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

Study Phase

Withdrawal Reason

Commentb

1

35

14SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

Dropped

1

35

14SEP2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

Subject withdrew consent

1

2

25AUG2020 VACCINATION

ADVERSE EVENT

ADVERSE EVENT/ABDOMINAL DISCOMFORT

1

2

25AUG2020 VACCINATION

ADVERSE EVENT

ADVERSE EVENT/DIARRHOEA

1

2

25AUG2020 VACCINATION

ADVERSE EVENT

ADVERSE EVENT/EYE PAIN

1

2

25AUG2020 VACCINATION

ADVERSE EVENT

ADVERSE EVENT/FATIGUE

1

2

25AUG2020 VACCINATION

ADVERSE EVENT

ADVERSE EVENT/HEADACHE

1

2

25AUG2020 VACCINATION

ADVERSE EVENT

ADVERSE EVENT/MUSCULAR WEAKNESS

1

5

30AUG2020 VACCINATION

ADVERSE EVENT

ADVERSE EVENT/HEADACHE

1

5

30AUG2020 VACCINATION

ADVERSE EVENT

ADVERSE EVENT/INJECTION SITE PAIN

1

5

30AUG2020 VACCINATION

ADVERSE EVENT

ADVERSE EVENT/PAIN IN EXTREMITY

2

1

18SEP2020 VACCINATION LOST TO FOLLOW-UP

subject is lost to follow up

2

1

18SEP2020

LOST TO FOLLOW-UP

subject is lost to follow up

1

57 02OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

subject withdrew consent

1

57 02OCT2020

WITHDRAWAL BY SUBJECT

subject withdrew consent

FOLLOW-UP

FOLLOW-UP

FDA-CBER-2021-5683-0129031

Page 42

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects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 1135 11351132 C4591001 1135 11351199 C4591001 1135 11351200 C4591001 1135 11351212

Dose Rel Withdrawal No. Daya Date

C4591001 1135 11351428

Withdrawal Reason

Commentb

2

38 08OCT2020 VACCINATION LOST TO FOLLOW-UP

2

38 08OCT2020

1

39 01OCT2020 VACCINATION LOST TO FOLLOW-UP

1

39 01OCT2020

1

54 16OCT2020 VACCINATION LOST TO FOLLOW-UP

Lost to follow up, certified letter sent to patient.

1

54 16OCT2020

subject lost to follow-up, certified letter was sent

1

35

28SEP2020 VACCINATION LOST TO FOLLOW-UP

1

35

28SEP2020

FOLLOW-UP

LOST TO FOLLOW-UP

subject lost to follow-up, certified letter was sent

19SEP2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

during screening visit, subject withdrew consent after randomization

C4591001 1135 11351389 C4591001 1135 11351420

Study Phase

FOLLOW-UP

FOLLOW-UP

FOLLOW-UP

LOST TO FOLLOW-UP

LOST TO FOLLOW-UP

LOST TO FOLLOW-UP

subject contact attempted several times, certified letter mailed on 08OCT2020. subject lost to follow-up Lost to follow up, certified letter sent to patient.

subject lost to follow-up, certified letter sent

patient was lost to follow up. certified letter was sent.

1

27 19OCT2020 VACCINATION LOST TO FOLLOW-UP

subject contact attempted several times and certified letter sent 19OCT2020

1

27 19OCT2020

LOST TO FOLLOW-UP

subject contact attempted several times and certified letter sent on 19OCT2020

1

27 19OCT2020 VACCINATION LOST TO FOLLOW-UP

subject contact attempted several times and certified letter was sent on 19OCT2020

1

27 19OCT2020

subject contact attempted several times and certified letter was sent on 19OCT2020

FOLLOW-UP

FOLLOW-UP

LOST TO FOLLOW-UP

FDA-CBER-2021-5683-0129032

Page 43

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 1135 11351430

Dose Rel Withdrawal No. Daya Date

Study Phase

Withdrawal Reason

Commentb

1

26 19OCT2020 VACCINATION LOST TO FOLLOW-UP

subject contact attempted several times and certified letter sent on 19OCT2020

1

26 19OCT2020

LOST TO FOLLOW-UP

subject contact attempted several times and certified letter sent on 19OCT2020

1

18 10NOV2020 VACCINATION

WITHDRAWAL BY SUBJECT

subject withdrew consent

1

18 10NOV2020 FOLLOW-UP

WITHDRAWAL BY SUBJECT

subject withdrew consent

1

75 06NOV2020 VACCINATION LOST TO FOLLOW-UP

Unable to contact subject after multiple attempts and certified letter sent

1

75 06NOV2020 FOLLOW-UP

LOST TO FOLLOW-UP

Unable to contact subject after multiple attempts and certified letter.

2

54 03NOV2020 VACCINATION

WITHDRAWAL BY SUBJECT

SUBJECT CONSIDERED WITHDRAWING CONSENT

2

54 03NOV2020 FOLLOW-UP

WITHDRAWAL BY SUBJECT

Subject withdrew consent via phone on 03Nov2020

1

23 13NOV2020 VACCINATION

ADVERSE EVENT

ADVERSE EVENT/AMNESIA

1

23 13NOV2020 VACCINATION

ADVERSE EVENT

ADVERSE EVENT/PARAPARESIS

C4591001 1141 11411146

1

50 16OCT2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

Subject no longer meets eligibility criteria. Exclusion #5

C4591001 1141 11411164

1

58 29OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

subject declined second vaccination

C4591001 1135 11351523

C4591001 1136 11361045

C4591001 1140 11401177

C4591001 1140 11401306

FOLLOW-UP

FDA-CBER-2021-5683-0129033

Page 44

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 1142 11421084

2

62 04NOV2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

Discontinued d/t medical history discovered after enrollment per instructions of CRA

C4591001 1147 11471035

1

49

23SEP2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

Meets exclusion criterion 5

C4591001 1147 11471212

1

21

23SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject withdrew consent

1

21

23SEP2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

Subject withdrew consent

1

21 25AUG2020 VACCINATION

WITHDRAWAL BY SUBJECT

patient will be out of state for a long period of time so unable to return for study visits

1

21 25AUG2020 FOLLOW-UP

WITHDRAWAL BY SUBJECT

pt withdrew consent from study. unable to return for visits due to upcoming scheduling conflicts

2

18

11SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

subject withdrew consent and no longer wishes to continue in study citing personal reasons

2

18

11SEP2020

WITHDRAWAL BY SUBJECT

subject withdrew consent and no longer wishes to participate in the study due to personal reasons

1

68 16OCT2020 VACCINATION LOST TO FOLLOW-UP

Lost to follow up left several VM and certified letter send 09oct2020.

1

68 16OCT2020

LOST TO FOLLOW-UP

patient has been unresponsive to repeated site contacts via phone, email and certified letter

1

31

11SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

pt is withdrawing consent from study due to personal reasons

1

31

11SEP2020

WITHDRAWAL BY SUBJECT

subject withdrew consent and does not wish to continue in study citing personal reasons

C4591001 1149 11491005

C4591001 1149 11491007

C4591001 1149 11491031

C4591001 1149 11491065

FOLLOW-UP

FOLLOW-UP

FOLLOW-UP

FDA-CBER-2021-5683-0129034

Page 45

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 1149 11491066

1

78 28OCT2020 VACCINATION

C4591001 1149 11491067

1

21

01SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

patient withdrew consent from the study

1

21

01SEP2020

WITHDRAWAL BY SUBJECT

subject withdrew consent and no longer wishes to participate in the study

1

60 09NOV2020 VACCINATION LOST TO FOLLOW-UP

1

60 09NOV2020 FOLLOW-UP

C4591001 1152 11521030

1

22

02SEP2020 VACCINATION PHYSICIAN DECISION

PHYSICIAN DECISION

C4591001 1152 11521034

1

41

21SEP2020 VACCINATION LOST TO FOLLOW-UP

Several phone messages were left for subject. Certified letter was sent.

