125742_S1_M5_5351_c4591001-fa-interim-discontinued-patients.pdf

16.2.1.1 Listing of Subjects Withdrawn From the Study – Phase 1, 2 Doses, 21 Days Apart Vaccine Candidate

Age Group (Years)

Vaccine Group (as Randomized) Subject

Dose No.

Rel Daya

Withdrawal Date

Study Phase

Withdrawal Reason

Commentb

090177e194d7854e\Final\Final On: 07-Sep-2020 03:52 (GMT)

No subject meets the reporting criteria. a. Relative Day (Rel Day) = date of withdrawal - date of last vaccination + 1. For a withdrawal that occurred before the date of the first study vaccination, +1 was not added to compute relative day. b. MedDRA (v23.0) coding dictionary applied. PFIZER CONFIDENTIAL SDTM Creation: 28AUG2020 (16:27) Source Data: adds Table Generation: 29AUG2020 (08:38) (Cutoff Date: 24AUG2020, Snapshot Date: 28AUG2020) Output File: (CDISC)/C4591001 IA P1/adds l001 p1

FDA-CBER-2021-5683-0128990

Page 1

16.2.1.1.1 Listing of Subjects Withdrawn From the Study Before Dose 2 – Phase 1 – BNT162b1 (100 μg) Vaccine Candidate

Age Group (Years)

Vaccine Group (as Randomized) Subject

Dose No.

Rel Daya

Withdrawal Date

Study Phase

Withdrawal Reason

Commentb

090177e194fbc02f\Final\Final On: 22-Sep-2020 14:25 (GMT)

No subject meets the reporting criteria. a. Relative Day (Rel Day) = date of withdrawal - date of last vaccination + 1. For a withdrawal that occurred before the date of the first study vaccination, +1 was not added to compute relative day. b. MedDRA (v23.0) coding dictionary applied. PFIZER CONFIDENTIAL SDTM Creation: 28AUG2020 (16:27) Source Data: adds Table Generation: 19SEP2020 (10:19) (Cutoff Date: 24AUG2020, Snapshot Date: 28AUG2020) Output File: ./nda3/C4591001 IA P1 100/adds l001 100 p1

FDA-CBER-2021-5683-0128991

Page 2

16.2.1.2 Listing of Subjects Withdrawn From the Study – Phase 2 Age Group (Years)

090177e194e7a3aa\Final\Final On: 14-Sep-2020 01:45 (GMT)

18-55

Subject C4591001 1079 10791004

Dose Rel Withdrawal No. Daya Date

Withdrawal Reason

Study Phase

1

23

20AUG2020 VACCINATION ADVERSE EVENT

1

30

27AUG2020

FOLLOW-UP

ADVERSE EVENT

Commentb ADVERSE EVENT/ADENOCARCINOMA GASTRIC ADVERSE EVENT

a. Relative Day (Rel Day) = date of withdrawal - date of last vaccination + 1. For a withdrawal that occurred before the date of the first study vaccination, + 1 was not added to compute relative day. b. MedDRA (v23.0) coding dictionary applied. PFIZER CONFIDENTIAL SDTM Creation: 05SEP2020 (14:11) Source Data: adds Table Generation: 09SEP2020 (23:17) (Cutoff Date: 02SEP2020, Snapshot Date: 04SEP2020) Output File: ./nda2 unblinded/C4591001 IA P2/adds l001 withdraw p2

FDA-CBER-2021-5683-0128992

Page 3

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects Age Group (Years)

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

16-55

Subject C4591001 1001 10011125

Dose Rel Withdrawal No. Daya Date

Study Phase

Withdrawal Reason

Commentb

1

37

09SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

Withdrew consent and decided not to continue in study.

1

37

09SEP2020

WITHDRAWAL BY SUBJECT

patient withdrew consent

FOLLOW-UP

C4591001 1003 10031140

04AUG2020 FOLLOW-UP

PROTOCOL DEVIATION

Randomized in error.

C4591001 1003 10031143

04AUG2020 FOLLOW-UP

PROTOCOL DEVIATION

Randomized in error.

C4591001 1005 10051308

C4591001 1005 10051341

1

1

19OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

busy work schedule

1

1

19OCT2020

WITHDRAWAL BY SUBJECT

busy work schedule

1

2

22OCT2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

subject tested COVID positive between visits 1 and 2

WITHDRAWAL BY SUBJECT

subject decided to withdraw consent after randomized in IVRS but before given vaccine

C4591001 1005 10051381 C4591001 1007 10071179

C4591001 1007 10071407

28OCT2020

FOLLOW-UP

FOLLOW-UP

2

29 01OCT2020 VACCINATION LOST TO FOLLOW-UP phone attempt 01oct2020, 02oct2020, 05oct2020; certified letter 05oct2020

2

29 01OCT2020

FOLLOW-UP

LOST TO FOLLOW-UP

phone attempt 01oct2020, 02oct2020,05oct2020; certified letter 05oct2020

1

15 05NOV2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

Exclusion # 5; Subject has diagnosis of COVID-19 with positive PCR and symptoms

FDA-CBER-2021-5683-0128993

Page 4

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject

Dose Rel Withdrawal No. Daya Date

Study Phase

Withdrawal Reason

Commentb

C4591001 1008 10081529

1

5

29SEP2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

subject tested positive for COVID19

C4591001 1008 10081721

1

13 10NOV2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

subject tested positive for COVID 19

C4591001 1009 10091211

1

19 03NOV2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

Subject tested positive for COVID-19

C4591001 1009 10091257

1

10 05NOV2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

positive for COVID-19

C4591001 1012 10121001

1

26 28AUG2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject refused second vaccination; will continue in study for follow-up.

C4591001 1012 10121103

2

2

23SEP2020 VACCINATION MEDICATION ERROR WITHOUT ASSOCIATED ADVERSE EVENT

MEDICATION ERROR WITHOUT ASSOCIATED ADVERSE EVENT

2

2

23SEP2020

MEDICATION ERROR WITHOUT ASSOCIATED ADVERSE EVENT

MEDICATION ERROR WITHOUT ASSOCIATED ADVERSE EVENT

1

16

24SEP2020 VACCINATION

ADVERSE EVENT

ADVERSE EVENT/INJECTION SITE DERMATITIS

1

39 17OCT2020

FOLLOW-UP

ADVERSE EVENT

ADVERSE EVENT

30JUL2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

SUBJECT WITHDREW CONSENT FROM STUDY.

C4591001 1012 10121163 C4591001 1013 10131017

FOLLOW-UP

FDA-CBER-2021-5683-0128994

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16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject C4591001 1013 10131046 C4591001 1013 10131048

C4591001 1013 10131054 C4591001 1013 10131131 C4591001 1013 10131138

C4591001 1013 10131216

C4591001 1013 10131332

Dose Rel Withdrawal No. Daya Date

Study Phase

Withdrawal Reason

Commentb

2

70 27OCT2020 VACCINATION LOST TO FOLLOW-UP subject is lost to follow up. certified letter sent and emailed 10-02-2020

2

70 27OCT2020

2

28

2

FOLLOW-UP

LOST TO FOLLOW-UP

SUBJECT IS LOST TO FOLLOW UP.

17SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

New job

28

17SEP2020

WITHDRAWAL BY SUBJECT

New Job

2

7

30AUG2020 VACCINATION LOST TO FOLLOW-UP

Attempted contact

2

7

30AUG2020 FOLLOW-UP

LOST TO FOLLOW-UP

Contact attempted

2

36 07OCT2020 VACCINATION LOST TO FOLLOW-UP

Certified letter sent

2

36 07OCT2020

LOST TO FOLLOW-UP

Certified letter sent

1

23

02SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

SUBJECT WITHDREW CONSENT FROM THE STUDY

1

23

02SEP2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

SUBJECT WITHDREW CONSENT.

1

46 02OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject withdrew from study

1

46 02OCT2020

WITHDRAWAL BY SUBJECT

SUBJECT WITHDREW CONSENT DUE TO FAMILY SITUATION.

2

56 09NOV2020 VACCINATION LOST TO FOLLOW-UP

FOLLOW-UP

FOLLOW-UP

FOLLOW-UP

UNKOWN

FDA-CBER-2021-5683-0128995

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16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject

C4591001 1013 10131426 C4591001 1013 10131592

C4591001 1013 10131670†

Dose Rel Withdrawal No. Daya Date

C4591001 1015 10151030

C4591001 1015 10151134

Withdrawal Reason

Commentb

LOST TO FOLLOW-UP

UNKNOWN

2

56 09NOV2020 FOLLOW-UP

1

1

03SEP2020 VACCINATION LOST TO FOLLOW-UP

1

1

03SEP2020

2

FOLLOW-UP

subject has not returned for next visit. is now considered lost to follow up

LOST TO FOLLOW-UP

subject is lost to follow up.

31 11NOV2020 VACCINATION

WITHDRAWAL BY SUBJECT

subject withdrew consent from study.

2

31 11NOV2020 FOLLOW-UP

WITHDRAWAL BY SUBJECT

MOVED OUT OF STATE NO LONGER WANTED TO PARTICIPATE.

