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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

NCT05422508 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2024-01-24

No results posted yet for this study

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

Conditions

  • Varicella

Interventions

BIOLOGICAL

MG1111 (BARICELA)

0.5ml, single dose, subcutaneous injection

BIOLOGICAL

VARIVAX

0.5ml, single dose, subcutaneous injection

BIOLOGICAL

Suduvax

0.5ml, single dose, subcutaneous injection

Sponsors & Collaborators

  • Green Cross Corporation

    lead INDUSTRY

Principal Investigators

  • Yun-kyung Kim, M.D., Ph.D · Korea University Ansan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-05
Primary Completion
2025-06-30
Completion
2027-06-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05422508 on ClinicalTrials.gov