1

41

21SEP2020

2

10

10SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

Now has 2 jobs and has no time to do study.

2

10

10SEP2020

WITHDRAWAL BY SUBJECT

Withdrawal by subject due to time constraints.

2

1

03SEP2020 VACCINATION

OTHER

Subject had both vaccinations and then moved out of state. No Visit 3 was or ever will be done.

2

33 05OCT2020

WITHDRAWAL BY SUBJECT

SUBJECT MOVED TO ARIZONA

C4591001 1149 11491230

C4591001 1152 11521043

C4591001 1152 11521077

FOLLOW-UP

FOLLOW-UP

FOLLOW-UP

FOLLOW-UP

NO LONGER MEETS Subject was asymptomatic and tested positive for COVIDELIGIBILITY CRITERIA 19 by outside provided.

Subject sent LTFU certified letter 30OCT2020.

LOST TO FOLLOW-UP Subject is non responsive. Certified letter sent 30OCT2020.

LOST TO FOLLOW-UP Certified letter sent; return receipt received back signed by someone other than the subject.

FDA-CBER-2021-5683-0129035

Page 46

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 1152 11521085

Dose Rel Withdrawal No. Daya Date

Study Phase

Withdrawal Reason

Commentb

1

8

26AUG2020 VACCINATION

DEATH

DEATH

1

8

26AUG2020 FOLLOW-UP

DEATH

DEATH

C4591001 1156 11561006

1

20

08SEP2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

Exclusion Criteria 5

C4591001 1156 11561015

1

39

28SEP2020 VACCINATION

PREGNANCY

PREGNANCY

C4591001 1156 11561033

1

16

10SEP2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

Exclusion Criteria 5

C4591001 1157 11571003

1

56 06OCT2020 VACCINATION LOST TO FOLLOW-UP

All attempts to contact subject have not been successful.

1

56 06OCT2020

LOST TO FOLLOW-UP

All attempts to contact subject have been unsuccessful

1

38 01OCT2020 VACCINATION LOST TO FOLLOW-UP

All attempts to contact subject have been unsuccessful

1

38 01OCT2020

LOST TO FOLLOW-UP

All attempts to contact subject have been unsuccessful

2

30 14OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject W/C due to moving

2

30 14OCT2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

Voluntary withdrawal not due to an AE or SAE

1

23

24SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

Voluntary withdrawal not due to an adverse event

1

23

24SEP2020

WITHDRAWAL BY SUBJECT

Voluntary withdrawal not due to an AE or SAE

C4591001 1157 11571070 C4591001 1157 11571077

C4591001 1157 11571135

FOLLOW-UP

FOLLOW-UP

FOLLOW-UP

FDA-CBER-2021-5683-0129036

Page 47

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 1161 11611002

1

85 23OCT2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

Exclusion 5

C4591001 1161 11611008

1

103 10NOV2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

Exclusion criterion 5

C4591001 1161 11611023

1

72 13OCT2020 VACCINATION LOST TO FOLLOW-UP

1

72 13OCT2020

C4591001 1161 11611024

1

25 27AUG2020 VACCINATION LOST TO FOLLOW-UP

C4591001 1162 11621005

1

32 31AUG2020 VACCINATION

WITHDRAWAL BY SUBJECT

The subject prematurely withdrew from study.

1

32 31AUG2020 FOLLOW-UP

WITHDRAWAL BY SUBJECT

subject prematurely withdrawn from study.

06AUG2020 FOLLOW-UP

WITHDRAWAL BY SUBJECT

Subject Randomized in error

LOST TO FOLLOW-UP

subject LTFU after multiple contact attempts.

C4591001 1162 11621024

FOLLOW-UP

subject had several contact attempts by site along with certified letter. Unable to contact subject.

LOST TO FOLLOW-UP cert. letter sent and signed by subject. unable to contact and subject has not called site. unable to contact subject. certified letter returned, no response from subject

C4591001 1162 11621074

2

73 13NOV2020 FOLLOW-UP

C4591001 1162 11621080

2

64 04NOV2020 VACCINATION LOST TO FOLLOW-UP

Subject LTFU

2

64 04NOV2020 FOLLOW-UP

Subject LTFU

LOST TO FOLLOW-UP

FDA-CBER-2021-5683-0129037

Page 48

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 1162 11621118

Dose Rel Withdrawal No. Daya Date

Study Phase

Withdrawal Reason

Commentb

1

35

16SEP2020 VACCINATION LOST TO FOLLOW-UP

1

35

16SEP2020

FOLLOW-UP

LOST TO FOLLOW-UP

Subject withdrew from study

C4591001 1162 11621137

2

66 13NOV2020 FOLLOW-UP

LOST TO FOLLOW-UP

Subject LTFU after multiple contact attempts.

C4591001 1162 11621164

2

66 13NOV2020 FOLLOW-UP

LOST TO FOLLOW-UP

Subject LTFU after multiple contact attempts.

C4591001 1162 11621294

1

60 06NOV2020 VACCINATION LOST TO FOLLOW-UP

Subject LTFU after many contact attempts

1

60 06NOV2020 FOLLOW-UP

Subject LTFU after many contact attempts

1

60 06NOV2020 VACCINATION LOST TO FOLLOW-UP

Subject LTFU

1

60 06NOV2020 FOLLOW-UP

LOST TO FOLLOW-UP

Subject LTFU

1

54 06NOV2020 VACCINATION LOST TO FOLLOW-UP

Subject LTFU

1

54 06NOV2020 FOLLOW-UP

C4591001 1162 11621310 C4591001 1162 11621374 C4591001 1162 11621477

30SEP2020

FOLLOW-UP

C4591001 1163 11631059

1

2

08AUG2020 VACCINATION

C4591001 1163 11631069

1

66 14OCT2020 VACCINATION

LOST TO FOLLOW-UP

SUBECT WITHDREW,CERTIFIED LETTER SENT 9/16/2020

LOST TO FOLLOW-UP

Subject LTFU after many contact attempts.

PROTOCOL DEVIATION

Randomized in error

ADVERSE EVENT

ADVERSE EVENT/UPPER BODYRASH DUE TO VACCINE@@

OTHER

REHAB

FDA-CBER-2021-5683-0129038

Page 49

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 1163 11631123

C4591001 1166 11661037

C4591001 1166 11661047

Dose Rel Withdrawal No. Daya Date

Commentb

58 04NOV2020 VACCINATION

WITHDRAWAL BY SUBJECT

SUBJECT WITHDREW CONSENT

2

58 04NOV2020 FOLLOW-UP

WITHDRAWAL BY SUBJECT

SUBJECT WITHDREW CONSENT

2

37 15OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject refused further procedures.

2

37 15OCT2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

Patient refused further study procedures. Updated per DM.

1

1

31AUG2020 VACCINATION

ADVERSE EVENT

ADVERSE EVENT/DIZZINESS

14AUG2020 FOLLOW-UP

NO LONGER MEETS ELIGIBILITY CRITERIA

Did not meet inclusion criteria #3

1

38 08OCT2020 VACCINATION LOST TO FOLLOW-UP Subject is lost to follow up tried multiple calls and certified letter

1

38 08OCT2020

FOLLOW-UP

LOST TO FOLLOW-UP

no answer after multiple calls and sent certified letter

15AUG2020

SCREENING

OTHER

randomized in error

15AUG2020 FOLLOW-UP

PROTOCOL DEVIATION

subject randomized in error

2

29 02NOV2020 VACCINATION

WITHDRAWAL BY SUBJECT

Pt. will no longer complete study visits due to her schedule and withdrew consent to participate

2

29 02NOV2020 FOLLOW-UP

WITHDRAWAL BY SUBJECT

Pt would not return for visits as required and chose to no longer participate Verbal WOC

C4591001 1168 11681030

C4591001 1168 11681070

Withdrawal Reason

2

C4591001 1167 11671003 C4591001 1167 11671111

Study Phase

FDA-CBER-2021-5683-0129039

Page 50

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 1168 11681077

Dose Rel Withdrawal No. Daya Date

Study Phase

Withdrawal Reason

Commentb

2

28 12OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

PATIENT WITHDREW CONSENT

2

28 12OCT2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

Patient withdrew consent

C4591001 1168 11681097

2

1

15SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

The subject is unable to complete V3 due to his work. Pt will complete the rest of the study visits

C4591001 1168 11681104

1

70 05NOV2020 VACCINATION LOST TO FOLLOW-UP multiple attempts to reach patient for missed Visit 2 and no response.

