Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2026-02-27 @ 10:33 PM
Study NCT ID:
NCT05422508
Status:
RECRUITING
Last Update Posted:
2024-01-24
First Post:
2022-05-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Green Cross Corporation
Organization:
Study Overview
Official Title:
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
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 ≥39.0℃) within 42 days after the IP administration
* Incidence of fever (temperature ≥39.0℃) within 7 days after the IP administration
* Solicited local/systemic 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)
-GMT(Geometric Mean Titer) and GMR(Geometric Mean Ratio(fold change))measured 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 ≥39.0℃) within 42 days after the IP administration
* Incidence of fever (temperature ≥39.0℃) within 7 days after the IP administration
* Solicited local/systemic 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)
-GMT(Geometric Mean Titer) and GMR(Geometric Mean Ratio(fold change))measured 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:
False
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?: