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 @ 10:56 AM
Ignite Modification Date:
2025-12-26 @ 10:56 AM
NCT ID:
NCT05422508
Eligibility Criteria:
Inclusion Criteria:
* Healthy children between 4 and 6 years of age as of the date of written consent
* Subjects who have a history of 1st Varicella vaccination at least 3 years ago from the administration of investigational product
* Subjects or parent/legal representative willing to provide written informed consent and able to comply with the study requirements
* Negative history of Varicella infection
Exclusion Criteria:
* Subjects with a history of exposure to varicella through contact with a varicella patient at home, school, or childcare facility within 4 weeks before the administration of investigational drug
* Subjects who have a history 2 times or more of varicella vaccine injections
* Subjects who had an acute febrile (at least 38.0 ℃) episode at some time during the 72 hours before the administration of investigational product
* Subjects who had any suspected allergy symptoms including systemic rash during the 72 hours before the administration of investigational product
* Subjects with a history of Guillain-Barre syndrome.
* Subjects with a severe chronic disease and considered ineligible for the study at Investigator's discretion
* Subjects with a history of hypersensitivity to any ingredient such as gelatin, antibiotics (Neomycin, Kanamycin, Erythromycin)
* Active tuberculosis patient
* Subjects who had received other vaccinations within 4 weeks before the administration of investigational product
* Subjects with immunodeficiency history
* Subjects who had received salicylates (aspirin, bismuth, subsalicylates) within 4 weeks before the administration of investigational drug
* Subjects who administered immune globulin, gamma globulin, or blood products such as whole blood within 44 weeks before the administration of investigational drug
* Subjects who had received immunosuppressant or immune modifying drug within 12 weeks before the administration of investigational drug
* A. Azathioprine, Cyclosporin, Interferon, G-CSF, Tacrolimus, Everolimus, Sirolimus, etc.
* B. Subjects who administered high dose of corticosteroids (greater than 2 mg/kg/day in case of under 10kg subjects or ≥20mg/day in case of above 10kg subject of prednisone for 14 days) (However, inhaled, intranasal, topical corticosteroids administration in allowed)
* Subjects who administered anti-viral drug within 4 weeks before the administration of investigational drug
* Subjects who have participated in any other clinical trials within 24 weeks of the administration of the investigational product
* Subjects with other clinically significant medical or psychological condition who are considered by the Investigator to be ineligible for the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
6 Years
Study:
NCT05422508
Study Brief:
Protocol Section:
NCT05422508