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 @ 10:40 PM
Ignite Modification Date:
2025-12-24 @ 10:40 PM
NCT ID:
NCT00473135
Eligibility Criteria:
Inclusion Criteria:
* Good general health
* Available for the duration of the study (23 weeks for Cohort 1 and 32 weeks for Cohort 2)
* 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, cognitive, or psychiatric disease that, in the opinion of the investigator, may interfere with the study
* Significant laboratory abnormalities
* Medical, work, or family problems as a result of alcohol or illegal drug use within 12 months prior to study entry
* History of severe allergic reaction or anaphylaxis
* Severe asthma
* HIV-1 infected
* Hepatitis C virus (HCV) infected
* Hepatitis B surface antigen positive
* Known immunodeficiency syndrome
* Use of corticosteroids or immunosuppressive medications within 30 days prior to study entry. Individuals using topical or nasal corticosteroids are not excluded.
* Previous receipt of a live vaccine within 4 weeks prior to study entry
* Previous receipt of a killed vaccine within 2 weeks prior to study entry
* Absence of spleen
* Previous receipt of blood products within 6 months prior to study entry
* Previous receipt of dengue virus or other flavivirus (e.g., yellow fever virus, St.Louis encephalitis, West Nile virus) infection
* Previous receipt of yellow fever or dengue vaccine
* Plans to travel to an area where dengue infection is common
* Previous receipt of any investigational agent within 30 days prior to study entry
* Other condition that, in the opinion of the investigator, would affect participation in the study
* Pregnant or breastfeeding
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT00473135
Study Brief:
Protocol Section:
NCT00473135