Comment Reference
Unrelated Forms, Informed Consent + Blood Sampling for HLA typing
Visit 1, Blood Samples for Immunogenicity
Unrelated Forms, Oral Swipe for SARS-CoV-2 Testing
Visit 6 (a1, b1, b2) / (c2) (EoT), Physical Examination
Visit 4, Local Tolerability at Injection Site, 1 hour
Visit 3, Local Tolerability at Injection Site
Unscheduled Forms, Oral Swipe for SARS-CoV-2 Testing
Unscheduled Forms, Urine Sampling for Urinalysis
Visit 4, Blood Samples for Immunogenicity
Unrelated Forms, Diary - Systemic Reactions, Study Day 23
Unrelated Forms, Diary - Systemic Reactions, Day 23
Visit 6 (a1, b1, b2) / (c2) (EoT), Informed Consent + Blood Sampling for Research
Unrelated Forms, Diary - Local Reactions, Day 22
Unrelated Forms, Diary - Systemic Reactions, Day 22
Unrelated Forms, Diary - Systemic Reactions, Day 2
Unrelated Forms, Diary - Systemic Reactions, Day 1
Visit 1, Oral Swipe for SARS-CoV-2 Testing
Phone Call at 48h (a1, b1, b2), Phone Call
Visit 8 (c2) (FU) / Visit 9 (a1, b1, b2) (FU)
Visit 4, Vital Signs, 6 hours after vaccination
Visit 7 (c2) (FU) / V 8 (a1, b1, b2, c2P/B) (FU), Diary - Systemic Reactions
Visit 7 (c2) (FU) / V 8 (a1, b1, b2, c2P/B) (FU), Diary - Local Reactions
Phone Call at 48h (a1, b1, b2, c2P/B), Phone Call
Visit 7 (a1, b1, b2) (EoT), Blood Samples for Safety Lab
Visit 6 (a1, b1, b2) / (c2) (EoT), Phone Call

Comment
IC for HLA Typing not given (23.10.2020 - 08:52)
Subject was a Joker for first Visit 1. Therefore sampling for immunogenicty was documented, but not send out for analysis.
Due to urgent private reason, visit was postponed in agreement with investigator.
Controlled result Suspicion of incorrect sampling, result implausible.
Due to AE study was early terminated, therefore visit 7 was performed earlier.
By mistake, subject did not complete "Diary - Local Reactions" for Day 1
By mistake, subject did not complete "Diary - Systemic Reactions" for Day 1
Subject has not documented the Body temperature due to misunderstanding = missing values. She felt no fever after questioning.
Subject was not in fasted state for the drawing of blood. Fasted state is not required according to CTP.
Subject was reserve subject on that day. Oral swipe was entered as unscheduled according to data entry completion guidelines.
Skin and conjunctivae normally colored. Examination done due to mild decrease of hemoglobin (ncs).
Subject showed up without diary. Diary will be sent to CRS as soon as possible. Subject reported that there are no entries - everything is ok.
AE, Decrease &gt|1,5mg/dl, Moderate, ncs
Diary was not available, left in car in Frankfurt; no new entries
sample hemolytic, interference by hemolysis expected
Volunteer felt stressed because he was not able to perform urine test.
Subject terminated the study due to private reason, therefore visit 7 was performed earlier than scheduled
presumably reactive (this group summarises e.g. irritated lymphocytes, virocytes, Pfeiffer cells)
Due to decision of SRC (05June2020) the boost vaccination was not administered. Therefore only the following assessments from Visit 4 were performed: physical examination, immunogenicity sampling. The
Discoloured (livid) at injection site (2x4 cm).
nearly before start of mensis, fluor albus
Due to SRC decision (05 June 2020) \n the boost vaccination was not administered. \n Therefore only the following assessments from visit 4 were performed - \n pregnancy test, physical examination,
Due to SRC decision (05 June 2020) the boost vaccination was not administered. Therefore only the following assessments from visit 4 were performed - pregnancy test, physical examination, immunogenici
Due to SRC decision (05 June 2020) the boost vaccination was not administered. Therefore only the following assessments from visit 4 were performed - physical examination, immunogenicity sampling. The
subj.was contacted by phone (18.06.2020)| no clinical Symptoms
Due to urgent private reason of the subject visit was splitted.
Subject handled as Screening Failure with violation of IN02 but later on accepted IN02 and enrolled on 16.07.2020.
Material older than 3 days. Deviations are to be expected.
Acc. to study team, urin was not analyzed since subject was a reserve subject
Platelets aggregation! Use of ThromboExact S-Monovette or citrate blood recommended.
On this day, 07.08.20, the temperature was measured three times and documented. Only the first measured temperature at 04:38 a.m., 39,1 degree, was entered into eCRF. 12:30 p.m.=39,1 degree, 2:00 p.m.
No biomarker blood draw because volunteer did not tolerate the last blood draw well (tiredness, Malaise)
Test failed, will be repeated 18.08.2020 (D1)
According to Query, Urea-N value is strongly increased (Grade 4). Investigator commented on this: "Urea is very high, but as creatinine and electrolytes are within ranges and the subject is fit, the I
Body temperature measured, but value not entered by mistake. No elevated temperature confirmed.
Discrepancy between volunteer's report at phone call and in diary
Test Failed. Will be repeated on Day 1, 20 Aug 2020.
Date and Sign of Investigator from 09.10.2020 with comment in source: Revision of inclusion and exclusion criteria was performed on 14.08.2020, checking of tickbox, date and sign was forgotten
Oral swipe for PCR-based test for SARS-CoV-2, date: 19.08.2020, time: 09:15, test name: on Site: Qiagen with the result NA failed and was repeated on Day 1.