1

4

NO LONGER MEETS ELIGIBILITY CRITERIA

SUBJECT TESTED POSITIVE FOR COVID-19

OTHER

randomized in error, needed to wait until course of antibiotics was done.

C4591001 1013 10131740 C4591001 1013 10131746

Study Phase

11OCT2020 VACCINATION

15OCT2020

FOLLOW-UP

1

22 09NOV2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

Currently taking corticosteroids

1

22 09NOV2020 FOLLOW-UP

NO LONGER MEETS ELIGIBILITY CRITERIA

Currently taking exclusionary medication

2

64 06NOV2020 VACCINATION LOST TO FOLLOW-UP Subject lost to follow up after multiple contact attempts and reciept of certified letter

2

64 06NOV2020 FOLLOW-UP

1

72 06NOV2020 VACCINATION

LOST TO FOLLOW-UP Subject lost to follow up after multiple contact attempts and reciept of certified letter ADVERSE EVENT

ADVERSE EVENT/VERTIGO

FDA-CBER-2021-5683-0128996

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16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject C4591001 1015 10151199

Dose Rel Withdrawal No. Daya Date

Study Phase

Withdrawal Reason

Commentb

1

24 01OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject decided not to continue with study.

1

24 01OCT2020

WITHDRAWAL BY SUBJECT

Subject withdrew consent.

C4591001 1016 10161047

1

24 27AUG2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

Subject stated at visit 2, had positive COVID test

C4591001 1016 10161087

1

22 31AUG2020 VACCINATION

ADVERSE EVENT

ADVERSE EVENT/INJECTION SITE SWELLING

C4591001 1016 10161126

1

39

WITHDRAWAL BY SUBJECT

subject declined further study vaccines,subject will continue with rest of visits and procedures

C4591001 1016 10161341

1

10 31OCT2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

subject with a positive covid-19 test

C4591001 1018 10181025

1

45

16SEP2020 VACCINATION LOST TO FOLLOW-UP

Follow-up attempts made on 21-Aug, 1-Sep, and 4-Sep with no response.

1

45

16SEP2020

LOST TO FOLLOW-UP

Follow-up attempts made on 21-Aug, 1-Sep, and 4-Sep. Certified letter sent 9-Sep-2020.

1

45

16SEP2020 VACCINATION LOST TO FOLLOW-UP

Subject missed V2 and did not respond to 3 Follow-up attempts.

1

45

16SEP2020

LOST TO FOLLOW-UP

no response to multiple follow up calls and contact attempts

1

39

11SEP2020 VACCINATION LOST TO FOLLOW-UP

patient returned to home country, did not respond to outreach, certified letter sent

C4591001 1018 10181036

C4591001 1018 10181054

FOLLOW-UP

21SEP2020 VACCINATION

FOLLOW-UP

FOLLOW-UP

FDA-CBER-2021-5683-0128997

Page 8

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject

Dose Rel Withdrawal No. Daya Date

Commentb

Study Phase

Withdrawal Reason

FOLLOW-UP

LOST TO FOLLOW-UP

subject returned to home country, according to call to emergency contact

1

39

11SEP2020

1

33

14SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject did not arrive at scheduled second visit and texted no longer wants to participate in study.

1

33

14SEP2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

Subject did not arrive at scheduled second visit and texted no longer wants to participate in study.

1

41 14OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

withdraw from study due to work schedule

1

41 14OCT2020

WITHDRAWAL BY SUBJECT

withdraw from study due to work schedule

C4591001 1019 10191098

1

18

11SEP2020 VACCINATION

C4591001 1019 10191166

1

22

25SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject withdrew consent.

1

22

25SEP2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

Subject withdrew consent.

C4591001 1027 10271105

1

15

11SEP2020 VACCINATION

ADVERSE EVENT

Subject has discontinued Study Drug. Subject has agreed to continue with follow-up visits./ALLERGY TO VACCINE

C4591001 1028 10281072

1

55 20OCT2020 VACCINATION LOST TO FOLLOW-UP

1

55 20OCT2020

1

7

C4591001 1018 10181142

C4591001 1018 10181266

C4591001 1028 10281294

FOLLOW-UP

NO LONGER MEETS Pt discontinued due to positive covid test. Will f/u with pt ELIGIBILITY CRITERIA

certified letter returned unclaimed 20oct2020

FOLLOW-UP

LOST TO FOLLOW-UP

Certified letter came back unclaimed on 20Oct2020

04NOV2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

patient had positive covid test prior to V2

FDA-CBER-2021-5683-0128998

Page 9

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject C4591001 1036 10361011 C4591001 1036 10361032

Dose Rel Withdrawal No. Daya Date

Study Phase

Withdrawal Reason

Commentb

1

1

20AUG2020 VACCINATION LOST TO FOLLOW-UP

Lost to follow up

1

1

20AUG2020 FOLLOW-UP

Lost to follow up

2

48 03NOV2020 VACCINATION LOST TO FOLLOW-UP

unreachable

2

48 03NOV2020 FOLLOW-UP

LOST TO FOLLOW-UP

unreachable

31AUG2020 FOLLOW-UP

OTHER

Subject randomized in error due to prohibitive drug.

27AUG2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

SUBJECT MET EXCL CRIT # 13

C4591001 1036 10361050

LOST TO FOLLOW-UP

C4591001 1037 10371068

1

3

C4591001 1037 10371077

1

66 30OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

SPOKE WITH SUBJECT ON 30 OCT. DUE TO SCHEDULE, HE CAN NO LONGER CONTINUE WITH STUDY VISITS

1

66 30OCT2020

WITHDRAWAL BY SUBJECT

SPOKE WITH SUBJECT ON 30 OCT. DUE TO SCHEDULE, HE CAN NO LONGER ATTEND VISITS

1

44 08OCT2020 VACCINATION LOST TO FOLLOW-UP SITE ATTEMPTED CONTACT ON 22 SEP 30 SEP AND CERTIFIED LETTER SENT 8 OCT NO RESPONSE

1

44 08OCT2020

C4591001 1039 10391021

1

C4591001 1039 10391080

1

C4591001 1037 10371078

FOLLOW-UP

FOLLOW-UP

LOST TO FOLLOW-UP

CERTIFIED LETTER SENT 8 ONT. PT DID NOT RESPOND

24

17SEP2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

Patient tested positive for COVID-19.

21

23SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

Patient withdrew consent. Patient will not be participating in follow-ups.

FDA-CBER-2021-5683-0128999

Page 10

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject

C4591001 1042 10421069

C4591001 1042 10421079

C4591001 1042 10421092

C4591001 1042 10421093

C4591001 1042 10421129

C4591001 1042 10421250

Dose Rel Withdrawal No. Daya Date 23SEP2020

Study Phase

Withdrawal Reason

Commentb

1

21

FOLLOW-UP

WITHDRAWAL BY SUBJECT

Patient withdrew from study and follow up.

1

22 31AUG2020 VACCINATION

WITHDRAWAL BY SUBJECT

SUBJECT WITHDREW CONSENT

1

22 31AUG2020 FOLLOW-UP

WITHDRAWAL BY SUBJECT

SUBJECT WITHDREW CONSENT

2

55 02NOV2020 VACCINATION LOST TO FOLLOW-UP

Lost to follow-up after unsuccessful attempts to contact

2

55 02NOV2020 FOLLOW-UP

LOST TO FOLLOW-UP

Lost to follow up after unsuccessful attempts to make contact.

2

27 06OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

subject called the office in withdrew consent-they will not be returning to the site for future visi

2

27 06OCT2020

WITHDRAWAL BY SUBJECT

subject withdrew from study participation

2

48 19OCT2020 VACCINATION LOST TO FOLLOW-UP

Lost to follow up after unsuccessful attempts to make contact.

2

48 19OCT2020

LOST TO FOLLOW-UP

Lost to follow up after unsuccessful attempts to make contact.

2

41 19OCT2020 VACCINATION LOST TO FOLLOW-UP

Lost to follow up after unsuccessful attempts to make contact.

2

41 19OCT2020

Lost to follow up after unsuccessful attempts to make contact.

1

58 13NOV2020 VACCINATION LOST TO FOLLOW-UP

Lost to follow up

1

58 13NOV2020 FOLLOW-UP

Lost to follow up

FOLLOW-UP

FOLLOW-UP

FOLLOW-UP

LOST TO FOLLOW-UP

LOST TO FOLLOW-UP

FDA-CBER-2021-5683-0129000

Page 11

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject C4591001 1042 10421251 C4591001 1046 10461040

C4591001 1046 10461049

C4591001 1046 10461099

C4591001 1046 10461140

C4591001 1047 10471221

Dose Rel Withdrawal No. Daya Date

Study Phase

Withdrawal Reason

Commentb

1

58 13NOV2020 VACCINATION LOST TO FOLLOW-UP

Lost to follow up

1

58 13NOV2020 FOLLOW-UP

LOST TO FOLLOW-UP

Lost to follow up

1

15 31AUG2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject chose to discontinue due to personal reasons.

