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 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT00703651
Eligibility Criteria:
Inclusion Criteria :
* Subject aged between 18 and 57 years (i.e., less than 60 at the last vaccination)
* For woman of child-bearing potential, negative urine pregnancy test at V#01
* Use of effective contraception prior to and during the trial
* Subject available during the trial period
* Subject able to read and understand the informed consent form
* Informed consent form signed and dated by the subject prior to any protocol-required intervention (and Visit 05 and Visit 07, respectively).
Exclusion Criteria :
* Self-reported allergy to egg proteins, chick proteins, or any of the constituents of the vaccine, in particular, neomycin, formaldehyde, and octoxinol 9
* Acute febrile disease within the 72 hours preceding V#01, or axillary temperature \>37.5°C the day of inclusion, prior to vaccination (\>37.0°C Czech Republic)
* Subject with an aggravation of existing chronic illness (heart disease, respiratory disease, etc.)
* Vaccination against influenza within the 6 months preceding V#01
* Any vaccination within the 28 days preceding V#01 or scheduled between V#01 and V#02
* Breast-feeding
* Immunosuppressive therapy including long term systemic corticotherapy (20 mg/day of prednisolone or equivalent for \>2 weeks) or cancer therapy within the month preceding V#01 or ongoing
* Immunoglobulin injection within the 3 months preceding V#01
* Subject taking part or planned to take part in another clinical trial (3 months before and through the trial duration)
* Subject having received extracted pituitary hormones
* Subjects who participated in the GID01 study (Lithuanian centers)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
57 Years
Study:
NCT00703651
Study Brief:
Protocol Section:
NCT00703651