Trial Outcomes & Findings for A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults for COVID-19 (NCT NCT04449276)
NCT ID: NCT04449276
Last Updated: 2023-01-30
Results Overview
Grade 3 refers to the highest grading on the FDA toxicity scale where a higher grade indicates a worse outcome. An SAE was defined as any untoward medical occurrence that, at any dose: * Resulted in death. * Was life-threatening. * Required inpatient hospitalization or prolongation of existing hospitalization. * Resulted in persistent disability/incapacity. * Was a congenital anomaly/birth defect in the offspring of the participant. * Was an important medical event.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
280 participants
Primary outcome timeframe
Up to 24 hours after vaccination on Day 1
Results posted on
2023-01-30
Participant Flow
This trial was performed in Belgium and Germany between June 2020 and December 2021.
Of the 408 participants who were screened, 280 participants were enrolled.
Participant milestones
| Measure |
Dose Escalation CVnCoV: 2 µg
Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 4 µg
Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 6 µg
Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 8 µg
Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 12 µg
Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 16 µg
Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 20 µg
Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation Placebo
Participants were given placebo on Day 1 and Day 29.
Placebo: Participants received an intramuscular injection by needle in the deltoid area.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
47
|
48
|
48
|
49
|
28
|
16
|
12
|
32
|
|
Overall Study
COMPLETED
|
44
|
44
|
45
|
46
|
26
|
16
|
12
|
30
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
3
|
3
|
2
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Dose Escalation CVnCoV: 2 µg
Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 4 µg
Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 6 µg
Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 8 µg
Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 12 µg
Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 16 µg
Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 20 µg
Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation Placebo
Participants were given placebo on Day 1 and Day 29.
Placebo: Participants received an intramuscular injection by needle in the deltoid area.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
0
|
0
|
2
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Other
|
0
|
2
|
3
|
2
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults for COVID-19
Baseline characteristics by cohort
| Measure |
Dose Escalation CVnCoV: 2 µg
n=47 Participants
Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 4 µg
n=48 Participants
Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 6 µg
n=48 Participants
Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 8 µg
n=49 Participants
Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 12 µg
n=28 Participants
Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 16 µg
n=16 Participants
Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 20 µg
n=12 Participants
Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation Placebo
n=32 Participants
Participants were given placebo on Day 1 and Day 29.
Placebo: Participants received an intramuscular injection by needle in the deltoid area.
|
Total
n=280 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
38.2 years
STANDARD_DEVIATION 12.48 • n=5 Participants
|
39.1 years
STANDARD_DEVIATION 13.17 • n=7 Participants
|
38.6 years
STANDARD_DEVIATION 12.74 • n=5 Participants
|
38.9 years
STANDARD_DEVIATION 12.87 • n=4 Participants
|
37.4 years
STANDARD_DEVIATION 13.51 • n=21 Participants
|
37.4 years
STANDARD_DEVIATION 13.89 • n=10 Participants
|
39.3 years
STANDARD_DEVIATION 12.11 • n=115 Participants
|
40.1 years
STANDARD_DEVIATION 13.46 • n=6 Participants
|
38.7 years
STANDARD_DEVIATION 12.85 • n=6 Participants
|
|
Age, Customized
18 - 40 years
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
16 Participants
n=6 Participants
|
145 Participants
n=6 Participants
|
|
Age, Customized
41 - 60 years
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
16 Participants
n=6 Participants
|
135 Participants
n=6 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
17 Participants
n=6 Participants
|
115 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
15 Participants
n=6 Participants
|
165 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
16 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
32 Participants
n=6 Participants
|
273 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
16 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
31 Participants
n=6 Participants
|
269 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
|
Region of Enrollment
Germany
|
34 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
26 Participants
n=6 Participants
|
218 Participants
n=6 Participants
|
|
Region of Enrollment
Belgium
|
13 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
6 Participants
n=6 Participants
|
62 Participants
n=6 Participants
|
|
Baseline Immunestatus
Seropositive
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
8 Participants
n=6 Participants
|
51 Participants
n=6 Participants
|
|
Baseline Immunestatus
Seronegative
|
39 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
24 Participants
n=6 Participants
|
229 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Up to 24 hours after vaccination on Day 1Population: Only participants with available data were used for this analysis.
Grade 3 refers to the highest grading on the FDA toxicity scale where a higher grade indicates a worse outcome. An SAE was defined as any untoward medical occurrence that, at any dose: * Resulted in death. * Was life-threatening. * Required inpatient hospitalization or prolongation of existing hospitalization. * Resulted in persistent disability/incapacity. * Was a congenital anomaly/birth defect in the offspring of the participant. * Was an important medical event.
Outcome measures
| Measure |
Dose Escalation CVnCoV: 2 µg
n=47 Participants
Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 4 µg
n=48 Participants
Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 6 µg
n=48 Participants
Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 8 µg
n=49 Participants
Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 12 µg
n=28 Participants
Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 16 µg
n=16 Participants
Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 20 µg
n=12 Participants
Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation Placebo
n=32 Participants
Participants were given placebo on Day 1 and Day 29.
Placebo: Participants received an intramuscular injection by needle in the deltoid area.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 24 Hours After the First Vaccination
Any Grade 3 Adverse Reaction
|
3 Participants
|
9 Participants
|
8 Participants
|
14 Participants
|
12 Participants
|
7 Participants
|
8 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 24 Hours After the First Vaccination
Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 60 hours after vaccination on Day 1Population: Only participants with available data were used for this analysis.
Grade 3 refers to the highest grading on the FDA toxicity scale where a higher grade indicates a worse outcome. An SAE was defined as any untoward medical occurrence that, at any dose: * Resulted in death. * Was life-threatening. * Required inpatient hospitalization or prolongation of existing hospitalization. * Resulted in persistent disability/incapacity. * Was a congenital anomaly/birth defect in the offspring of the participant. * Was an important medical event.
Outcome measures
| Measure |
Dose Escalation CVnCoV: 2 µg
n=47 Participants
Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 4 µg
n=48 Participants
Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 6 µg
n=48 Participants
Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 8 µg
n=49 Participants
Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 12 µg
n=28 Participants
Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 16 µg
n=16 Participants
Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 20 µg
n=12 Participants
Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation Placebo
n=32 Participants
Participants were given placebo on Day 1 and Day 29.
Placebo: Participants received an intramuscular injection by needle in the deltoid area.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 60 Hours After the First Vaccination
Any Grade 3 Adverse Reaction
|
3 Participants
|
9 Participants
|
8 Participants
|
14 Participants
|
12 Participants
|
7 Participants
|
8 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 Adverse Reactions or Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 60 Hours After the First Vaccination
Any Serious Adverse Event (SAE) Considered Related to Trial Vaccine
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 7 days after vaccination (Days 1 to 8 and Day 29 to 36)Population: Only participants with available data were used for this analysis.
Reactogenicity was assessed daily via collection of solicited local AEs (injection site pain, redness, swelling, and itching) using paper diary cards.
Outcome measures
| Measure |
Dose Escalation CVnCoV: 2 µg
n=47 Participants
Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 4 µg
n=48 Participants
Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 6 µg
n=48 Participants
Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 8 µg
n=49 Participants
Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 12 µg
n=28 Participants
Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 16 µg
n=16 Participants
Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 20 µg
n=12 Participants
Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation Placebo
n=32 Participants
Participants were given placebo on Day 1 and Day 29.
Placebo: Participants received an intramuscular injection by needle in the deltoid area.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Local Adverse Events
|
32 Participants
|
43 Participants
|
38 Participants
|
41 Participants
|
26 Participants
|
16 Participants
|
11 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)Population: Per the statistical analysis plan for this endpoint, the overall number of participants analyzed includes all randomized participants to show the rate of grade 1, 2, and 3 events in the entire analysis set.
Reactogenicity was assessed daily via collection of solicited local AEs (injection site pain, redness, swelling, and itching) using paper diary cards. Intensity of solicited local AEs and solicited systemic AEs were graded per the FDA Toxicity Grading Scale at Grades 1-3, where higher grades indicate a worse outcome.
Outcome measures
| Measure |
Dose Escalation CVnCoV: 2 µg
n=47 Participants
Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 4 µg
n=48 Participants
Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 6 µg
n=48 Participants
Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 8 µg
n=49 Participants
Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 12 µg
n=28 Participants
Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 16 µg
n=16 Participants
Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 20 µg
n=12 Participants
Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation Placebo
n=32 Participants
Participants were given placebo on Day 1 and Day 29.
