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:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 12:27 AM
NCT ID:
NCT01981967
Eligibility Criteria:
Inclusion Criteria:
* Children requiring vaccination against Japanese encephalitis
* Children aged 9 months to less than 5 years on the day of inclusion
* In good general health at the time of inclusion
* Informed consent form has been signed and dated by the parent(s)/legal guardian(s)
* Subject and parent(s)/legal guardian(s) are able to attend the scheduled visit and any additional visits that may need to be done in case of an SAE (including AESI), and are able to comply with all trial procedures
* The subject's parent(s)/legal guardian(s) have a telephone number at which they can be contacted throughout the study
Exclusion Criteria:
* Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the vaccination
* Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned receipt of any vaccine in the 4 weeks following the study vaccination
* Planned participation in another clinical trial during the present trial period
* Children previously vaccinated with the live attenuated Japanese encephalitis vaccine CD-JEVAX® (SA14-14-2 LAV)
* Contraindications to vaccination according to the IMOJEV® Summary of Product Characteristics (SmPC)
* Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
* Children who received IMOJEV® as primary vaccination in this study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
9 Months
Maximum Age:
4 Years
Study:
NCT01981967
Study Brief:
Protocol Section:
NCT01981967