1

15 31AUG2020 FOLLOW-UP

WITHDRAWAL BY SUBJECT

Subject Decision

2

31 09OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject Withdrew

2

31 09OCT2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

Subject decision

1

64 27OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject Decision

1

64 27OCT2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

Subject Decision

1

22

19SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject Decision

1

22

19SEP2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

Subject Decision

1

44 29OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

withdrew consent

1

44 29OCT2020

WITHDRAWAL BY SUBJECT

Withdrew consent

FOLLOW-UP

FDA-CBER-2021-5683-0129001

Page 12

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject

Dose Rel Withdrawal No. Daya Date

Study Phase

Withdrawal Reason

Commentb

C4591001 1047 10471314

1

32 12NOV2020 VACCINATION LOST TO FOLLOW-UP

Subject is lost to follow up

C4591001 1052 10521021

2

63 11NOV2020 VACCINATION LOST TO FOLLOW-UP

lost to follow up

2

63 11NOV2020 FOLLOW-UP

LOST TO FOLLOW-UP

lost to follow up

2

63 11NOV2020 VACCINATION LOST TO FOLLOW-UP

lost to follow up

2

63 11NOV2020 FOLLOW-UP

lost to follow up

1

25

21SEP2020 VACCINATION LOST TO FOLLOW-UP

1

25

21SEP2020

1

25

1

C4591001 1052 10521022 C4591001 1052 10521054 C4591001 1052 10521057

C4591001 1052 10521058 C4591001 1052 10521064

FOLLOW-UP

LOST TO FOLLOW-UP

n/a

LOST TO FOLLOW-UP

lost to follow up

21SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

withdrew consent

25

21SEP2020

WITHDRAWAL BY SUBJECT

Withdrawal by subject

1

25

21SEP2020 VACCINATION LOST TO FOLLOW-UP

lost to follow up

1

25

21SEP2020

lost to follow up

1

25

24SEP2020 VACCINATION LOST TO FOLLOW-UP

1

25

24SEP2020

FOLLOW-UP

FOLLOW-UP

FOLLOW-UP

LOST TO FOLLOW-UP

LOST TO FOLLOW-UP

n/a

lost of follow up

FDA-CBER-2021-5683-0129002

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16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject C4591001 1052 10521080

Dose Rel Withdrawal No. Daya Date

Study Phase

Withdrawal Reason

Commentb

1

28

29SEP2020 VACCINATION LOST TO FOLLOW-UP

lost of follow up

1

28

29SEP2020

lost of follow up

1

64 23OCT2020 VACCINATION LOST TO FOLLOW-UP

Pt deemed LTFU by site.

1

64 23OCT2020

LOST TO FOLLOW-UP

Pt deemed LTFU by site.

1

64 23OCT2020 VACCINATION LOST TO FOLLOW-UP

Pt deemed LTFU by site.

1

64 23OCT2020

C4591001 1054 10541033

1

21

C4591001 1054 10541055

1

59 23OCT2020 VACCINATION LOST TO FOLLOW-UP

Pt deemed LTFU by site.

1

59 23OCT2020

Pt deemed LTFU by site.

1

78 12NOV2020 VACCINATION LOST TO FOLLOW-UP

> 3 attempts at contacting pt via telephone; certified letter sent

1

78 12NOV2020 FOLLOW-UP

LOST TO FOLLOW-UP

> 3 attempts at contacting pt via telephone; certified letter sent

1

23 02OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject doesn't want to continue in study.

1

23 02OCT2020

WITHDRAWAL BY SUBJECT

Subject doesn't want to continue in study.

C4591001 1054 10541022 C4591001 1054 10541023

C4591001 1054 10541064

C4591001 1054 10541138

FOLLOW-UP

FOLLOW-UP

LOST TO FOLLOW-UP

FOLLOW-UP

LOST TO FOLLOW-UP

Pt deemed LTFU by site.

11SEP2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

Per sponsor, participant met EXC #5, and should not receive VAX2 but may remain in study.

FOLLOW-UP

FOLLOW-UP

LOST TO FOLLOW-UP

FDA-CBER-2021-5683-0129003

Page 14

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject C4591001 1054 10541150

Dose Rel Withdrawal No. Daya Date

Study Phase

Withdrawal Reason

Commentb

1

22 05OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

No longer interested in study, and walked out of clinic w/o talking to Investigator.

1

22 05OCT2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

Pt is no longer interested in study. Walked out of clinic w/o seeing the Investigator.

C4591001 1055 10551145

1

48 14OCT2020 VACCINATION

ADVERSE EVENT

ADVERSE EVENT/DYSPHAGIA

C4591001 1056 10561027

1

35

25SEP2020 VACCINATION LOST TO FOLLOW-UP

Subject couldn't be reached. Caregiver states he left the house and nobody knows where he is.

1

35

25SEP2020

LOST TO FOLLOW-UP

Subject couldn't be reached. Caregiver states he left the house and nobody knows where he is.

1

24

25SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject states he doesn't want to continue in the study

1

24

25SEP2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

Subject states he doesn't want to continue in the study

1

27

29SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

SUBJECT STATED HE DOES NOT WANT TO CONTINUE HIS PARTICIPATION IN THE STUDY.

1

27

29SEP2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

SUBJECT STATED HE DOES NOT WANT TO CONTINUE HIS PARTICIPATION IN THE STUDY.

2

32 05NOV2020 VACCINATION

WITHDRAWAL BY SUBJECT

SUBJECT MOVED OUT OF STATE AND HE IS UNABLE TO CONTINUE PARTICIPATING IN THE STUDY.

2

32 05NOV2020 FOLLOW-UP

WITHDRAWAL BY SUBJECT

SUBJECT MOVED OUT OF STATE AND HE IS UNABLE TO CONTINUE PARTICIPATING IN THE STUDY.

C4591001 1056 10561129

C4591001 1056 10561152

C4591001 1056 10561253

FOLLOW-UP

FDA-CBER-2021-5683-0129004

Page 15

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject C4591001 1056 10561293

C4591001 1056 10561372

C4591001 1056 10561395

Dose Rel Withdrawal No. Daya Date

Study Phase

Withdrawal Reason

Commentb

1

50 06NOV2020 VACCINATION LOST TO FOLLOW-UP

Subject lost to follow up after several unsuccessful attempts to contact.

1

50 06NOV2020 FOLLOW-UP

LOST TO FOLLOW-UP

Subject lost to follow up after several unsuccessful attempts to contact.

1

38 06NOV2020 VACCINATION LOST TO FOLLOW-UP

Subject lost to follow up after several unsuccessful attempts to contact.

1

38 06NOV2020 FOLLOW-UP

LOST TO FOLLOW-UP

Subject lost to follow up after several unsuccessful attempts to contact.

1

25 29OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

SUBJECT MOVED TO ANOTHER TOWN

1

25 29OCT2020

WITHDRAWAL BY SUBJECT

Subject moved out of town. met delay criteria, reported by subject after subject was randomized, discontinued prior to vaccine

FOLLOW-UP

C4591001 1057 10571031

18AUG2020 FOLLOW-UP

NO LONGER MEETS ELIGIBILITY CRITERIA

C4591001 1057 10571211

18SEP2020

FOLLOW-UP

NO LONGER MEETS subject was randomized but failed to meet entry criteria, no ELIGIBILITY CRITERIA vaccine was given

C4591001 1057 10571212

18SEP2020

FOLLOW-UP

NO LONGER MEETS subject was randomized and then failed to meet criteria, no ELIGIBILITY CRITERIA vaccine was administered

C4591001 1057 10571215

18SEP2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

refused further study procedures

30 10NOV2020 VACCINATION

WITHDRAWAL BY SUBJECT

MOVED TO SAN FRANCISCO

C4591001 1057 10571216

2

FDA-CBER-2021-5683-0129005

Page 16

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject

Dose Rel Withdrawal No. Daya Date

Study Phase

Withdrawal Reason

Commentb

2

30 10NOV2020 FOLLOW-UP

WITHDRAWAL BY SUBJECT

MOVED TO SAN FRANCISCO

1

36 30OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

subject refused to return for Visit 2, withdrew consent, No adverse events reported

1

36 30OCT2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

subject withdrew consent from further study participation

C4591001 1057 10571268

06OCT2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

w/d consent

C4591001 1066 10661335

14OCT2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

subject withdrew consent to participate

C4591001 1057 10571248

C4591001 1071 10711095

1

61 24OCT2020 VACCINATION LOST TO FOLLOW-UP

SUBJECT IS LOST TO FOLLOW UP

1

61 24OCT2020

LOST TO FOLLOW-UP

SUBJECT IS LOST TO FOLLOW UP

11SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

During discussing the diary, the subject withdrew consent and subject left.

