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 @ 10:50 PM
Ignite Modification Date:
2025-12-24 @ 10:50 PM
NCT ID:
NCT00586469
Eligibility Criteria:
Inclusion Criteria:
* Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
* Male and female adults, 18 to 60 years.
* Written informed consent obtained from the subject.
* If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for the duration of the study.
Exclusion Criteria:
* Acute disease at the time of enrollment.
* Any confirmed or suspected immunosuppressive condition
* Presence of blood dyscrasias, including hemaglobinopathies and myelo- or lymphoproliferative disorder.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* A history of any demyelinating disease including Guillain-Barré syndrome.
* Presence of an active neurological disorder.
* Any significant disorder of coagulation that increases the risk of intramuscular injections or treatment with coumadin derivatives or heparin.
* Receipt of an influenza vaccine within 6 months prior to study enrollment.
* Administration of any vaccines within 30 days prior to study enrollment or during the study period.
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period.
* Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study.
* Any known or suspected allergy to any constituent of Fluviral and/or a history of anaphylactic type reaction to consumption of eggs, and/or reactions to products containing mercury.
* A history of severe adverse reaction to a previous influenza vaccination.
* Lactating/nursing female.
* Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00586469
Study Brief:
Protocol Section:
NCT00586469