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:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-25 @ 3:24 AM
NCT ID:
NCT00584805
Eligibility Criteria:
Inclusion Criteria:
* At least 18 years old.
* EEE PRNT80 ≤ 1:20.
* EEE PRNT80 ≤ 1:40 for booster series
* (females) Negative pregnancy test on the same day before vaccination.
* Not planning pregnancy for 3 months.
* At risk for exposure to virulent EEE virus (with up-to-date risk assessment).
* Up-to-date (within 1 year) physical examination/tests.
* Sign and date the approved informed consent.
* Willing to return for all follow-up visits.
* Agree to report adverse events (AE) up to 28 days after each vaccination.
Exclusion Criteria:
* Over 65 years of age (for Primary Immunization).
* Clinically significant abnormal lab results including evidence of Hepatitis C, Hepatitis B carrier state, or elevated (2X normal) liver function tests.
* History of immunodeficiency or current treatment with immunosuppressive medication.
* (females) Currently breastfeeding.
* Confirmed human immunodeficiency virus (HIV) titer.
* Any known allergies to components of the vaccine.
* A medical condition that, in the judgment of the Principal Investigator (PI), would impact subject safety (i.e.-vaccination or exposure to another Alphavirus).
* Administration of any IND product or live vaccine within 28 days of EEE.
* Any unresolved AEs resulting from a previous immunization.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00584805
Study Brief:
Protocol Section:
NCT00584805