11SEP2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

SUBJECT WITHDREW CONSENT

WITHDRAWAL BY SUBJECT

SUBJECT WITHDREW CONSENT TO 2ND INJECTION BUT WILL RETURN FOR FOLLOW UP VST

NO LONGER MEETS ELIGIBILITY CRITERIA

diagnosis COVID-19 exclusion 5

C4591001 1071 10711162

FOLLOW-UP

C4591001 1071 10711211

1

32 05NOV2020 VACCINATION

C4591001 1072 10721051

1

12

06SEP2020 VACCINATION

C4591001 1073 10731038

1

37

10SEP2020 VACCINATION LOST TO FOLLOW-UP

Subject was Discontinue

FDA-CBER-2021-5683-0129006

Page 17

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject

Dose Rel Withdrawal No. Daya Date

Withdrawal Reason

Commentb

FOLLOW-UP

LOST TO FOLLOW-UP

Discontinue

1

37

1

23 20AUG2020 VACCINATION

ADVERSE EVENT

ADVERSE EVENT/ADENOCARCINOMA GASTRIC

1

30 27AUG2020 FOLLOW-UP

ADVERSE EVENT

ADVERSE EVENT

2

45 07OCT2020 VACCINATION LOST TO FOLLOW-UP

2

45 07OCT2020

C4591001 1079 10791130

1

1

C4591001 1079 10791253

1

67 13NOV2020 VACCINATION LOST TO FOLLOW-UP

patient unresponsive

C4591001 1081 10811071

1

48 05OCT2020 VACCINATION LOST TO FOLLOW-UP

lack of follow-up, does not return calls & had multiple no show appointments

1

48 05OCT2020

C4591001 1079 10791004 C4591001 1079 10791040

C4591001 1081 10811105 C4591001 1081 10811194 C4591001 1082 10821013

10SEP2020

Study Phase

FOLLOW-UP

17AUG2020 VACCINATION MEDICATION ERROR WITHOUT ASSOCIATED ADVERSE EVENT

FOLLOW-UP

26AUG2020 FOLLOW-UP

2

LOST TO FOLLOW-UP

34 01NOV2020 FOLLOW-UP

03AUG2020 FOLLOW-UP

Subject has not returned calls, emails or letters

Subject is lost to follow up MEDICATION ERROR WITHOUT ASSOCIATED ADVERSE EVENT

LOST TO FOLLOW-UP unable to reach subj, multiple no-show appts. This was the last scheduled visit that was a no-show. WITHDRAWAL BY SUBJECT

Subject withdrew consent

DEATH

DEATH

PROTOCOL DEVIATION

Subject was randomized but left site prior to receiving vaccination.

FDA-CBER-2021-5683-0129007

Page 18

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject C4591001 1082 10821077

Dose Rel Withdrawal No. Daya Date

Study Phase

Withdrawal Reason

Commentb

1

22 28AUG2020 VACCINATION

WITHDRAWAL BY SUBJECT

scheduling conflicts. live out of state.

1

22 28AUG2020 FOLLOW-UP

WITHDRAWAL BY SUBJECT

subject withdrew consent

1

22 28AUG2020 VACCINATION

WITHDRAWAL BY SUBJECT

scheduling conflicts. live out of state.

1

22 28AUG2020 FOLLOW-UP

WITHDRAWAL BY SUBJECT

subject withdrew consent

2

30 23OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

subject withdrew consent due to occupation

2

30 23OCT2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

subject withdrew consent due to occupation

C4591001 1083 10831029

1

20 23AUG2020 VACCINATION

ADVERSE EVENT

ADVERSE EVENT/ATRIAL FIBRILLATION

C4591001 1083 10831060

1

9

14AUG2020 VACCINATION

ADVERSE EVENT

ADVERSE EVENT/DIVERTICULAR PERFORATION

C4591001 1083 10831141

1

34

23SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject no longers wants to participate in the study subject was offered safety F/U Sub Declined

1

34

23SEP2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

Subject decision Subject no longers wants to participate in the study subject was offered safety F/U

2

28 22OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

SUBJECT MOVE OUT OF STATE

2

28 22OCT2020

WITHDRAWAL BY SUBJECT

22OCT2020 subject was contacted for V3 Appointment reminder 23OCT2020 and verbally withdrew consent

C4591001 1082 10821078

C4591001 1082 10821145

C4591001 1083 10831187

FOLLOW-UP

FDA-CBER-2021-5683-0129008

Page 19

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject C4591001 1083 10831219

C4591001 1084 10841035

C4591001 1084 10841057 C4591001 1084 10841119 C4591001 1084 10841272 C4591001 1085 10851286

C4591001 1087 10871085

Dose Rel Withdrawal No. Daya Date

Study Phase

Withdrawal Reason

Commentb

2

37 05NOV2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject was contacted to reschedule Visit 3 and he withdrew consent

2

37 05NOV2020 FOLLOW-UP

WITHDRAWAL BY SUBJECT

05NOV2020 After mulitple attempts to contact subj to reschedule V3 subj returned call and WC

1

22 24AUG2020 VACCINATION

WITHDRAWAL BY SUBJECT

subject does not want to do study anymore; now engaged and wants to start a family

1

22 24AUG2020 FOLLOW-UP

WITHDRAWAL BY SUBJECT

Withdrew consent because subject wants to start a family

1

35

08SEP2020 VACCINATION LOST TO FOLLOW-UP

subject never answered phone calls; certified letter sent

1

35

08SEP2020

subject never answered phone calls; certified letter sent

2

38 07OCT2020 VACCINATION LOST TO FOLLOW-UP

2

38 07OCT2020

1

32

22SEP2020 VACCINATION LOST TO FOLLOW-UP

LTFU

1

32

22SEP2020

FOLLOW-UP

LOST TO FOLLOW-UP

LTFU

1

34 12OCT2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

Positive COVID-19 test result prior to vaccination 2 as such subject meets exclusion criteria.

1

58 05NOV2020 FOLLOW-UP

NO LONGER MEETS ELIGIBILITY CRITERIA

Positive Covid test prior to vaccine 2

2

13

WITHDRAWAL BY SUBJECT

Pt moved to another State for job. Closest Site 1+ hr away from pt's new location. Withdrew consent.

FOLLOW-UP

FOLLOW-UP

20SEP2020 VACCINATION

LOST TO FOLLOW-UP

LOST TO FOLLOW-UP

certified letter sent

subject LTFU; certified letter sent

FDA-CBER-2021-5683-0129009

Page 20

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject

Dose Rel Withdrawal No. Daya Date

Commentb

Study Phase

Withdrawal Reason

FOLLOW-UP

WITHDRAWAL BY SUBJECT

Pt moved to another State for job. Closest Site 1+ hr away from pt's new location. Withdrew consent.

2

13

20SEP2020

C4591001 1087 10871089

1

19

04SEP2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

Exclusion Criteria #5

C4591001 1087 10871209

1

7

31AUG2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

Subject has met exclusion #5

1

38 01OCT2020

WITHDRAWAL BY SUBJECT

Subject chose to withdraw from study because felt no longer necessary due to positive COVID dx.

1

61 02NOV2020 VACCINATION LOST TO FOLLOW-UP

Lost to follow up

1

61 02NOV2020 FOLLOW-UP

LOST TO FOLLOW-UP

Lost to follow up

1

10

17SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject does not feel comfortable continuing in the study. Withdrawal of participation and consent.

1

10

17SEP2020

WITHDRAWAL BY SUBJECT

Subject does not feel comfortable continuing in study. Withdrawal of participation & consent.

1

54 31OCT2020 VACCINATION LOST TO FOLLOW-UP

Lost to follow up.

1

54 31OCT2020

LOST TO FOLLOW-UP

Lost to follow up.

C4591001 1087 10871557

1

23 05NOV2020 VACCINATION

PREGNANCY

PREGNANCY

C4591001 1089 10891076

1

22 27AUG2020 VACCINATION LOST TO FOLLOW-UP

8/25-# out of service, sent email 8/27-no response, sent certified letter

1

22 27AUG2020 FOLLOW-UP

number invaild and sent certified letter. no response

C4591001 1087 10871336 C4591001 1087 10871354

C4591001 1087 10871356

FOLLOW-UP

FOLLOW-UP

FOLLOW-UP

LOST TO FOLLOW-UP

FDA-CBER-2021-5683-0129010

Page 21

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject C4591001 1089 10891158

Dose Rel Withdrawal No. Daya Date

Study Phase

Withdrawal Reason

Commentb

1

44 02OCT2020 VACCINATION

NO LONGER MEETS site was notified that subject has been incarcerated and will ELIGIBILITY CRITERIA not be able to complete study visit

1

44 02OCT2020

FOLLOW-UP

NO LONGER MEETS site was notified that subject has been incarcerated and will ELIGIBILITY CRITERIA not be able to complete study visit

C4591001 1089 10891346

22SEP2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

subject withdrew consent prior to receiving vaccine

C4591001 1089 10891351

25SEP2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

subject withdrew consent, and left office prior to vaccination

C4591001 1090 10901047

2

45 07OCT2020 VACCINATION LOST TO FOLLOW-UP

2

45 07OCT2020

1

29

1

29

1

54 02NOV2020 VACCINATION LOST TO FOLLOW-UP

1

54 02NOV2020 FOLLOW-UP

LOST TO FOLLOW-UP

unable to contact

C4591001 1090 10901507

1

20 04NOV2020 VACCINATION

ADVERSE EVENT

ADVERSE EVENT/URTICARIA

C4591001 1091 10911039

1

50

WITHDRAWAL BY SUBJECT

withdrew consent to future visits

C4591001 1090 10901068

C4591001 1090 10901379

FOLLOW-UP

Pt was not reachable the last 2 weeks. HE is in prison per his sister. Pt will be discontinued.

