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090177e198d9dae1\Approved\Approved On: 13-Dec-2021 02:06 (GMT)
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FDA-CBER-2022-5812-0228959
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 –Adolescent 6- Month Update: A Phase1/2/3,
Placebo- Controlled, Randomized, O bserver -Blind,
Dose -Finding Study to Evaluate the Safety , Tolerability,
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 thatit 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 HE AD: Kenn eth Koury, PhD
CLINICAL LEAD: John L. Perez, MD, MBA, MA
090177e198d878b8\Approved\Approved On: 11-Dec-2021 18:38 (GMT)
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FDA-CBER-2022-5812-0228960
Document Approval Record
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090177e198d878b8\Approved\Approved On: 11-Dec-2021 18:38 (GMT)
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FDA-CBER-2022-5812-0228961