Trial Outcomes & Findings for A Study to Evaluate the Safety and Immunogenicity of Vaccine CVnCoV in Healthy Adults in Germany for COVID-19 (NCT NCT04674189)
NCT ID: NCT04674189
Last Updated: 2023-10-06
Results Overview
Medically attended AEs were defined as AEs with medically attended visits that are not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. The Investigator assessed the relationship between trial vaccine and occurrence of each AE.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2357 participants
Primary outcome timeframe
Up to 6 months after Dose 2 (Days 29 to 211)
Results posted on
2023-10-06
Participant Flow
This trial was performed in Germany between 23 December 2020 and 08 June 2022.
Of the 2357 participants who were randomized, 2351 participants were treated.
Participant milestones
| Measure |
CVnCoV: Group 1, Lot 1
Participants in Group 1 were vaccinated with CVnCoV 12 µg Lot 1 as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
CVnCoV: Group 2, Lot 2
Participants in Group 2 were vaccinated with CVnCoV 12 µg Lot 2 as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
Placebo
Participants received a placebo as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
|---|---|---|---|
|
Overall Study
STARTED
|
786
|
786
|
785
|
|
Overall Study
Safety Analysis Set
|
783
|
785
|
783
|
|
Overall Study
COMPLETED
|
617
|
637
|
372
|
|
Overall Study
NOT COMPLETED
|
169
|
149
|
413
|
Reasons for withdrawal
| Measure |
CVnCoV: Group 1, Lot 1
Participants in Group 1 were vaccinated with CVnCoV 12 µg Lot 1 as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
CVnCoV: Group 2, Lot 2
Participants in Group 2 were vaccinated with CVnCoV 12 µg Lot 2 as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
Placebo
Participants received a placebo as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
|
Overall Study
Received Alternative Authorized Vaccine
|
0
|
1
|
17
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Participant
|
83
|
71
|
142
|
|
Overall Study
Lost to Follow-up
|
55
|
53
|
44
|
|
Overall Study
Miscellaneous
|
27
|
23
|
207
|
|
Overall Study
Did Not Receive Treatment
|
3
|
1
|
2
|
Baseline Characteristics
A Study to Evaluate the Safety and Immunogenicity of Vaccine CVnCoV in Healthy Adults in Germany for COVID-19
Baseline characteristics by cohort
| Measure |
CVnCoV: Group 1, Lot 1
n=783 Participants
Participants in Group 1 were vaccinated with CVnCoV 12 µg Lot 1 as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
CVnCoV: Group 2, Lot 2
n=785 Participants
Participants in Group 2 were vaccinated with CVnCoV 12 µg Lot 2 as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
Placebo
n=783 Participants
Participants received a placebo as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
Total
n=2351 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
42.2 years
STANDARD_DEVIATION 14.88 • n=5 Participants
|
43.4 years
STANDARD_DEVIATION 14.80 • n=7 Participants
|
42.7 years
STANDARD_DEVIATION 14.52 • n=5 Participants
|
42.7 years
STANDARD_DEVIATION 14.73 • n=4 Participants
|
|
Sex: Female, Male
Female
|
527 Participants
n=5 Participants
|
539 Participants
n=7 Participants
|
521 Participants
n=5 Participants
|
1587 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
256 Participants
n=5 Participants
|
246 Participants
n=7 Participants
|
262 Participants
n=5 Participants
|
764 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
764 Participants
n=5 Participants
|
759 Participants
n=7 Participants
|
758 Participants
n=5 Participants
|
2281 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
755 Participants
n=5 Participants
|
765 Participants
n=7 Participants
|
760 Participants
n=5 Participants
|
2280 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 6 months after Dose 2 (Days 29 to 211)Population: Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
Medically attended AEs were defined as AEs with medically attended visits that are not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. The Investigator assessed the relationship between trial vaccine and occurrence of each AE.
Outcome measures
| Measure |
CVnCoV: Group 1, Lot 1
n=783 Participants
Participants in Group 1 were vaccinated with CVnCoV 12 µg Lot 1 as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
CVnCoV: Group 2, Lot 2
n=785 Participants
Participants in Group 2 were vaccinated with CVnCoV 12 µg Lot 2 as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
Placebo
n=783 Participants
Participants received a placebo as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
Placebo
Participants received a placebo as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
|---|---|---|---|---|
|
Number of Participants Who Experienced a Medically Attended Adverse Event (AE) Occurring in the Following 6 Months After Dose 2
Any medically attended AEs
|
95 Participants
|
133 Participants
|
58 Participants
|
—
|
|
Number of Participants Who Experienced a Medically Attended Adverse Event (AE) Occurring in the Following 6 Months After Dose 2
Any related medically attended AEs
|
34 Participants
|
32 Participants
|
13 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 1 to Day 393Population: Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
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 occurrence of each AE.
Outcome measures
| Measure |
CVnCoV: Group 1, Lot 1
n=783 Participants
Participants in Group 1 were vaccinated with CVnCoV 12 µg Lot 1 as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
CVnCoV: Group 2, Lot 2
n=785 Participants
Participants in Group 2 were vaccinated with CVnCoV 12 µg Lot 2 as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
Placebo
n=783 Participants
Participants received a placebo as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
Placebo
Participants received a placebo as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
|---|---|---|---|---|
|
Number of Participants Who Experienced a Serious Adverse Event (SAE)
Any SAEs
|
8 Participants
|
10 Participants
|
6 Participants
|
—
|
|
Number of Participants Who Experienced a Serious Adverse Event (SAE)
Any related SAEs
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 1 to Day 393Population: Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
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 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 |
CVnCoV: Group 1, Lot 1
n=783 Participants
Participants in Group 1 were vaccinated with CVnCoV 12 µg Lot 1 as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
CVnCoV: Group 2, Lot 2
n=785 Participants
Participants in Group 2 were vaccinated with CVnCoV 12 µg Lot 2 as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
Placebo
n=783 Participants
Participants received a placebo as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
Placebo
Participants received a placebo as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
|---|---|---|---|---|
|
Intensity of SAEs Per the Investigator's Assessment
Any mild SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Intensity of SAEs Per the Investigator's Assessment
Any moderate SAEs
|
2 Participants
|
5 Participants
|
1 Participants
|
—
|
|
Intensity of SAEs Per the Investigator's Assessment
Any severe SAEs
|
6 Participants
|
5 Participants
|
5 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 1 year after Dose 2 (Days 29 to 393)Population: Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
The following events were considered and collected as AESI throughout the trial: * AEs with a suspected immune-mediated etiology. * Other AEs relevant to SARS-CoV-2 vaccine development or the target disease. * COVID-19. The Investigator assessed the relationship between trial vaccine and occurrence of each AE.
Outcome measures
| Measure |
CVnCoV: Group 1, Lot 1
n=783 Participants
Participants in Group 1 were vaccinated with CVnCoV 12 µg Lot 1 as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
CVnCoV: Group 2, Lot 2
n=785 Participants
Participants in Group 2 were vaccinated with CVnCoV 12 µg Lot 2 as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
Placebo
n=783 Participants
Participants received a placebo as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
Placebo
Participants received a placebo as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
|---|---|---|---|---|
|
Number of Participants Who Experienced an Adverse Event of Special Interest (AESI) Occurring in the Following 1 Year After Dose 2
Any AESIs
|
14 Participants
|
14 Participants
|
5 Participants
|
—
|
|
Number of Participants Who Experienced an Adverse Event of Special Interest (AESI) Occurring in the Following 1 Year After Dose 2
Any related AESIs
|
7 Participants
|
5 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 1 to Day 393Population: Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
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 |
CVnCoV: Group 1, Lot 1
n=783 Participants
Participants in Group 1 were vaccinated with CVnCoV 12 µg Lot 1 as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
CVnCoV: Group 2, Lot 2
n=785 Participants
Participants in Group 2 were vaccinated with CVnCoV 12 µg Lot 2 as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
Placebo
n=783 Participants
Participants received a placebo as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
Placebo
Participants received a placebo as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
|---|---|---|---|---|
|
Number of Participants Who Experienced Death Due to SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 1 year after Dose 2 (Days 29 to 393)Population: Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
Outcome measures
| Measure |
CVnCoV: Group 1, Lot 1
n=783 Participants
Participants in Group 1 were vaccinated with CVnCoV 12 µg Lot 1 as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
CVnCoV: Group 2, Lot 2
n=785 Participants
Participants in Group 2 were vaccinated with CVnCoV 12 µg Lot 2 as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
Placebo
n=783 Participants
Participants received a placebo as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
Placebo
Participants received a placebo as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
|---|---|---|---|---|
|
Number of Participants Who Experienced an AE Leading to Vaccine Withdrawal Occurring in the Following 1 Year After Dose 2
|
7 Participants
|
5 Participants
|
2 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 1 year after Dose 2 (Days 29 to 393)Population: Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
Outcome measures
| Measure |
CVnCoV: Group 1, Lot 1
n=783 Participants
Participants in Group 1 were vaccinated with CVnCoV 12 µg Lot 1 as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
CVnCoV: Group 2, Lot 2
n=785 Participants
Participants in Group 2 were vaccinated with CVnCoV 12 µg Lot 2 as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
Placebo
n=783 Participants
Participants received a placebo as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
Placebo
Participants received a placebo as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
|---|---|---|---|---|
|
Number of Participants Who Experienced an AE Leading to Trial Discontinuation Occurring in the Following 1 Year After Dose 2
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 1 to 28 days after Dose 2 (Day 57)Population: Safety Analysis Subset: The first 1289 participants enrolled who belong to the Safety Analysis Set.
eDiaries were used for the collection of unsolicited AEs on each vaccination day and the following 28 days. The Investigator assessed the relationship between trial vaccine and occurrence of each AE.
Outcome measures
| Measure |
CVnCoV: Group 1, Lot 1
n=430 Participants
Participants in Group 1 were vaccinated with CVnCoV 12 µg Lot 1 as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
CVnCoV: Group 2, Lot 2
n=429 Participants
Participants in Group 2 were vaccinated with CVnCoV 12 µg Lot 2 as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
Placebo
n=430 Participants
Participants received a placebo as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
Placebo
Participants received a placebo as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
|---|---|---|---|---|
|
Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Any Dose
Any unsolicited AEs
|
245 Participants
|
270 Participants
|
187 Participants
|
—
|
|
Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Any Dose
Any related unsolicited AEs
|
183 Participants
|
186 Participants
|
88 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 1 to 28 days after Dose 2 (Day 57)Population: Safety Analysis Subset: The first 1289 participants enrolled who belong to the Safety Analysis Set.
eDiaries were used for the collection of unsolicited AEs on each vaccination day and the following 28 days. 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 |
CVnCoV: Group 1, Lot 1
n=430 Participants
Participants in Group 1 were vaccinated with CVnCoV 12 µg Lot 1 as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
CVnCoV: Group 2, Lot 2
n=429 Participants
Participants in Group 2 were vaccinated with CVnCoV 12 µg Lot 2 as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
Placebo
n=430 Participants
Participants received a placebo as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
Placebo
Participants received a placebo as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
|---|---|---|---|---|
|
Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Any Dose
Any mild unsolicited AEs
|
133 Participants
|
149 Participants
|
114 Participants
|
—
|
|
Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Any Dose
Any moderate unsolicited AEs
|
73 Participants
|
71 Participants
|
42 Participants
|
—
|
|
Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Any Dose
Any severe unsolicited AEs
|
14 Participants
|
28 Participants
|
10 Participants
|
—
|
|
Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Any Dose
Any unsolicited AEs without intensity assessment
|
25 Participants
|
22 Participants
|
21 Participants
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1), Day 29 and Day 43Population: Per Protocol Immunogenicity Set: 250 participants who received both doses as randomized and within the windows defined in the protocol, had no major protocol deviations expected to impact the immunogenicity outcomes, and had not received medical treatments that may interfere with any of the immunogenicity measurements. Only participants seronegative at Baseline with evaluable samples at each visit are included.