Placebo: Participants received an intramuscular injection by needle in the deltoid area.
|
|---|---|---|---|---|---|---|---|---|
|
Intensity of Solicited Local Adverse Events Per the FDA Toxicity Grading Scale
Grade 1
|
30 Participants
|
39 Participants
|
32 Participants
|
29 Participants
|
17 Participants
|
12 Participants
|
6 Participants
|
5 Participants
|
|
Intensity of Solicited Local Adverse Events Per the FDA Toxicity Grading Scale
Grade 2
|
2 Participants
|
3 Participants
|
5 Participants
|
11 Participants
|
9 Participants
|
4 Participants
|
5 Participants
|
0 Participants
|
|
Intensity of Solicited Local Adverse Events Per the FDA Toxicity Grading Scale
Grade 3
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)Population: Only participants who experienced solicited local AEs were used for this analysis.
Reactogenicity was assessed daily via collection of solicited local AEs (injection site pain, redness, swelling, and itching) using paper diary cards. Duration was calculated as consecutive days with a respective solicited AE regardless of the grade of the AE.
Outcome measures
| Measure |
Dose Escalation CVnCoV: 2 µg
n=32 Participants
Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 4 µg
n=43 Participants
Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 6 µg
n=38 Participants
Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 8 µg
n=41 Participants
Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 12 µg
n=26 Participants
Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 16 µg
n=16 Participants
Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 20 µg
n=11 Participants
Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation Placebo
n=5 Participants
Participants were given placebo on Day 1 and Day 29.
Placebo: Participants received an intramuscular injection by needle in the deltoid area.
|
|---|---|---|---|---|---|---|---|---|
|
Duration of Solicited Local Adverse Events
|
1.8 days
Standard Deviation 0.99
|
2.0 days
Standard Deviation 0.84
|
2.3 days
Standard Deviation 1.02
|
2.4 days
Standard Deviation 1.44
|
2.6 days
Standard Deviation 1.44
|
2.5 days
Standard Deviation 0.82
|
3.0 days
Standard Deviation 1.18
|
1.2 days
Standard Deviation 0.45
|
PRIMARY outcome
Timeframe: Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)Population: Only participants with available data were used for this analysis.
Reactogenicity was assessed daily via collection of solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using paper diary cards.
Outcome measures
| Measure |
Dose Escalation CVnCoV: 2 µg
n=47 Participants
Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 4 µg
n=48 Participants
Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 6 µg
n=48 Participants
Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 8 µg
n=49 Participants
Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 12 µg
n=28 Participants
Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 16 µg
n=16 Participants
Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 20 µg
n=12 Participants
Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation Placebo
n=32 Participants
Participants were given placebo on Day 1 and Day 29.
Placebo: Participants received an intramuscular injection by needle in the deltoid area.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Systemic Adverse Events
|
29 Participants
|
45 Participants
|
44 Participants
|
45 Participants
|
28 Participants
|
16 Participants
|
12 Participants
|
19 Participants
|
PRIMARY outcome
Timeframe: Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)Population: Per the statistical analysis plan for this endpoint, the overall number of participants analyzed includes all randomized participants to show the rate of grade 1, 2, and 3 events in the entire analysis set.
Reactogenicity was assessed daily via collection of solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using paper diary cards. Intensity of solicited local AEs and solicited systemic AEs were graded per the FDA Toxicity Grading Scale at Grades 1-3, where higher grades indicate a worse outcome.
Outcome measures
| Measure |
Dose Escalation CVnCoV: 2 µg
n=47 Participants
Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 4 µg
n=48 Participants
Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 6 µg
n=48 Participants
Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 8 µg
n=49 Participants
Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 12 µg
n=28 Participants
Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 16 µg
n=16 Participants
Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 20 µg
n=12 Participants
Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation Placebo
n=32 Participants
Participants were given placebo on Day 1 and Day 29.
Placebo: Participants received an intramuscular injection by needle in the deltoid area.
|
|---|---|---|---|---|---|---|---|---|
|
Intensity of Solicited Systemic Adverse Events Per the FDA Toxicity Grading Scale
Grade 2
|
5 Participants
|
14 Participants
|
16 Participants
|
20 Participants
|
16 Participants
|
7 Participants
|
5 Participants
|
4 Participants
|
|
Intensity of Solicited Systemic Adverse Events Per the FDA Toxicity Grading Scale
Grade 3
|
3 Participants
|
9 Participants
|
8 Participants
|
14 Participants
|
11 Participants
|
7 Participants
|
7 Participants
|
0 Participants
|
|
Intensity of Solicited Systemic Adverse Events Per the FDA Toxicity Grading Scale
Grade 1
|
21 Participants
|
22 Participants
|
20 Participants
|
11 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
15 Participants
|
PRIMARY outcome
Timeframe: Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)Population: Only participants who experienced solicited systemic AEs were used for this analysis.
Reactogenicity was assessed daily via collection of solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using paper diary cards. Duration was calculated as consecutive days with a respective solicited AE regardless of the grade of the AE.
Outcome measures
| Measure |
Dose Escalation CVnCoV: 2 µg
n=29 Participants
Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 4 µg
n=45 Participants
Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 6 µg
n=44 Participants
Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 8 µg
n=45 Participants
Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 12 µg
n=28 Participants
Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 16 µg
n=16 Participants
Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 20 µg
n=12 Participants
Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation Placebo
n=19 Participants
Participants were given placebo on Day 1 and Day 29.
Placebo: Participants received an intramuscular injection by needle in the deltoid area.
|
|---|---|---|---|---|---|---|---|---|
|
Duration of Solicited Systemic Adverse Events
|
3.1 days
Standard Deviation 5.38
|
2.1 days
Standard Deviation 1.15
|
2.4 days
Standard Deviation 2.16
|
3.2 days
Standard Deviation 2.40
|
3.6 days
Standard Deviation 1.73
|
2.5 days
Standard Deviation 0.73
|
3.4 days
Standard Deviation 1.24
|
1.8 days
Standard Deviation 0.96
|
PRIMARY outcome
Timeframe: Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)Population: Per the statistical analysis plan for this endpoint, the overall number of participants analyzed includes all randomized participants to show the number of participants with solicited adverse events considered related to trial vaccine in the entire analysis set.
Reactogenicity was assessed daily via collection of solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using paper diary cards. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE.
Outcome measures
| Measure |
Dose Escalation CVnCoV: 2 µg
n=47 Participants
Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 4 µg
n=48 Participants
Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 6 µg
n=48 Participants
Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 8 µg
n=49 Participants
Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 12 µg
n=28 Participants
Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 16 µg
n=16 Participants
Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 20 µg
n=12 Participants
Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation Placebo
n=32 Participants
Participants were given placebo on Day 1 and Day 29.
Placebo: Participants received an intramuscular injection by needle in the deltoid area.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Systemic Adverse Events Considered Related to Trial Vaccine
|
28 Participants
|
45 Participants
|
44 Participants
|
44 Participants
|
28 Participants
|
16 Participants
|
12 Participants
|
17 Participants
|
PRIMARY outcome
Timeframe: Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57)Population: Only participants with available data were used for this analysis.
Diaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants were contacted by phone to verify whether they had any health concerns since the last visit.
Outcome measures
| Measure |
Dose Escalation CVnCoV: 2 µg
n=47 Participants
Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 4 µg
n=48 Participants
Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 6 µg
n=48 Participants
Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 8 µg
n=49 Participants
Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 12 µg
n=28 Participants
Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 16 µg
n=16 Participants
Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 20 µg
n=12 Participants
Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation Placebo
n=32 Participants
Participants were given placebo on Day 1 and Day 29.
Placebo: Participants received an intramuscular injection by needle in the deltoid area.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Unsolicited Adverse Events
|
26 Participants
|
32 Participants
|
29 Participants
|
31 Participants
|
23 Participants
|
13 Participants
|
11 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57)Population: Per the statistical analysis plan for this endpoint, the overall number of participants analyzed includes all randomized participants to show the rate of mild, moderate, and severe adverse events in the entire analysis set.
Diaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants were contacted by phone to verify whether they had any health concerns since the last visit. Participants were included only once, at the maximum severity. The Investigator made an assessment of intensity for each AE reported during the trial and assigned it to one of the following categories: * Mild: an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities. * Moderate: an event that caused sufficient discomfort to interfere with normal everyday activities. * Severe: an event that prevented normal everyday activities.
Outcome measures
| Measure |
Dose Escalation CVnCoV: 2 µg
n=47 Participants
Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 4 µg
n=48 Participants
Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 6 µg
n=48 Participants
Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 8 µg
n=49 Participants
Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 12 µg
n=28 Participants
Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 16 µg
n=16 Participants
Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 20 µg
n=12 Participants
Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation Placebo
n=32 Participants
Participants were given placebo on Day 1 and Day 29.