1

70 05NOV2020 FOLLOW-UP

LOST TO FOLLOW-UP

multiple attempts to reach patient after missed Visit 2 and no response.

2

34 10NOV2020 VACCINATION

WITHDRAWAL BY SUBJECT

The patient chose to no longer participate due to distance and an assumption of placebo group

2

34 10NOV2020 FOLLOW-UP

WITHDRAWAL BY SUBJECT

the subject withdrew consent to participate

C4591001 1169 11691058

1

17 02OCT2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

Covid +

C4591001 1170 11701311

1

33 16OCT2020 VACCINATION LOST TO FOLLOW-UP

Subject contacted multiple times, never responded.

1

33 16OCT2020

LOST TO FOLLOW-UP

lost to follow-up subjects subject didnt come for visit.

2

29

28SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject stated they do not want to participate in the study anymore. Subject withdrew consent.

2

29

28SEP2020

WITHDRAWAL BY SUBJECT

Subject stated they do not want to participate in the study anymore. Subject withdrew consent.

C4591001 1168 11681178

C4591001 1171 11711004

FOLLOW-UP

FOLLOW-UP

FDA-CBER-2021-5683-0129040

Page 51

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 1171 11711042

Dose Rel Withdrawal No. Daya Date

Study Phase

Withdrawal Reason

Commentb

1

39

24SEP2020 VACCINATION LOST TO FOLLOW-UP

Per PI instructions subject LTFU

1

39

24SEP2020

LOST TO FOLLOW-UP

Per PI instructions subject LTFU

1

37

24SEP2020 VACCINATION LOST TO FOLLOW-UP

Per PI instructions subject is LTFU

1

37

24SEP2020

Per PI instructions subject LTFU

1

45 09OCT2020 VACCINATION LOST TO FOLLOW-UP

1

45 09OCT2020

1

39 08OCT2020 VACCINATION LOST TO FOLLOW-UP

Per PI, subject LTFU.

1

39 08OCT2020

Per PI, subject LTFU

1

74 06NOV2020 VACCINATION LOST TO FOLLOW-UP

1

74 06NOV2020 FOLLOW-UP

C4591001 1178 11781107

1

22

C4591001 1179 11791138

1

11 03NOV2020 VACCINATION

NO LONGER MEETS Exclusion criterion 5. VAX2 is not given but FUP will be ELIGIBILITY CRITERIA completed.

C4591001 1194 11941061

1

8

NO LONGER MEETS ELIGIBILITY CRITERIA

C4591001 1171 11711072 C4591001 1171 11711131 C4591001 1171 11711159 C4591001 1177 11771139

FOLLOW-UP

FOLLOW-UP

FOLLOW-UP

FOLLOW-UP

25SEP2020 VACCINATION

26OCT2020 VACCINATION

LOST TO FOLLOW-UP

LOST TO FOLLOW-UP

LOST TO FOLLOW-UP

Subject LTFU.

Per PI instructions, subject LTFU.

LOST TO FOLLOW-UP

LOST TO FOLLOW-UP

Lost to follow-up

ADVERSE EVENT

ADVERSE EVENT/LYMPHADENOPATHY

Exclusion Criterion 5

FDA-CBER-2021-5683-0129041

Page 52

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

C4591001 1195 11951061

1

21 06NOV2020 VACCINATION

C4591001 1203 12031037

1

6

C4591001 1204 12041197†

1

37 13NOV2020 VACCINATION

C4591001 1205 12051028

26OCT2020 VACCINATION

30OCT2020

FOLLOW-UP

Withdrawal Reason

Commentb

WITHDRAWAL BY SUBJECT

patient withdrawal consent. she is afraid about the second vaccination

NO LONGER MEETS ELIGIBILITY CRITERIA

Covid-19 Illness between V1 and V2(Positive self swab+symptoms) no 2ndvaccination administered.

WITHDRAWAL BY SUBJECT

Participant has chosen to withdraw from the study.

ADVERSE EVENT

ADVERSE EVENT/BLOOD PRESSURE INCREASED

C4591001 1207 12071024

1

17 13NOV2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

Participant symptomatic COVID +

C4591001 1209 12091013

1

9

10NOV2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

Exclusion criterion 5. VAX2 is not given but follow-up will be completed

03NOV2020 FOLLOW-UP

NO LONGER MEETS ELIGIBILITY CRITERIA

After PI judgement, subject was not vaccinated.

10NOV2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

Exclusion criterion 5

C4591001 1212 12121023 C4591001 1217 12171044

1

7

C4591001 1223 12231200

21SEP2020

FOLLOW-UP

PROTOCOL DEVIATION

subject randomized in error

C4591001 1223 12231234

12OCT2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

subject left the site before vaccination 1

FDA-CBER-2021-5683-0129042

Page 53

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 1224 12241009

Dose Rel Withdrawal No. Daya Date

Study Phase

Withdrawal Reason

Commentb

1

37

18SEP2020 VACCINATION LOST TO FOLLOW-UP

1

37

18SEP2020

1

13

05SEP2020 VACCINATION

ADVERSE EVENT

ADVERSE EVENT/HEART RATE IRREGULAR

1

13

05SEP2020

FOLLOW-UP

ADVERSE EVENT

ADVERSE EVENT

C4591001 1226 12261072

1

22

01SEP2020 VACCINATION

ADVERSE EVENT

ADVERSE EVENT/MYALGIA

C4591001 1226 12261108

2

32 01OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

Participant withdrew consent for not wanting to comply with the study procedures.

2

32 01OCT2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

withdrawal by subject

C4591001 1226 12261205

2

51 28OCT2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

Subject did not want to continue in the study.

C4591001 1226 12261272

2

28 07OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

The subject withdrew consent due unavailability.

2

28 07OCT2020

REFUSED FURTHER STUDY PROCEDURES

REFUSED FURTHER STUDY PROCEDURES

1

44 07OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

The subject did not want to continue in the studies procedures.

1

44 07OCT2020

WITHDRAWAL BY SUBJECT

The subject has no more availability to continue in the study.

C4591001 1224 12241065

C4591001 1226 12261409

FOLLOW-UP

FOLLOW-UP

FOLLOW-UP

PT failed to attend V2; site attempted contact via phone and certified letter

LOST TO FOLLOW-UP PT failed to return for V2; site attempted contact via phone and certified letter

FDA-CBER-2021-5683-0129043

Page 54

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 1226 12261894

1

5

29SEP2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

The subject had a RT-PCR test COVID-19, so he was discontinued from the study, not recieving the V2.

C4591001 1226 12262108

1

20 27OCT2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

Exclusion criterion 5

C4591001 1226 12262189

1

14 27OCT2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

Exclusion criterion 5

C4591001 1226 12262267

1

2

NO LONGER MEETS ELIGIBILITY CRITERIA

Exclusion criteria 5

C4591001 1229 12291204

1

30 11NOV2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject withdrew consent.