Subjects consent for HLA answered with NO on IC Version 7.0, CTP 8
Subjects consent for HLA answered with NO on IC Version 8.0.1, CTP 8
Same kind of AE ('Orthostatic dysregulation') is documented once with relationship 'related'(AE no. 1) and once with relationship 'not related' (AE no. 2). Inv Comment: AE 01+AE 02; both realtionships
Time is missing on source for Documentation of Diary Local Reaction
Time is missing on source for Documentation of Diary Systemic Reaction
Alcohol breath test was done before allocation, but within the same minute
Comment of volunteer: Diary entry regarding body temperature 23.09.2020 possibly wrong due to low battery of device
injection site reaction resolved 08Jul 2020 21h
injection site reaction resolved 08JUL2020 20h
1. flu-like Symptoms (Day 22-23), CM: Paracetamol once Grade 2 \n \n 2. injection site reaction since Day 22 Grade 1, no CM 3. pain left Axilla since Day 24, no CM
slight erythema at injection site, Diary to be checked at visit 3
-injection site reaction (start day21 no CM Grade 2); -flu-like Symptoms (start day 21- day 23, CM: Paracetamol, Grade 2); - pain left Axilla (start day 22, no CM, Grade1), - Herpes pustula ( start da
Screening Visit postponed due to blood donation on 12 May 2020
injection site reaction more pronounced than last time. Resolved at 08Jul2020 20h.
subject was a spare volunteer in another group
Subject called on 07.Jul 2020 that sche suffered from common Cold and could not attend to the scheduled V4 (Booster)
During V5 at 16. Jul. 2020 she reported to feel better but still not in the condition for Booster. After consultation with the Sponsor it was decided not to inject abooster at a later time Point even
Subject has forgotten to bring diary, will turn it in via email/fax today
Arm changed for Blood Pressure as injection was in left arm side.
Diary forgotten, will be sent - Diary per email sent 1 hour later
ECG due to probablystress induced stabbing pains in the heart region
Diarrhea was assessed as not related due to dietary habits
flu-like Symptoms (12:00-21:00) on Day 2 (Fever, myalgia, Fatigue, headache, arthralgia), no Con. Med.
Subject stated that he suffered from gastro-entritis with discomfort in the upper abdomen and loose stool after ingestion of minced meat. This was reported during V3
Fatigue from 01 JUL 2020 17:00 mild reported. No CM intake
Flu-like symptoms ongoing started 30JUn2020 15:00 mild (headache, arthralgia, myalgia, malaise), no Fever, no con. med. intake
Subject decided not to take the booster vaccination
No pointout possible. Result confirmed by M. Casjens
-pain+tenderness at injection site; headache; tiredness
still pain and tenderness at injection site, \n aggravated headache on day 2 (Grade 2 12:00-23:00), no medication
There was an unscheduled EKG because electrodes were mixed up
Additional unscheduled Control for manuel differential blood Count was performed
no more tooth ache, no systemic reaction, no injection site reaction today
no fever; local reaction (tenderness) since 01OCT2020; systemic reaction (loss of appetite, headache, malaise, tiredness) since 30SEP2020; intake of Paracetamol 500mg once on 01OCT2020 1h
subject was spare volunteer, but not needed the following day
systemic reaction (Fatigue, headache) grade 1, start on Booster day, nearly resolved; local reaction (grade 1, resolved)
Local reaction 2 nearly resolved. Systemic reaction 1 resolved. no fever. No co-med.
still mild local reaction (pain, tenderness), recovering \n .no systemic reactions, no conmed, no fever
systemic reaction, grade 1, resolved (slightly elevated temperature); local reaction (grade 1, reasolved); No co-med
Local reaction resolved. Systemic reaction resolved. No co-med intake. No fever.
fracture left ankle: surgery left ankle on 20 Oct 2020 performed, subject reported no dizziness or drowsiness as cause of accident. Slipped on the stairs when entered to Train. CM will be reported whe
Local reaction 2 nearly resolved. No systemic reaction . no fever. No co-med.
yesterday(day 2) flu-like Symptoms (Fatigue, Joint pain, headache), recovered. Intake of paracetamol13:30 and21:00, 250 mg each, Body temperature 38,0C, no local reactions
No local reactions. No systemic reactions. No co-med intake. No fever.
Local reactions resolved. No systemic reactions. No co-med intake. No fever.
systemic reaction (headache, Fatigue, muscle and joint pain, start on evening of Booster day, grade 1, resolved); local reaction (redness, swelling), grade 1, start on evening of booster day, resolved
no fever; no conmed; systemic reaction (headache) since 01OCT2020; injection site (tenderness) resolved
local reaction recovering; no systemic; no fever; no conmed
yesterday systemic reaction (headache 2, chills 1)today recovered, max Body temperature 37,9 Degree C at 10 SEP 2020 21:20 Hours , intake of Paracetamol 500mg at 10 SEP 2020, 21:45, thereafter tempera

Comment 1
Local tolerability, vital signs and temperature were only performed for schedule predose timepoint.
immunogenicity sampling. \n The local tolerability, vital signs and temperature were only performed for scheduled predose timepoint.
ty sampling. The local tolerability, vital signs and temperature were only performed for scheduled predose timepoint.
local tolerability, vital signs and temperature were only performed for scheduled predose timepoint.
though she did not withdraw due to operational reason (subject too Long out of time Frame for Booster)
vered; intake of 500 mg Paracetamol 1 OCT 2020, 3:00 AM
ture under 37 Degree Celsius, local reaction recovering