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 @ 10:30 PM
Ignite Modification Date:
2025-12-24 @ 10:30 PM
NCT ID:
NCT00516035
Eligibility Criteria:
Inclusion Criteria:
* Good general health
* Available for the duration of the trial
* Willing to use acceptable forms of contraception for the duration of the study
Exclusion Criteria:
* Clinically significant neurologic, heart, lung, liver, rheumatologic, autoimmune, or kidney disease
* Behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may affect study participation
* Previously enrolled in an H7N3 influenza vaccine trial or in any study of an avian influenza vaccine
* Seropositive to the H7N3 influenza A virus (serum hemagglutination inhibition \[HI\] titer greater than 1:8)
* Illegal drug use or dependency determined by urine test
* Medical, work, or family problems as a result of alcohol or illicit drug use within 12 months prior to study entry
* History of severe allergic reaction
* Allergy to oseltamivir
* Asthma or reactive airways disease within 2 years prior to study entry
* History of Guillain-Barre syndrome
* HIV infected
* Hepatitis C virus infected
* Positive for hepatitis B surface antigen (HBsAg)
* Known immunodeficiency syndrome
* Use of corticosteroids or immunosuppressive drugs within 30 days prior to vaccination. Participants who have used topical corticosteroids are not excluded.
* Live vaccines within 4 weeks prior to study vaccination
* Killed vaccines within 2 weeks prior to study vaccination
* Absence of spleen
* Blood products within 6 months prior to study vaccination
* Current smoker unwilling to stop smoking for the duration of the study
* Have traveled to the Southern Hemisphere, Asia, or the United Kingdom within 14 days prior to study vaccination
* Have traveled on a cruise ship within 14 days prior to study vaccination
* Work in the poultry industry
* Other investigational vaccine or drug within 30 days prior to study vaccination
* Allergy to eggs or egg products
* Purified protein derivative (PPD) positive (positive tuberculosis \[TB\] test)
* Have family member with immunodeficiency
* Other condition that, in the opinion of the investigator, may interfere with the study
* Pregnancy or breastfeeding
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
49 Years
Study:
NCT00516035
Study Brief:
Protocol Section:
NCT00516035