[Hinews] SEOUL, South Korea — GC Green Cross, a major South Korean pharmaceutical firm, announced on August 27 that it had filed a Phase 3 clinical trial application with Thailand’s Food and Drug Administration for its varicella vaccine, Varicella-Z. This is the first time a South Korean drugmaker has progressed 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 directly compare Varicella-Z with Merck & Co.’s Varivax, a widely used 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 courtesy of GC Green Cross)
One vial of Varicella-Z (Photo courtesy of GC Green Cross)


The two-dose varicella vaccination schedule is now the global standard, recommended in over 28 countries—including the United States, Canada, and Japan—to prevent breakthrough infections, where vaccinated individuals still contract the disease. GC Green Cross aims to complete the trial by late 2027 and pursue regulatory approval across Southeast Asia, starting with Thailand. The company also plans to file a similar Phase 3 trial application in Vietnam before year’s end.

“This clinical trial marks a critical step in building the scientific basis for Varicella-Z’s two-dose regimen,” 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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