Status:
RECRUITING
Evaluate the Safety and Immunogenicity After MG1111(BARICELA Inj.) as 2nd Vaccination in 4 ~ 6 Year Old Healthy Children With a History of 1st Varicella Vaccination
Lead Sponsor:
Green Cross Corporation
Conditions:
Varicella
Eligibility:
All Genders
4-6 years
Phase:
PHASE2
Brief Summary
* Primary objective is to assess the safety of MG1111 until Day 42 using as 2nd vaccination * Secondary objective to assess the immunogenicity and safety of MG1111 using as 2nd vaccination
Detailed Description
1. Safety * Incidence of fever (temperature ≥39.0℃) within 42 days after the IP administration * Incidence of fever (temperature ≥39.0℃) within 7 days after the IP administration * Solicited...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT05422508
Start Date
July 5 2022
End Date
June 1 2027
Last Update
January 24 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Korea University Ansan Hospital
Ansan, South Korea