GCT is pleased to conduct a multicentre, double-blind, randomized, prospective, placebo-controlled Phase IIb trial to determine the immunogenicity, efficacy and safety of a COVID-19 vaccine in healthy volunteers aged 18 years and older.
Based on the results of phase IIb, an interim data analysis will be carried out to identify the best vaccine regimen in terms of immunogenicity and safety. If the study succeeds, there will be a multinational Phase III project with more than 25 000 subjects.
The current study shows a very rapid enrollment of subjects. For instance, in just 2 weeks almost 300 healthy volunteers already passed screening visits. Active sites are top recruiters and have a proven successful record with the Sponsor in the past. GCT team is providing site management and monitoring services to ensure 100% SDV and compliance with the study protocol.
Dr. Eugene Selivra, GCT CEO, highlights the importance of this trial, «We are proud to have the opportunity to be selected as a CRO of choice for this pivotal clinical trial. Due to the extremely strict timelines, we make sure all required resources and efforts are invested in order to meet Sponsor’s goals and expectations for this important coronavirus vaccine trial.”.