Ignite Creation Date:
2024-05-06 @ 5:45 PM
Last Modification Date:
2024-10-26 @ 2:35 PM
Study NCT ID:
NCT05422508
Status:
RECRUITING
Last Update Posted:
2024-01-24
First Post:
2022-05-24
Brief Title:
Evaluate the Safety and Immunogenicity After MG1111BARICELA Inj as 2nd Vaccination in 4 6 Year Old Healthy Children With a History of 1st Varicella Vaccination
Sponsor:
Green Cross Corporation
Organization:
GC Biopharma Corp
Study Overview
Official Title:
A Double-blind Randomized Multi-Center Active Controlled Phase 2 Clinical Trial to Evaluate the Safety and Immunogenicity After MG1111BARICELA Inj as 2nd Vaccination in 4 6 Year Old Healthy Children With a History of 1st Varicella Vaccination
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Secondary objective to assess the immunogenicity and safety of MG1111 using as 2nd vaccination
Detailed Description:
1 Safety
Incidence of fever temperature 390 within 42 days after the IP administration
Incidence of fever temperature 390 within 7 days after the IP administration
Solicited localsystemic AEs occurred within 7 days after the IP administration
Unsolicited adverse events that occurred within 42 days after the IP administration
Serious adverse events that occurred within 1 year after the IP administration
Vital signs and physical examinations
2 Efficacy Immunogenicity
-GMTGeometric Mean Titer and GMRGeometric Mean Ratiofold changemeasured by the glycoprotein enzyme-linked immunosorbent assay gpELISA at before and 42 days after the IP administration
3 Exploratory assessment
GMV and GMR of VZV-CMI response measured by INF-r ELISPOT at before and 42 days after the IP administration
GMT and GMR of the antibody titer measured by gpELISA at before and after the IP administration for 3 years
Varicella-like rash and Varicella-zoster virus genotyping analysis occurred after IP administration for 3 years
Incidence of fever temperature 390 within 42 days after the IP administration
Incidence of fever temperature 390 within 7 days after the IP administration
Solicited localsystemic AEs occurred within 7 days after the IP administration
Unsolicited adverse events that occurred within 42 days after the IP administration
Serious adverse events that occurred within 1 year after the IP administration
Vital signs and physical examinations
2 Efficacy Immunogenicity
-GMTGeometric Mean Titer and GMRGeometric Mean Ratiofold changemeasured by the glycoprotein enzyme-linked immunosorbent assay gpELISA at before and 42 days after the IP administration
3 Exploratory assessment
GMV and GMR of VZV-CMI response measured by INF-r ELISPOT at before and 42 days after the IP administration
GMT and GMR of the antibody titer measured by gpELISA at before and after the IP administration for 3 years
Varicella-like rash and Varicella-zoster virus genotyping analysis occurred after IP administration for 3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None