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 @ 4:20 PM
Ignite Modification Date:
2025-12-24 @ 4:20 PM
NCT ID:
NCT01652066
Eligibility Criteria:
Inclusion Criteria:
* healthy male and female adult
* between 18 and 60 years old non menopausal female( with effective contraception)
* female non pregnant- not wishing to be pregnat during the study capable to respect the protocol
* affialted to the social security system aggreeing to be registered in the national fileof volunteers
Exclusion Criteria:
* food allergy( component of the experimental product- vaccines)
* manifestation of allergy
* vaccinated against flu during the 2 previous winters
* Food allergy, allergy to one of the component of the experimental products or allergy to one of the component of the flu vaccine;
* Subject displaying manifestation of allergy or being treated for these;
* Subject vaccinated against flu during the 2 previous winter (winter 2009-2010 and winter 2010-2011);
* Subject who had symptoms evocating flu during the previous winter (winter 2010-2011);
* Subject immunodepressed;
* Subject with immunomodulatory treatment;
* Subject who received a treatment resulting in systemic immunossuppression or local immunosuppression at pulmonary level, for at least 1 week during the last 3 months before inclusion (V1);
* Subject with auto-immune disease;
* Subject with inflammatory and chronic diseases;
* Subject with on-going antibiotics treatment at the time of the inclusion;
* Subject not agree to stop his/her usual probiotics supplementation during the study;
* Use of medication which could interfere with the study in the investigator's opinion (antibiotics, etc…);
* Any health condition for which the influenza vaccine is not recommended;
* Subject having received any other vaccine within one month prior to enrolment or intent to receive any other vaccination during the study period.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01652066
Study Brief:
Protocol Section:
NCT01652066