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A Controlled Phase 2/3 Study of Adjuvanted Recombinant SARS-CoV-2 Trimeric S-protein Vaccine (SCB-2019) for the Prevention of COVID-19 (SCB-2019)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04672395
Recruitment Status : Active, not recruiting
First Posted : December 17, 2020
Last Update Posted : August 29, 2022
Sponsor:
Collaborators:
Coalition for Epidemic Preparedness Innovations
International Vaccine Institute
Information provided by (Responsible Party):
Clover Biopharmaceuticals AUS Pty Ltd

No Study Results Posted on ClinicalTrials.gov for this Study
Recruitment Status : Active, not recruiting
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : April 2023
Publications:
Food and Drug Administration letter. Device: BinaxNOW COVID-19 Ag Card. 26 August 2020. https://www.fda.gov/media/141567/download. Accessed on 15 September 2020.
Food and Drug Administration Guidance Document: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Available at https://www.fda.gov/media/73679/download. Accessed on 15 September 2020.
Safety Platform for Emergency vACcines (SPEAC). D2.3 Priority List of Adverse Events of Special Interest: COVID-19. V1.1 Date 05 March 2020. https://media.tghn.org/articles/COVID-19_AESIs_SPEAC_V1.1_5Mar2020.pdf. Accessed on 15 September 2020.
Chan ISF, Bohidar NR (1998) Exact power and sample size for vaccine efficacy studies, Communications in Statistics - Theory and Methods 1998;27(6):1305-22.
Maurer W, Bretz F. Multiple testing in group sequential trials using graphical approaches. Stat Biopharm Res 2013;5(4):311-20.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):