Placebo: Participants received an intramuscular injection by needle in the deltoid area.
|
|---|---|---|---|---|---|---|---|---|
|
Intensity of Unsolicited Adverse Events Assessed by the Investigator
Mild
|
14 Participants
|
17 Participants
|
15 Participants
|
12 Participants
|
9 Participants
|
8 Participants
|
4 Participants
|
9 Participants
|
|
Intensity of Unsolicited Adverse Events Assessed by the Investigator
Moderate
|
10 Participants
|
13 Participants
|
10 Participants
|
17 Participants
|
10 Participants
|
5 Participants
|
2 Participants
|
6 Participants
|
|
Intensity of Unsolicited Adverse Events Assessed by the Investigator
Severe
|
2 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
5 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57)Population: Per the statistical analysis plan for this endpoint, the overall number of participants analyzed includes all randomized participants to show the number of participants with unsolicited adverse events considered related to trial vaccine in the entire analysis set.
Diaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants were contacted by phone to verify whether they had any health concerns since the last visit. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE.
Outcome measures
| Measure |
Dose Escalation CVnCoV: 2 µg
n=47 Participants
Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 4 µg
n=48 Participants
Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 6 µg
n=48 Participants
Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 8 µg
n=49 Participants
Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 12 µg
n=28 Participants
Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 16 µg
n=16 Participants
Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 20 µg
n=12 Participants
Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation Placebo
n=32 Participants
Participants were given placebo on Day 1 and Day 29.
Placebo: Participants received an intramuscular injection by needle in the deltoid area.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Unsolicited Adverse Events Considered Related to Trial Vaccine
|
7 Participants
|
20 Participants
|
15 Participants
|
16 Participants
|
12 Participants
|
4 Participants
|
10 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 393Population: Only participants with available data were used in this analysis.
An SAE was defined as any untoward medical occurrence that, at any dose: * Resulted in death. * Was life-threatening. * Required inpatient hospitalization or prolongation of existing hospitalization. * Resulted in persistent disability/incapacity. * Was a congenital anomaly/birth defect in the offspring of the participant. * Was an important medical event.
Outcome measures
| Measure |
Dose Escalation CVnCoV: 2 µg
n=47 Participants
Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 4 µg
n=48 Participants
Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 6 µg
n=48 Participants
Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 8 µg
n=49 Participants
Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 12 µg
n=28 Participants
Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 16 µg
n=16 Participants
Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 20 µg
n=12 Participants
Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation Placebo
n=32 Participants
Participants were given placebo on Day 1 and Day 29.
Placebo: Participants received an intramuscular injection by needle in the deltoid area.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With One or More Serious Adverse Events (SAEs)
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 393Population: Per the statistical analysis plan for this endpoint, the overall number of participants analyzed includes all randomized participants to show the number of participants with one or more SAEs considered related to trial vaccine in the entire analysis set.
An SAE was defined as any untoward medical occurrence that, at any dose: * Resulted in death. * Was life-threatening. * Required inpatient hospitalization or prolongation of existing hospitalization. * Resulted in persistent disability/incapacity. * Was a congenital anomaly/birth defect in the offspring of the participant. * Was an important medical event. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE.
Outcome measures
| Measure |
Dose Escalation CVnCoV: 2 µg
n=47 Participants
Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 4 µg
n=48 Participants
Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 6 µg
n=48 Participants
Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 8 µg
n=49 Participants
Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 12 µg
n=28 Participants
Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 16 µg
n=16 Participants
Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 20 µg
n=12 Participants
Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation Placebo
n=32 Participants
Participants were given placebo on Day 1 and Day 29.
Placebo: Participants received an intramuscular injection by needle in the deltoid area.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With One or More Serious Adverse Events (SAEs) Considered Related to Trial Vaccine
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 393Population: Only participants with available data were used for this analysis.
The following events will be considered as AESIs: adverse events with a suspected immune-mediated etiology, COVID-19 disease and other adverse events relevant to SARS-CoV vaccine development or the target disease.
Outcome measures
| Measure |
Dose Escalation CVnCoV: 2 µg
n=47 Participants
Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 4 µg
n=48 Participants
Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 6 µg
n=48 Participants
Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 8 µg
n=49 Participants
Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 12 µg
n=28 Participants
Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 16 µg
n=16 Participants
Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 20 µg
n=12 Participants
Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation Placebo
n=28 Participants
Participants were given placebo on Day 1 and Day 29.
Placebo: Participants received an intramuscular injection by needle in the deltoid area.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With One or More Adverse Events of Special Interest (AESIs)
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211Population: Participants who received at least 1 dose of trial vaccine and for whom the baseline blood sample and at least one additional blood sample are available for analysis (Immunogenicity Set).
Measured using Enzyme-Linked Immunosorbent Assay (ELISA). In participants who did not get exposed to SARS-CoV-2 before the trial or during the trial before the applicable sample was collected, as measured by ELISA to SARS-CoV-2 N-antigen, seroconversion is defined as an increase in titer in antibodies against SARS-CoV-2 spike protein versus baseline. In subjects seropositive for SARS-CoV-2 at baseline, seroconversion is defined as a 2-fold increase in titer in antibodies against SARS-CoV-2 spike protein versus baseline.
Outcome measures
| Measure |
Dose Escalation CVnCoV: 2 µg
n=46 Participants
Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 4 µg
n=48 Participants
Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 6 µg
n=48 Participants
Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 8 µg
n=49 Participants
Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 12 µg
n=28 Participants
Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 16 µg
n=16 Participants
Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 20 µg
n=12 Participants
Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation Placebo
n=32 Participants
Participants were given placebo on Day 1 and Day 29.
Placebo: Participants received an intramuscular injection by needle in the deltoid area.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies
Day 8
|
18 Participants
|
17 Participants
|
19 Participants
|
19 Participants
|
9 Participants
|
8 Participants
|
6 Participants
|
12 Participants
|
|
Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies
Day 15
|
23 Participants
|
22 Participants
|
23 Participants
|
28 Participants
|
14 Participants
|
11 Participants
|
7 Participants
|
8 Participants
|
|
Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies
Day 29
|
26 Participants
|
27 Participants
|
27 Participants
|
29 Participants
|
16 Participants
|
15 Participants
|
11 Participants
|
9 Participants
|
|
Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies
Day 36
|
42 Participants
|
44 Participants
|
39 Participants
|
39 Participants
|
27 Participants
|
16 Participants
|
12 Participants
|
17 Participants
|
|
Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies
Day 43
|
42 Participants
|
44 Participants
|
43 Participants
|
44 Participants
|
26 Participants
|
16 Participants
|
12 Participants
|
12 Participants
|
|
Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies
Day 57
|
38 Participants
|
42 Participants
|
38 Participants
|
43 Participants
|
24 Participants
|
16 Participants
|
11 Participants
|
7 Participants
|
|
Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies
Day 120
|
29 Participants
|
39 Participants
|
31 Participants
|
34 Participants
|
26 Participants
|
15 Participants
|
12 Participants
|
10 Participants
|
|
Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies
Day 211
|
23 Participants
|
31 Participants
|
22 Participants
|
27 Participants
|
24 Participants
|
16 Participants
|
10 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211Population: The Immunogenicity Set including only a subset of participants receiving 2 doses and who did not get exposed to SARS-CoV-2 before the trial, or during the trial before the applicable sample was collected, as measured by ELISA to SARS-CoV-2 N-antigen.
Measured using Enzyme-Linked Immunosorbent Assay (ELISA).
Outcome measures
| Measure |
Dose Escalation CVnCoV: 2 µg
n=36 Participants
Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 4 µg
n=37 Participants
Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 6 µg
n=37 Participants
Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 8 µg
n=35 Participants
Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 12 µg
n=23 Participants
Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 16 µg
n=12 Participants
Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 20 µg
n=12 Participants
Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation Placebo
n=22 Participants
Participants were given placebo on Day 1 and Day 29.
Placebo: Participants received an intramuscular injection by needle in the deltoid area.
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies
Day 211
|
195.059 titers
Standard Deviation 3.0680
|
330.530 titers
Standard Deviation 2.8422
|
317.495 titers
Standard Deviation 4.2611
|
175.809 titers
Standard Deviation 2.3936
|
623.730 titers
Standard Deviation 2.8041
|
408.985 titers
Standard Deviation 2.0742
|
1027.909 titers
Standard Deviation 4.3847
|
84.518 titers
Standard Deviation 2.8642
|
|
Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies
Day 8
|
133.655 titers
Standard Deviation 3.2545
|
147.911 titers
Standard Deviation 3.9771
|
236.879 titers
Standard Deviation 3.7524
|
126.603 titers
Standard Deviation 2.9179
|
154.168 titers
Standard Deviation 5.4433
|
75.715 titers
Standard Deviation 1.8549
|
251.617 titers
Standard Deviation 6.1263
|
157.993 titers
Standard Deviation 4.5998
|
|
Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies
Day 15
|
171.645 titers
Standard Deviation 2.8681
|
174.350 titers
Standard Deviation 3.5613
|
265.287 titers
Standard Deviation 3.6827
|
191.152 titers
Standard Deviation 2.4129
|
288.123 titers
Standard Deviation 6.6294
|
134.706 titers
Standard Deviation 2.8976
|
310.262 titers
Standard Deviation 6.7709
|
130.610 titers
Standard Deviation 4.3417
|
|
Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies
Day 29
|
173.625 titers
Standard Deviation 2.7202
|
216.617 titers
Standard Deviation 3.7230
|
284.084 titers
Standard Deviation 3.0997
|
210.045 titers
Standard Deviation 2.6297
|
253.696 titers
Standard Deviation 3.8848
|
415.167 titers
Standard Deviation 2.3220
|
497.175 titers
Standard Deviation 4.5434
|
129.860 titers
Standard Deviation 3.9097
|
|
Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies
Day 36
|
664.889 titers
Standard Deviation 2.9730
|
1700.053 titers
Standard Deviation 2.8334
|
1111.904 titers
Standard Deviation 2.8305
|
1254.241 titers
Standard Deviation 2.9320
|
1617.127 titers
Standard Deviation 3.2917
|
1163.062 titers
Standard Deviation 2.3845
|
1837.995 titers
Standard Deviation 3.4748
|
192.185 titers
Standard Deviation 3.8983
|
|
Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies
Day 43
|
1627.741 titers
Standard Deviation 2.6501
|
2375.689 titers
Standard Deviation 2.3220
|
2721.933 titers
Standard Deviation 2.7489
|
3052.067 titers
Standard Deviation 2.1718
|
3955.571 titers
Standard Deviation 3.3468
|
1815.393 titers
Standard Deviation 2.2767
|
6128.616 titers
Standard Deviation 2.8347
|
111.508 titers
Standard Deviation 3.9442
|
|
Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies
Day 57
|
1013.096 titers
Standard Deviation 2.8774
|
1845.542 titers
Standard Deviation 2.6503
|
1402.290 titers
Standard Deviation 2.3704
|
1591.849 titers
Standard Deviation 2.3855
|
2008.570 titers
Standard Deviation 2.6719
|
807.740 titers
Standard Deviation 2.2712
|
4793.501 titers
Standard Deviation 2.8151
|
108.232 titers
Standard Deviation 3.7280
|
|
Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies
Day 120
|
301.870 titers
Standard Deviation 4.3641
|
792.188 titers
Standard Deviation 2.2970
|
421.869 titers
Standard Deviation 3.3192
|
360.492 titers
Standard Deviation 2.4772
|
807.498 titers
Standard Deviation 2.9110
|
687.391 titers
Standard Deviation 3.4095
|
1100.769 titers
Standard Deviation 2.7710
|
99.688 titers
Standard Deviation 2.9239
|
SECONDARY outcome
Timeframe: Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211Population: Participants who received at least 1 dose of trial vaccine and for whom the baseline blood sample and at least one additional blood sample are available for analysis (Immunogenicity Set).
Measured using Enzyme-Linked Immunosorbent Assay (ELISA). In participants who did not get exposed to SARS-CoV-2 before the trial or during the trial before the applicable sample was collected, as measured by ELISA to SARS-CoV-2 N-antigen, seroconversion is defined as an increase in titer in antibodies against SARS-CoV-2 spike RBD protein versus baseline. In subjects seropositive for SARS-CoV-2 at baseline, seroconversion is defined as a 2-fold increase in titer in antibodies against SARS-CoV-2 spike RBD protein versus baseline.
Outcome measures
| Measure |
Dose Escalation CVnCoV: 2 µg
n=46 Participants
Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 4 µg
n=48 Participants
Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 6 µg
n=48 Participants
Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 8 µg
n=49 Participants
Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 12 µg
n=28 Participants
Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 16 µg
n=16 Participants
Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 20 µg
n=12 Participants
Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation Placebo
n=32 Participants
Participants were given placebo on Day 1 and Day 29.
Placebo: Participants received an intramuscular injection by needle in the deltoid area.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies
Day 8
|
8 Participants
|
8 Participants
|
8 Participants
|
13 Participants
|
4 Participants
|
5 Participants
|
1 Participants
|
7 Participants
|
|
Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies
Day 15
|
8 Participants
|
8 Participants
|
10 Participants
|
10 Participants
|
4 Participants
|
5 Participants
|
1 Participants
|
5 Participants
|
|
Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies
Day 29
|
9 Participants
|
11 Participants
|
9 Participants
|
12 Participants
|
7 Participants
|
6 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies
Day 36
|
20 Participants
|
30 Participants
|
26 Participants
|
34 Participants
|
21 Participants
|
14 Participants
|
8 Participants
|
3 Participants
|
|
Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies
Day 43
|
31 Participants
|
37 Participants
|
37 Participants
|
43 Participants
|
26 Participants
|
16 Participants
|
12 Participants
|
2 Participants
|
|
Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies
Day 57
|
23 Participants
|
32 Participants
|
33 Participants
|
40 Participants
|
23 Participants
|
16 Participants
|
11 Participants
|
2 Participants
|
|
Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies
Day 120
|
13 Participants
|
22 Participants
|
24 Participants
|
34 Participants
|
20 Participants
|
13 Participants
|
11 Participants
|
3 Participants
|
|
Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies
Day 211
|
7 Participants
|
13 Participants
|
16 Participants
|
17 Participants
|
17 Participants
|
8 Participants
|
9 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211Population: The Immunogenicity Set including only a subset of participants receiving 2 doses and who did not get exposed to SARS-CoV-2 before the trial, or during the trial before the applicable sample was collected, as measured by ELISA to SARS-CoV-2 N-antigen.
Measured using Enzyme-Linked Immunosorbent Assay (ELISA).
Outcome measures
| Measure |
Dose Escalation CVnCoV: 2 µg
n=36 Participants
Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 4 µg
n=37 Participants
Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 6 µg
n=37 Participants
Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 8 µg
n=35 Participants
Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 12 µg
n=23 Participants
Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 16 µg
n=12 Participants
Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 20 µg
n=12 Participants
Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation Placebo
n=22 Participants
Participants were given placebo on Day 1 and Day 29.
Placebo: Participants received an intramuscular injection by needle in the deltoid area.
