Clinical Research Directory

Phase 2/3 Clinical Trial to Evaluate the Immunogenicity and Safety of GC3114B in Adults Aged 65 Years or Older

Sponsor: GC Biopharma Corp

Summary

This is a multicenter, randomized, double-blind, active-controlled, parallel-group clinical trial in adults aged 65 years or older. The study will evaluate the safety of GC3114B and assess whether its immune response is non-inferior to that of the active control. After providing written informed consent, participants will undergo screening to determine whether they are eligible. Eligible participants will be randomly assigned to a study group and receive a single dose of the investigational product on Day 0. Participants will record solicited adverse events in a subject diary from Day 0 through Day 7. The study site will contact participants by telephone on Day 7 to check on adverse events, concomitant medications, and diary completion. On Day 28, participants will visit the study site for safety follow-up and blood sampling. Participants will be monitored for serious adverse events for 6 months.

Official title: A Multi-center, Randomized, Double-blind, Active-controlled, Parallel-group, Phase 2/3 Clinical Trial to Evaluate the Immunogenicity and Safety of GC3114B in Adults Aged 65 Years or Older

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