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:
2025-12-26 @ 5:24 PM
Ignite Modification Date:
2025-12-26 @ 5:24 PM
NCT ID:
NCT00693706
Eligibility Criteria:
Inclusion Criteria:
* Subjects who the investigator believes can and will comply with the requirements of the protocol
* A male or non-pregnant, non-lactating female between 18 and 49 years of age at the time of vaccination
* Access to a telephone for scheduled follow-up telephone contacts
* Ability to provide written informed consent
* Healthy subjects as established by medical history and physical examination before entering into the study
* 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 and continue such precautions for 2 months after receipt of the study vaccine. All women will have a pregnancy test on the day of vaccination.
Exclusion Criteria:
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period
* Receipt of systemic glucocorticoids within 30 days of study enrollment
* Administration of immunosuppressant, cytotoxic, or other immune-modifying drugs (other than glucocorticoids) or irradiation within 6 months prior to study enrollment or planned administration during the study period
* Administration of immunoglobulins and/or blood products within 3 months prior to study enrollment or planned administration during the study period
* Previous vaccination against influenza (2007-2008 influenza season)
* History of anaphylactic or other allergic reaction to influenza vaccine, any other vaccine, or any vaccine component or excipient
* History of Guillain-Barre Syndrome (GBS)
* Acute disease, febrile illness, or upper respiratory infection at screening.
* History of splenectomy
* Any confirmed or suspected, acquired, congenital, or hereditary immunodeficiency or immunosuppressive condition (including human immunodeficiency virus \[HIV\]) based on medical history and physical examination
* Acquired or congenital coagulation disorders or known thrombocytopenia
* Current treatment with warfarin or heparin derivatives
* Known use of an analgesic or antipyretic medication within 12 hours prior to treatment for the purposes of prophylaxis of adverse events
* Any medical condition for which the US Advisory Committee on Immunization Practices recommends vaccination against influenza
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
49 Years
Study:
NCT00693706
Study Brief:
Protocol Section:
NCT00693706