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies
Day 8
|
50.000 titers
Standard Deviation 1.0000
|
50.000 titers
Standard Deviation 1.0000
|
50.000 titers
Standard Deviation 1.0000
|
58.735 titers
Standard Deviation 1.5490
|
50.000 titers
Standard Deviation 1.0000
|
69.659 titers
Standard Deviation 2.9999
|
72.203 titers
Standard Deviation 3.5712
|
54.509 titers
Standard Deviation 1.3290
|
|
Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies
Day 15
|
50.000 titers
Standard Deviation 1.0000
|
50.000 titers
Standard Deviation 1.0000
|
55.894 titers
Standard Deviation 1.6444
|
53.520 titers
Standard Deviation 1.3017
|
50.000 titers
Standard Deviation 1.0000
|
68.942 titers
Standard Deviation 3.0430
|
74.942 titers
Standard Deviation 4.0629
|
52.644 titers
Standard Deviation 1.2734
|
|
Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies
Day 29
|
51.515 titers
Standard Deviation 1.1962
|
55.237 titers
Standard Deviation 1.4574
|
53.447 titers
Standard Deviation 1.5000
|
52.773 titers
Standard Deviation 1.2523
|
60.458 titers
Standard Deviation 1.5674
|
74.346 titers
Standard Deviation 2.7022
|
89.597 titers
Standard Deviation 4.1779
|
50.000 titers
Standard Deviation 1.0000
|
|
Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies
Day 36
|
92.943 titers
Standard Deviation 2.4539
|
201.936 titers
Standard Deviation 4.2892
|
144.011 titers
Standard Deviation 3.1421
|
255.615 titers
Standard Deviation 3.5880
|
351.489 titers
Standard Deviation 4.7386
|
321.393 titers
Standard Deviation 3.2174
|
388.660 titers
Standard Deviation 6.5376
|
54.303 titers
Standard Deviation 1.4598
|
|
Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies
Day 43
|
215.648 titers
Standard Deviation 3.3361
|
510.141 titers
Standard Deviation 4.0840
|
418.085 titers
Standard Deviation 3.9185
|
884.327 titers
Standard Deviation 3.5980
|
1401.175 titers
Standard Deviation 3.7419
|
1280.261 titers
Standard Deviation 2.6560
|
2035.914 titers
Standard Deviation 3.3154
|
54.694 titers
Standard Deviation 1.4938
|
|
Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies
Day 57
|
122.337 titers
Standard Deviation 3.0011
|
215.011 titers
Standard Deviation 3.5638
|
237.379 titers
Standard Deviation 3.7169
|
532.756 titers
Standard Deviation 3.3394
|
739.659 titers
Standard Deviation 3.9186
|
948.298 titers
Standard Deviation 2.7761
|
1516.255 titers
Standard Deviation 3.7810
|
50.000 titers
Standard Deviation 1.0000
|
|
Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies
Day 120
|
61.466 titers
Standard Deviation 1.7283
|
97.041 titers
Standard Deviation 2.5246
|
126.160 titers
Standard Deviation 3.6256
|
161.237 titers
Standard Deviation 2.5113
|
222.516 titers
Standard Deviation 3.4086
|
231.544 titers
Standard Deviation 2.8738
|
551.059 titers
Standard Deviation 3.7490
|
50.000 titers
Standard Deviation 1.0000
|
|
Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies
Day 211
|
50.000 titers
Standard Deviation 1.0000
|
73.596 titers
Standard Deviation 2.2529
|
102.077 titers
Standard Deviation 4.2320
|
70.541 titers
Standard Deviation 1.9584
|
208.484 titers
Standard Deviation 3.7448
|
139.858 titers
Standard Deviation 4.1588
|
390.307 titers
Standard Deviation 4.9577
|
50.000 titers
Standard Deviation 1.0000
|
SECONDARY outcome
Timeframe: Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211Population: Participants who received at least 1 dose of trial vaccine and for whom the baseline blood sample and at least one additional blood sample are available for analysis (Immunogenicity Set).
Measured using an activity assay. In participants who did not get exposed to SARS-CoV-2 before the trial or during the trial before the applicable sample was collected, as measured by ELISA to SARS-CoV-2 N-antigen, seroconversion is defined as an increase in titer in SARS-CoV-2 neutralizing antibodies versus baseline. In participants seropositive for SARS-CoV-2 at baseline, seroconversion is defined as a 2-fold increase in titer in SARS-CoV-2 neutralizing antibodies versus baseline.
Outcome measures
| Measure |
Dose Escalation CVnCoV: 2 µg
n=46 Participants
Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 4 µg
n=48 Participants
Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 6 µg
n=48 Participants
Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 8 µg
n=49 Participants
Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 12 µg
n=28 Participants
Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 16 µg
n=16 Participants
Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 20 µg
n=12 Participants
Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation Placebo
n=32 Participants
Participants were given placebo on Day 1 and Day 29.
Placebo: Participants received an intramuscular injection by needle in the deltoid area.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies
Day 8
|
7 Participants
|
8 Participants
|
8 Participants
|
12 Participants
|
4 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies
Day 15
|
8 Participants
|
7 Participants
|
9 Participants
|
21 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies
Day 29
|
8 Participants
|
9 Participants
|
9 Participants
|
19 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies
Day 36
|
24 Participants
|
28 Participants
|
29 Participants
|
35 Participants
|
23 Participants
|
12 Participants
|
9 Participants
|
4 Participants
|
|
Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies
Day 43
|
34 Participants
|
35 Participants
|
36 Participants
|
39 Participants
|
25 Participants
|
15 Participants
|
10 Participants
|
4 Participants
|
|
Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies
Day 57
|
26 Participants
|
24 Participants
|
28 Participants
|
45 Participants
|
22 Participants
|
14 Participants
|
9 Participants
|
4 Participants
|
|
Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies
Day 120
|
16 Participants
|
18 Participants
|
22 Participants
|
28 Participants
|
16 Participants
|
10 Participants
|
11 Participants
|
2 Participants
|
|
Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies
Day 211
|
13 Participants
|
14 Participants
|
22 Participants
|
19 Participants
|
7 Participants
|
5 Participants
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120 and Day 211Population: The Immunogenicity Set including only a subset of participants receiving 2 doses and who did not get exposed to SARS-CoV-2 before the trial, or during the trial before the applicable sample was collected, as measured by ELISA to SARS-CoV-2 N-antigen.
Measured using an activity assay.
Outcome measures
| Measure |
Dose Escalation CVnCoV: 2 µg
n=36 Participants
Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 4 µg
n=37 Participants
Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 6 µg
n=37 Participants
Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 8 µg
n=35 Participants
Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 12 µg
n=23 Participants
Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 16 µg
n=12 Participants
Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 20 µg
n=12 Participants
Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation Placebo
n=22 Participants
Participants were given placebo on Day 1 and Day 29.
Placebo: Participants received an intramuscular injection by needle in the deltoid area.
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies
Day 8
|
5.000 titers
Standard Deviation 1.0000
|
5.000 titers
Standard Deviation 1.0000
|
5.000 titers
Standard Deviation 1.0000
|
5.221 titers
Standard Deviation 1.1859
|
5.000 titers
Standard Deviation 1.000
|
5.000 titers
Standard Deviation 1.0000
|
8.170 titers
Standard Deviation 5.4783
|
5.242 titers
Standard Deviation 1.2481
|
|
Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies
Day 15
|
5.000 titers
Standard Deviation 1.0000
|
5.000 titers
Standard Deviation 1.0000
|
5.106 titers
Standard Deviation 1.1282
|
8.269 titers
Standard Deviation 2.3683
|
5.000 titers
Standard Deviation 1.0000
|
5.000 titers
Standard Deviation 1.0000
|
9.715 titers
Standard Deviation 6.7304
|
5.000 titers
Standard Deviation 1.0000
|
|
Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies
Day 29
|
5.000 titers
Standard Deviation 1.0000
|
5.191 titers
Standard Deviation 1.2560
|
5.095 titers
Standard Deviation 1.1207
|
8.042 titers
Standard Deviation 2.3671
|
5.000 titers
Standard Deviation 1.0000
|
5.496 titers
Standard Deviation 1.3681
|
10.905 titers
Standard Deviation 7.3473
|
5.160 titers
Standard Deviation 1.1593
|
|
Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies
Day 36
|
12.240 titers
Standard Deviation 3.2214
|
17.340 titers
Standard Deviation 4.0855
|
13.577 titers
Standard Deviation 3.1691
|
26.336 titers
Standard Deviation 3.9767
|
22.224 titers
Standard Deviation 2.9539
|
14.142 titers
Standard Deviation 3.0248
|
38.860 titers
Standard Deviation 6.7690
|
5.430 titers
Standard Deviation 1.3051
|
|
Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies
Day 43
|
41.664 titers
Standard Deviation 5.0333
|
33.813 titers
Standard Deviation 4.0230
|
26.696 titers
Standard Deviation 4.2447
|
51.086 titers
Standard Deviation 3.5503
|
52.462 titers
Standard Deviation 3.4275
|
33.108 titers
Standard Deviation 3.2347
|
119.865 titers
Standard Deviation 6.8222
|
6.050 titers
Standard Deviation 1.8413
|
|
Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies
Day 57
|
13.419 titers
Standard Deviation 2.9626
|
11.892 titers
Standard Deviation 3.2240
|
13.348 titers
Standard Deviation 3.0155
|
49.044 titers
Standard Deviation 3.1527
|
24.786 titers
Standard Deviation 2.9671
|
28.284 titers
Standard Deviation 3.0577
|
96.647 titers
Standard Deviation 7.8329
|
5.612 titers
Standard Deviation 1.4462
|
|
Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies
Day 120
|
6.547 titers
Standard Deviation 1.6565
|
7.564 titers
Standard Deviation 2.0377
|
8.369 titers
Standard Deviation 2.2413
|
11.462 titers
Standard Deviation 2.2848
|
14.366 titers
Standard Deviation 3.1876
|
20.640 titers
Standard Deviation 5.0609
|
49.869 titers
Standard Deviation 4.5037
|
5.000 titers
Standard Deviation 1.0000
|
|
Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies
Day 211
|
7.001 titers
Standard Deviation 2.3126
|
9.247 titers
Standard Deviation 2.8688
|
11.107 titers
Standard Deviation 4.0813
|
8.086 titers
Standard Deviation 1.9730
|
6.234 titers
Standard Deviation 1.6616
|
5.325 titers
Standard Deviation 1.2324
|
11.487 titers
Standard Deviation 4.3194
|
5.000 titers
Standard Deviation 1.0000
|
Adverse Events
Dose Escalation CVnCoV: 2 µg
Serious events: 2 serious events
Other events: 23 other events
Deaths: 0 deaths
Dose Escalation CVnCoV: 4 µg
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Dose Escalation CVnCoV: 6 µg
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
Dose Escalation CVnCoV: 8 µg
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Dose Escalation CVnCoV: 12 µg
Serious events: 2 serious events
Other events: 22 other events
Deaths: 0 deaths
Dose Escalation CVnCoV: 16 µg
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Dose Escalation CVnCoV: 20 µg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Dose Escalation Placebo
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose Escalation CVnCoV: 2 µg
n=47 participants at risk
Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 4 µg
n=48 participants at risk
Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 6 µg
n=48 participants at risk
Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 8 µg
n=49 participants at risk
Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 12 µg
n=28 participants at risk
Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 16 µg
n=16 participants at risk
Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 20 µg
n=12 participants at risk
Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation Placebo
n=32 participants at risk
Participants were given placebo on Day 1 and Day 29.
