GC Green Cross has received approval for its Phase 3 clinical trial plan for the varicella vaccine, Varicella, which involves two doses. As the two-dose vaccination system gains traction in the global market, the company aims to enhance its competitiveness through multinational clinical trials.
On July 2, GC Green Cross announced that it has obtained approval from the Ministry of Food and Drug Safety for its Investigational New Drug (IND) application for the two-dose Phase 3 clinical trial of Varicella.
The trial will include 474 healthy children aged between 12 months and 12 years, adding South Korea to the ongoing global trials in Thailand and Vietnam. The study is designed to directly compare the immunogenicity and safety of Varicella with Merck's Varivax vaccine.
Currently, the chickenpox vaccination market is shifting towards a two-dose system to reduce breakthrough infections that can occur after a single dose. Two-dose vaccinations are being implemented in 28 countries, including the United States, Canada, and Japan, and the World Health Organization (WHO) also recommends two doses.
Varicella is a chickenpox vaccine developed by GC Green Cross based on the MAV/06 strain, which was created in 1993. It was listed in the WHO Position Paper last year, establishing its reliability on par with Oka-based chickenpox vaccines.
GC Green Cross plans to obtain approval for the two-dose product by 2028, focusing on major Southeast Asian countries, following the completion of the multinational clinical trials.
Lee Jae-woo, head of the development division at GC Green Cross, stated, "The Phase 3 clinical trial for Varicella is a significant opportunity to enhance the value of our vaccine portfolio. We will work to expand its use in global public procurement and private vaccine markets."
Additionally, the company received WHO Good Manufacturing Practice (GMP) certification for its flu vaccine, GC Flu, and Varicella through a document review without an on-site inspection, following its application in September of last year.
* This article has been translated by AI.
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