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Interim Clinical Study Report
Protocol C4591001
CONFIDENTIAL
Template date: 01- July-2020
Page 116.1.5.1 S PONSOR AGENT
CLINICAL STUDY REPORT APPR OVAL FORM
PROTOCOL NUMBER: C4591001
REPORT TITLE : Interim Report –6 Month Update: A Phase 1/2/3,
Placebo-Controlled, Randomized, Observer -Blind,
Dose -Finding Study to Evaluate the Safety , Tolerabil ity,
Immunogenicity , and Efficacy of SARS -COV -2 RNA Vaccine
Candidates Against COVI D-19 in Healthy Individuals
AUTHOR: Dzung Nguy en
I have reviewed this clinical study report , which is fro m its definitive source and final in
content . I confirm that it is a complete and accurate representation of the relevant data and
statistical analy sesforthis report.
Know n deviations in the study did not impact overall compliance with Good Clinical Practice
and local regulations .
STATISTICS LINE HEAD: Kenn eth Koury, PhD
CLINICAL LEAD: John L. Pere z, MD, MBA, MA
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Document Approval Record
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