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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03375502
Other study ID # MG1111_P2/3
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date November 26, 2016
Est. completion date July 31, 2019

Study information

Verified date December 2017
Source Green Cross Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To assess the safety of MG1111 and to evaluate immunological non-inferiority of MG1111 versus comparator


Recruitment information / eligibility

Status Completed
Enrollment 814
Est. completion date July 31, 2019
Est. primary completion date January 29, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Months to 12 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Varicella Vaccine
The subject will receive investigational product or comparator.

Locations

Country Name City State
Korea, Republic of The catholic university of Korea, Seoul st. mary's hospital Banpo-dong Seoul

Sponsors (1)

Lead Sponsor Collaborator
Green Cross Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Other Incidence of Local/systemic solicited AEs [Safety] during the first 7 days after administration of IP
Other Incidence of Unsolicited AEs [Safety] Until Day 42 after administration of IP
Other Incidence of Serious adverse events [Safety] Until 6 months after administration of IP
Primary Proportion of subjects who achieved seroconversion 42 days after vaccination
Secondary Geometric mean titer(GMT) measured by the FAMA assay At day 0 and Day 42 post-vaccination
Secondary Geometric mean titer(GMT) measured by gpELISA At day 0 and Day 42 post-vaccination
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