[Hinews] SEOUL, South Korea — GC Green Cross, a leading South Korean pharmaceutical company, announced on August 27 that it has submitted an Investigational New Drug (IND) application to Thailand’s Food and Drug Administration for a Phase 3 clinical trial of its varicella vaccine, Varicella-Z. This marks the first time a South Korean drugmaker has advanced to a Phase 3 trial for a two-dose varicella vaccine regimen.

The trial will enroll 474 children aged 12 months to 12 years and will compare Varicella-Z directly with Merck & Co.’s Varivax, a well-established varicella vaccine. This head-to-head evaluation is designed to objectively assess the competitive strength of Varicella-Z in the global market.

One vial of Varicella-Z (Photo provided by GC Green Cross)
One vial of Varicella-Z (Photo provided by GC Green Cross)


The two-dose varicella vaccination schedule is the global standard, with more than 28 countries, including the United States, Canada, and Japan, recommending it to prevent breakthrough infections. GC Green Cross aims to complete the trial by the second half of 2027 and plans to seek regulatory approval in Southeast Asia, with a focus on Thailand. The company also intends to submit a similar IND application in Vietnam before the end of the year.

“This clinical trial represents a critical milestone in establishing the scientific foundation for the two-dose regimen of Varicella-Z,” said Jae-Woo Lee, head of GC Green Cross’s development division. “We are committed to ensuring our vaccine meets global standards of competitiveness.”

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