LOST TO FOLLOW-UP

pt in prison

02SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

pt is not willing to come to any m visits

02SEP2020

WITHDRAWAL BY SUBJECT

subject no longer interested in study

FOLLOW-UP

22SEP2020 VACCINATION

pt never contacted us to reschedule V2

FDA-CBER-2021-5683-0129011

Page 22

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject

Dose Rel Withdrawal No. Daya Date

Withdrawal Reason

Commentb

1

50

FOLLOW-UP

WITHDRAWAL BY SUBJECT

withdrew consent to further visits

C4591001 1091 10911077

1

22 27AUG2020 VACCINATION

WITHDRAWAL BY SUBJECT

Patient agrees to stay in the trial for follow up but denied second vaccination.

C4591001 1091 10911083

1

23 28AUG2020 VACCINATION

WITHDRAWAL BY SUBJECT

Did not want to come to scheduled visits

1

23 28AUG2020 FOLLOW-UP

WITHDRAWAL BY SUBJECT

subject no longer wanted to come to study appointments

1

23 28OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject was a NCNS for his V2 today. Stated over the phone he would like to withdraw consent

1

23 28OCT2020

WITHDRAWAL BY SUBJECT

Subject was a NCNS for his V2. Stated over the phone he would like to withdraw consent

C4591001 1091 10911387

1

5

09NOV2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

NO LONGER MEETS ELIGIBILITY CRITERIA

C4591001 1092 10921080

1

22

16SEP2020 VACCINATION

OTHER

Incarcerated 09Sep2020

1

22

16SEP2020

OTHER

Incarcerated

2

35 20OCT2020 VACCINATION LOST TO FOLLOW-UP

2

35 20OCT2020

FOLLOW-UP

LOST TO FOLLOW-UP

Subject is Lost to follow up

01SEP2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

Pt withdrew consent due to anxiety of having blood drawn

C4591001 1091 10911352

C4591001 1092 10921082 C4591001 1092 10921128

22SEP2020

Study Phase

FOLLOW-UP

FOLLOW-UP

unable to make contact with subject

FDA-CBER-2021-5683-0129012

Page 23

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject C4591001 1092 10921130

Dose Rel Withdrawal No. Daya Date 2

Study Phase

Withdrawal Reason

Commentb

21 12OCT2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

confirmed covid illness

31AUG2020 FOLLOW-UP

NO LONGER MEETS ELIGIBILITY CRITERIA

UNABLE TO OBTAIN BLOOD FROM SUBJECT.

18SEP2020 VACCINATION

ADVERSE EVENT

ADVERSE EVENT/EXPOSURE DURING PREGNANCY

C4591001 1093 10931055 C4591001 1093 10931058

1

25

C4591001 1093 10931065

1

81 14NOV2020 VACCINATION LOST TO FOLLOW-UP

SUBJECT WAS SENT A CERTIFIED LETTER AND WAS UNABLE TO BE CONTACTED MULTIPLE TIMES.

1

81 14NOV2020 FOLLOW-UP

LOST TO FOLLOW-UP

SUBJECT WAS SENT A CERTIFIED LETTER AND WAS UNABLE TO BE CONTACTED MULTIPLE TIMES.

1

76 14NOV2020 VACCINATION LOST TO FOLLOW-UP

SUBJECT WAS SENT A CERTIFIED LETTER AFTER MULTIPLE ATTEMPTS TO CONTACT THEM.

1

76 14NOV2020 FOLLOW-UP

LOST TO FOLLOW-UP

SUBJECT WAS SENT A CERTIFIED LETTER AFTER MULTIPLE ATTEMPTS TO CONTACT THEM.

1

35

08SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

Participant is no longer able to participate

1

37

10SEP2020

OTHER

Participant not able to continue in study at this time. Participant did not withdraw consent

C4591001 1095 10951110

1

71 28OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

completed Vac 1, but declined vac 2 but will participate in all other study procedures. approved MD

C4591001 1095 10951141

1

22

ADVERSE EVENT

ADVERSE EVENT

C4591001 1093 10931094

C4591001 1095 10951056

FOLLOW-UP

16SEP2020 VACCINATION

FDA-CBER-2021-5683-0129013

Page 24

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject

Dose Rel Withdrawal No. Daya Date 16SEP2020

Study Phase

Withdrawal Reason

Commentb

1

22

FOLLOW-UP

ADVERSE EVENT

ADVERSE EVENT/DIABETIC FOOT

C4591001 1095 10951168

1

48 15OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

subject will not receive vaccination however will participate in all other study procedures

C4591001 1095 10951173

1

8

05SEP2020 VACCINATION

ADVERSE EVENT

ADVERSE EVENT/ACUTE MYOCARDIAL INFARCTION

C4591001 1096 10961031

1

22

04SEP2020 VACCINATION

PREGNANCY

PREGNANCY

C4591001 1096 10961081

1

54 12OCT2020 VACCINATION LOST TO FOLLOW-UP

1

54 12OCT2020

C4591001 1096 10961141

1

C4591001 1096 10961276

LTFU, unresponsive to contact attempts

FOLLOW-UP

LOST TO FOLLOW-UP

site unable to contact subject after multiple attempts and certified letter sent

22

16SEP2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

per protocol

1

21

25SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

due to moving out of town unexpectedly

1

21

25SEP2020

WITHDRAWAL BY SUBJECT

due to moving out of town unexpectedly

C4591001 1096 10961321

1

22 03OCT2020 VACCINATION

NO LONGER MEETS subject met exclusion #1 on visit 2 (suicidal ideation) so no ELIGIBILITY CRITERIA vaccine was administered

C4591001 1096 10961388

1

21 29OCT2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

FOLLOW-UP

subject was diagnosed with COVID between vaccination one and vaccination two

FDA-CBER-2021-5683-0129014

Page 25

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject C4591001 1098 10981001

Dose Rel Withdrawal No. Daya Date

Study Phase

Withdrawal Reason

Commentb

1

31

17SEP2020 VACCINATION LOST TO FOLLOW-UP

1

31

17SEP2020

1

22

1

22

1

46 05NOV2020 VACCINATION LOST TO FOLLOW-UP

Subject called multiple times and certified letter was sent. No response from subject

1

46 05NOV2020 FOLLOW-UP

LOST TO FOLLOW-UP

Subject called multiple times and certified letter was sent. No response from subject.

1

43 05NOV2020 VACCINATION

WITHDRAWAL BY SUBJECT

withdraw by subject due to no longer wanting to take part in the study.

1

43 05NOV2020 FOLLOW-UP

WITHDRAWAL BY SUBJECT

withdraw by subject due to no longer wanting to take part in the study.

C4591001 1101 11011024

1

21

NO LONGER MEETS ELIGIBILITY CRITERIA

the subject was diagnoses with COVID between vaccination one and vaccination two

C4591001 1107 11071074

2

74 12NOV2020 FOLLOW-UP

WITHDRAWAL BY SUBJECT

SUBJECT WITHDREW CONSENT ON 12NOV2020

C4591001 1109 11091030

2

37

WITHDRAWAL BY SUBJECT

SUBJECT CALLED TO WITHDRAW FROM TRIAL DUE TO TRANSPORTATION ISSUES AS WELL AS BEING TO BUSY.

C4591001 1098 10981029

C4591001 1098 10981200

C4591001 1098 10981219

FOLLOW-UP

Lost to followup

LOST TO FOLLOW-UP

Certified letter was sent. Site is unable to contact the subject. Thanks.

11SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject wanted to be discontinued from the study for unknown reasons.

11SEP2020

WITHDRAWAL BY SUBJECT

Subject inform, it is due to wellbeing

FOLLOW-UP

29SEP2020 VACCINATION

23SEP2020 VACCINATION

FDA-CBER-2021-5683-0129015

Page 26

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject

C4591001 1109 11091059

C4591001 1109 11091068

C4591001 1109 11091127

C4591001 1109 11091148

C4591001 1109 11091234

Dose Rel Withdrawal No. Daya Date

Study Phase

Withdrawal Reason

FOLLOW-UP

WITHDRAWAL BY SUBJECT

Commentb

2

37

23SEP2020

1

40

08SEP2020 VACCINATION LOST TO FOLLOW-UP

SUBJECT NEVER RETURNED PHONE CALLS OR RESPOND TO CERTIFIED LETTER.

1

40

08SEP2020

LOST TO FOLLOW-UP

SUBJECT NEVER RETURNED PHONE CALLS OR RESPOND TO CERTIFIED LETTER.

1

40

08SEP2020 VACCINATION LOST TO FOLLOW-UP

SUBJECT NEVER RETURNED NUMEROUS CALLS OR CERTIFIED LETTER SENT TO HIM.

1

40

08SEP2020

LOST TO FOLLOW-UP

SUBJECT NEVER RESPONDED TO CALLS OR CERTIFIED LETTER.

