KATHMANDU, Sept 28: Sanofi and GSK have received approval for their Phase 3 clinical study in Nepal to assess the safety, efficacy and immunogenicity of their adjuvant recombinant-protein COVID-19 vaccine candidate.
The International Vaccine Institute (IVI), an international organization, will conduct the Phase 3 clinical trial in Nepal, expecting to enroll 4,000 volunteers across three study sites in the country.
Enrollment for efficacy trial of COVID-19 vaccine begins
According to a statement issued by Sanofi, the primary endpoint of the study is the prevention of symptomatic COVID-19 in SARS-CoV-2 naïve adults, with secondary endpoints being the prevention of severe COVID-19 disease and prevention of asymptomatic infection.
The statement also states that as part of the study design, all participants including the control group will be offered the study vaccine as soon as it is determined to be safe and effective.
