Healthy Children
Conditions
Brief summary
To assess the safety of MG1111 and to evaluate immunological non-inferiority of MG1111 versus comparator
Interventions
The subject will receive investigational product or comparator.
Sponsors
Green Cross Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Months to 12 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects who achieved seroconversion | 42 days after vaccination |
Secondary
| Measure | Time frame |
|---|---|
| Geometric mean titer(GMT) measured by the FAMA assay | At day 0 and Day 42 post-vaccination |
| Geometric mean titer(GMT) measured by gpELISA | At day 0 and Day 42 post-vaccination |
Other
| Measure | Time frame |
|---|---|
| Incidence of Local/systemic solicited AEs [Safety] | during the first 7 days after administration of IP |
| Incidence of Unsolicited AEs [Safety] | Until Day 42 after administration of IP |
| Incidence of Serious adverse events [Safety] | Until 6 months after administration of IP |
Countries
South Korea
Outcome results
None listed