Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2025-12-24 @ 3:37 PM
NCT ID:
NCT03546192
Eligibility Criteria:
Inclusion Criteria:
* Participants were \>= 18 years of age on the day of inclusion .
* Informed consent form had been signed and dated.
* Able to attend all scheduled visits and to comply with all trial procedures.
Exclusion Criteria:
* History of serious adverse reaction to any influenza vaccine.
* Receipt of any vaccine within 30 days before receiving study vaccine, or plans to receive another vaccine before Visit 2.
* Participation in another interventional clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 30 days preceding the first study vaccination or during the course of the study.
* Self-reported thrombocytopenia, which may be a contraindication for intramuscular vaccination, at the discretion of the Investigator.
* Vaccination against influenza in the previous 12 months if administered in the context of a clinical trial or a flu vaccination campaign.
* Known systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a history of a life-threatening reaction to the vaccine or to a vaccine containing any of the same substances (the complete list of vaccine components is included in the Prescribing Information) .
* Receipt of immune globulins, blood, or blood-derived products in the past 3 months.
* Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, which may be a contraindication for intramuscular vaccination, at the discretion of the Investigator.
* Participant was pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 3 weeks after vaccination).
* Any condition that in the opinion of the Investigator would pose a health risk to the participant if enrolled or could interfere with the evaluation of the vaccine.
* Personal history of Guillain-Barré syndrome.
* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
* Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion .
* Known seropositivity for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C, as reported by the participant. (No screening procedures were implemented.)
* Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
* Current alcohol or drug addiction that, in the opinion of the Investigator, might interfere with the ability to comply with trial procedures.
* Moderate or severe acute illness/infection (according to Investigator judgment) or febrile illness (temperature ≥ 38°C) on the day of vaccination. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
* Identified as an Investigator or employee of an Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e. parent, spouse, natural or adopted child) of an Investigator or employee with direct involvement in the proposed study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03546192
Study Brief:
Protocol Section:
NCT03546192