Reference ID
Visit 1, Local Tolerability at Injection Site, 06 h a.v.
Visit 4, Body Temperature, 1h, 3h, 6h after vaccination
Visit 4, Vital Signs, 1h, 3h, 6h after vaccination
Visit 4, Local Tolerability at Injection Site, 1h, 3h, 6h after vaccination
Visit 4, Vital Signs, 1h, 3h and 6h after
Visit 4, Body Temperature, 1h, 3h and 6h after
Visit 4, Local Tolerability at Injection Site, 1h, 3h and 6h after
Visit 1, Local Tolerability at Injection Site, 6 h.a.v.
Visit 8 (c2) (FU) / Visit 9 (a1, b1, b2) (FU)
Phone Call at 48h (a1, b1, b2, c2P/B), Phone Call
Visit 4, Local Tolerability at Injection Site, 1 h a.v.
Visit 4, Systemic Events Assessment, 1 h a.v.
Visit 1, Local Tolerability at Injection Site, 3 h a.v.
Visit 1, Systemic Events Assessment, 3 h a.v.
Visit 6 (a1, b1, b2, c2P/B) / (c2) (EoT), Vital Signs
Unrelated Forms, Diary - Local Reactions, Day 3-7
Unrelated Forms, Diary - Local Reactions
Unrelated Forms, Diary - Systemic Reactions
Visit 4, Systemic Events Assessment, 3 h a.v.
Visit 5, Systemic Events Assessment, D29
Visit 1, Blood Samples for Immunogenicity
Visit 4, Vital Signs, D22 (1h after Vaccination)
Visit 5, Diary - Local Reactions, Day 29
Visit 5, Diary - Systemic Reactions, Day 29
Visit 1, Local Tolerability at Injection Site, 1h
Visit 4, Oral Swipe for SARS-CoV-2 Testing
Visit 1, Informed Consent + Blood Sampling for HLA typing
Visit 2, Body Temperature, 24 h (+/- 2h)
Visit 3, Blood Samples for Immunogenicity
Visit 1, Oral Swipe for SARS-CoV-2 Testing
Visit 5, Diary - Local Reactions, day 28

Protocol Deviation Term
The measurement was not performed in the scheduled time frame.
The measurement was not performed in the scheduled time Frame
The measurement was not performed in the scheduled time frame
Assessment of local reaction at injection site was performed 4 min later than the allowed time window
Measurements (Body Temperature, Vital Signs, ECG) not prior to Allocation
Measurements (Vital Signs, ECG) not prior to Allocation
The measurement was not performed in the scheduled timeframe.
The measurements were not performed in the scheduled timeframe
The measurements were not performed in the scheduled timeframe.
Diary entries for Day 04.06.2020 for Local and Systemic Reactions are not available.
Diary Entries for Day 04.06.2020 for Local and Systemic Reactions are not available
Diary entries for Day 03.06.2020 for Local and Systemic Reactions are not available.
Diary entries for Day 02.06.2020 for Local and Systemic Reactions are not available.
Diary entries for Day 09.06.2020 for Local and Systemic Reactions are not available.
Assessment of local reaction at injection site was performed 7 min later than the allowed time window
The planned activities were not performed in the scheduled timeframe
Subject takes Novaminsulfon (oral, 1x1tbl. 500 mg)
Measurements (Body temp./Vital signs/ECG) not prior to Allocation
Time field for ICF Version 6.0, dated on 26 JUN 2020 left blank by mistake. Therefore MEMO 03 Missing time ICF Version 6.0 was written.
Vital Signs and Body Temperature measurements performed, but values not documented
Physical examination, assessment of local and systemic reactions not done
The visit was performed outside study scheme
diary entries for local reactions are entered for only 5 consecutive days after V4 (day 23-27)
diary entries for local and systemic reactions are entered for only 5 consecutive days after V4 (day 23-27)
Body temperature time is not correct entered, time is unknown
Phone call was not performed in the scheduled time frame
predefined timeframe of 30 minutes between the vaccination of subjects was not adhered.
urine sample was given outside the scheduled time frame of +/-2 h of vaccination
Vital signs and body temperature were performed outside the allowed time window of +/-15 min
Body temperature was performed outside the allowed time window of +/-15 min
diary entries for local reactions are entered for only 4 consecutive days after V4 (day 22-25)
diary entries for systemic reactions are entered for only 5 consecutive days after V4 (day 22-26)
wrong entry for pulse rate (012), so value is unknown
measurements performed, but values not documented
no detailed information beside date/day reported in diary on day 3-7
items for nausea and vomiting not assessed
wrong entry for pulse rate (011), so value is unknown
Vital Signs and body temperature: measurements performed, but values not documented
diary entries for local and systemic reactions are entered for only 5 consecutive days after V4 (day 22-26)
Measurement performed but value not documented
Body temperature was performed outside the allowed time window of +/- 15 min
diary entries for local and systemic reactions are entered for only 5 consecutive days after after V4 (day 22-26
By mistake, allocation was done before the alcohol breath testing
diary entries for local reactions are entered for only 5 consecutive days after V4 (until day 27)
diary entries for systemic reactions are entered for only 5 consecutive days after V4 (until day 27)
Allocation was done prior to predose measurements (vital signs, body temperature, ecg)
Measurements (Body temp./Vital signs/ECG) not prior to allocation
predefined timeframe of 30 minutes between the vaccination of subjects was not adhered. (done after 29 minutes)
No modules except for fever were ticked, although assessments were done. No symptoms were reported.
Assessment not done because the CRF was not available at that time
FSH is missing, subject has a tubal ligation
centrifugation Glucose 8 minutes too late
The test person had rhinitis on day 22 and could not be vaccinated. The vaccination was delayed on day 28.
Visit 6 was skipped because subject \n prematurely terminated the Trial, so EoT \n Visit 7 was performed earlier than \n planned.
Because of private appointments of the subject, this appointment is cancelled completely.
Subject removed from the room unasked before the measurements, so the measures were taken a few minutes too late
No entries available. The test Person appears on day 26. The Diary was collected
the action took place 20 minutes later, 5 minutes outside the time range
The subject moved his visit 6 by 5 days. That's one day too many
an additional Control test on visit 4 drior to vaccination
The consent form for "Pharmagenomic Examination HLA" was signed 3 min before the consent form version 6.0 Protocol Version 7.0, June 26, 2020
Body temperature was measured outside the allowed timeframe ( 13 min too early)
The consent form for "Pharmagenomic Examination HLA" was signed 2 min before the consent form version 6.0, June 26, 2020
Body temperature measurement is 2 minutes out of range of tolerance ( 2 minutes too early)
All measures are outside the 2h timedeviation
The PCR test was repeated at Visit1 before the predose recording, because at Visit -1 the test was not evaluable

Protocol Deviation Coded Term
Laboratory Data, ECG Data, Pregnancy Data
Medical History and Concomitant Diseases