Titers of IgG antibodies directed against the SARS-CoV-2 RBD of Spike Protein antigen were measured by enzyme-linked immunosorbent assay (ELISA). Percentage with 95% confidence interval (CI) of participants for whom a seroconversion was observed is presented by group. Seroconversion was defined as a fold increase above 1 in SARS-CoV-2 Spike Protein RBD IgG antibody levels in participants seronegative at Baseline. Participants who tested positive for COVID-19 had their data included up to the point of a positive test result. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
Outcome measures
| Measure |
CVnCoV: Group 1, Lot 1
n=99 Participants
Participants in Group 1 were vaccinated with CVnCoV 12 µg Lot 1 as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
CVnCoV: Group 2, Lot 2
n=98 Participants
Participants in Group 2 were vaccinated with CVnCoV 12 µg Lot 2 as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
Placebo
n=197 Participants
Participants received a placebo as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
Placebo
n=48 Participants
Participants received a placebo as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
|---|---|---|---|---|
|
Occurrence of Seroconversion for SARS-CoV-2 Receptor-Binding Domain (RBD) of Spike Protein Antibodies (IgG) on Day 29 and Day 43
Day 29
|
8.1 percentage of participants
Interval 3.6 to 15.3
|
18.4 percentage of participants
Interval 11.3 to 27.5
|
13.2 percentage of participants
Interval 8.8 to 18.7
|
0.0 percentage of participants
Interval 0.0 to 7.4
|
|
Occurrence of Seroconversion for SARS-CoV-2 Receptor-Binding Domain (RBD) of Spike Protein Antibodies (IgG) on Day 29 and Day 43
Day 43
|
95.5 percentage of participants
Interval 88.8 to 98.7
|
94.2 percentage of participants
Interval 87.0 to 98.1
|
94.8 percentage of participants
Interval 90.4 to 97.6
|
0.0 percentage of participants
Interval 0.0 to 8.6
|
PRIMARY outcome
Timeframe: Day 1, Day 29 and Day 43Population: Per Protocol Immunogenicity Set: 250 participants who received both doses as randomized and within the windows defined in the protocol, had no major protocol deviations expected to impact the immunogenicity outcomes, and had not received medical treatments that may interfere with any of the immunogenicity measurements. Only participants seronegative at Baseline with evaluable samples at each visit are included.
