Authorised Therapeutic confirmatory (Phase III) Influenza immunisation

A Phase 3 Study to Assess the Safety and Immunogenicity of High-dose Influenza Vaccine in Adults ≥ 60 years of Age

EU CTIS ID: 2024-519743-15-00

What this study is testing

To demonstrate in adults ≥ 60 years of age the noninferiority of Abbott’s candidate trivalent high-dose (TIV-HD) vaccine with respect to the postvaccination hemagglutination-inhibition (HI) antibody titers compared with Efluelda® 28 days after the first vaccination.

Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

1. Willing and able to give informed consent and able to adhere to all protocol-required study procedures.
2. Adults ≥ 60 years of age who are overall healthy in the clinical judgment of the investigator based on the medical history and clinical assessment (including physical examination, vital signs, clinical laboratory tests). Subjects may have underlying illnesses as long as their symptoms/signs are controlled. If on regular prescribed medication for a condition, the medication dose must have been stable for at least 3 months preceding study vaccination.
3. Female subjects must be postmenopausal, defined as female subjects with at least 1 year of absence of menstruation or follicle-stimulating hormone and luteinizing hormone values of ovarian suppression.
4. Ability to comply with study requirements, including the use of an application on a personal device (i.e., smartphone, tablet, etc.) or a provisioned device to record solicited events and other per-protocol required data.

You likely can't join if

1. History of allergy to egg or chicken proteins, or history of any reaction or hypersensitivity to a previous dose of influenza vaccine components.
19. Any concurrent condition that in the opinion of the investigator would pose a health risk to the subject if enrolled or could interfere with the evaluation of the study vaccine including (but not limited to) bleeding disorder, immunodeficiency, seizure disorder, or acute or progressive hepatic, renal, neurological, neuromuscular, or psychiatric disease.
20. Any other reason that, in the investigator’s opinion, prohibits the inclusion of the subject into the study.
2. History of serious adverse reaction to any influenza vaccine.
3. History of Guillain-Barré syndrome.
4. Laboratory confirmed influenza infection or vaccination against influenza in the 6 months preceding enrollment.

See the full eligibility criteria

Who can join

1. Willing and able to give informed consent and able to adhere to all protocol-required study procedures.
2. Adults ≥ 60 years of age who are overall healthy in the clinical judgment of the investigator based on the medical history and clinical assessment (including physical examination, vital signs, clinical laboratory tests). Subjects may have underlying illnesses as long as their symptoms/signs are controlled. If on regular prescribed medication for a condition, the medication dose must have been stable for at least 3 months preceding study vaccination.
3. Female subjects must be postmenopausal, defined as female subjects with at least 1 year of absence of menstruation or follicle-stimulating hormone and luteinizing hormone values of ovarian suppression.
4. Ability to comply with study requirements, including the use of an application on a personal device (i.e., smartphone, tablet, etc.) or a provisioned device to record solicited events and other per-protocol required data.

What rules you out

1. History of allergy to egg or chicken proteins, or history of any reaction or hypersensitivity to a previous dose of influenza vaccine components.
19. Any concurrent condition that in the opinion of the investigator would pose a health risk to the subject if enrolled or could interfere with the evaluation of the study vaccine including (but not limited to) bleeding disorder, immunodeficiency, seizure disorder, or acute or progressive hepatic, renal, neurological, neuromuscular, or psychiatric disease.
20. Any other reason that, in the investigator’s opinion, prohibits the inclusion of the subject into the study.
2. History of serious adverse reaction to any influenza vaccine.
3. History of Guillain-Barré syndrome.
4. Laboratory confirmed influenza infection or vaccination against influenza in the 6 months preceding enrollment.
5. Receipt of any vaccine within the preceding 4 weeks of study vaccination or planned vaccination within the 4-week period following each study vaccination.
7. Having fever and/or acute disease or infection on the day of the first study vaccination (enrollment can be deferred for up to 2 weeks, provided the subject remains otherwise eligible). - Fever is defined as body temperature ≥ 38.0°C (measured by oral method). - Subjects with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
8. Immunocompromising condition or immunosuppressive therapy within 6 months preceding enrollment.
9. Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
10. Chronic use of systemic corticosteroids at a dose ≥ 20 mg/day of prednisone or equivalent for 14 consecutive days or more, prior to the first study vaccination or planned use thereof during the study. Topical use of corticosteroids (e.g., cream, ocular drops, inhalation and intranasal sprays), within the dosage noted on the product label, is allowed.
11. Chronic systemic administration (defined as more than 14 days) of immunosuppressant or immune-modifying medication (such as monoclonal antibodies) for five elimination half-lives or the proposed time in Appendix 16.5, whichever is longer, prior to the first study vaccination or planned use thereof during the study.
6. Planned administration of any influenza vaccine (other than the study vaccine) for the entire study period.
12. Receipt of blood or blood products within 3 months preceding enrollment.
13. Being a solid organ or bone marrow/stem cell transplant recipient.
14. Use of cytotoxic drugs, anticancer chemotherapy, or radiation therapy within 36 months before the day of study vaccination.
15. Receipt of another investigational agent within 30 days prior to study vaccination, or planned use during the entire study period.
16. Known drug or alcohol abuse.
17. Planned surgery requiring a general anesthetic, or planned surgery requiring inpatient hospitalization for at least 24 hours during the entire study period.
18. Being an employee of the Sponsor/CRO conducting this study, personnel of the study site or placed in an institution by regulatory or legal ordinance.

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.