Placebo: Participants received an intramuscular injection by needle in the deltoid area.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/47 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/49 • Day 1 up to Day 393
|
0.00%
0/28 • Day 1 up to Day 393
|
0.00%
0/16 • Day 1 up to Day 393
|
0.00%
0/12 • Day 1 up to Day 393
|
3.1%
1/32 • Number of events 1 • Day 1 up to Day 393
|
|
Gastrointestinal disorders
Crohn's disease
|
2.1%
1/47 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/49 • Day 1 up to Day 393
|
0.00%
0/28 • Day 1 up to Day 393
|
0.00%
0/16 • Day 1 up to Day 393
|
0.00%
0/12 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.00%
0/47 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/49 • Day 1 up to Day 393
|
3.6%
1/28 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/16 • Day 1 up to Day 393
|
0.00%
0/12 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
|
Nervous system disorders
Seizure
|
0.00%
0/47 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/49 • Day 1 up to Day 393
|
3.6%
1/28 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/16 • Day 1 up to Day 393
|
0.00%
0/12 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
|
Eye disorders
Retinal detachment
|
2.1%
1/47 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/49 • Day 1 up to Day 393
|
0.00%
0/28 • Day 1 up to Day 393
|
0.00%
0/16 • Day 1 up to Day 393
|
0.00%
0/12 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
|
Eye disorders
Retinal disorder
|
2.1%
1/47 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/49 • Day 1 up to Day 393
|
0.00%
0/28 • Day 1 up to Day 393
|
0.00%
0/16 • Day 1 up to Day 393
|
0.00%
0/12 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
|
Infections and infestations
COVID-19
|
0.00%
0/47 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
2.0%
1/49 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/28 • Day 1 up to Day 393
|
0.00%
0/16 • Day 1 up to Day 393
|
0.00%
0/12 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/47 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
2.1%
1/48 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/49 • Day 1 up to Day 393
|
0.00%
0/28 • Day 1 up to Day 393
|
0.00%
0/16 • Day 1 up to Day 393
|
0.00%
0/12 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
Other adverse events
| Measure |
Dose Escalation CVnCoV: 2 µg
n=47 participants at risk
Participants were vaccinated with CVnCoV at a dose of 2 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 4 µg
n=48 participants at risk
Participants were vaccinated with CVnCoV at a dose of 4 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 6 µg
n=48 participants at risk
Participants were vaccinated with CVnCoV at a dose of 6 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 8 µg
n=49 participants at risk
Participants were vaccinated with CVnCoV at a dose of 8 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 12 µg
n=28 participants at risk
Participants were vaccinated with CVnCoV at a dose of 12 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 16 µg
n=16 participants at risk
Participants were vaccinated with CVnCoV at a dose of 16 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation CVnCoV: 20 µg
n=12 participants at risk
Participants were vaccinated with CVnCoV at a dose of 20 µg on Day 1 and Day 29.
Dose levels of 2, 4, 6, 8, 12, 16, and 20 µg were evaluated.
CVnCoV Vaccine: Participants received an intramuscular injection by needle in the deltoid area.
|
Dose Escalation Placebo
n=32 participants at risk
Participants were given placebo on Day 1 and Day 29.
Placebo: Participants received an intramuscular injection by needle in the deltoid area.
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
4.3%
2/47 • Number of events 2 • Day 1 up to Day 393
|
4.2%
2/48 • Number of events 2 • Day 1 up to Day 393
|
2.1%
1/48 • Number of events 1 • Day 1 up to Day 393
|
4.1%
2/49 • Number of events 3 • Day 1 up to Day 393
|
3.6%
1/28 • Number of events 1 • Day 1 up to Day 393
|
6.2%
1/16 • Number of events 1 • Day 1 up to Day 393
|
8.3%
1/12 • Number of events 1 • Day 1 up to Day 393
|
3.1%
1/32 • Number of events 1 • Day 1 up to Day 393
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/47 • Day 1 up to Day 393
|
4.2%
2/48 • Number of events 2 • Day 1 up to Day 393
|
4.2%
2/48 • Number of events 2 • Day 1 up to Day 393
|
0.00%
0/49 • Day 1 up to Day 393
|
7.1%
2/28 • Number of events 2 • Day 1 up to Day 393
|
0.00%
0/16 • Day 1 up to Day 393
|
16.7%
2/12 • Number of events 2 • Day 1 up to Day 393
|
3.1%
1/32 • Number of events 1 • Day 1 up to Day 393
|
|
Infections and infestations
Oral Herpes
|
2.1%
1/47 • Number of events 3 • Day 1 up to Day 393
|
2.1%
1/48 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/49 • Day 1 up to Day 393
|
3.6%
1/28 • Number of events 1 • Day 1 up to Day 393
|
12.5%
2/16 • Number of events 3 • Day 1 up to Day 393
|
0.00%
0/12 • Day 1 up to Day 393
|
3.1%
1/32 • Number of events 1 • Day 1 up to Day 393
|
|
Infections and infestations
COVID-19
|
0.00%
0/47 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
4.2%
2/48 • Number of events 2 • Day 1 up to Day 393
|
0.00%
0/49 • Day 1 up to Day 393
|
0.00%
0/28 • Day 1 up to Day 393
|
0.00%
0/16 • Day 1 up to Day 393
|
16.7%
2/12 • Number of events 3 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
|
Infections and infestations
Cystitis
|
0.00%
0/47 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
4.1%
2/49 • Number of events 2 • Day 1 up to Day 393
|
0.00%
0/28 • Day 1 up to Day 393
|
0.00%
0/16 • Day 1 up to Day 393
|
0.00%
0/12 • Day 1 up to Day 393
|
6.2%
2/32 • Number of events 2 • Day 1 up to Day 393
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/47 • Day 1 up to Day 393
|
2.1%
1/48 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
4.1%
2/49 • Number of events 3 • Day 1 up to Day 393
|
0.00%
0/28 • Day 1 up to Day 393
|
6.2%
1/16 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/12 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
|
Infections and infestations
Rhinitis
|
2.1%
1/47 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
2.0%
1/49 • Number of events 1 • Day 1 up to Day 393
|
3.6%
1/28 • Number of events 1 • Day 1 up to Day 393
|
6.2%
1/16 • Number of events 3 • Day 1 up to Day 393
|
0.00%
0/12 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
|
Infections and infestations
Tooth infection
|
4.3%
2/47 • Number of events 2 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/49 • Day 1 up to Day 393
|
0.00%
0/28 • Day 1 up to Day 393
|
6.2%
1/16 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/12 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
|
Infections and infestations
Bronchitis
|
0.00%
0/47 • Day 1 up to Day 393
|
2.1%
1/48 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/49 • Day 1 up to Day 393
|
0.00%
0/28 • Day 1 up to Day 393
|
6.2%
1/16 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/12 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
|
Infections and infestations
Gingivitis
|
0.00%
0/47 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/49 • Day 1 up to Day 393
|
0.00%
0/28 • Day 1 up to Day 393
|
12.5%
2/16 • Number of events 2 • Day 1 up to Day 393
|
0.00%
0/12 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
|
Infections and infestations
Enterobiasis
|
0.00%
0/47 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/49 • Day 1 up to Day 393
|
0.00%
0/28 • Day 1 up to Day 393
|
6.2%
1/16 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/12 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
|
Infections and infestations
Epstein-Barr virus infection
|
0.00%
0/47 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/49 • Day 1 up to Day 393
|
0.00%
0/28 • Day 1 up to Day 393
|
0.00%
0/16 • Day 1 up to Day 393
|
8.3%
1/12 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
|
Nervous system disorders
Headache
|
17.0%
8/47 • Number of events 10 • Day 1 up to Day 393
|
14.6%
7/48 • Number of events 13 • Day 1 up to Day 393
|
14.6%
7/48 • Number of events 10 • Day 1 up to Day 393
|
8.2%
4/49 • Number of events 6 • Day 1 up to Day 393
|
25.0%
7/28 • Number of events 13 • Day 1 up to Day 393
