A Study of MG1111 in Healthy Children
- Registration Number
- NCT03375502
- Lead Sponsor
- Green Cross Corporation
- Brief Summary
To assess the safety of MG1111 and to evaluate immunological non-inferiority of MG1111 versus comparator
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 814
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Comparator(Varicella vaccine) Varicella Vaccine A single injection of 0.5ml comparator will be administered subcutaneously at Visit 1 MG1111(Varicella vaccine) Varicella Vaccine A single injection of 0.5ml MG1111 will be administered subcutaneously at Visit 1
- Primary Outcome Measures
Name Time Method Proportion of subjects who achieved seroconversion 42 days after vaccination
- Secondary Outcome Measures
Name Time Method Geometric mean titer(GMT) measured by gpELISA At day 0 and Day 42 post-vaccination Geometric mean titer(GMT) measured by the FAMA assay At day 0 and Day 42 post-vaccination
Trial Locations
- Locations (1)
The catholic university of Korea, Seoul st. mary's hospital
🇰🇷Banpo-dong, Seoul, Korea, Republic of