C4591001 1230 12301045†

1

22 20OCT2020 VACCINATION

PREGNANCY

PREGNANCY

C4591001 1230 12301148

1

23 28OCT2020 VACCINATION

OTHER

Patient confirmed re-location for work purposes not foreseen. Not able to attend study visits

1

23 28OCT2020

OTHER

Participant relocated and cannot attend study procedures.

1

23 28OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject withdrew their consent.

1

23 28OCT2020

WITHDRAWAL BY SUBJECT

Subject cannot commit to all the study procedures.

1

37

C4591001 1230 12301150

C4591001 1231 12311031

18OCT2020 VACCINATION

FOLLOW-UP

FOLLOW-UP

15SEP2020 VACCINATION

NO LONGER MEETS Previous clinical or microbiological diagnosis of COVIDELIGIBILITY CRITERIA 19

FDA-CBER-2021-5683-0129044

Page 55

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 1231 12311054

Dose Rel Withdrawal No. Daya Date

Study Phase

Withdrawal Reason

Commentb

1

45

24SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

The subject refers that the decision to stop participating in the study is due to lack of time

1

45

24SEP2020

WITHDRAWAL BY SUBJECT

No time necessary to comply with the visits and the demand that it takes to participate in the study

1

39

19SEP2020 VACCINATION

NO LONGER MEETS Previous clinical or microbiological diagnosis of COVIDELIGIBILITY CRITERIA 19

1

39

19SEP2020

NO LONGER MEETS ELIGIBILITY CRITERIA

C4591001 1231 12311088

1

48

28SEP2020 VACCINATION

NO LONGER MEETS Previous clinical or microbiological diagnosis of COVIDELIGIBILITY CRITERIA 19

C4591001 1231 12311125

1

23

04SEP2020 VACCINATION

NO LONGER MEETS Participants who, in the judment of the investigator, are at ELIGIBILITY CRITERIA risk for acquiring COVID-19

C4591001 1231 12311147

1

7

19AUG2020 VACCINATION

NO LONGER MEETS Previous clinical or microbiological diagnosis of COVIDELIGIBILITY CRITERIA 19

C4591001 1231 12311189

1

39

21SEP2020 VACCINATION

NO LONGER MEETS Previous clinical or microbiological diagnosis of COVIDELIGIBILITY CRITERIA 19

C4591001 1231 12311191

1

32

14SEP2020 VACCINATION

NO LONGER MEETS Previous clinical or microbiological diagnosis of COVIDELIGIBILITY CRITERIA 19

C4591001 1231 12311195

1

40

22SEP2020 VACCINATION

NO LONGER MEETS Previous clinical or microbiological diagnosis of COVIDELIGIBILITY CRITERIA 19

C4591001 1231 12311200

1

22

04SEP2020 VACCINATION

C4591001 1231 12311087

FOLLOW-UP

FOLLOW-UP

WITHDRAWAL BY SUBJECT

Discontinued due to previous clinical or microbiological diagnosis of COVID-19

the subject did not sign amendment 5 because he did not agree

FDA-CBER-2021-5683-0129045

Page 56

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 1231 12311356

C4591001 1231 12311374

C4591001 1231 12311391 C4591001 1231 12311402

Dose Rel Withdrawal No. Daya Date

C4591001 1231 12311431

C4591001 1231 12311441

Withdrawal Reason

Commentb

1

22

FOLLOW-UP

WITHDRAWAL BY SUBJECT

the subject did not sign amendment 5 because he did not agree

1

64 17OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

The volunteer did not specify the reason why she decided to stop participating.

1

64 17OCT2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

The volunteer did not specify the reason why she decided to stop participating.

1

31

14SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

The subject reports that the decision to stop participating in the study is of a personal nature

1

31

14SEP2020

WITHDRAWAL BY SUBJECT

The subject reports that the decision to stop participating in the study is of a personal nature

1

14 28AUG2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

COVID 19 DIAGNOSIS

1

80 02NOV2020 FOLLOW-UP

LOST TO FOLLOW-UP

lost to follow up after several tries of contact

1

30

NO LONGER MEETS Previous clinical or microbiological diagnosis of COVIDELIGIBILITY CRITERIA 19

C4591001 1231 12311409

04SEP2020

Study Phase

FOLLOW-UP

13SEP2020 VACCINATION

25SEP2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

the subject decided to withdraw the consent.

1

27

10SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

The subject is afraid of exposure to COVID-19 in next study visits

1

27

10SEP2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

you fear going to a health institution and that this will expose you to be reinfected by SARS-COV2

1

28

11SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

for having moved to Gualeguaychu (Province of Entre Rios)

FDA-CBER-2021-5683-0129046

Page 57

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

for having moved to Gualeguaychu (Province of Entre Rios) Codiv 19 positive

1

28

11SEP2020

C4591001 1231 12311443

1

27

10SEP2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

C4591001 1231 12311473

1

29

12SEP2020 VACCINATION

NO LONGER MEETS Previous clinical or microbiological diagnosis of COVIDELIGIBILITY CRITERIA 19

C4591001 1231 12311516

13OCT2020

FOLLOW-UP

does not want to continue with the controls, after informing you that it was discontinued.

C4591001 1231 12311532

1

23

C4591001 1231 12311557

2

46 19OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

He believes that received a placebo and therefore has no interest in continuing with further control

2

46 19OCT2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

subject THINKS received placebo, so withdrew consent

1

28

12SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

The subject reports that the decision to stop participating in the study is of a personal nature

1

28

12SEP2020

WITHDRAWAL BY SUBJECT

subject decided to withdraw consent

C4591001 1231 12311568

1

37

21SEP2020 VACCINATION

C4591001 1231 12311577

2

57 02NOV2020 FOLLOW-UP

C4591001 1231 12311559

07SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

FOLLOW-UP

NO LONGER MEETS Previous clinical or microbiological diagnosis of COVIDELIGIBILITY CRITERIA 19

NO LONGER MEETS Previous clinical or microbiological diagnosis of COVIDELIGIBILITY CRITERIA 19 WITHDRAWAL BY SUBJECT

the decision to stop participating is due to personal reasons

FDA-CBER-2021-5683-0129047

Page 58

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 1231 12311641

1

29

13SEP2020 VACCINATION

NO LONGER MEETS Previous clinical or microbiological diagnosis of COVIDELIGIBILITY CRITERIA 19

C4591001 1231 12311656

1

40

24SEP2020 VACCINATION

NO LONGER MEETS Previous clinical or microbiological diagnosis of COVIDELIGIBILITY CRITERIA 19

C4591001 1231 12311816

1

31

16SEP2020 VACCINATION

NO LONGER MEETS Previous clinical or microbiological diagnosis of COVIDELIGIBILITY CRITERIA 19

C4591001 1231 12311911

1

38

24SEP2020 VACCINATION

NO LONGER MEETS Previous clinical or microbiological diagnosis of COVIDELIGIBILITY CRITERIA 19

C4591001 1231 12311926 C4591001 1231 12311973

C4591001 1231 12311991

C4591001 1231 12311996 C4591001 1231 12312176

18AUG2020 FOLLOW-UP

ADVERSE EVENT

ADVERSE EVENT/SYNCOPE

2

43 20OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

The volunteer communicated his desire to withdraw consent to participate in the study when the alarm

2

43 20OCT2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

The volunteer communicated his desire to withdraw consent to participate in the study when the alarm

1

21

07SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

subject decided to withdraw consent

1

21

07SEP2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

subject decided to withdraw consent

2

60 06NOV2020 FOLLOW-UP

WITHDRAWAL BY SUBJECT

the decision to stop participating is due to going to live abroad.

PROTOCOL DEVIATION

Subject randomized for error

19AUG2020 FOLLOW-UP

FDA-CBER-2021-5683-0129048

Page 59

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 1231 12312186

Dose Rel Withdrawal No. Daya Date

Study Phase

Withdrawal Reason

Commentb

2

35 13OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

the decision to stop participating is due to personal and work issues.

2

35 13OCT2020

WITHDRAWAL BY SUBJECT

the decision to stop participating is due to personal and work issues.

C4591001 1231 12312244

1

23

10SEP2020 VACCINATION

NO LONGER MEETS Previous clinical or microbiological diagnosis of COVIDELIGIBILITY CRITERIA 19

C4591001 1231 12312284

1

22

09SEP2020 VACCINATION

NO LONGER MEETS Previous clinical or microbiological diagnosis of COVIDELIGIBILITY CRITERIA 19

C4591001 1231 12312320

1

61 18OCT2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

C4591001 1231 12312326

1

34

21SEP2020 VACCINATION

NO LONGER MEETS Previous clinical or microbiological diagnosis of COVIDELIGIBILITY CRITERIA 19

C4591001 1231 12312334

1

32

19SEP2020 VACCINATION

NO LONGER MEETS Previous clinical or microbiological diagnosis of COVIDELIGIBILITY CRITERIA 19

C4591001 1231 12312339

1

38

25SEP2020 VACCINATION

NO LONGER MEETS Previous clinical or microbiological diagnosis of COVIDELIGIBILITY CRITERIA 19

C4591001 1231 12312361

1

68 25OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

Inability to attend visits for work reasons

1

68 25OCT2020

WITHDRAWAL BY SUBJECT

subject withdraw consent due to personal reasons

1

28

C4591001 1231 12312365

FOLLOW-UP

FOLLOW-UP

15SEP2020 VACCINATION

subject with previous clinically or microbiological diagnosis of COVID-19

NO LONGER MEETS Previous clinical or microbiological diagnosis of COVIDELIGIBILITY CRITERIA 19

FDA-CBER-2021-5683-0129049

Page 60

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

FOLLOW-UP

WITHDRAWAL BY SUBJECT

Commentb

1

56 13OCT2020

C4591001 1231 12312375

1

26

13SEP2020 VACCINATION

C4591001 1231 12312403

1

24

11SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

The patient does not want to take the second dose.

C4591001 1231 12312451

1

23

11SEP2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

Participants who are willing and able to comply with all scheduled visits, vaccination plan, lab...

20AUG2020 FOLLOW-UP

PROTOCOL DEVIATION

subject randomized in error

C4591001 1231 12312483

subject decided to withdraw consent due to lack of time

NO LONGER MEETS Previous clinical or microbiological diagnosis of COVIDELIGIBILITY CRITERIA 19

C4591001 1231 12312559

1

23

11SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

The subject is available to attend the protocol visits

C4591001 1231 12312577

1

9

28AUG2020 VACCINATION

ADVERSE EVENT

ADVERSE EVENT/METASTASES TO CENTRAL NERVOUS SYSTEM

C4591001 1231 12312594

1

77 04NOV2020 VACCINATION

WITHDRAWAL BY SUBJECT

Stop participating for personal reasons

1

77 04NOV2020 FOLLOW-UP

WITHDRAWAL BY SUBJECT

Subject Withdraws his consent for personal reasons

C4591001 1231 12312660

1

56 14OCT2020 VACCINATION

C4591001 1231 12312713

2

35 14OCT2020

FOLLOW-UP

NO LONGER MEETS Previous clinical or microbiological diagnosis of COVIDELIGIBILITY CRITERIA 19 WITHDRAWAL BY SUBJECT

the decision to stop participating is due to personal reason.

FDA-CBER-2021-5683-0129050

Page 61

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

29SEP2020 VACCINATION

Withdrawal Reason

Commentb

C4591001 1231 12312752

1

40

C4591001 1231 12312759

2

36 16OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

the volunteer reported her desire to withdraw consent to participate in the study

2

36 16OCT2020

WITHDRAWAL BY SUBJECT

the volunteer reported her desire to withdraw consent to participate in the study

C4591001 1231 12312763

1

35

24SEP2020 VACCINATION

C4591001 1231 12312848

1

29

18SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject withdraws consent. Subject declares she does not want to be part of the research study

1

29

18SEP2020

WITHDRAWAL BY SUBJECT

Subject withdraws consent. Subject declares she does not want to be part of the research study

C4591001 1231 12312916

1

20

09SEP2020 VACCINATION

C4591001 1231 12312982

2

15

23SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

The subject reports that the decision to stop participating in the study is of a personal nature

2

15

23SEP2020

WITHDRAWAL BY SUBJECT

Withdrawal of consent for personal reasons

C4591001 1231 12313006

1

21

10SEP2020 VACCINATION

C4591001 1231 12313030

2

37 16OCT2020 VACCINATION

FOLLOW-UP

FOLLOW-UP

FOLLOW-UP

NO LONGER MEETS Previous clinical or microbiological diagnosis of COVIDELIGIBILITY CRITERIA 19

NO LONGER MEETS Previous clinical or microbiological diagnosis of COVIDELIGIBILITY CRITERIA 19

NO LONGER MEETS Previous clinical or microbiological diagnosis of COVIDELIGIBILITY CRITERIA 19.

NO LONGER MEETS Previous clinical or microbiological diagnosis of COVIDELIGIBILITY CRITERIA 19 WITHDRAWAL BY SUBJECT

The decision to stop participating is due to personal reasons.

FDA-CBER-2021-5683-0129051

Page 62

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

FOLLOW-UP

WITHDRAWAL BY SUBJECT

Commentb

2

37 16OCT2020

C4591001 1231 12313068

1

23

13SEP2020 VACCINATION

NO LONGER MEETS Previous clinical or microbiological diagnosis of COVIDELIGIBILITY CRITERIA 19

C4591001 1231 12313069

1

35

25SEP2020 VACCINATION

NO LONGER MEETS Previous clinical or microbiological diagnosis of COVIDELIGIBILITY CRITERIA 19

C4591001 1231 12313115

1

20

10SEP2020 VACCINATION

NO LONGER MEETS Previous clinical or microbiological diagnosis of COVIDELIGIBILITY CRITERIA 19

C4591001 1231 12313125

1

24

14SEP2020 VACCINATION

NO LONGER MEETS Previous clinical or microbiological diagnosis of COVIDELIGIBILITY CRITERIA 19

C4591001 1231 12313175

1

32

22SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

The subject refuses to receive the second dosis of the investigation product

C4591001 1231 12313207

1

21

11SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

The volunteer wishes to have a child with his current partner in the short term

1

21

11SEP2020

WITHDRAWAL BY SUBJECT

the volunteer wants to have a child in the short term

C4591001 1231 12313211

1

11

01SEP2020 VACCINATION

NO LONGER MEETS Previous clinical or microbiological diagnosis of COVIDELIGIBILITY CRITERIA 19.

C4591001 1231 12313225

1

20

10SEP2020 VACCINATION

NO LONGER MEETS Previous clinical or microbiological diagnosis of COVIDELIGIBILITY CRITERIA 19

C4591001 1231 12313357

1

20

11SEP2020 VACCINATION

NO LONGER MEETS Previous clinical or microbiological diagnosis of COVIDELIGIBILITY CRITERIA 19

FOLLOW-UP

The decision to stop participating is due to personal reasons.

FDA-CBER-2021-5683-0129052

Page 63

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 1231 12313376

Dose Rel Withdrawal No. Daya Date

Study Phase

Withdrawal Reason

Commentb

1

22

13SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

being written phase 2/3 does not assure you that the safety of the product has been fully evaluated

1

22

13SEP2020

WITHDRAWAL BY SUBJECT

being written phase 2/3 does not assure you that the safety of the product has been fully evaluated

C4591001 1231 12313395

1

23

14SEP2020 VACCINATION

C4591001 1231 12313428

1

24

15SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

The patient decided not to apply the second dose.

