A Study of MG1111 in Healthy Children

A Phase II/III, Single-blind(Stage 1), Double-blinded(Stage 2), Randomized, Active-controlled, Dose-escalation(Stage 1), Non-inferiority(Stage 2) Study to Evaluate Immunogenicity and Safety of MG1111 in Healthy Children

To assess the safety of MG1111 and to evaluate immunological non-inferiority of MG1111 versus comparator

Study Overview

• Status: Completed
• Conditions: Healthy Children
• Intervention / Treatment: Drug: Varicella Vaccine

• Study Type: Interventional
• Enrollment (Actual): 814
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul
    • Banpo-dong, Seoul, Korea, Republic of
      • The Catholic University of Korea, Seoul St. Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 12 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: MG1111(Varicella vaccine); A single injection of 0.5ml MG1111 will be administered subcutaneously at Visit 1	Drug: Varicella Vaccine; The subject will receive investigational product or comparator.; Other Names: vaccination
ACTIVE_COMPARATOR: Comparator(Varicella vaccine); A single injection of 0.5ml comparator will be administered subcutaneously at Visit 1	Drug: Varicella Vaccine; The subject will receive investigational product or comparator.; Other Names: vaccination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects who achieved seroconversion	42 days after vaccination

Secondary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Green Cross Corporation

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 26, 2016
• Primary Completion (ACTUAL): January 29, 2019
• Study Completion (ACTUAL): July 31, 2019

Study Registration Dates

• First Submitted: November 28, 2017
• First Submitted That Met QC Criteria: December 14, 2017
• First Posted (ACTUAL): December 18, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 14, 2021
• Last Update Submitted That Met QC Criteria: May 13, 2021
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: MG1111_P2/3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO