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 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT02532569
Eligibility Criteria:
Inclusion Criteria:
* Parent/guardian (legally authorized representative) has given voluntary written consent to the subject's participation after being fully informed of the purpose, methods, risks, and benefits of the study.
* Male and female children who have completed the primary 3 doses of JEV in the KD287-BR-CT-301study.
* Male and female children reaching at least 6 years of age on the day of booster dosing of JEV.
* Male and female children who are identified to be healthy based on physical examination and medical history.
Exclusion Criteria:
* Children who have acute febrile illness with tympanic temperature of ≥38.0 ℃ on the day of booster dosing of JEV.
* Children who have moderate or severe acute disease (regardless of fever).
* Children who have history of encephalitis, encephalopathy, cerebromeningitis, or convulsion.
* Children who have received JEV (including live JEV) other than the investigational products administered in the KD287-BR-CT-301study.
* Children who have had fever (≥ 40 °C) or systemic allergy within 48 hours after vaccination.
* Children who have shown anaphylactic reaction to the investigational products administered in the KD287-BR-CT-301study or who are likely to be allergic to the ingredients of the investigational product.
* Children who have been diagnosed with immunodeficiency such as acquired immune deficiency or who have family history of immunodeficiency.
* Children who have received other vaccines within 28 days before booster dosing of JEV (vaccines to be administered according to the national vaccination program.
* Children who have received immunosuppressive thera-py within 28 days before booster dosing of JEV.
* There is a possibility that immune globulin preparations has not been excreted enough on the day of booster dosing of JEV if children have received such a product.
* Children who are currently participating or planning to participate in other clinical stud-ies during the study period.
* Other ineligible conditions judged at the discretion of principal investigators or subinvestigators.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
7 Years
Study:
NCT02532569
Study Brief:
Protocol Section:
NCT02532569