GC Green Cross Submits Phase 3 IND for Two-Dose Varicellavax Clinical Trial in Vietnam

Expected Entry into the Two-Dose Chickenpox Vaccine Market Starting in 2028

GC Green Cross announced on November 14 that it has submitted a phase 3 clinical trial protocol (IND) for the two-dose regimen of its chickenpox vaccine, Varicellavax, to the Vietnam Ministry of Health.

The company explained that it plans to complete both the clinical trial approved in Thailand in October and the new trial in Vietnam by 2027, with the goal of entering the two-dose chickenpox vaccine market in earnest starting in 2028.

Exterior view of GC Green Cross headquarters in Yongin, Gyeonggi Province. GC Green Cross

This Southeast Asian clinical trial will be conducted as a head-to-head comparison with Varivax, the chickenpox vaccine developed by Merck (MSD) in the United States. GC Green Cross expects this will objectively demonstrate the competitiveness of the two-dose regimen of Varicellavax.

Varicellavax is a live attenuated vaccine independently developed by GC Green Cross, based on the MAV/06 strain. Notably, it is the world's first chickenpox vaccine produced without the use of antibiotics during manufacturing, which enhances safety at the time of administration.

Lee Jaewoo, Head of R&D at GC Green Cross, stated, "Varicellavax, a domestically developed chickenpox vaccine, has already proven its high safety and efficacy. We will continue to expand our global vaccine business based on the results of clinical trials in Southeast Asia."

Meanwhile, in May of this year, GC Green Cross obtained marketing authorization in Vietnam for the single-dose regimen of Varicellavax. The company expects that its previous clinical trial experience and regulatory expertise in Vietnam will provide a positive foundation for advancing the two-dose clinical trial.

This content was produced with the assistance of AI translation services.