Titers of IgG antibodies directed against the SARS-CoV-2 RBD of Spike Protein antigen were measured by ELISA and expressed as geometric mean of titers (GMT) with 95% CI, by group. Individual values below the lower limit of quantification (LLOQ) were set to half of the LLOQ. Participants who tested positive for COVID-19 had their data included up to the point of a positive test result. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
Outcome measures
| Measure |
CVnCoV: Group 1, Lot 1
n=99 Participants
Participants in Group 1 were vaccinated with CVnCoV 12 µg Lot 1 as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
CVnCoV: Group 2, Lot 2
n=98 Participants
Participants in Group 2 were vaccinated with CVnCoV 12 µg Lot 2 as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
Placebo
n=197 Participants
Participants received a placebo as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
Placebo
n=48 Participants
Participants received a placebo as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
|---|---|---|---|---|
|
SARS-CoV-2 RBD of Spike Protein Antibody (IgG) Levels on Days 1, 29 and 43
Day 1
|
50.000 GMT
Interval 50.0 to 50.0
|
50.000 GMT
Interval 50.0 to 50.0
|
50.000 GMT
Interval 50.0 to 50.0
|
50.000 GMT
Interval 50.0 to 50.0
|
|
SARS-CoV-2 RBD of Spike Protein Antibody (IgG) Levels on Days 1, 29 and 43
Day 29
|
55.145 GMT
Interval 51.403 to 59.16
|
62.236 GMT
Interval 56.437 to 68.631
|
58.566 GMT
Interval 55.144 to 62.199
|
50.000 GMT
Interval 50.0 to 50.0
|
|
SARS-CoV-2 RBD of Spike Protein Antibody (IgG) Levels on Days 1, 29 and 43
Day 43
|
1285.722 GMT
Interval 1003.885 to 1646.683
|
1151.416 GMT
Interval 869.345 to 1525.008
|
1217.489 GMT
Interval 1011.594 to 1465.289
|
50.000 GMT
Interval 50.0 to 50.0
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 29 and Day 43Population: Per Protocol Immunogenicity Set: 250 participants who received both doses as randomized and within the windows defined in the protocol, had no major protocol deviations expected to impact the immunogenicity outcomes, and had not received medical treatments that may interfere with any of the immunogenicity measurements. Only participants seronegative at Baseline with evaluable samples at each visit are included.
Neutralizing activity of induced antibodies was determined by an activity assay. Percentage with 95% CI of participants for whom a seroconversion was observed is presented by group. Seroconversion was defined as a fold increase above 1 in SARS-CoV-2 neutralizing antibody levels in participants seronegative at Baseline. Participants who tested positive for COVID-19 had their data included up to the point of a positive test result. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
Outcome measures
| Measure |
CVnCoV: Group 1, Lot 1
n=99 Participants
Participants in Group 1 were vaccinated with CVnCoV 12 µg Lot 1 as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
CVnCoV: Group 2, Lot 2
n=98 Participants
Participants in Group 2 were vaccinated with CVnCoV 12 µg Lot 2 as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
Placebo
n=197 Participants
Participants received a placebo as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
Placebo
n=48 Participants
Participants received a placebo as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
|---|---|---|---|---|
|
Occurrence of Seroconversion for SARS-CoV-2 Neutralizing Antibodies on Day 29 and Day 43
Day 29
|
2.0 percentage of participants
Interval 0.2 to 7.1
|
2.0 percentage of participants
Interval 0.2 to 7.2
|
2.0 percentage of participants
Interval 0.6 to 5.1
|
0.0 percentage of participants
Interval 0.0 to 7.4
|
|
Occurrence of Seroconversion for SARS-CoV-2 Neutralizing Antibodies on Day 29 and Day 43
Day 43
|
76.1 percentage of participants
Interval 65.9 to 84.6
|
75.6 percentage of participants
Interval 65.1 to 84.2
|
75.9 percentage of participants
Interval 68.8 to 82.0
|
0.0 percentage of participants
Interval 0.0 to 8.6
|
SECONDARY outcome
Timeframe: Day 1, Day 29 and Day 43Population: Per Protocol Immunogenicity Set: 250 participants who received both doses as randomized and within the windows defined in the protocol, had no major protocol deviations expected to impact the immunogenicity outcomes, and had not received medical treatments that may interfere with any of the immunogenicity measurements. Only participants seronegative at Baseline with evaluable samples at each visit are included.
