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 @ 3:01 PM
Ignite Modification Date:
2025-12-24 @ 3:01 PM
NCT ID:
NCT00606359
Eligibility Criteria:
Inclusion Criteria:
* Able to attend all scheduled visits and to comply with all trial procedures.
* Subject with renal transplant for at least 6 months.
* Subject with stable renal function, i.e. with a variation of creatinin value \< 20% and with a creatinin clearance estimated according to Cockroft and Gault calculation \> 20 mL/min during the 3 months preceding inclusion.
* Aged 18 to 59 years on the day of the screening visit.
* Informed Consent Form signed.
* Subject entitled to national social security.
* Subject under immunosuppressive therapy.
* For a woman, inability to bear a child or negative urine pregnancy test.
* Subject non-responder to previous IM vaccination with the 2006-2007 Northern Hemisphere Vaxigrip® formulation.
Exclusion Criteria:
* Subject with sign of transplanted kidney reject within 3 months preceding vaccination according to medical practice.
* Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
* Febrile illness (oral temperature ≥ 37.5°C, or rectal equivalent temperature ≥ 38.0°C) on the day of inclusion.
* Breast-feeding.
* Participation in another clinical trial in the 4 weeks preceding the trial vaccination.
* Planned participation in another clinical trial during the present trial period.
* Congenital immunodeficiency, anti-cancer chemotherapy or radiation therapy within the preceding 6 months.
* Chronic illness, except renal failure or renal disorders, at a stage that could interfere with trial conduct or completion.
* Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures.
* Blood or blood-derived products received in the past 3 months .
* Any vaccination in the 4 weeks preceding the trial vaccination.
* Vaccination planned in the 4 weeks following the trial vaccination.
* Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination
* Previous vaccination against influenza in the preceding 6 months.
* Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00606359
Study Brief:
Protocol Section:
NCT00606359