1

37

08SEP2020 VACCINATION LOST TO FOLLOW-UP

SUBJECT NEVER RESPONDED TO MULTIPLE CALLS AND CERTIFIED LETTER SENT TO HER

1

37

08SEP2020

2

33

2

FOLLOW-UP

FOLLOW-UP

FOLLOW-UP

SUBJECT CALLED TO WITHDRAW FROM TRIAL DUE TO TRANSPORTATION ISSUES AS WELL AS BEING TO BUSY.

LOST TO FOLLOW-UP

SUBJECT NEVE RESPONDED TO CALLS OR CERTIFIED LETTER SENT TO HER.

26SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

SUBJECT CALLED AND WITHDREW CONSENT

33

26SEP2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

SUBJECT CALLED AND WITHDREW CONSENT

1

25

08SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

WORK HAD GOTTEN TOO BUSY WITH OPENING BACK UP AND SHE WAS UNABLE TO CONTINUE HER PARTICIPATION.

1

25

08SEP2020

WITHDRAWAL BY SUBJECT

WORK HAD GOTTEN TOO BUSY WITH OPENING BACK UP AND SHE WAS UNABLE TO CONTINUE HER PARTICIPATION.

FOLLOW-UP

FDA-CBER-2021-5683-0129016

Page 27

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject C4591001 1109 11091335

Dose Rel Withdrawal No. Daya Date

Withdrawal Reason

Commentb

1

43 07OCT2020 VACCINATION LOST TO FOLLOW-UP

SUBJECT NEVER RESPONDED TO MULTIPLE CALLS AND CERTIFIED LETTER SENT TO HER

1

43 07OCT2020

LOST TO FOLLOW-UP

SUBJECT NEVER RESPONDED TO MULTIPLE CALLS AND CERTIFIED LETTER SENT TO HER

PROTOCOL DEVIATION

Subject randomized in error.

C4591001 1109 11091349 C4591001 1109 11091419

Study Phase

FOLLOW-UP

28AUG2020 FOLLOW-UP

2

40 06NOV2020 VACCINATION LOST TO FOLLOW-UP Subject did not respond to multiple phone calls or certified letter.

2

40 06NOV2020 FOLLOW-UP

1

29 07OCT2020 VACCINATION LOST TO FOLLOW-UP

1

29 07OCT2020

LOST TO FOLLOW-UP

SUBJECT NEVER RESPONDED TO MULTIPLE CALLS AND CERTIFIED LETTER SENT

1

30 14OCT2020 VACCINATION LOST TO FOLLOW-UP

Subject never returned for visit, responded to call or certified letter sent.

1

30 14OCT2020

C4591001 1109 11091556

1

C4591001 1110 11101006

1

C4591001 1109 11091478

C4591001 1109 11091515

FOLLOW-UP

LOST TO FOLLOW-UP Subject did not respond to multiple phone calls or certified letter. LOST TO FOLLOW-UP

FOLLOW-UP

LOST TO FOLLOW-UP

Subject never returned for visit, responded to call or certified letter sent.

9

12OCT2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

Exclusion criterion 5

53

21SEP2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

Subject meets exclusion criteria #5

FDA-CBER-2021-5683-0129017

Page 28

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject C4591001 1110 11101010 C4591001 1110 11101038

C4591001 1110 11101039

C4591001 1110 11101069

C4591001 1110 11101085

C4591001 1110 11101110

Dose Rel Withdrawal No. Daya Date

Study Phase

Withdrawal Reason

Commentb

2

63 22OCT2020 VACCINATION LOST TO FOLLOW-UP

Subject did not comply with inclusion criteria #2.

2

63 22OCT2020

Subject did not comply with inclusion criteria #2.

1

35

08SEP2020 VACCINATION LOST TO FOLLOW-UP

Subject was contact over the phone 3 times and a certified letter was sent. Subject never reply.

1

35

08SEP2020

LOST TO FOLLOW-UP

Lost to follow is status, subject has been withdrawn from trial.

1

35

08SEP2020 VACCINATION LOST TO FOLLOW-UP

subject failed to contact site after many calls and certified letter.

1

35

08SEP2020

1

59 08OCT2020 VACCINATION LOST TO FOLLOW-UP

1

59 08OCT2020

1

58 08OCT2020 VACCINATION LOST TO FOLLOW-UP

1

58 08OCT2020

1

22

08SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject withdrew consent

1

22

08SEP2020

WITHDRAWAL BY SUBJECT

subject withdrew consent

FOLLOW-UP

FOLLOW-UP

FOLLOW-UP

FOLLOW-UP

FOLLOW-UP

FOLLOW-UP

LOST TO FOLLOW-UP

LOST TO FOLLOW-UP Subject did not respond to many phones calls from site and did not respond to certified letter fromi

LOST TO FOLLOW-UP

Subject was called more the 3 times,was texted 2 times,email/certified letter were sent we did more than 3 attempts via phone, 1 text message, 4 emails and a certified letter. Subject was tried to contact by phone, text, email and certified letter several times.

LOST TO FOLLOW-UP we did 4 phone call attempts, 1 text message, 1 email and a certified letter.

FDA-CBER-2021-5683-0129018

Page 29

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject C4591001 1110 11101141

Dose Rel Withdrawal No. Daya Date

Study Phase

Withdrawal Reason

Commentb

2

56 12NOV2020 VACCINATION LOST TO FOLLOW-UP

4 attempts via phone call, 1 text message, 1 email and 1 certified letter.

2

56 12NOV2020 FOLLOW-UP

LOST TO FOLLOW-UP

4 attempts via phone call, 1 text message, 1 email and 1 certified letter.

1

21

17SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject was contacted over the phone because she missed visit 2 and subject withdraw consent.

1

21

17SEP2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

subject withdrew consent verbally over the phone.

1

21

17SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject was contacted over the phone because she missed visit 2 and subject withdraw consent.

1

21

17SEP2020

WITHDRAWAL BY SUBJECT

subject verbally withdrew consent.

C4591001 1110 11101229

1

21

30SEP2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

Subject meets exclusion criterion #5

C4591001 1110 11101247

1

22 06OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject WICF because he is unable to continue with the visit due to work.

1

22 06OCT2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

Subject WICF because he is unable to continue with the visit due to work.

1

22 06OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject did not provide a reason to be discontinued from the study.

1

22 06OCT2020

WITHDRAWAL BY SUBJECT

Subject did not provide a reason to be discontinued from the study.

1

35 05NOV2020 VACCINATION LOST TO FOLLOW-UP

C4591001 1110 11101154

C4591001 1110 11101155

C4591001 1110 11101250

C4591001 1110 11101333

FOLLOW-UP

FOLLOW-UP

we attempt 3 phone calls, 1 text message and 1 certified letter. FDA-CBER-2021-5683-0129019

Page 30

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject

Dose Rel Withdrawal No. Daya Date

Study Phase

Commentb

Withdrawal Reason

1

35 05NOV2020 FOLLOW-UP

LOST TO FOLLOW-UP

we attempt 3 phone calls, 1 text message and 1 certified letter.

1

31 05NOV2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject sent and email, he state he will like to withdraw from the study due to a private reason.

1

31 05NOV2020 FOLLOW-UP

WITHDRAWAL BY SUBJECT

Subject sent and email, he state he will like to withdraw from the study due to a private reason.

C4591001 1111 11111099

1

71 20OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject refused second vaccination but will continue with follow-up procedures

C4591001 1112 11121054

2

43 07OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

sujbect withdrew consent due to work schedule

2

43 07OCT2020

WITHDRAWAL BY SUBJECT

subject withdrew due to busy work schedule

1

22 25AUG2020 VACCINATION

OTHER

1

22 25AUG2020 FOLLOW-UP

OTHER

1

34

30SEP2020 VACCINATION LOST TO FOLLOW-UP

1

34

30SEP2020

FOLLOW-UP

LOST TO FOLLOW-UP

Unable to contact subject for Vs 2

04SEP2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

subject left clinic after randomization and prior to vaccination

NO LONGER MEETS ELIGIBILITY CRITERIA

unstable viral load and Hepatitis B

C4591001 1110 11101342

C4591001 1112 11121058 C4591001 1112 11121192 C4591001 1112 11121229 C4591001 1112 11121270†

1

1

FOLLOW-UP

08OCT2020 VACCINATION

(b) (6)

(b) (6)

unable to reach subject for missed appts

FDA-CBER-2021-5683-0129020

Page 31

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject C4591001 1114 11141029

C4591001 1114 11141037

Dose Rel Withdrawal No. Daya Date

C4591001 1116 11161172

C4591001 1116 11161292

C4591001 1117 11171186

Withdrawal Reason

Commentb

2

45 29OCT2020 VACCINATION LOST TO FOLLOW-UP

Subject no show to apt and no response from certified letter.

2

45 29OCT2020

Subject no show to apt and no response from certified letter.

