A study on the efficacy of a vaccine against influenza in adults ≥65 years of age
EU CTIS ID: 2026-526682-14-00
What this study is testing
To demonstrate the non-inferiority of the investigational study intervention in terms of relative efficacy as compared to the active comparator against laboratory-confirmed protocol-defined ILI caused by influenza subtypes/lineages contained in the investigational study intervention. To evaluate the safety and reactogenicity of the study interventions
- 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
- Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary, return for follow-up visits, attendance to study contacts, ability to access and utilize a phone or other electronic communications and collection of nasal self-swabs) independently or with the assistance of a caregiver.
- Written or witnessed (physically or digitally) informed consent obtained from the participant/LAR(s) of the participant prior to performance of any study-specific procedure.
- Healthy participants or medically stable patients as established by medical history and clinical examination. Participants with chronic medical conditions with or without specific treatment (e.g., chronic metabolic, cardiac, pulmonary, renal, hepatic, neurologic, and hematologic diseases) are allowed to participate in this study if considered by the investigator as medically stable. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during 3 months before enrollment.
- A male participant or a female participant of non-childbearing potential at least 65 YOA at the time of the study intervention administration.
You likely can't join if
- History of test-confirmed influenza infection within 180 days prior to study intervention administration.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). HIV-infected individuals may be enrolled if they have been stable on antiretroviral therapy for the past 6 consecutive months, i.e., their treatment has not been modified, their CD4 cell count is ≥ 200/mm³ and their viral load has been undetectable (i.e., HIV-RNA < 50 copies/mL).
- History of myocarditis or pericarditis considered causally associated with the administration of an mRNA vaccine.
- Acute or unstable chronic conditions [clinically significant pulmonary, cardiovascular, hepatic, metabolic/endocrine disorders, renal functional abnormality, or psychiatric conditions], as determined by medical history and clinical examination.
- Administration of an influenza vaccine in the period starting 180 days before the study intervention administration or planned administration at any time during the study.
- Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune-modifying treatments at any time up to the end of the study. Up to 90 days prior to the study intervention administration: o For systemic corticosteroids: prednisone equivalent ≥20 mg/day for >14 days. Inhaled, intra articular/intra-bursal, and topical steroids are allowed. o Long-acting immune-modifying drugs including among others immunotherapy (e.g., TNF-inhibitors), monoclonal antibodies, antitumoral medication.
See the full eligibility criteria
Who can join
- Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary, return for follow-up visits, attendance to study contacts, ability to access and utilize a phone or other electronic communications and collection of nasal self-swabs) independently or with the assistance of a caregiver.
- Written or witnessed (physically or digitally) informed consent obtained from the participant/LAR(s) of the participant prior to performance of any study-specific procedure.
- Healthy participants or medically stable patients as established by medical history and clinical examination. Participants with chronic medical conditions with or without specific treatment (e.g., chronic metabolic, cardiac, pulmonary, renal, hepatic, neurologic, and hematologic diseases) are allowed to participate in this study if considered by the investigator as medically stable. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during 3 months before enrollment.
- A male participant or a female participant of non-childbearing potential at least 65 YOA at the time of the study intervention administration.
What rules you out
- History of test-confirmed influenza infection within 180 days prior to study intervention administration.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). HIV-infected individuals may be enrolled if they have been stable on antiretroviral therapy for the past 6 consecutive months, i.e., their treatment has not been modified, their CD4 cell count is ≥ 200/mm³ and their viral load has been undetectable (i.e., HIV-RNA < 50 copies/mL).
- History of myocarditis or pericarditis considered causally associated with the administration of an mRNA vaccine.
- Acute or unstable chronic conditions [clinically significant pulmonary, cardiovascular, hepatic, metabolic/endocrine disorders, renal functional abnormality, or psychiatric conditions], as determined by medical history and clinical examination.
- Administration of an influenza vaccine in the period starting 180 days before the study intervention administration or planned administration at any time during the study.
- Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune-modifying treatments at any time up to the end of the study. Up to 90 days prior to the study intervention administration: o For systemic corticosteroids: prednisone equivalent ≥20 mg/day for >14 days. Inhaled, intra articular/intra-bursal, and topical steroids are allowed. o Long-acting immune-modifying drugs including among others immunotherapy (e.g., TNF-inhibitors), monoclonal antibodies, antitumoral medication.
- For further exclusion criteria, kindly refer to the protocol (Section 5.2)
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United States
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 Canada; United States. 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.