BridgeMD
A Phase 3/3b, Randomized, Observer-blind, Multicenter Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of Fluad and Fluad Quadrivalent Compared to a Non-adjuvanted Influenza Vaccine in Adults ≥65 Years of Age
EU CTIS ID: 2022-503004-24-00
What this study is testing
To demonstrate the efficacy of Fluad in the prevention of RT-PCR-confirmed influenza A and/or B disease due to any influenza strain is non-inferior to that of a non-adjuvanted trivalent influenza vaccine comparator in adults ≥65 years of age.
- 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. Adults of ≥65 years of age on the day of vaccination.
- 2. Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
- 3. Individuals who have the ability to comply with study procedures including follow-up.
You likely can't join if
- 1. Bedridden subjects (i.e. confined to bed by sickness or old age).
- 7. Abnormal function of the immune system resulting from: a. Clinical conditions; b. Systemic administration of corticosteroids (PO/IV/IM)8 at a dose ≥20 mg/day of prednisone (or equivalent) for more than 14 consecutive days within 90 days prior to informed consent; Topical, inhaled and intranasal corticosteroids are permitted. Intermittent use (one dose in 30 days) of intra-articular corticosteroids are also permitted; c. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent;
- 8. Receipt of immunoglobulins or any blood products within 180 days prior to informed consent;
- 9. Receipt of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the study vaccination, or planned use during the entire study period.
- 10. Acute (severe) febrile illness.
- 11. Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.
See the full eligibility criteria
- 1. Adults of ≥65 years of age on the day of vaccination.
- 2. Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
- 3. Individuals who have the ability to comply with study procedures including follow-up.
- 1. Bedridden subjects (i.e. confined to bed by sickness or old age).
- 7. Abnormal function of the immune system resulting from: a. Clinical conditions; b. Systemic administration of corticosteroids (PO/IV/IM)8 at a dose ≥20 mg/day of prednisone (or equivalent) for more than 14 consecutive days within 90 days prior to informed consent; Topical, inhaled and intranasal corticosteroids are permitted. Intermittent use (one dose in 30 days) of intra-articular corticosteroids are also permitted; c. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent;
- 8. Receipt of immunoglobulins or any blood products within 180 days prior to informed consent;
- 9. Receipt of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the study vaccination, or planned use during the entire study period.
- 10. Acute (severe) febrile illness.
- 11. Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.
- 12. Study personnel or immediate family members (brother, sister, child, parent) or the spouse of study personnel.
- 2. Subjects that are incapacitated and because of that in need of a Legally Authorized Representative.
- 3. Receipt of any influenza vaccine within 6 months prior to enrollment or any plan to receive influenza vaccine while participating in the study.
- 4. Hypersensitivity, including allergy, to any component of vaccines whose use is foreseen in this study, or severe allergic reaction (e.g. anaphylaxis) to previous influenza vaccination.
- 5. Known history of Guillain-Barré syndrome or another demyelinating disease such as encephalomyelitis and transverse myelitis.
- 6. Clinical conditions representing a contra-indication to intramuscular administration of vaccines or blood draw.
The study team makes the final eligibility decision.
Where it's taking place
- Argentina
- Korea, Republic of
- Taiwan
- South Africa
- Zimbabwe
- Chile
- United States
- Serbia
- New Zealand
- Philippines
- Australia
- Colombia
- Turkey
- Georgia
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, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Argentina; Korea, Republic of; Taiwan; South Africa; Zimbabwe; Chile and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.