GC Green Cross Submits IND for Phase 3 Clinical Trial of Two-Dose Varicellazoo in Thailand

Additional Phase 3 Clinical Trial IND Submission Planned in Vietnam This Year

GC Green Cross announced on August 27 that it has submitted a Phase 3 clinical trial protocol (IND) for the two-dose regimen of its chickenpox vaccine, Bacillus Calmette-Gu?rin, to the Thai Food and Drug Administration. This marks the first time a Korean pharmaceutical company has entered a Phase 3 clinical trial for a two-dose chickenpox vaccine.

Barycellage. GC Green Cross

This clinical trial will be conducted on 474 healthy children aged between 12 months and 12 years. A direct comparative study will be carried out against Varivax, the chickenpox vaccine developed by Merck (MSD), a global leader in the chickenpox vaccine market, which is expected to objectively demonstrate the product’s competitiveness.

Globally, a two-dose regimen is the standard for chickenpox vaccination. In 28 countries worldwide, including advanced nations such as the United States, Canada, Japan, and several European countries, two doses are recommended to prevent breakthrough infections after the first dose.

GC Green Cross plans to complete this Phase 3 trial by the second half of 2027. The company explained that, upon completion of the trial, it will pursue two-dose product approvals, focusing on Southeast Asian countries.

Lee Jaewoo, Head of Development at GC Green Cross, stated, "This clinical trial is an important milestone in establishing the basis for the two-dose regimen of Bacillus Calmette-Gu?rin. We will achieve global vaccine competitiveness that meets the standards of advanced markets."

Meanwhile, GC Green Cross also plans to submit a Phase 3 clinical trial IND for the two-dose regimen of Bacillus Calmette-Gu?rin in Vietnam within this year.

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