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 @ 9:26 PM
Ignite Modification Date:
2025-12-24 @ 9:26 PM
NCT ID:
NCT00314132
Eligibility Criteria:
Inclusion Criteria:
* Informed consent obtained from the subject.
* Aged 18 years or above at screening.
* In good general health
* Subject available for the study duration
* For female subjects (of child bearing potential) a negative pregnancy tests at Screening and Day 0.
Exclusion Criteria:
* A history of vaccination against or infection with JE.
* Known or suspected immunodeficiency, use of immunosuppressive or antineoplastic drugs.
* History of thymoma, thymic surgery (removal) or myasthenia gravis.
* Clinically significant abnormalities on laboratory assessment
* Anaphylaxis or other serious adverse reactions characterised by urticaria or angioedema to foods, Hymenoptera (bee family) stings, or drugs including vaccines).
* Transfusion of blood or treatment with any blood product, including intramuscular or intravenous serum globulin within six months of the Screening Visit or up to Day 30.
* Administration of another vaccine or antiviral within 30 days preceding the Screening visit or up to Day 30.
* Physical examination indicating any clinically significant medical condition.
* Oral temperature \>38°C (100.4°F) or acute illness within 3 days prior to inoculation.
* Intention to travel out of the area for an extended period that may affect the subjects ability to attend clinic visits prior to the study visit up to Day 30.
* Seropositive to hepatitis C virus (HCV) or HIV or positive for Hepatitis B Surface Antigen.
* Lactation or intended pregnancy in female subjects.
* Excessive alcohol consumption, drug abuse, significant psychiatric illness.
* A known or suspected physiological or structural condition that compromises the integrity of the blood-brain barrier (e.g. cerebrovascular disease, multiple sclerosis, trauma, infection, inflammation of the brain or meninges).
* Participation in another clinical study within 30 days of the screening visit for this study.
* Employee of the study site, Sponsor or Clinical Research Organization (CRO) involved with the management of the study.
* Any other reasons, which in the investigator's opinion, makes the subject unsuitable to participate in the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00314132
Study Brief:
Protocol Section:
NCT00314132