Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-26 @ 10:56 AM
NCT ID:
NCT05422508
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
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
Study:
NCT05422508
Study Brief:
Protocol Section:
NCT05422508