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 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
NCT ID:
NCT01396512
Eligibility Criteria:
Inclusion Criteria:
* Aged 12 to 24 months on the day of inclusion
* In good general health, without significant medical history.
* Provision of informed consent form signed by at least one parent or other legally acceptable representative.
* Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures.
Exclusion Criteria:
* Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination.
* Planned participation in another clinical trial during the present trial period.
* Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.
* Known systemic hypersensitivity to any of IMOJEV™ components or history of a life-threatening reaction to a vaccine containing any of the same substances and vaccination,known systemic hypersensitivity to CD.JEVAX® main components and the other components (including Gelatin, kanamycin, and gentamicin).
* Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
* Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of the immune response.
* Previous vaccination against flavivirus disease, including Japanese encephalitis (JE).
* Administration of any anti-viral within 2 months preceding Visit 01 and up to the 4 weeks following the trial vaccination.
* Receipt of any vaccine in the 4 weeks preceding the first trial vaccination, except for pandemic influenza vaccination, which may be received at least two weeks before the study vaccines.
* Planned receipt of any vaccine from the inclusion up to the 4 weeks following the trial vaccination.
* History of central nervous system disorder or disease, including seizures.
* Planned receipt of any JE vaccine during the course of the study.
* History of flavivirus infection (confirmed either clinically, serologically or virologically).
* Administration of systemic corticosteroids for more than two consecutive weeks within the 4 weeks preceding vaccination.
* Febrile illness (temperature ≥38.0°C) or moderate or severe acute illness/infection 3 days before vaccination as well as the day of vaccination, according to Investigator judgment.
* Thrombocytopenia or bleeding disorder contraindicated for vaccination with same administration route, or receipt of anticoagulants in the 3 weeks preceding inclusion.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Months
Maximum Age:
24 Months
Study:
NCT01396512
Study Brief:
Protocol Section:
NCT01396512