A Double-blind, Randomized, Multi-Center, Active Controlled Phase 2 Clinical Trial to Evaluate the Safety and Immunogenicity After MG1111(BARICELA Inj.) as 2nd Vaccination in 4 ~ 6 Year Old Healthy Children With a History of 1st Varicella Vaccination
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
* Primary objective is to assess the safety of MG1111 until Day 42 using as 2nd vaccination * Secondary objective to assess the immunogenicity and safety of MG1111 using as 2nd vaccination
Eligibility
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 6
Healthy Volunteers: t
View:
• Healthy children between 4 and 6 years of age as of the date of written consent
• Subjects who have a history of 1st Varicella vaccination at least 3 years ago from the administration of investigational product
• Subjects or parent/legal representative willing to provide written informed consent and able to comply with the study requirements
• Negative history of Varicella infection
Locations
Other Locations
Republic of Korea
Korea University Ansan Hospital
RECRUITING
Ansan
Contact Information
Primary
Hye Won Shin
hwshin27@gccorp.com
+82-31-260-9032
Time Frame
Start Date: 2022-07-05
Estimated Completion Date: 2027-06
Participants
Target number of participants: 230
Treatments
Experimental: MG1111(BARICELA) arm
0.5ml, single dose, subcutaneous injection
Active_comparator: VARIVAX arm
0.5ml, single dose, subcutaneous injection
Active_comparator: Suduvax arm
0.5ml, single dose, subcutaneous injection
Related Therapeutic Areas
Sponsors
Leads: Green Cross Corporation