Status:
COMPLETED
A Study of MG1111 in Healthy Children
Lead Sponsor:
Green Cross Corporation
Conditions:
Healthy Children
Eligibility:
All Genders
12-12 years
Phase:
PHASE2
PHASE3
Brief Summary
To assess the safety of MG1111 and to evaluate immunological non-inferiority of MG1111 versus comparator
Eligibility Criteria
Inclusion
- Healthy children aged 12 months to 12 years.
- Subjects or parent/legal representative willing to provide written informed consent and able to comply with the requirements for the study - Subject able to attend all scheduled visits and to comply with all study procedures
- Negative history of Varicella and varicella vaccine
- Subject in good health, based on medical history and physical examination
Exclusion
- Subjects who have a history of Varicella or administration of varicella vaccine
- Subjects who have ahd an acute febrile episode at some time during the 72 hours before administration of investigational product or those who had any symptom suspected to be allergy including systemic rash.
Key Trial Info
Start Date :
November 26 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2019
Estimated Enrollment :
814 Patients enrolled
Trial Details
Trial ID
NCT03375502
Start Date
November 26 2016
End Date
July 31 2019
Last Update
May 14 2021
Active Locations (1)
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1
The catholic university of Korea, Seoul st. mary's hospital
Banpo-dong, Seoul, South Korea