Neutralizing activity of induced antibodies was determined by an activity assay. GMT with 95% CI of SARS-CoV-2 neutralizing antibody levels is presented by group. Individual values below the LLOQ were set to half of the LLOQ. Participants who tested positive for COVID-19 had their data included up to the point of a positive test result. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
Outcome measures
| Measure |
CVnCoV: Group 1, Lot 1
n=99 Participants
Participants in Group 1 were vaccinated with CVnCoV 12 µg Lot 1 as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
CVnCoV: Group 2, Lot 2
n=98 Participants
Participants in Group 2 were vaccinated with CVnCoV 12 µg Lot 2 as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
Placebo
n=197 Participants
Participants received a placebo as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
Placebo
n=48 Participants
Participants received a placebo as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
|---|---|---|---|---|
|
SARS-CoV-2 Neutralizing Antibody Levels on Days 1, 29 and 43
Day 1
|
5.000 GMT
Interval 5.0 to 5.0
|
5.000 GMT
Interval 5.0 to 5.0
|
5.000 GMT
Interval 5.0 to 5.0
|
5.000 GMT
Interval 5.0 to 5.0
|
|
SARS-CoV-2 Neutralizing Antibody Levels on Days 1, 29 and 43
Day 29
|
5.160 GMT
Interval 4.906 to 5.427
|
5.071 GMT
Interval 4.972 to 5.172
|
5.116 GMT
Interval 4.98 to 5.256
|
5.000 GMT
Interval 5.0 to 5.0
|
|
SARS-CoV-2 Neutralizing Antibody Levels on Days 1, 29 and 43
Day 43
|
28.846 GMT
Interval 21.716 to 38.318
|
23.976 GMT
Interval 18.394 to 31.252
|
26.327 GMT
Interval 21.707 to 31.929
|
5.000 GMT
Interval 5.0 to 5.0
|
Adverse Events
CVnCoV: Group 1, Lot 1
Serious events: 8 serious events
Other events: 542 other events
Deaths: 0 deaths
CVnCoV: Group 2, Lot 2
Serious events: 10 serious events
Other events: 547 other events
Deaths: 0 deaths
Placebo
Serious events: 6 serious events
Other events: 475 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
CVnCoV: Group 1, Lot 1
n=783 participants at risk
Participants in Group 1 were vaccinated with CVnCoV 12 µg Lot 1 as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
CVnCoV: Group 2, Lot 2
n=785 participants at risk
Participants in Group 2 were vaccinated with CVnCoV 12 µg Lot 2 as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
Placebo
n=783 participants at risk
Participants received a placebo as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
|---|---|---|---|
|
Cardiac disorders
Arrhythmia
|
0.13%
1/783 • Number of events 1 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.00%
0/785 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.00%
0/783 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/783 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.13%
1/785 • Number of events 1 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.00%
0/783 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/783 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.13%
1/785 • Number of events 1 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.00%
0/783 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.00%
0/783 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.00%
0/785 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.13%
1/783 • Number of events 1 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/783 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.00%
0/785 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.13%
1/783 • Number of events 1 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/783 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.13%
1/785 • Number of events 1 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.00%
0/783 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
|
Infections and infestations
Small intestine gangrene
|
0.00%
0/783 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.00%
0/785 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.13%
1/783 • Number of events 1 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.13%
1/783 • Number of events 2 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.00%
0/785 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.00%
0/783 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/783 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.00%
0/785 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.13%
1/783 • Number of events 1 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/783 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.13%
1/785 • Number of events 1 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.00%
0/783 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/783 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.13%
1/785 • Number of events 1 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.00%
0/783 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/783 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.25%
2/785 • Number of events 2 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.00%
0/783 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.13%
1/783 • Number of events 1 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.00%
0/785 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.00%
0/783 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/783 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.00%
0/785 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.26%
2/783 • Number of events 2 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.13%
1/783 • Number of events 1 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.13%
1/785 • Number of events 1 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.00%
0/783 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ganglioglioma
|
0.00%
0/783 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.00%
0/785 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.13%
1/783 • Number of events 2 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.13%
1/783 • Number of events 1 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.00%
0/785 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.00%
0/783 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive lobular breast carcinoma
|
0.13%
1/783 • Number of events 1 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.00%
0/785 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.00%
0/783 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.13%
1/783 • Number of events 1 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.00%
0/785 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.00%
0/783 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/783 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.13%
1/785 • Number of events 1 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.00%
0/783 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.13%
1/783 • Number of events 1 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.00%
