NCT03375502CompletedPhase 2
A Phase II/III, Single-blind(Stage 1), Double-blinded(Stage 2), Randomized, Active-controlled, Dose-escalation(Stage 1), Non-inferiority(Stage 2) Study to Evaluate Immunogenicity and Safety of MG1111 in Healthy Children
Green Cross Corporation1 site in 1 country814 target enrollmentStarted: November 26, 2016Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Green Cross Corporation
- Enrollment
- 814
- Locations
- 1
- Primary Endpoint
- Proportion of subjects who achieved seroconversion
Study Overview
Brief Summary
To assess the safety of MG1111 and to evaluate immunological non-inferiority of MG1111 versus comparator
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 12 Months to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
MG1111(Varicella vaccine)
Experimental
A single injection of 0.5ml MG1111 will be administered subcutaneously at Visit 1
Intervention: Varicella Vaccine (Drug)
Comparator(Varicella vaccine)
Active Comparator
A single injection of 0.5ml comparator will be administered subcutaneously at Visit 1
Intervention: Varicella Vaccine (Drug)
Outcomes
Primary Outcomes
Proportion of subjects who achieved seroconversion
Time Frame: 42 days after vaccination
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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