|
31.2%
5/16 • Number of events 5 • Day 1 up to Day 393
|
25.0%
3/12 • Number of events 3 • Day 1 up to Day 393
|
9.4%
3/32 • Number of events 4 • Day 1 up to Day 393
|
|
Nervous system disorders
Dizziness
|
2.1%
1/47 • Number of events 2 • Day 1 up to Day 393
|
12.5%
6/48 • Number of events 6 • Day 1 up to Day 393
|
8.3%
4/48 • Number of events 5 • Day 1 up to Day 393
|
8.2%
4/49 • Number of events 5 • Day 1 up to Day 393
|
7.1%
2/28 • Number of events 5 • Day 1 up to Day 393
|
0.00%
0/16 • Day 1 up to Day 393
|
0.00%
0/12 • Day 1 up to Day 393
|
3.1%
1/32 • Number of events 1 • Day 1 up to Day 393
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/47 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/49 • Day 1 up to Day 393
|
3.6%
1/28 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/16 • Day 1 up to Day 393
|
8.3%
1/12 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
|
Nervous system disorders
Morton's neuralgia
|
0.00%
0/47 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/49 • Day 1 up to Day 393
|
0.00%
0/28 • Day 1 up to Day 393
|
6.2%
1/16 • Number of events 2 • Day 1 up to Day 393
|
0.00%
0/12 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
|
General disorders
Fatigue
|
6.4%
3/47 • Number of events 3 • Day 1 up to Day 393
|
2.1%
1/48 • Number of events 1 • Day 1 up to Day 393
|
6.2%
3/48 • Number of events 4 • Day 1 up to Day 393
|
4.1%
2/49 • Number of events 2 • Day 1 up to Day 393
|
3.6%
1/28 • Number of events 1 • Day 1 up to Day 393
|
6.2%
1/16 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/12 • Day 1 up to Day 393
|
9.4%
3/32 • Number of events 4 • Day 1 up to Day 393
|
|
General disorders
Feeling hot
|
4.3%
2/47 • Number of events 2 • Day 1 up to Day 393
|
6.2%
3/48 • Number of events 4 • Day 1 up to Day 393
|
2.1%
1/48 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/49 • Day 1 up to Day 393
|
0.00%
0/28 • Day 1 up to Day 393
|
12.5%
2/16 • Number of events 3 • Day 1 up to Day 393
|
25.0%
3/12 • Number of events 4 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
|
General disorders
Malaise
|
2.1%
1/47 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/49 • Day 1 up to Day 393
|
3.6%
1/28 • Number of events 1 • Day 1 up to Day 393
|
6.2%
1/16 • Number of events 1 • Day 1 up to Day 393
|
25.0%
3/12 • Number of events 5 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
|
General disorders
Injection site pain
|
0.00%
0/47 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
2.1%
1/48 • Number of events 1 • Day 1 up to Day 393
|
2.0%
1/49 • Number of events 2 • Day 1 up to Day 393
|
3.6%
1/28 • Number of events 1 • Day 1 up to Day 393
|
6.2%
1/16 • Number of events 2 • Day 1 up to Day 393
|
0.00%
0/12 • Day 1 up to Day 393
|
3.1%
1/32 • Number of events 2 • Day 1 up to Day 393
|
|
General disorders
Pyrexia
|
0.00%
0/47 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
2.1%
1/48 • Number of events 1 • Day 1 up to Day 393
|
2.0%
1/49 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/28 • Day 1 up to Day 393
|
6.2%
1/16 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/12 • Day 1 up to Day 393
|
6.2%
2/32 • Number of events 2 • Day 1 up to Day 393
|
|
General disorders
Chest pain
|
2.1%
1/47 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/49 • Day 1 up to Day 393
|
3.6%
1/28 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/16 • Day 1 up to Day 393
|
8.3%
1/12 • Number of events 1 • Day 1 up to Day 393
|
3.1%
1/32 • Number of events 1 • Day 1 up to Day 393
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/47 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
2.1%
1/48 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/49 • Day 1 up to Day 393
|
0.00%
0/28 • Day 1 up to Day 393
|
6.2%
1/16 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/12 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
|
General disorders
Injection site discomfort
|
0.00%
0/47 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/49 • Day 1 up to Day 393
|
0.00%
0/28 • Day 1 up to Day 393
|
0.00%
0/16 • Day 1 up to Day 393
|
8.3%
1/12 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.4%
3/47 • Number of events 4 • Day 1 up to Day 393
|
8.3%
4/48 • Number of events 7 • Day 1 up to Day 393
|
4.2%
2/48 • Number of events 2 • Day 1 up to Day 393
|
12.2%
6/49 • Number of events 6 • Day 1 up to Day 393
|
10.7%
3/28 • Number of events 3 • Day 1 up to Day 393
|
6.2%
1/16 • Number of events 1 • Day 1 up to Day 393
|
8.3%
1/12 • Number of events 1 • Day 1 up to Day 393
|
12.5%
4/32 • Number of events 6 • Day 1 up to Day 393
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/47 • Day 1 up to Day 393
|
4.2%
2/48 • Number of events 2 • Day 1 up to Day 393
|
8.3%
4/48 • Number of events 4 • Day 1 up to Day 393
|
6.1%
3/49 • Number of events 5 • Day 1 up to Day 393
|
3.6%
1/28 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/16 • Day 1 up to Day 393
|
0.00%
0/12 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/47 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
2.1%
1/48 • Number of events 1 • Day 1 up to Day 393
|
2.0%
1/49 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/28 • Day 1 up to Day 393
|
6.2%
1/16 • Number of events 1 • Day 1 up to Day 393
|
8.3%
1/12 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/47 • Day 1 up to Day 393
|
4.2%
2/48 • Number of events 2 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
2.0%
1/49 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/28 • Day 1 up to Day 393
|
6.2%
1/16 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/12 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
|
Gastrointestinal disorders
Diarrhoea
|
6.4%
3/47 • Number of events 3 • Day 1 up to Day 393
|
2.1%
1/48 • Number of events 1 • Day 1 up to Day 393
|
4.2%
2/48 • Number of events 2 • Day 1 up to Day 393
|
4.1%
2/49 • Number of events 2 • Day 1 up to Day 393
|
0.00%
0/28 • Day 1 up to Day 393
|
0.00%
0/16 • Day 1 up to Day 393
|
0.00%
0/12 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/47 • Day 1 up to Day 393
|
2.1%
1/48 • Number of events 1 • Day 1 up to Day 393
|
2.1%
1/48 • Number of events 1 • Day 1 up to Day 393
|
2.0%
1/49 • Number of events 1 • Day 1 up to Day 393
|
3.6%
1/28 • Number of events 2 • Day 1 up to Day 393
|
0.00%
0/16 • Day 1 up to Day 393
|
8.3%
1/12 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/47 • Day 1 up to Day 393
|
4.2%
2/48 • Number of events 3 • Day 1 up to Day 393
|
2.1%
1/48 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/49 • Day 1 up to Day 393
|
0.00%
0/28 • Day 1 up to Day 393
|
0.00%
0/16 • Day 1 up to Day 393
|
0.00%
0/12 • Day 1 up to Day 393
|
6.2%
2/32 • Number of events 2 • Day 1 up to Day 393
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.3%
2/47 • Number of events 2 • Day 1 up to Day 393
|
6.2%
3/48 • Number of events 4 • Day 1 up to Day 393
|
4.2%
2/48 • Number of events 3 • Day 1 up to Day 393
|
6.1%
3/49 • Number of events 4 • Day 1 up to Day 393
|
0.00%
0/28 • Day 1 up to Day 393
|
12.5%
2/16 • Number of events 2 • Day 1 up to Day 393
|
0.00%
0/12 • Day 1 up to Day 393
|
6.2%
2/32 • Number of events 2 • Day 1 up to Day 393
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/47 • Day 1 up to Day 393
|
4.2%
2/48 • Number of events 3 • Day 1 up to Day 393
|
2.1%
1/48 • Number of events 1 • Day 1 up to Day 393
|
2.0%
1/49 • Number of events 1 • Day 1 up to Day 393
|
7.1%
2/28 • Number of events 3 • Day 1 up to Day 393
|
6.2%
1/16 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/12 • Day 1 up to Day 393
|
3.1%
1/32 • Number of events 1 • Day 1 up to Day 393
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/47 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/49 • Day 1 up to Day 393
|
0.00%
0/28 • Day 1 up to Day 393
|
0.00%
0/16 • Day 1 up to Day 393
|
8.3%
1/12 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/47 • Day 1 up to Day 393
|
2.1%
1/48 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
4.1%
2/49 • Number of events 2 • Day 1 up to Day 393
|
0.00%
0/28 • Day 1 up to Day 393
|
0.00%
0/16 • Day 1 up to Day 393
|
0.00%
0/12 • Day 1 up to Day 393
|
6.2%
2/32 • Number of events 2 • Day 1 up to Day 393
