to record any events or information needed for the study.

Who Cannot Join the Study?

Participants must be at least 60 years old.
Both men and women can participate.
Participants should not belong to any vulnerable population. This means groups of people who might be at a higher risk of harm or exploitation, such as those with certain disabilities or those who cannot make decisions for themselves.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Clinico San Carlos	Madrid	Spain
Rokotetutkimuskeskus Finvac Oy	Tampere	Finland
Fundacion De Oftalmologia Medica De La Comunitat Valenciana	Valencia	Spain
Al Mare Perearstikeskus OU	Tallin	Estonia
Innomedica OÜ	Tallin	Estonia

Other Sites

Site Name	City	Country
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov	Sofia	Bulgaria
Medical Center Hera EOOD	Sofia	Bulgaria
Universitair Ziekenhuis Gent	Gent	Belgium
Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov-Ruse	Ruse	Bulgaria
Pneumocare	Namur	Belgium
Asclepius Medical Center OOD	Dupnitsa	Bulgaria
Multi-Profile Hospital For Active Treatment Dr. Stamen Iliev AD	Montana	Bulgaria
Hospital Quironsalud Barcelona	Barcelona	Spain
Medical Center Excelsior OOD	Sofia	Bulgaria
Kliiniliste Uuringute Keskus OÜ	Tartu	Estonia
Multiprofile Hospital For Active Treatment Dr. Tota Venkova AD	Gabrovo	Bulgaria
Jan Yperman Ziekenhuis	Ieper	Belgium
University Multiprofile Hospital For Active Treatment Eurohospital Plovdiv Ltd.	Plovdiv	Bulgaria
Ziekenhuis Oost Limburg	Genk	Belgium
Center for Clinical and Basic Research AS	Tallin	Estonia
Medical Center 1 Sevlievo EOOD	Sevlievo	Bulgaria
Mduoppb Cfuhhd Nak Pkbtrrekrl Gcjgykz Lmka	Gabrovo	Bulgaria
Mfxotjm Csgufk Pclrvl Coszqz Egvp	Lovech	Bulgaria
Etdiaky	Mechelen	Belgium
Tpssg Uqydcxyiqm Hyixxfml	Tartu	Estonia
Svnxik Tpczjlypbpc Ou	Jyvaskyla	Finland
Ulrpkmflwv Ot Amsuzmc	Edegem	Belgium
Mpnlgxw Cbsmjx Dyh Mssyljac Ecje	Kyustendil	Bulgaria
Hdndsjqt Uyvyhwthai Cddaamg Hgawjooc	Helsinki	Finland
Fxsdlzrnj Ptkp Lz Ixlbqthlnycdu Bqoulnyyo Dgh Hanwbmes Uogbfrqfotqpa Le Prn	Madrid	Spain
Sjwhhp Tnsbofutqqe Os	Turku	Finland

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	08.09.2025
Bulgaria	Not recruiting	08.09.2025
Estonia	Not recruiting	08.09.2025
Finland	Not recruiting	08.09.2025
Spain	Not recruiting	08.09.2025

Trial locations

Investigated drugs:

Abbott’s Candidate High-Dose Influenza Vaccine is a new vaccine being tested to see how well it works in people aged 60 and older. This vaccine is designed to protect against the flu by helping the body build up defenses, known as antibodies, against the virus. The study is checking if this new vaccine can create a strong immune response, similar to or better than another flu vaccine already in use.

Efluelda® is an existing flu vaccine used as a comparison in this study. It is given to people to help protect them from getting the flu by boosting their immune system. The study is comparing the immune response generated by Efluelda® to that of the new vaccine being tested, to see if the new vaccine is just as effective or better at preventing the flu.

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 is characterized by symptoms such as fever, cough, sore throat, runny or stuffy nose, muscle or body aches, headaches, and fatigue. In some cases, it can lead to more severe complications, especially in older adults, young children, and individuals with certain health conditions. The virus spreads mainly through droplets made when people with the flu cough, sneeze, or talk. The progression of the disease can vary, with symptoms lasting from a few days to less than two weeks.

Trial ID:

2024-519743-15-00

Protocol code:

INFQ-324-0476

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Safety and Immune Response of a High-Dose Influenza Vaccine in Adults Aged 60 and Over, Comparing Trivalent Influenza Vaccine with a Drug Combination

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?