1

54 09OCT2020 VACCINATION LOST TO FOLLOW-UP

no show to visit 2,two times.subject no responsive to calls and voicemails and subjects emerg.contac

1

54 09OCT2020

LOST TO FOLLOW-UP

no show to visit 2,two times.subject no responsive to calls and voicemails and subjects emerg.contac

WITHDRAWAL BY SUBJECT

Subject withdrew consent. Left site prior to IP administration.

C4591001 1116 11161015 C4591001 1116 11161143

Study Phase

FOLLOW-UP

FOLLOW-UP

26AUG2020 FOLLOW-UP

LOST TO FOLLOW-UP

1

68 14NOV2020 VACCINATION LOST TO FOLLOW-UP

Contact attempts 29SEP 30SEP 2OCT 13OCT 6NOV 9NOV

1

68 14NOV2020 FOLLOW-UP

LOST TO FOLLOW-UP

Contact attempts 29SEP 30SEP 2OCT 13OCT 6NOV 9NOV

1

67 14NOV2020 VACCINATION LOST TO FOLLOW-UP

Contact attempts 2OCT 5OCT 7OCT 9OCT 13OCT 23OCT 9NOV

1

67 14NOV2020 FOLLOW-UP

LOST TO FOLLOW-UP

Contact attempts 2OCT 5OCT 7OCT 9OCT 13OCT 23OCT 9NOV

1

52 14NOV2020 VACCINATION LOST TO FOLLOW-UP

Contact attempts 16OCT 22OCT 23OCT 3NOV 4NOV 9NOV 10NOV

1

52 14NOV2020 FOLLOW-UP

LOST TO FOLLOW-UP

Contact attempts 16OCT 22OCT 23OCT 3NOV 4NOV 9NOV 10NOV

1

21 26OCT2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

SAE EVENT, INVESTIGATOR DETERMINED SUBJECT NO LONGER MEETS CRITERIA FOR INCLUSION FDA-CBER-2021-5683-0129021

Page 32

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject C4591001 1120 11201013

Dose Rel Withdrawal No. Daya Date

C4591001 1120 11201085 C4591001 1120 11201104

C4591001 1120 11201249

C4591001 1120 11201252

Withdrawal Reason

Commentb

1

20 18AUG2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject states he no longer wants to be in study

1

20 18AUG2020 FOLLOW-UP

WITHDRAWAL BY SUBJECT

Subject states he no longer wants to be in study

SCREEN FAILURE

SCREEN FAILURE

C4591001 1120 11201038 C4591001 1120 11201083

Study Phase

04AUG2020

SCREENING

2

71 04NOV2020 VACCINATION LOST TO FOLLOW-UP

2

71 04NOV2020 FOLLOW-UP

1

79 23OCT2020 VACCINATION LOST TO FOLLOW-UP

subject would not come in office for visit

1

79 23OCT2020

LOST TO FOLLOW-UP

Subject never showed to appointment.

1

50

24SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject states no longer wishes to be in study about to have weight lost surgery

1

50

24SEP2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

Subject no longer wished to be in study subject is about to have weight lost surgery

1

50 09OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

SUBJECT IS STILL BEING FOLLOWED JUST REFUSED VAX 2

1

50 09OCT2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

subject still being followed. refused vax 2

09SEP2020

FOLLOW-UP

FOLLOW-UP

LOST TO FOLLOW-UP

certified letter sent and moved to lost to follow up

Subject lost to follow up

LOST TO FOLLOW-UP Subject was randomized, but had to leave for work. Subject never return for next appointment

FDA-CBER-2021-5683-0129022

Page 33

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject C4591001 1121 11211009

Dose Rel Withdrawal No. Daya Date

Study Phase

Withdrawal Reason

Commentb

2

40 22OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject withdrew due to busy schedule.

2

40 22OCT2020

WITHDRAWAL BY SUBJECT

Subject withdrew consent due to busy schedule. Does not want to be FU

1

22

16SEP2020 VACCINATION

OTHER

Participants significant other notified the site, participant is in jail for the foreseeable future

1

22

16SEP2020

FOLLOW-UP

OTHER

Subject incarcerated. Subject to be dropped from the study.

C4591001 1122 11221006

03SEP2020

FOLLOW-UP

PROTOCOL DEVIATION

Subject randomized in error

C4591001 1122 11221026

11SEP2020

FOLLOW-UP

ADVERSE EVENT

ADVERSE EVENT/PRESYNCOPE

11SEP2020

FOLLOW-UP

ADVERSE EVENT

ADVERSE EVENT/VOMITING

04AUG2020 FOLLOW-UP

WITHDRAWAL BY SUBJECT

subject withdrew consent after randomization prior to vaccination.

2

43 08OCT2020 VACCINATION

OTHER

moved to hawaii

2

43 08OCT2020

OTHER

Moved to Hawaii

C4591001 1123 11231144

1

42

NO LONGER MEETS ELIGIBILITY CRITERIA

Exclusion criteria #5.

C4591001 1123 11231154

1

73 04NOV2020 VACCINATION LOST TO FOLLOW-UP

no response from subject after certified letter

1

73 04NOV2020 FOLLOW-UP

no response from subject after certified letter

C4591001 1121 11211025

C4591001 1123 11231027 C4591001 1123 11231051

FOLLOW-UP

FOLLOW-UP

30SEP2020 VACCINATION

LOST TO FOLLOW-UP

FDA-CBER-2021-5683-0129023

Page 34

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject C4591001 1123 11231168 C4591001 1123 11231290

Dose Rel Withdrawal No. Daya Date

Study Phase

Withdrawal Reason

Commentb

1

72 04NOV2020 VACCINATION LOST TO FOLLOW-UP

Pt is LTF

1

72 04NOV2020 FOLLOW-UP

LOST TO FOLLOW-UP

Pt is LTF

1

29 21OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

subejct withdrew consent.

1

29 21OCT2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

subject withdrew consent.

24SEP2020

FOLLOW-UP

PROTOCOL DEVIATION

subject randomized in error

C4591001 1123 11231301 C4591001 1123 11231313

1

13 06OCT2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

Exc. criterion 5 COVID-19 positive

C4591001 1123 11231386

1

22 09NOV2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

exclusion no. 5 positive covid test

C4591001 1124 11241049

1

26

11SEP2020 VACCINATION LOST TO FOLLOW-UP

Subject not responding to any phone calls, certified letter sent

1

26

11SEP2020

Subject not responding to any phone calls, certified letter sent

1

10

02SEP2020 VACCINATION

1

18

10SEP2020

1

48

29SEP2020 VACCINATION LOST TO FOLLOW-UP

C4591001 1124 11241084

C4591001 1125 11251019

FOLLOW-UP

FOLLOW-UP

LOST TO FOLLOW-UP

NO LONGER MEETS Previous clinical or Microbiological COVID 19 Diagnosis ELIGIBILITY CRITERIA WITHDRAWAL BY SUBJECT

Subject not interested in participating any longer lost to follow

FDA-CBER-2021-5683-0129024

Page 35

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject

Dose Rel Withdrawal No. Daya Date

Withdrawal Reason

Commentb

FOLLOW-UP

LOST TO FOLLOW-UP

post to follow

1

48

2

57 28OCT2020 VACCINATION LOST TO FOLLOW-UP

patient is a lost to follow

2

57 28OCT2020

FOLLOW-UP

LOST TO FOLLOW-UP

patient was a lost to follow

C4591001 1125 11251148

1

43 14OCT2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

Subject tested positive for Covid-19

C4591001 1125 11251159

1

1

03SEP2020 VACCINATION LOST TO FOLLOW-UP attempted to contact patient and sent certified letter wih no response back

1

1

03SEP2020

LOST TO FOLLOW-UP

patient is a lost to follow

1

33 05OCT2020 VACCINATION LOST TO FOLLOW-UP

Patient is a lost to follow

1

33 05OCT2020

C4591001 1125 11251022

C4591001 1125 11251160 C4591001 1126 11261074

29SEP2020

Study Phase

FOLLOW-UP

FOLLOW-UP

25AUG2020 FOLLOW-UP

LOST TO FOLLOW-UP

lost to follow

PROTOCOL DEVIATION

During enrollment, after consent signed, inc/exc criteria reviewed, serology/nasal swab completed

C4591001 1127 11271022

1

50

17SEP2020 VACCINATION PHYSICIAN DECISION

C4591001 1127 11271099

1

22

09SEP2020 VACCINATION

C4591001 1128 11281055

2

65 29OCT2020 VACCINATION LOST TO FOLLOW-UP subject contact attempted several times, certified letter sent, no response

2

65 29OCT2020

FOLLOW-UP

NO LONGER MEETS ELIGIBILITY CRITERIA

LOST TO FOLLOW-UP

PHYSICIAN DECISION

Subject tested positive and symptoms for COVID

after several attempts and certified letter, subject has not responded FDA-CBER-2021-5683-0129025

Page 36

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject C4591001 1128 11281086

C4591001 1128 11281146

C4591001 1128 11281159

C4591001 1128 11281164

C4591001 1128 11281279

C4591001 1128 11281368

Dose Rel Withdrawal No. Daya Date

Study Phase

Withdrawal Reason

Commentb

2

43 13OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

subject wishes to discontinue from study

2

43 13OCT2020

WITHDRAWAL BY SUBJECT

subject wished to discontinue study

1

64 21OCT2020 VACCINATION LOST TO FOLLOW-UP

1

64 21OCT2020

2

49 29OCT2020 VACCINATION LOST TO FOLLOW-UP after several attempts and certified letter sent, subject is lost to follow up

