BridgeMD
A study to assess the immune response and safety of a vaccine against influenza in adults 18 years of age and older.
EU CTIS ID: 2025-522278-35-00
What this study is testing
To evaluate the humoral immune response induced by the study interventions. To evaluate the safety and reactogenicity profile of the study interventions.
- Therapeutic exploratory (Phase II)
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, attendance to study contacts and study site visits, and ability to access and utilize a phone or other electronic communications) independently or with the assistance of a caregiver.
- Written (physically, or digitally) informed consent obtained from the participant prior to performance of any study-specific procedure.
- A male or female at least 18 YOA at the time of the screening. (except for certain states in the US, where only adults as per local regulations will be eligible).
- 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, 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.
- Female participants of non-childbearing potential may be enrolled in the clinical study.
- Female participants of childbearing potential may be enrolled in the clinical study, if the participant: o Has practiced adequate contraception for at least 4 weeks prior to the study intervention administration, and o Has a negative urine pregnancy test within 24 hours prior to the study intervention administration, and o Has agreed to continue adequate contraception (Table 26) for at least 8 weeks after study intervention administration.
You likely can't join if
- Where applicable, FDA toxicity grades will be exclusionary.
- History of or current suspicion of myocarditis or pericarditis (including following administration of an mRNA vaccine); or idiopathic cardiomyopathy, or presence of any medical condition that increases the risk of myocarditis or pericarditis, including cocaine abuse, cardiomyopathy, endomyocardial fibrosis, Hyper Eosinophilic Syndrome (HES), hypersensitivity myocarditis, eosinophilic granulomatosis with polyangiitis and persistent myocardial infection.
- Condition that in the judgment of the investigator would make intramuscular injection unsafe.
- Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the clinical study.
- History of confirmed influenza infection by local health authority-approved testing methods within 180 days prior to study intervention administration.
- Use of any investigational or non-registered product (drug, vaccine or invasive medical device) other than the study intervention(s) during the period beginning 28 days before the dose of study intervention(s) (Day -28 to Day 1), or their planned use during the study period.
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, attendance to study contacts and study site visits, and ability to access and utilize a phone or other electronic communications) independently or with the assistance of a caregiver.
- Written (physically, or digitally) informed consent obtained from the participant prior to performance of any study-specific procedure.
- A male or female at least 18 YOA at the time of the screening. (except for certain states in the US, where only adults as per local regulations will be eligible).
- 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, 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.
- Female participants of non-childbearing potential may be enrolled in the clinical study.
- Female participants of childbearing potential may be enrolled in the clinical study, if the participant: o Has practiced adequate contraception for at least 4 weeks prior to the study intervention administration, and o Has a negative urine pregnancy test within 24 hours prior to the study intervention administration, and o Has agreed to continue adequate contraception (Table 26) for at least 8 weeks after study intervention administration.
- Body mass index (BMI) ≥18 kg/m² and ≤33 kg/m².
What rules you out
- Where applicable, FDA toxicity grades will be exclusionary.
- History of or current suspicion of myocarditis or pericarditis (including following administration of an mRNA vaccine); or idiopathic cardiomyopathy, or presence of any medical condition that increases the risk of myocarditis or pericarditis, including cocaine abuse, cardiomyopathy, endomyocardial fibrosis, Hyper Eosinophilic Syndrome (HES), hypersensitivity myocarditis, eosinophilic granulomatosis with polyangiitis and persistent myocardial infection.
- Condition that in the judgment of the investigator would make intramuscular injection unsafe.
- Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the clinical study.
- History of confirmed influenza infection by local health authority-approved testing methods within 180 days prior to study intervention administration.
- Use of any investigational or non-registered product (drug, vaccine or invasive medical device) other than the study intervention(s) during the period beginning 28 days before the dose of study intervention(s) (Day -28 to Day 1), or their planned use during the study period.
- Administration of an influenza vaccine within 180 days before the study intervention administration or planned administration prior to Visit 4 (Day 29) during the study.
- Administration of any non-live attenuated non-study vaccine in the period starting 14 days before the study intervention administration, or planned administration within 14 days after study intervention administration.
- Administration of any live attenuated and/or mRNA non-study non-influenza vaccine in the period starting 28 days before the study intervention administration, or planned administration within 28 days after study intervention administration.
- 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, this will mean prednisone equivalent ≥20 mg/day for adult participants for >14 days. Inhaled, intra-articular/intra-bursal, and topical corticosteroids are allowed. o Long-acting immune-modifying drugs including among others immunotherapy (e.g., TNF-inhibitors), monoclonal antibodies, antitumoral medication.
- Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the study intervention, or planned administration during the study period.
- Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Administration of anti-tumoral medication during the period starting 90 days before the study intervention or planned administration during the study period.
- Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention.
- Any study personnel or their immediate dependents, family, or household members.
- Has a history of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures.
- Participant is pregnant.
- Participant is breastfeeding or will (re)start breastfeeding during the study.
- 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 Guillain-Barré Syndrome within 6 weeks of receiving any vaccine.
- Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study (e.g., life-threatening disease likely to limit survival to less than 1 year).
- Hypersensitivity to latex.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).
- History of hypersensitivity or severe allergic reaction to any previous influenza vaccine.
- History of hypersensitivity or severe allergic reaction to any previous mRNA vaccine.
The study team makes the final eligibility decision.
Where it's taking place
- 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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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.