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 @ 12:16 PM
Ignite Modification Date:
2025-12-26 @ 12:16 PM
NCT ID:
NCT02585700
Eligibility Criteria:
Inclusion Criteria:
* Healthy male or female adult 18 through 45 years of age at the enrollment visit.
* Literate (by self-report) and willing to provide written informed consent.
* Healthy, as established by the medical history, physical examination, and screening laboratory evaluations.
* Capable and willing to complete Memory Aids and willing to return for all follow-up visits.
* For females, willing to utilize reliable birth control measures (e.g., intrauterine device, hormonal contraception, condoms) from Day 0 through the Day 21 visit.
Exclusion Criteria:
* Participation in another clinical trial involving any therapy within the previous three months or planned enrollment in such a trial during the period of this study.
* Receipt of any non-study vaccine within 4 weeks prior to enrollment or refusal to postpone receipt of such vaccines until after the Day 21 visit.
* Current or recent (within 2 weeks of vaccination) acute illness with or without fever.
* Receipt of immune globulin or other blood products within 3 months prior to study enrollment or planned receipt of such products prior to the Day 21 visit.
* Chronic administration (defined as more than 14 consecutively-prescribed days) of immunosuppressants or other immune-modulating therapy within six months prior to study vaccination. (For corticosteroids, this means prednisone or equivalent, equal or more than 0.5 mg per kg per day; topical steroids are allowed.)
* History of asthma.
* Hypersensitivity after previous administration of any vaccine.
* Suspected or known hypersensitivity to any of the study vaccine components, including chicken or egg protein.
* Acute or chronic clinically significant pulmonary, cardiovascular, hepatobiliary, metabolic, neurologic, psychiatric or renal functional abnormality, as determined by medical history, physical examination or clinical laboratory screening tests, which in the opinion of the investigator, might interfere with the study objectives.
* History of any blood or solid organ cancer.
* History of thrombocytopenic purpura or known bleeding disorder.
* History of seizures.
* Known or suspected immunosuppressed or immunodeficient condition of any kind.
* Confirmed hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
* Known HIV infection (self-report).
* Known active tuberculosis or symptoms of active tuberculosis, regardless of cause (self-report).
* History of chronic alcohol abuse and/or illegal drug use.
* Pregnancy or lactation. (A negative pregnancy test will be required before administration of study product for all women of childbearing potential.)
* History of Guillain-Barré Syndrome
* Any condition that, in the opinion of the investigator, would increase the health risk to the subject if he/she participates in the study or would interfere with the evaluation of the study objectives.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT02585700
Study Brief:
Protocol Section:
NCT02585700