![]() Control (placebo or licensed vaccine) - (i.e., no SARS-CoV-2 antigen).Vaccine Candidate (volume mL contains xx amount of antigen and xx amount of adjuvant).We propose to conduct a Phase 3, individually randomized, double-blind, placebo-controlled trial in location to determine the safety and efficacy of the vaccine candidate among healthy adults > 18 years of age. Preliminary analysis from Phase 1/2 trials indicate Vaccine Candidate has an acceptable safety and immunogenicity profile. Phase 1/2 clinical trials of Vaccine Candidate, the SARS-CoV-2 vaccine candidate manufactured by Sponsor, are now being conducted in location to evaluate the vaccine candidate’s safety and immunogenicity among healthy adults (Clinical Trial Registry #). Fast-tracked vaccine development is urgently needed. There are no specific therapies or vaccines to prevent COVID-19 and the numbers of new cases and deaths continue to increase daily. ![]() The 2019 outbreak of coronavirus disease (COVID-19)-caused by a novel coronavirus, SARS-CoV-2-has now spread to more than 210 countries and territories globally. Phase 3 randomized, double-blinded, placebo-controlled trial to evaluate the safety, immunogenicity, and efficacy of against COVID-19 in adults ≥ 18 years of age Regulatory Authority (for each participating country) Review Committee / Institutional Review Boards (for each participatingĪDDITIONAL REVIEW BOARDS/ETHICS COMMITTEES TO BE ADDED Research Manager (for each participating institution) Vaccine-Associated Enhanced Respiratory DiseaseĪDDITONAL INVESTIGATORS TO BE ADDED BELOW Severe Acute Respiratory Syndrome Coronavirus 2 Real Time Reverse Transcription Polymerase Chain Reaction Medical Dictionary for Regulatory Activities Middle East Respiratory Syndrome Coronavirus Council for International Organization of Medical SciencesĬonsolidated Standards of Reporting Trials
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