0/785 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.00%
0/783 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/783 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.13%
1/785 • Number of events 1 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.00%
0/783 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/783 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.13%
1/785 • Number of events 1 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.00%
0/783 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.13%
1/783 • Number of events 2 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.00%
0/785 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.00%
0/783 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.13%
1/783 • Number of events 1 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.00%
0/785 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.13%
1/783 • Number of events 1 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/783 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.13%
1/785 • Number of events 1 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.00%
0/783 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.13%
1/783 • Number of events 1 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.00%
0/785 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
0.00%
0/783 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
Other adverse events
| Measure |
CVnCoV: Group 1, Lot 1
n=783 participants at risk
Participants in Group 1 were vaccinated with CVnCoV 12 µg Lot 1 as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
CVnCoV: Group 2, Lot 2
n=785 participants at risk
Participants in Group 2 were vaccinated with CVnCoV 12 µg Lot 2 as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
Placebo
n=783 participants at risk
Participants received a placebo as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
13.3%
104/783 • Number of events 146 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
14.4%
113/785 • Number of events 144 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
8.4%
66/783 • Number of events 78 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
|
Gastrointestinal disorders
Nausea
|
17.9%
140/783 • Number of events 197 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
16.8%
132/785 • Number of events 195 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
8.3%
65/783 • Number of events 82 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
|
General disorders
Chills
|
35.2%
276/783 • Number of events 419 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
35.0%
275/785 • Number of events 457 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
10.3%
81/783 • Number of events 95 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
|
General disorders
Fatigue
|
54.3%
425/783 • Number of events 835 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
54.4%
427/785 • Number of events 852 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
35.5%
278/783 • Number of events 530 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
|
General disorders
Injection site pain
|
49.4%
387/783 • Number of events 693 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
49.7%
390/785 • Number of events 698 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
20.4%
160/783 • Number of events 205 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
|
General disorders
Injection site pruritus
|
3.4%
27/783 • Number of events 31 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
5.5%
43/785 • Number of events 53 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
2.3%
18/783 • Number of events 22 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
|
General disorders
Pyrexia
|
27.8%
218/783 • Number of events 309 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
28.2%
221/785 • Number of events 330 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
7.8%
61/783 • Number of events 64 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
31.9%
250/783 • Number of events 376 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
31.2%
245/785 • Number of events 378 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
9.6%
75/783 • Number of events 98 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
43.9%
344/783 • Number of events 569 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
43.4%
341/785 • Number of events 565 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
17.4%
136/783 • Number of events 183 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
|
Nervous system disorders
Dizziness
|
4.7%
37/783 • Number of events 42 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
5.9%
46/785 • Number of events 54 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
4.3%
34/783 • Number of events 43 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
|
Nervous system disorders
Headache
|
54.7%
428/783 • Number of events 924 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
54.8%
430/785 • Number of events 952 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
37.4%
293/783 • Number of events 615 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.9%
70/783 • Number of events 89 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
10.8%
85/785 • Number of events 106 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
7.9%
62/783 • Number of events 84 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
12.5%
98/783 • Number of events 128 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
13.5%
106/785 • Number of events 145 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
12.1%
95/783 • Number of events 121 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
13.5%
106/783 • Number of events 134 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
13.6%
107/785 • Number of events 135 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
12.6%
99/783 • Number of events 133 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
|
General disorders
Pain
|
5.9%
46/783 • Number of events 53 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
7.9%
62/785 • Number of events 68 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
6.0%
47/783 • Number of events 52 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.1%
32/783 • Number of events 38 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
5.0%
39/785 • Number of events 44 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
5.2%
41/783 • Number of events 47 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
|
Infections and infestations
COVID-19
|
13.5%
106/783 • Number of events 111 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
12.6%
99/785 • Number of events 103 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
15.7%
123/783 • Number of events 131 • Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place