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 @ 4:02 PM
Ignite Modification Date:
2025-12-26 @ 4:02 PM
NCT ID:
NCT01073306
Eligibility Criteria:
Inclusion Criteria:
* Good general health as determined by physical examination, laboratory screening, and review of medical history
* Available for the duration of the study, approximately 6 weeks post-vaccination
* Female participants of childbearing potential must be willing to use effective contraception for the duration of the trial
Exclusion Criteria:
* Currently breastfeeding or pregnant
* Exhibits evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies
* Presence of a behavioral, cognitive, or psychiatric disease that affects the ability of the participant to understand and cooperate with the requirements of the study protocol
* Has screening laboratory values of Grade 1 or above for absolute neutrophil count (ANC), alanine aminotransferase (ALT), and serum creatinine, as defined in protocol
* Presence of any condition that would jeopardize the safety or rights of the participant or would render the participant unable to comply with the protocol
* Significant alcohol or drug abuse in the past 12 months that has caused medical, occupational, or family problems, as indicated by participant history
* History of a severe allergic reaction or anaphylaxis
* Presence of severe asthma, defined as requiring emergency room visit or hospitalization within the last 6 months
* Presence of HIV infection, determined by screening and confirmatory assays
* Presence of hepatitis C virus (HCV) infection, determined by screening and confirmatory assays
* Presence of hepatitis B virus (HBV) infection, determined by hepatitis B surface antigen (HBsAg) screening
* Presence of any known immunodeficiency syndrome
* Uses anticoagulant medications
* Has used corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 42 days prior to or following vaccination. An immunosuppressive dose of corticosteroids is defined as greater than or equal to 10 mg prednisone or equivalent per day for greater than or equal to 14 days.
* Has received a live vaccine within 28 days or a killed vaccine within 14 days prior to vaccination or anticipates receipt of any vaccine during the 42 days following vaccination
* Has no spleen
* Has received blood products within the past 6 months, including transfusions or immunoglobulin, or anticipates receipt of any blood products or immunoglobulin during the 42 days following vaccination
* History or serologic evidence of previous dengue virus infection or other flavivirus infection (e.g., yellow fever virus, St. Louis encephalitis, West Nile virus)
* Has received a flavivirus vaccine (licensed or experimental)
* Anticipates receipt of any investigational agent in the 42 days before or after vaccination
* Has definite plans to travel to a dengue endemic area during the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01073306
Study Brief:
Protocol Section:
NCT01073306