23AUG2020 FOLLOW-UP

WITHDRAWAL BY SUBJECT

randomized, no vaccinated

C4591001 1231 12313443

FOLLOW-UP

NO LONGER MEETS Previous clinical or microbiological diagnosis of COVIDELIGIBILITY CRITERIA 19

C4591001 1231 12313449

1

24

15SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject refused to receive the second dose due to the previous medication dosis error.

C4591001 1231 12313459

1

24

15SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

subject made the decision not to receive the second vaccination

C4591001 1231 12313467

1

24

15SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

the subject did not agree to be vaccinated a second time,but will continue in the study

C4591001 1231 12313469

1

24

15SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

the subject did not want to receive a second dose but did continue in the study

C4591001 1231 12313479

1

24

15SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

the subject decided not to received second dose of the investigational product

C4591001 1231 12313486

1

24

15SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

the subject did not agree to be vaccinated a second time,but will continue in the study FDA-CBER-2021-5683-0129053

Page 64

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 1231 12313492

1

28

19SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

the subject did not agree to be vaccinated a second time,but will continue in the study

C4591001 1231 12313497

1

25

16SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

the subject did not agree to be vaccinated a second time,but will continue in the study

C4591001 1231 12313498

1

25

16SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

the subject did not agree to be vaccinated a second time,but will continue in the study

C4591001 1231 12313506

1

25

16SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject refused to receive the second dose of treatment due to medication error in the first dose.

C4591001 1231 12313509

1

24

15SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

The subject didnt agree to receive the second dose of the vaccine but continues in the Study

C4591001 1231 12313510

1

48 09OCT2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

Exclusion criteria: Previous diagnosis (clinical or microbiological) of COVID-19

C4591001 1231 12313512

1

24

15SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject refused to receive the second dose of the treatment due to the medication error

C4591001 1231 12313514

1

24

15SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

subject declined to receive the second vaccination

C4591001 1231 12313517

1

27

18SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

subject declined to receive the second vaccination

C4591001 1231 12313518

1

25

16SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

Did not accept to receive second dose but accept continue with the rest of study procedures

FDA-CBER-2021-5683-0129054

Page 65

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 1231 12313519

Dose Rel Withdrawal No. Daya Date 1

24

C4591001 1231 12313527

Study Phase

Withdrawal Reason

Commentb

15SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

Did not accept to receive second dose but accept continue with the rest of study procedures

02OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

subject declined from receiving the investigation product

C4591001 1231 12313528

1

24

15SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

subject declined to receive the second vaccination

C4591001 1231 12313534

1

28

19SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

medication error in V1, the subject decided not to vaccinate in V2

C4591001 1231 12313537

1

25

16SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

medication error in V1, subject decided not to vaccinate in V2

C4591001 1231 12313541

1

26

17SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject did not receive the second vaccination but continued otherwise with study procedures

C4591001 1231 12313546

1

26

17SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject did not receive the second vaccination but continued otherwise with study procedures

C4591001 1231 12313551

1

27

18SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

The subject did not agree to receive the second dose, but continues in the study

C4591001 1231 12313554

1

28

19SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

The subject did not agree to receive the second dose, but continues in the study

C4591001 1231 12313567

1

26

17SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

The subject did not agree to receive the second dose, but continues in the study

FDA-CBER-2021-5683-0129055

Page 66

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

C4591001 1231 12313592

1

28

C4591001 1231 12313609

2

44 26OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

Withdrawal by subject due to personal (work) issues.

2

44 26OCT2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

the decision to stop participating is due to personal (work) issues.

2

43 27OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

the decision to stop participating is due to personal issues.

2

43 27OCT2020

WITHDRAWAL BY SUBJECT

the decision to stop participating is due to personal issues.

C4591001 1231 12313622

1

24

16SEP2020 VACCINATION

NO LONGER MEETS Healthy participants eligible for inclusion in the study and ELIGIBILITY CRITERIA Previous diagnosis of COVID-19

C4591001 1231 12313657

1

36

28SEP2020 VACCINATION

NO LONGER MEETS Previous clinical or microbiological diagnosis of COVIDELIGIBILITY CRITERIA 19

C4591001 1231 12313662

1

26

18SEP2020 VACCINATION

NO LONGER MEETS Previous clinical or microbiological diagnosis of COVIDELIGIBILITY CRITERIA 19

C4591001 1231 12313699

2

44 27OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

wants to leave the study

2

44 27OCT2020

WITHDRAWAL BY SUBJECT

wants to leave the study

1

52 14OCT2020 VACCINATION

C4591001 1231 12313619

C4591001 1231 12313709

19SEP2020 VACCINATION

Withdrawal Reason

FOLLOW-UP

FOLLOW-UP

NO LONGER MEETS Previous clinical or microbiological diagnosis of COVIDELIGIBILITY CRITERIA 19.

NO LONGER MEETS Previous clinical or microbiological diagnosis of COVIDELIGIBILITY CRITERIA 19

FDA-CBER-2021-5683-0129056

Page 67

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 1231 12313758

1

44 06OCT2020 VACCINATION

C4591001 1231 12313823

2

45 28OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

the decision to stop participating is due to personal reasons.

2

45 28OCT2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

the decision to stop participating is due to personal reasons.

2

40 28OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

Personal reason that he preferred not to share

2

40 28OCT2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

Personal reason that he preferred not to share

25AUG2020 FOLLOW-UP

WITHDRAWAL BY SUBJECT

the volunteer requests that she be withdrawn from the study

2

30 14OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

the decision to stop participating is due to strict personal family causes.

2

30 14OCT2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

the decision to stop participating is due to strict personal family causes

2

45 29OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

The decision to stop participating must be a move to the province of Santiago del Estero.

2

45 29OCT2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

The decision to stop participating must be a move to the province of Santiago del Estero.

2

37 23OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

the decision to stop participating is due to personal reasons.

2

37 23OCT2020

WITHDRAWAL BY SUBJECT

the decision to stop participating is due to personal reasons

C4591001 1231 12313851

C4591001 1231 12313869 C4591001 1231 12313955

C4591001 1231 12313981

C4591001 1231 12314030

FOLLOW-UP

NO LONGER MEETS Previous clinical or microbiological diagnosis of COVIDELIGIBILITY CRITERIA 19

FDA-CBER-2021-5683-0129057

Page 68

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 1231 12314134

1

20

14SEP2020 VACCINATION

C4591001 1231 12314179

1

30

24SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

subject withdrew consent after visit 1

1

30

24SEP2020

WITHDRAWAL BY SUBJECT

subject withdrew consent after visit 1

C4591001 1231 12314205

1

20

14SEP2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

Clinical diagnosis of covid 19

C4591001 1231 12314266

1

22

16SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

The subject reports that the decision to stop participating in the study is of a personal nature

1

22

16SEP2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

The subject reports that the decision to stop participating in the study is of a personal nature

1

27

21SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

The subject reports that the decision to stop participating in the study is of a personal nature

1

27

21SEP2020

WITHDRAWAL BY SUBJECT

The subject reports that the decision to stop participating in the study is of a personal nature.

1

55 20OCT2020 VACCINATION LOST TO FOLLOW-UP

1

55 20OCT2020

1

44 09OCT2020 VACCINATION

C4591001 1231 12314314

C4591001 1231 12314381

C4591001 1231 12314385

FOLLOW-UP

FOLLOW-UP

FOLLOW-UP

NO LONGER MEETS Previous clinical or microbiological diagnosis of COVIDELIGIBILITY CRITERIA 19

LOST TO FOLLOW-UP

Subject did not answer phone call or certified letter. Contact is considered lost subject did not answer phone or certified letter. Contact is consider lost

NO LONGER MEETS For meeting the exclusion criterion of previous diagnosis, ELIGIBILITY CRITERIA subject discontinued

FDA-CBER-2021-5683-0129058

Page 69

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 1231 12314492

1

20

15SEP2020 VACCINATION

NO LONGER MEETS Previous clinical or microbiological diagnosis of COVIDELIGIBILITY CRITERIA 19

C4591001 1231 12314580

1

33

28SEP2020 VACCINATION

NO LONGER MEETS Previous clinical or microbiological diagnosis of COVIDELIGIBILITY CRITERIA 19

C4591001 1231 12314590

1

15

10SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

The volunteer states that the decision to stop participating in the study is of a personal nature.

