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Phase III Double-blind, Placebo-controlled Study of AZD1222 for the Prevention of COVID-19 in Adults

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. Identifier: NCT04516746
Recruitment Status : Active, not recruiting
First Posted : August 18, 2020
Last Update Posted : December 1, 2021
Iqvia Pty Ltd
Information provided by (Responsible Party):

No Study Results Posted on for this Study
Recruitment Status : Active, not recruiting
Actual Primary Completion Date : March 5, 2021
Estimated Study Completion Date : February 14, 2023
CDC. (Centers for Disease Control and Prevention). Coronavirus Disease 2019 (COVID-19), Symptoms of Coronavrus. symptoms.html. Published 2020. Accessed 01 July 2020.
FDA. (Food and Drug Administration). Guidance for Industry. Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials. . Published 2007. Accessed 20 June 2020.
SPEAC. (Safety Platform for Emergency Vaccines) D2.3 Priority list of adverse events of special interest: COVID-19. Work Package: WP2 Standards and Tools. v1.1. 05 March 2020. Published 2020. Accessed 14 June 2020.
WHO. (World Health Organization) Coronavirus disease (COVID-19) situation report-175. 13 July 2020. covid-19-sitrep-175.pdf?sfvrsn=d6acef25_2. Published 2020. Accessed 13 July 2020.
Clinical Study Protocol - 1.0 AstraZeneca AZD1222 - D8110C00001 CONFIDENTIAL AND PROPRIETARY 92 of 92
Zhu N, Zhang D, Wang W, Li X, Yang B, Song J et al. A Novel Coronavirus from Patients with Pneumonia in China, 2019. New England Journal of Medicine. 2020;382(8):727-33. Zou G. A modified poisson regression approach to prospective studies with binary data. Am J Epidemiol. 2004;159(7):702-6.

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