125742 45 S211 M5 c4591001 interim ado mth6 summary of changes
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CLINICAL STUDY REPORT AMENDMENT SUMMARY OF CHANGES Protocol Number: C4591001 CONFIDENTIAL Page 1Study Report Title: Interim Report –Adolescent 6- Month Update : A Phase 1/2/3, Placebo -Controlled, Randomized, Observer -Blind, Dose -Finding Study to Ev aluate the Safety , Tolerability , Immunogenicit y, and Efficacy of SARS -CoV- 2 RNA Vaccine Candidates Agains t COVID -19 in Healthy Individuals Clinical Study Report Date: 03December 2021 Date o f Form Completion: 10December 2021 The Clinical Study Report (CSR) was amended to make the changes noted below. Section Change CSR Title Pag eand CSR SynopsisCSR Title Page and CSR Synopsis Report Date and Previous Report Date were updated. Section 11.1.1.1.1, Table 14 The data values for the comorbidities and obese subgroups were flipped with e ach other. Table 14 was updated to correct thesevalues . Section 14, Supplemental Tables 14.12 and 14.13The data values for the comorbidities and obese subgroups were flipped with each other. Supplemental Tables 14.12 and 14.13 were updated to correct th ese values. 090177e198d7ba4a\Approved\Approved On: 13-Dec-2021 02:30 (GMT) FDA-CBER-2022-5812-0228962