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 @ 2:58 PM
Ignite Modification Date:
2025-12-24 @ 2:58 PM
NCT ID:
NCT00922259
Eligibility Criteria:
Inclusion Criteria:
* Able to provide informed consent
* General good health, without significant medical illness, physical examination findings, or significant laboratory abnormalities as determined by the investigator
* Available for the duration of the trial
* Female participants must agree to use effective birth control methods for the duration of the study. More information on this criterion can be found in the study protocol.
* Agrees to store blood specimens for future research
Exclusion Criteria:
* Pregnancy or breast-feeding
* Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies including urine testing. Clinically significant ALT levels, as determined by the Principal Investigator, will be exclusionary at baseline, prior to vaccination.
* Behavioral or cognitive impairment or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the study protocol
* Previous enrollment in an H7 influenza vaccine trial or in any study of an avian influenza vaccine
* Seropositive to the H7N7 influenza A virus (serum HI titer greater than 1:8)
* Positive urine drug toxicology test indicating narcotic use or dependency
* Have medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months
* Other condition that in the opinion of the investigator would jeopardize the safety or rights of a participant participating in the trial or would render the participant unable to comply with the protocol
* History of anaphylaxis
* Allergy to oseltamivir
* Diagnosis of asthma or reactive airway disease within the past 2 years
* History of Guillain-Barre Syndrome
* Positive ELISA and confirmatory Western blot tests for HIV-1
* Positive ELISA and confirmatory test (for example, recombinant immunoblot assay \[RIBA\]) for hepatitis C virus (HCV)
* Positive test for hepatitis B virus surface antigen (HBsAg) by ELISA.
* Known immunodeficiency syndrome
* Use of corticosteroids (excluding topical preparations) or immunosuppressive drugs within 30 days prior to vaccination
* Receipt of a live vaccine within 4 weeks or a killed vaccine within 2 weeks prior to study vaccination
* History of a surgical splenectomy
* Receipt of blood or blood-derived products (including immunoglobulin) within 6 months prior to study vaccination
* Current smoker unwilling to stop smoking for the duration of the study. More information on this criterion can be found in the study protocol.
* Travel to the Southern Hemisphere within 14 days prior to study vaccination.
* Travel on a cruise ship within 14 days prior to study vaccination
* Current involvement with the poultry industry. This refers to direct contact with poultry within the 14 days prior to the study or after the study completion.
* Receipt of another investigational vaccine or drug within 30 days prior to study vaccination
* Allergy to eggs or egg products
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
49 Years
Study:
NCT00922259
Study Brief:
Protocol Section:
NCT00922259