1

15

10SEP2020

WITHDRAWAL BY SUBJECT

The volunteer states that the decision to stop participating in the study is of a personal nature.

C4591001 1231 12314700

1

22

18SEP2020 VACCINATION

C4591001 1231 12314713

1

22

18SEP2020 VACCINATION

C4591001 1231 12314848

1

20

16SEP2020 VACCINATION

1

64 30OCT2020

2

43 28OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

unforeseen move out of the country, with no probable date of return.

2

43 28OCT2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

unforeseen move out of the country, with no probable date of return.

1

31

27SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

subject not being able to continue attending visits.

C4591001 1231 12314853

C4591001 1231 12314923

FOLLOW-UP

FOLLOW-UP

NO LONGER MEETS Previous clinical or microbiological diagnosis of COVIDELIGIBILITY CRITERIA 19 WITHDRAWAL BY SUBJECT

subject refused to recieve second dose of investigation product

NO LONGER MEETS Previous clinical or microbiological diagnosis of COVIDELIGIBILITY CRITERIA 19 LOST TO FOLLOW-UP after failed attempts of contact by phone and certified letter, it is consider lost of follow up

FDA-CBER-2021-5683-0129059

Page 70

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 1231 12314964

C4591001 1231 12314984

C4591001 1231 12315269

Dose Rel Withdrawal No. Daya Date

C4591001 1231 12315357

C4591001 1231 12315429 C4591001 1231 12315441

Withdrawal Reason

FOLLOW-UP

WITHDRAWAL BY SUBJECT

Commentb

1

31

2

48 04NOV2020 VACCINATION LOST TO FOLLOW-UP

The volunteer does not answer calls. Contact was lost, the study was withdrawn

2

48 04NOV2020 FOLLOW-UP

LOST TO FOLLOW-UP

The volunteer does not answer calls. Contact was lost, the study was withdrawn

1

21

NO LONGER MEETS Previous clinical or microbiological diagnosis of COVIDELIGIBILITY CRITERIA 19

1

36 02OCT2020

1

42 09OCT2020 VACCINATION

C4591001 1231 12315308

27SEP2020

Study Phase

17SEP2020 VACCINATION

16SEP2020

FOLLOW-UP

FOLLOW-UP

WITHDRAWAL BY SUBJECT

subject not being able to continue attending visits.

It is due to having been discontinued from the study.

NO LONGER MEETS Previous clinical or microbiological diagnosis of COVIDELIGIBILITY CRITERIA 19 PROTOCOL DEVIATION

Subject randomized in error

1

13

10SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

The subject does not specify the reasons for withdrawing from the study

1

13

10SEP2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

The subject does not specify the reasons for withdrawing from the study

1

37 05OCT2020 VACCINATION

ADVERSE EVENT

ADVERSE EVENT/INJECTION SITE PAIN

1

37 05OCT2020

FOLLOW-UP

ADVERSE EVENT

ADVERSE EVENT

1

54 22OCT2020 VACCINATION

ADVERSE EVENT

ADVERSE EVENT/DEPRESSION

FDA-CBER-2021-5683-0129060

Page 71

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

C4591001 1231 12315600

1

22

21SEP2020 VACCINATION

C4591001 1232 12321015

1

21

02SEP2020 VACCINATION LOST TO FOLLOW-UP

patient is labeled a "no show"

1

21

02SEP2020

LOST TO FOLLOW-UP

patient labeled as a "no show"

PROTOCOL DEVIATION

Subject Randomized in Error

C4591001 1232 12321037 C4591001 1232 12321093

FOLLOW-UP

18AUG2020 FOLLOW-UP

WITHDRAWAL BY SUBJECT

Commentb subject refused to recieve second dose of investigation product

2

29 13OCT2020 VACCINATION LOST TO FOLLOW-UP

treatment period was not completed

2

29 13OCT2020

LOST TO FOLLOW-UP

Treatment period was not completed

2

27 13OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject relocated out of state

2

27 13OCT2020

WITHDRAWAL BY SUBJECT

Subject Withdrew Consent

C4591001 1232 12321100

1

51 15OCT2020 VACCINATION

C4591001 1232 12321142

1

57 26OCT2020 VACCINATION LOST TO FOLLOW-UP

1

57 26OCT2020

1

51 23OCT2020 VACCINATION

C4591001 1232 12321094

C4591001 1232 12321175

FOLLOW-UP

FOLLOW-UP

FOLLOW-UP

NO LONGER MEETS V2 Vaccination was not given due to COVID 19 symptoms ELIGIBILITY CRITERIA present at that time due to subject's job she will not be able to attend appointments.

LOST TO FOLLOW-UP

Lost to follow up

OTHER

Subject did not received Vaccination 2

FDA-CBER-2021-5683-0129061

Page 72

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 1232 12321213

1

52 30OCT2020 VACCINATION

PREGNANCY

PREGNANCY

C4591001 1232 12321293

1

22 22OCT2020 VACCINATION

PREGNANCY

PREGNANCY

C4591001 1235 12351027

1

18

23SEP2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

COVID-19 positive with symptoms. Will not receive Vaccine 2.

C4591001 1235 12351071

1

9

22SEP2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

Will continue follow up, but will not receive vaccine 2.

PROTOCOL DEVIATION

randomized but not vaccinated-met exclusion criteria

C4591001 1235 12351167

09OCT2020

FOLLOW-UP

C4591001 1235 12351187

1

9

24OCT2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

meets exclusion #5

C4591001 1235 12351188

1

7

22OCT2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

positive COVID 19- exclusion #5

C4591001 1241 12411132

1

2

15AUG2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

Discontinued.Exc #5

C4591001 1241 12411144

1

1

17AUG2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

Discontinued Exc 5

C4591001 1241 12411260

1

12 30AUG2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

Discontinued. Exc#5

FDA-CBER-2021-5683-0129062

Page 73

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 1241 12411279

1

23

10SEP2020 VACCINATION

PREGNANCY

PREGNANCY

C4591001 1241 12411482

1

7

31AUG2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

Discontinued. RT-PCR SARS Cov-2 Positive

C4591001 1241 12411688

1

13

27SEP2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

Discontinued Exc#5

C4591001 1241 12411695

1

4

18SEP2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

Discontinued Exc#5

C4591001 1241 12411766

1

24 09OCT2020 VACCINATION

PREGNANCY

PREGNANCY

C4591001 1241 12412355

1

22 09NOV2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

Discontinued Exc#5

C4591001 1246 12461025

1

22 19OCT2020 VACCINATION

ADVERSE EVENT

ADVERSE EVENT/URTICARIA

C4591001 1247 12471121

2

10 30OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

Patient withdrew from study after motorcycle accident

C4591001 1247 12471149

1

1

01OCT2020 VACCINATION LOST TO FOLLOW-UP

Patient not answering calls from site; possibly relocated

1

1

01OCT2020

FOLLOW-UP

LOST TO FOLLOW-UP

Patient not answering calls from site; could possibly have relocated

1

22 22OCT2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

Pt. sold e-diary smart phone. Does not meet eligibility Inclusion 2. E-diary deactivated.

