Healthy Children Clinical Trial
Official title:
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
Verified date | December 2017 |
Source | Green Cross Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To assess the safety of MG1111 and to evaluate immunological non-inferiority of MG1111 versus comparator
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. |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | The catholic university of Korea, Seoul st. mary's hospital | Banpo-dong | Seoul |
Lead Sponsor | Collaborator |
---|---|
Green Cross Corporation |
Korea, Republic of,
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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