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 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 12:05 AM
NCT ID:
NCT01502358
Eligibility Criteria:
Inclusion Criteria:
* Male or female age 18 to 50 (inclusive) years old at the time of enrollment
* Have negative anti-dengue, Japanese encephalitis, West Nile, and yellow fever ELISA serological tests
* Be informed of the nature of the study and provide written informed consent
* If the subject is of child-producing potential, he/she agrees to practice adequate birth control or abstain from sex
* Have access to the WRAIR Clinical Trials for at least 270 days, and be willing to refrain from participation in other investigational clinical trials
* Be in good general health
Exclusion Criteria-Subjects meeting any of the following criteria will be excluded from the study:
* History of Flavivirus infection or history of Flavivirus vaccine (experimental or licensed product) including Japanese encephalitis, yellow fever, and dengue
* Have a known or suspected hypersensitivity or adverse reaction to vaccines including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain
* Have received a live-attenuated vaccine within 42 days prior to the initial injection on Day 0 or a subunit or killed vaccine within 30 days of the initial injection on Day 0
* Have a positive screen for hepatitis B surface antigen (HBsAg), hepatitis C antibody, or HIV antibody
* Are pregnant or breastfeeding
* Have donated or received blood, blood products, or plasma within 30 days prior to Day 0
* Have any acute illness, including an oral body temperature \>100.4°F, within 7 days before the initial injection on Day 0
* Have a past or current history of malignant disease except for adequately treated skin cancer
* Exclusions include but are not limited to conditions pertaining to or evidence of immunodeficiency; allergies requiring treatment with antigen injections; autoimmune disease; severe migraine headaches; unstable asthma; clinically significant cardiac arrhythmias, diabetes mellitus, thyroid disease, a bleeding disorder or a seizure disorder.
* Have participated in an investigational drug, vaccine, or device study within a period of 30 days prior to Day 0;
* History of splenectomy
* Planned travel to dengue endemic areas during the study period
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01502358
Study Brief:
Protocol Section:
NCT01502358