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 @ 12:32 PM
Ignite Modification Date:
2025-12-24 @ 12:32 PM
NCT ID:
NCT03356561
Eligibility Criteria:
Inclusion Criteria:
* Participant must be healthy, without significant medical illness, on the basis of physical examination, medical history, and vital signs performed at screening
* Participant must be healthy on the basis of clinical laboratory tests performed at screening. If the results of the laboratory screening tests are outside the laboratory normal reference ranges, and additionally within the limits representing Food and Drug Administration (FDA) toxicity Grade 1, the participant may be considered eligible only if the investigator judges the abnormalities or deviations from normal to be not clinically significant and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
* Participant must agree not to donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after the last study vaccine administration
* Participant must be willing to provide verifiable identification
* All female participants of childbearing potential must have:
1. a negative serum beta human chorionic gonadotropin (beta-hCG) pregnancy test at screening
2. a negative urine (beta-hCG) pregnancy test immediately prior to each study vaccine administration
Exclusion Criteria:
* Participant has a known history of flavivirus infection or previous receipt of flavivirus vaccine such as dengue virus (DENV) types 1-4, yellow fever virus (YFV), Japanese encephalitis virus (JEV), and West Nile virus (WNV)
* Participant has traveled to an area with active flavivirus transmission (as per Centers for Disease Control and Prevention \[CDC\]'s 'Zika travel notices') or Zika cautionary areas ('Yellow and Red areas') within 4 weeks before screening
* Participant has chronic active hepatitis B or hepatitis C virus infection, verified at screening by hepatitis B surface antigen (HBsAg) or hepatitis C antibody, respectively
* Participant has human immunodeficiency virus (HIV) type 1 or type 2 infection
* Participant received or plans to receive licensed live-attenuated vaccines within 28 days before or after each planned study vaccine administration; licensed inactivated, subunit, or conjugate vaccines within 14 days before or after each planned study vaccine administration
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT03356561
Study Brief:
Protocol Section:
NCT03356561