2

49 29OCT2020

2

61 10NOV2020 VACCINATION

WITHDRAWAL BY SUBJECT

SUBJECT WITHDREW CONSENT, GOT A NEW JOB AND CAN'T RETURN FOR VISITS

2

61 10NOV2020 FOLLOW-UP

WITHDRAWAL BY SUBJECT

SUBJECT WITHDREW CONSENT, GOT A NEW JOB AND CAN'T RETURN FOR VISITS

2

48 09NOV2020 VACCINATION LOST TO FOLLOW-UP

AFTER SEVERAL ATTEMPTS TO REACH SUBJECT, CERTIFIED LETTER WAS SENT WITH NO RESPONSE

2

48 09NOV2020 FOLLOW-UP

AFTER SEVERAL ATTEMPTS TO REACH SUBJECT, CERTIFIED LETTER WAS SENT WITH NO RESPONSE

1

46 31OCT2020 VACCINATION LOST TO FOLLOW-UP

SUBJECT DID NOT RETURN TO CLINIC FOR V2. CERTIFIED LETTER SENT

1

46 31OCT2020

SUBJECT DID NOT RETURN TO CLINIC FOR V2. CERTIFIED LETTER SENT

FOLLOW-UP

FOLLOW-UP

FOLLOW-UP

FOLLOW-UP

LOST TO FOLLOW-UP

subject is lost to follow up

AFTER SEVERAL ATTEMPTS TO CONTACT, CERTIFITED LETTER SENT 16SEP2020

LOST TO FOLLOW-UP after several attempts and certified letter sent, subject is lost to follow up

LOST TO FOLLOW-UP

LOST TO FOLLOW-UP

FDA-CBER-2021-5683-0129026

Page 37

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject

Dose Rel Withdrawal No. Daya Date

C4591001 1129 11291048 C4591001 1131 11311024

C4591001 1133 11331023

C4591001 1133 11331037

C4591001 1133 11331042

C4591001 1133 11331047

C4591001 1133 11331052

Study Phase

04AUG2020 FOLLOW-UP

Withdrawal Reason PROTOCOL DEVIATION

1

39

24SEP2020 VACCINATION LOST TO FOLLOW-UP

1

39

24SEP2020

2

36

2

36

FOLLOW-UP

Commentb violation exclusion criteria 2 f. immunocompromised. randomized but not dosed subject received vax1 (17AUG2020) but no showed for vax2. Now LTFU

LOST TO FOLLOW-UP

Multiple attempts made after no-show for V2,no response.Certified letter sent. Signed 24SEP2020

25SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject withdrew consent

25SEP2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

SUBJECT WITHDREW CONSENT

1

27 26AUG2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject withdrew consent.

1

27 26AUG2020 FOLLOW-UP

WITHDRAWAL BY SUBJECT

SUBJECT WITHDREW CONSENT

1

21 20AUG2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject withdrew consent.

1

21 20AUG2020 FOLLOW-UP

WITHDRAWAL BY SUBJECT

Subject withdrew consent

2

8

31AUG2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject does not want to continue in the study

2

8

31AUG2020 FOLLOW-UP

WITHDRAWAL BY SUBJECT

SUBJECT WITHDREW CONSENT

1

10 12AUG2020 VACCINATION LOST TO FOLLOW-UP

Certified Letter sent out Subject Lost to Follow up

FDA-CBER-2021-5683-0129027

Page 38

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject

C4591001 1133 11331069 C4591001 1133 11331087

C4591001 1133 11331119 C4591001 1133 11331122

C4591001 1133 11331138

C4591001 1133 11331162

Dose Rel Withdrawal No. Daya Date

Study Phase

Withdrawal Reason

Commentb

1

10 12AUG2020 FOLLOW-UP

LOST TO FOLLOW-UP

Certified letter was sent

2

75 10NOV2020 VACCINATION LOST TO FOLLOW-UP

Unable to contact subject

2

75 10NOV2020 FOLLOW-UP

1

7

1

7

2

49 10NOV2020 VACCINATION LOST TO FOLLOW-UP

2

49 10NOV2020 FOLLOW-UP

LOST TO FOLLOW-UP

Site sent certified letter on 10Nov2020

1

20 31AUG2020 VACCINATION

WITHDRAWAL BY SUBJECT

The subject was called because he was not complying with the diary. Subject withdrew consent

1

20 31AUG2020 FOLLOW-UP

WITHDRAWAL BY SUBJECT

SUBJECT WITHDREW CONSENT

1

24

04SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject stated she is not happy with the study number of visits, number of vaccines, payments.

1

24

04SEP2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

Subject stated she is not happy with the study number of visits, number of vaccines, payments.

14AUG2020

SCREENING

OTHER

DELAY CRITERIA MET

05OCT2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

SUBJECT WITHDREW CONSENT

LOST TO FOLLOW-UP

Site sent certified letter on 10Nov2020

14AUG2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject withdrew consent.

14AUG2020 FOLLOW-UP

WITHDRAWAL BY SUBJECT

Subject withdrew consent Unable to contact subject

FDA-CBER-2021-5683-0129028

Page 39

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject C4591001 1133 11331170 C4591001 1133 11331177 C4591001 1133 11331207

C4591001 1133 11331291 C4591001 1133 11331294 C4591001 1133 11331295

C4591001 1133 11331338

Dose Rel Withdrawal No. Daya Date

Study Phase

1

67 19OCT2020 VACCINATION

1

67 19OCT2020

Withdrawal Reason

Commentb

ADVERSE EVENT

ADVERSE EVENT/HYPERTENSION

PHYSICIAN DECISION

PHYSICIAN DECISION

2

68 10NOV2020 VACCINATION LOST TO FOLLOW-UP

Unable to contact subject

2

68 10NOV2020 FOLLOW-UP

1

43

1

43

1

47 12OCT2020 VACCINATION LOST TO FOLLOW-UP

Certified letter sent on 12/OCT/2020

1

47 12OCT2020

LOST TO FOLLOW-UP

Certified letter sent on 12/OCT/2020

2

54 10NOV2020 VACCINATION LOST TO FOLLOW-UP

Site sent certified letter on 10Nov2020

2

54 10NOV2020 FOLLOW-UP

LOST TO FOLLOW-UP

Site sent certified letter on 10Nov2020

1

44 09OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

SUBJECT WITHDREW CONSENT

1

44 09OCT2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

SUBJECT WITHDREW CONSENT

1

50 17OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject withdrew consent

FOLLOW-UP

LOST TO FOLLOW-UP

Site sent certified letter on 10Nov2020

30SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

SUBJECT WITHDREW CONSENT

30SEP2020

WITHDRAWAL BY SUBJECT

Subject withdrew consent

FOLLOW-UP

FOLLOW-UP

FDA-CBER-2021-5683-0129029

Page 40

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject

C4591001 1133 11331341

C4591001 1133 11331348 C4591001 1133 11331499

C4591001 1133 11331509 C4591001 1133 11331510

C4591001 1133 11331512

Dose Rel Withdrawal No. Daya Date

Study Phase

Withdrawal Reason

FOLLOW-UP

WITHDRAWAL BY SUBJECT

Commentb

1

50 17OCT2020

1

45 12OCT2020 VACCINATION LOST TO FOLLOW-UP

Subject is LTF. Certified letter sent 12/OCT/20

1

45 12OCT2020

SUBJECT IS LTF. CERTIFIED LETTER SENT 12/OCT/20

2

51 10NOV2020 VACCINATION LOST TO FOLLOW-UP

Site sent certified letter on 10Nov2020

2

51 10NOV2020 FOLLOW-UP

LOST TO FOLLOW-UP

Site sent certified letter on 10Nov2020

2

17 30OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject does not wish to continue with study,he asked us to please do notcall him again.

2

17 30OCT2020

WITHDRAWAL BY SUBJECT

Subject does not want to be contacted anymore

1

26 20OCT2020 VACCINATION LOST TO FOLLOW-UP

Unable to contact subject

1

26 20OCT2020

LOST TO FOLLOW-UP

Unable to contact subject

1

20 14OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject doesn't feels comfortable receiving the second vaccine.

1

20 14OCT2020

WITHDRAWAL BY SUBJECT

SUBJECT DOES NOT FEEL COMFORTABLE RECEIVING 2ND VACCINE. Subject wishies to no longer be contacted.

1

26 20OCT2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

Meets exclusion 5

FOLLOW-UP

FOLLOW-UP

FOLLOW-UP

FOLLOW-UP

LOST TO FOLLOW-UP

Subject withdrew consent

FDA-CBER-2021-5683-0129030

Page 41

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject C4591001 1134 11341033

C4591001 1134 11341153

C4591001 1134 11341174

C4591001 1134 11341210 C4591001 1135 11351061

Dose Rel Withdrawal No. Daya Date