Document text
CLINICAL STUDY REPOR T ERRATA
Protocol Nu mber: C4591001
CONFIDENTIAL
Page 1Study Report Title: Interim Report –6 Month Update: A Phase 1/2/3,
Placebo- Controlled, Randomized, Observer -Blind,
Dose -Finding Study to Evaluate the Safety ,
Tolerability , Immunogenicity , and Efficacy of
SARS -COV -2 RNA Vaccine Candidates Against
COVID -19 in Healthy Individuals
Minor errors were identified in the Clinical Study Report. Those errors are listed below.
Although these errors do not affect the conclusions of th e study , they have been included in
this Errata to ensure the accuracy of the report.
Section Description of Error
Sections 10.1.2, 12.2.3, 12.2.4, and
14
Section 16.2.7 Narratives (contain
corrected information)
Appendix 16.2.7.4.1 L isting of
Adverse Events –All Subjects
≥16Years of Age
Appendix 16.2.7.5 L isting of
Serious Adverse Events – All
Subjects ≥16 Years of Agea
Appendix 16.2.7.6 Listing of
Adverse Events Leading to
Discontinuation – All Subjects
≥16Years of AgeAfter the data cutoff date of 13 Mar 2021 (with
database snapshot taken on 25 Mar 2021), it was
determined that :
Participant sC4591001 1044 10441163 and
C4591001 1090 10901140 did not withdraw from
the study because of the injection site pain and
remain in the study
Participant sC4591001 1090 10901492 and
C4591001 1091 10911297 d id not withdraw from
the study because of the fatigue and remain in the
study
Participant C4591001 1091 10911247 did not
withdraw from the stud y because of the dermatitis
and remains in the stud y
Participant C4591001 1092 10921021 did not
withdraw from the study because of the pain and
remains in the study
Participant C4591001 1254 12541006 did not
withdraw from the stud y because of the chills and
remains in the study
Participant C4591001 1254 12541189 did not
withdraw from the stud y because of the headache
and remains in the stud y
Participant C4591001 1096 10961036 did not
discontinue from the study intervention because of
the suicidal depression but discontinued from the
study because she no longer met the eligibility
criteria
090177e196e70672\Approved\Approved On: 29-Apr-2021 15:44 (GMT)
FDA-CBER-2021-5683-0220378
CLINICAL STUDY REPOR T ERRATA
Protocol Nu mber: C4591001
CONFIDENTIAL
Page 2Participant C4591001 1232 12321299 was not
withdrawn from the study for safety reasons
(hypertension) but was lost to follow -up
Participant C4591001 1037 10371141 was not
pregnant and remains in the study
a.Participant C4591001 1096 10961036 only.
090177e196e70672\Approved\Approved On: 29-Apr-2021 15:44 (GMT)
FDA-CBER-2021-5683-0220379