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/47 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
2.1%
1/48 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/49 • Day 1 up to Day 393
|
0.00%
0/28 • Day 1 up to Day 393
|
6.2%
1/16 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/12 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/47 • Day 1 up to Day 393
|
2.1%
1/48 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
2.0%
1/49 • Number of events 1 • Day 1 up to Day 393
|
7.1%
2/28 • Number of events 2 • Day 1 up to Day 393
|
6.2%
1/16 • Number of events 1 • Day 1 up to Day 393
|
16.7%
2/12 • Number of events 2 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
|
Skin and subcutaneous tissue disorders
Eccymosis
|
0.00%
0/47 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
2.1%
1/48 • Number of events 2 • Day 1 up to Day 393
|
0.00%
0/49 • Day 1 up to Day 393
|
0.00%
0/28 • Day 1 up to Day 393
|
0.00%
0/16 • Day 1 up to Day 393
|
8.3%
1/12 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/47 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
2.0%
1/49 • Number of events 2 • Day 1 up to Day 393
|
0.00%
0/28 • Day 1 up to Day 393
|
6.2%
1/16 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/12 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/47 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/49 • Day 1 up to Day 393
|
0.00%
0/28 • Day 1 up to Day 393
|
0.00%
0/16 • Day 1 up to Day 393
|
8.3%
1/12 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
|
Skin and subcutaneous tissue disorders
Neurodermatitis
|
0.00%
0/47 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/49 • Day 1 up to Day 393
|
0.00%
0/28 • Day 1 up to Day 393
|
6.2%
1/16 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/12 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/47 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/49 • Day 1 up to Day 393
|
0.00%
0/28 • Day 1 up to Day 393
|
6.2%
1/16 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/12 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/47 • Day 1 up to Day 393
|
2.1%
1/48 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
4.1%
2/49 • Number of events 2 • Day 1 up to Day 393
|
3.6%
1/28 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/16 • Day 1 up to Day 393
|
0.00%
0/12 • Day 1 up to Day 393
|
6.2%
2/32 • Number of events 3 • Day 1 up to Day 393
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/47 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/49 • Day 1 up to Day 393
|
10.7%
3/28 • Number of events 6 • Day 1 up to Day 393
|
0.00%
0/16 • Day 1 up to Day 393
|
25.0%
3/12 • Number of events 3 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
2.1%
1/47 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
2.1%
1/48 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/49 • Day 1 up to Day 393
|
0.00%
0/28 • Day 1 up to Day 393
|
0.00%
0/16 • Day 1 up to Day 393
|
8.3%
1/12 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/47 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
2.1%
1/48 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/49 • Day 1 up to Day 393
|
7.1%
2/28 • Number of events 3 • Day 1 up to Day 393
|
0.00%
0/16 • Day 1 up to Day 393
|
0.00%
0/12 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
|
Blood and lymphatic system disorders
Macrocytosis
|
0.00%
0/47 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/49 • Day 1 up to Day 393
|
0.00%
0/28 • Day 1 up to Day 393
|
6.2%
1/16 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/12 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/47 • Day 1 up to Day 393
|
2.1%
1/48 • Number of events 2 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
2.0%
1/49 • Number of events 1 • Day 1 up to Day 393
|
7.1%
2/28 • Number of events 2 • Day 1 up to Day 393
|
0.00%
0/16 • Day 1 up to Day 393
|
0.00%
0/12 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
|
Investigations
Eosinophil count increased
|
0.00%
0/47 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/49 • Day 1 up to Day 393
|
0.00%
0/28 • Day 1 up to Day 393
|
6.2%
1/16 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/12 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/47 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
4.1%
2/49 • Number of events 3 • Day 1 up to Day 393
|
3.6%
1/28 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/16 • Day 1 up to Day 393
|
25.0%
3/12 • Number of events 3 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
|
Cardiac disorders
Cardiovascular disorder
|
0.00%
0/47 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
2.1%
1/48 • Number of events 1 • Day 1 up to Day 393
|
2.0%
1/49 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/28 • Day 1 up to Day 393
|
0.00%
0/16 • Day 1 up to Day 393
|
8.3%
1/12 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.1%
1/47 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
4.1%
2/49 • Number of events 2 • Day 1 up to Day 393
|
0.00%
0/28 • Day 1 up to Day 393
|
0.00%
0/16 • Day 1 up to Day 393
|
8.3%
1/12 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/47 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/49 • Day 1 up to Day 393
|
0.00%
0/28 • Day 1 up to Day 393
|
0.00%
0/16 • Day 1 up to Day 393
|
8.3%
1/12 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/47 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/49 • Day 1 up to Day 393
|
0.00%
0/28 • Day 1 up to Day 393
|
6.2%
1/16 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/12 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/47 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/49 • Day 1 up to Day 393
|
0.00%
0/28 • Day 1 up to Day 393
|
6.2%
1/16 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/12 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
|
Vascular disorders
Hypertension
|
4.3%
2/47 • Number of events 2 • Day 1 up to Day 393
|
2.1%
1/48 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
2.0%
1/49 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/28 • Day 1 up to Day 393
|
0.00%
0/16 • Day 1 up to Day 393
|
8.3%
1/12 • Number of events 1 • Day 1 up to Day 393
|
3.1%
1/32 • Number of events 1 • Day 1 up to Day 393
|
|
Vascular disorders
Hot flush
|
0.00%
0/47 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/49 • Day 1 up to Day 393
|
0.00%
0/28 • Day 1 up to Day 393
|
0.00%
0/16 • Day 1 up to Day 393
|
0.00%
0/12 • Day 1 up to Day 393
|
6.2%
2/32 • Number of events 2 • Day 1 up to Day 393
|
|
Eye disorders
Asthenopia
|
0.00%
0/47 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/49 • Day 1 up to Day 393
|
7.1%
2/28 • Number of events 2 • Day 1 up to Day 393
|
0.00%
0/16 • Day 1 up to Day 393
|
0.00%
0/12 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/47 • Day 1 up to Day 393
|
2.1%
1/48 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
2.0%
1/49 • Number of events 1 • Day 1 up to Day 393
|
7.1%
2/28 • Number of events 2 • Day 1 up to Day 393
|
0.00%
0/16 • Day 1 up to Day 393
|
0.00%
0/12 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/47 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
2.1%
1/48 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/49 • Day 1 up to Day 393
|
0.00%
0/28 • Day 1 up to Day 393
|
6.2%
1/16 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/12 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
|
Reproductive system and breast disorders
Dysmerorrhoea
|
0.00%
0/47 • Day 1 up to Day 393
|
2.1%
1/48 • Number of events 2 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
6.1%
3/49 • Number of events 4 • Day 1 up to Day 393
|
0.00%
0/28 • Day 1 up to Day 393
|
0.00%
0/16 • Day 1 up to Day 393
|
8.3%
1/12 • Number of events 2 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
|
Congenital, familial and genetic disorders
Gilbert's syndrome
|
0.00%
0/47 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/48 • Day 1 up to Day 393
|
0.00%
0/49 • Day 1 up to Day 393
|
0.00%
0/28 • Day 1 up to Day 393
|
6.2%
1/16 • Number of events 1 • Day 1 up to Day 393
|
0.00%
0/12 • Day 1 up to Day 393
|
0.00%
0/32 • Day 1 up to Day 393
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER