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:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT01707602
Eligibility Criteria:
Inclusion Criteria:
* Healthy volunteers, age between 18 and 45 years,
* BMI between 21 - 26,
* Phototype I to IV,
* Subjects able to receive vaccine administration by any of the three administration routes,
* Signature of the written informed consent,
* Affiliated to a health social security system,
Exclusion Criteria:
* Known pregnancy or positive urine pregnancy test for women of child-bearing age,
* Known infection with HIV or/and HCV or/and HBV (AgHBs+),
* Known or suspected immune dysfunction that is caused by a medical condition, or any other Cause,
* Use, within the past 3 months, of any topical and systemic treatment that would interfere with assessment and/or investigational treatment (anti-inflammatory drugs, immunosuppressors or any immune modulator agent),
* Use of any topical treatment on the injection site within the last four weeks,
* Excessive terminal hair growth on the two investigational skin areas used for the transcutaneous mode of vaccination,
* Phototype V-VI,
* Any allergy or hypersensibility to one of the components of the Investigational Product,
* Medical history of allergy or hypersensitization to any ingredient of colorant used in the transcutaneous mode of administration,
* Administration of a live vaccine(≤ 28 days) or inactivated (≤ 14 days) or planned vaccination within 3months of inclusion (D0),
* Medical history of skin cancer,
* Any acute skin affection which may interfere with the trial assessment on the injection site,
* Any acute or chronic infectious which may interfere with the trial assessment four weeks prior to enrolment,
* Prevision of UV sessions or sun exposure 6 weeks prior to the study or during the study period,
* Febrile illness(at least 37.5°Cmeasuredorally), any acute infectious event within one week prior to enrolment,
* Flu confirmed by the presence of fever≥38.5°Cassociated with respiratory symptoms
* History of GuillainBarre syndrome or brachial neuritis following a previous vaccination.
* Participation in an other biomedical research during the study period or period of exclusion when inclusion
* Subject being in the exclusion period of a previous clinical trial,
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01707602
Study Brief:
Protocol Section:
NCT01707602