C4591001 1247 12471151

FDA-CBER-2021-5683-0129063

Page 74

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 1248 12481018

28AUG2020 FOLLOW-UP

WITHDRAWAL BY SUBJECT

Subject Withdrew Consent

C4591001 1248 12481025

29AUG2020 FOLLOW-UP

WITHDRAWAL BY SUBJECT

Subject Withdrew Consent

C4591001 1248 12481046 C4591001 1248 12481048

1

66 04NOV2020 VACCINATION LOST TO FOLLOW-UP

1

66 04NOV2020 FOLLOW-UP

1

66 04NOV2020 VACCINATION LOST TO FOLLOW-UP

1

66 04NOV2020 FOLLOW-UP

C4591001 1248 12481060 C4591001 1248 12481110

02SEP2020

FOLLOW-UP

LOST TO FOLLOW-UP

Missed V2 on 20Sep2020; site has been unable to contact subject despite multiple calls. Please see EOT page Subject missed V2 on 20Sep2020; multiple attempts to reach subject were unsuccessful.

LOST TO FOLLOW-UP

Please see EOT page.

WITHDRAWAL BY SUBJECT

Participant withdrew consent

1

59 06NOV2020 VACCINATION LOST TO FOLLOW-UP

Subject was no show for V2; unable to contact subject.

1

59 06NOV2020 FOLLOW-UP

LOST TO FOLLOW-UP

Subject was no show for V2; unable to contact subject.

C4591001 1248 12481175

1

22 06OCT2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

Exclusion criterion 5

C4591001 1248 12481199

1

35 21OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject withdrew consent

1

35 21OCT2020

WITHDRAWAL BY SUBJECT

Subject withdrew consent

FOLLOW-UP

FDA-CBER-2021-5683-0129064

Page 75

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 1248 12481218 C4591001 1251 12511095

Study Phase

Withdrawal Reason

Commentb

21SEP2020 VACCINATION

ADVERSE EVENT

ADVERSE EVENT

21SEP2020

FOLLOW-UP

ADVERSE EVENT

ADVERSE EVENT/SYNCOPE

1

21

21SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject wished to withdraw from the study

1

21

21SEP2020

WITHDRAWAL BY SUBJECT

Subject withdrew consent

C4591001 1251 12511207

1

1

23SEP2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

clinical diagnosis of Covid-19

C4591001 1254 12541023

1

25

21SEP2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

Per PI, subject no longer meets eligibility criteria by meeting exclusion #1

C4591001 1254 12541116

1

21

29SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

PATIENT WITHDREW CONSENT

1

21

29SEP2020

WITHDRAWAL BY SUBJECT

Subject called the site and withdrew consent without any specific reason.

1

26 07OCT2020 VACCINATION

PREGNANCY

PREGNANCY

C4591001 1254 12541142

FOLLOW-UP

FOLLOW-UP

C4591001 1260 12601049

02SEP2020

FOLLOW-UP

C4591001 1260 12601070

04SEP2020

FOLLOW-UP

NO LONGER MEETS hypertension after randomization so withdrawn from study ELIGIBILITY CRITERIA WITHDRAWAL BY SUBJECT

pt withdrawal due to pregnancy partner protocol guidelines

FDA-CBER-2021-5683-0129065

Page 76

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 1260 12601126

Dose Rel Withdrawal No. Daya Date 1

C4591001 1264 12641018

Study Phase

Withdrawal Reason

Commentb

30 16OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

patient refusing vaccination # 2 at this time but she will continue with the rest of the visits

25AUG2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject withdrew prior to IP administration due to needing MMR booster.

25AUG2020 FOLLOW-UP

WITHDRAWAL BY SUBJECT

Subject randomized but remembered she had an MMR vaccine within last 28 days and would need booster.

C4591001 4444 44441025

1

12 02OCT2020 VACCINATION

NO LONGER MEETS Previous clinical or microbiological diagnosis of COVIDELIGIBILITY CRITERIA 19

C4591001 4444 44441043

1

19 09OCT2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

diagnosis covid 19 illness

C4591001 4444 44441044

1

16 06OCT2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

Positive COVID-19 Diagnosis

C4591001 4444 44441048

1

18 08OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

Husband is a cancer patient and asked her not to continue for the fear of her going to a hospital

1

18 08OCT2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

Husband is a cancer patient and asked her not to continue for the fear of her going to a hospital

1

22 12OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

disagree with not knowing whether to receive placebo or research product

1

22 12OCT2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

disagree with not knowing whether to receive placebo or research product

21SEP2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

She does not want to be part of the study due to personal problems.

C4591001 4444 44441079

C4591001 4444 44441135

FDA-CBER-2021-5683-0129066

Page 77

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 4444 44441179

Dose Rel Withdrawal No. Daya Date

Study Phase

Withdrawal Reason

Commentb

1

22 12OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

the decision to stop participating is due to personal problems.

1

22 12OCT2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

the decision to stop participating is due to personal problems.

2

31 12NOV2020 VACCINATION

WITHDRAWAL BY SUBJECT

due to the fact that he did not agree to their follow-up for the covid disease

2

31 12NOV2020 FOLLOW-UP

WITHDRAWAL BY SUBJECT

due to the fact that he did not agree to their follow-up for the covid disease

1

24 15OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

The subject expressed his decision to stop participating for work reasons.

1

24 15OCT2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

The subject expressed his decision to stop participating for work reasons.

1

21 12OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

For work reasons he is unable to complete the visits scheduled by protocol

1

21 12OCT2020

WITHDRAWAL BY SUBJECT

For work reasons he is unable to complete the visits scheduled by protocol

C4591001 4444 44441560

1

10 02OCT2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

Positive COVID-19 diagnosis.

C4591001 4444 44441569

1

22 14OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

the decision to stop participating is due to personal reasons

1

22 14OCT2020

WITHDRAWAL BY SUBJECT

the decision to stop participating is due to personal reasons

1

31 23OCT2020 VACCINATION

C4591001 4444 44441224

C4591001 4444 44441273

C4591001 4444 44441522

C4591001 4444 44441572

FOLLOW-UP

FOLLOW-UP

NO LONGER MEETS Participant who is willing and able to comply with all study ELIGIBILITY CRITERIA procedures FDA-CBER-2021-5683-0129067

Page 78

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 4444 44441818

Dose Rel Withdrawal No. Daya Date

Study Phase

Withdrawal Reason

Commentb

1

28 22OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

He refers not being able to continue with the study due to personal problems.

1

28 22OCT2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

He refers not being able to continue with the study due to personal problems.

C4591001 4444 44441931

1

21 15OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

For recommendation of his doctor.

C4591001 4444 44441951

1

43 06NOV2020 VACCINATION LOST TO FOLLOW-UP 30OCT unsuccessful phone call 06NOV registered letter is sent. Still no answer

1

43 06NOV2020 FOLLOW-UP

1

21 15OCT2020 VACCINATION

PREGNANCY

PREGNANCY

1

48 11NOV2020 FOLLOW-UP

WITHDRAWAL BY SUBJECT

the decision to stop participating is due to particular reasons

1

48 13NOV2020 VACCINATION

WITHDRAWAL BY SUBJECT

personal motives

1

48 13NOV2020 FOLLOW-UP

WITHDRAWAL BY SUBJECT

personal motives

1

20 16OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

the decision to stop participating must be traveled abroad.

1

20 16OCT2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

the decision to stop participating must be traveled abroad.

1

24 20OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

Will not be able to continue in the trial since she has had to travel abroad for personal reasons

C4591001 4444 44441979

C4591001 4444 44442107

C4591001 4444 44442194

C4591001 4444 44442263

LOST TO FOLLOW-UP 30OCT unsuccessful phone call 06NOV registered letter is sent. Still no answer

FDA-CBER-2021-5683-0129068

Page 79

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

Study Phase

Withdrawal Reason

Commentb