Trial Outcomes & Findings for COVID-19: A Study to Evaluate Safety, Reactogenicity and Immunogenicity of the SARS-CoV-2 mRNA Vaccine CVnCoV in Adults With Co-morbidities (NCT NCT04860258)
NCT ID: NCT04860258
Last Updated: 2022-05-13
Results Overview
Reactogenicity was assessed daily via collection of solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using paper diary cards. By definition, all solicited local AEs occurring from the time of first vaccination were considered related to trial vaccination. For solicited systemic AEs, the Investigator assessed the relationship between trial vaccine and each occurrence of each AE.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
129 participants
Primary outcome timeframe
Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)
Results posted on
2022-05-13
Participant Flow
This trial was performed in Belgium between 22 April 2021 and 21 September 2021.
Of the 172 participants who were screened, 129 participants with co-morbidities known to increase the risk for (severe) COVID-19 were enrolled. Participants received investigational severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) messenger ribonucleic acid (mRNA) vaccine (CVnCoV) 12 µg on Day 1 and Day 29.
Participant milestones
| Measure |
Chronic Kidney Disease
Participants with chronic kidney disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Kidney function was ascertained from the serum creatinine measurement within the last 6 months, converted into estimated glomerular filtration rate (eGFR) using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation, with impaired kidney function defined as eGFR \<60 mL/min/1.73m².
|
Chronic Obstructive Pulmonary Disease (COPD)
Participants with COPD received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. COPD included emphysema and chronic bronchitis.
|
Obesity
Participants with obesity received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Obesity was defined as a body mass index (BMI) \>32 kg/m².
|
Chronic Cardiovascular Disease
Participants with chronic cardiovascular disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Chronic cardiovascular disease included heart failure, structural heart disorder, coronary artery disease, cardiomyopathies and arterial hypertension.
|
Chronic Human Immunodeficiency Virus (HIV) Infection
Participants with chronic HIV infection received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with chronic HIV infection required stable aviremia (\<50 copies/mL) and CD4 count \>350/mL as documented by blood samples taken within 12 months before enrollment. Viral load \<50 copies/mL over 12 months with transient changes of 50-350 copies/mL was allowed.
|
Type 2 Diabetes Mellitus
Participants with type 2 diabetes mellitus received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with type 2 diabetes mellitus required diabetes mellitus to be controlled with medication \[HbA1c \<58 mmol/mol (7.45%)\].
|
Renal Transplant
Participants with renal transplant received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants had a renal transplant at least a year ago under stable conditions for at least 6 months with medications, categorized as low risk of rejection.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
52
|
33
|
33
|
7
|
2
|
|
Overall Study
COMPLETED
|
1
|
1
|
48
|
32
|
29
|
6
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
4
|
1
|
4
|
1
|
0
|
Reasons for withdrawal
| Measure |
Chronic Kidney Disease
Participants with chronic kidney disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Kidney function was ascertained from the serum creatinine measurement within the last 6 months, converted into estimated glomerular filtration rate (eGFR) using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation, with impaired kidney function defined as eGFR \<60 mL/min/1.73m².
|
Chronic Obstructive Pulmonary Disease (COPD)
Participants with COPD received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. COPD included emphysema and chronic bronchitis.
|
Obesity
Participants with obesity received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Obesity was defined as a body mass index (BMI) \>32 kg/m².
|
Chronic Cardiovascular Disease
Participants with chronic cardiovascular disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Chronic cardiovascular disease included heart failure, structural heart disorder, coronary artery disease, cardiomyopathies and arterial hypertension.
|
Chronic Human Immunodeficiency Virus (HIV) Infection
Participants with chronic HIV infection received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with chronic HIV infection required stable aviremia (\<50 copies/mL) and CD4 count \>350/mL as documented by blood samples taken within 12 months before enrollment. Viral load \<50 copies/mL over 12 months with transient changes of 50-350 copies/mL was allowed.
|
Type 2 Diabetes Mellitus
Participants with type 2 diabetes mellitus received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with type 2 diabetes mellitus required diabetes mellitus to be controlled with medication \[HbA1c \<58 mmol/mol (7.45%)\].
|
Renal Transplant
Participants with renal transplant received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants had a renal transplant at least a year ago under stable conditions for at least 6 months with medications, categorized as low risk of rejection.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
4
|
1
|
4
|
1
|
0
|
Baseline Characteristics
COVID-19: A Study to Evaluate Safety, Reactogenicity and Immunogenicity of the SARS-CoV-2 mRNA Vaccine CVnCoV in Adults With Co-morbidities
Baseline characteristics by cohort
| Measure |
Chronic Kidney Disease
n=1 Participants
Participants with chronic kidney disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Kidney function was ascertained from the serum creatinine measurement within the last 6 months, converted into eGFR using the CKD-EPI equation, with impaired kidney function defined as eGFR \<60 mL/min/1.73m².
|
COPD
n=1 Participants
Participants with COPD received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. COPD included emphysema and chronic bronchitis.
|
Obesity
n=52 Participants
Participants with obesity received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Obesity was defined as a BMI \>32 kg/m².
|
Chronic Cardiovascular Disease
n=33 Participants
Participants with chronic cardiovascular disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Chronic cardiovascular disease included heart failure, structural heart disorder, coronary artery disease, cardiomyopathies and arterial hypertension.
|
Chronic HIV Infection
n=33 Participants
Participants with chronic HIV infection received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with chronic HIV infection required stable aviremia (\<50 copies/mL) and CD4 count \>350/mL as documented by blood samples taken within 12 months before enrollment. Viral load \<50 copies/mL over 12 months with transient changes of 50-350 copies/mL was allowed.
|
Type 2 Diabetes Mellitus
n=7 Participants
Participants with type 2 diabetes mellitus received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with type 2 diabetes mellitus required diabetes mellitus to be controlled with medication \[HbA1c \<58 mmol/mol (7.45%)\].
|
Renal Transplant
n=2 Participants
Participants with renal transplant received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants had a renal transplant at least a year ago under stable conditions for at least 6 months with medications, categorized as low risk of rejection.
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
54.0 years
STANDARD_DEVIATION NA • n=99 Participants
|
73.0 years
STANDARD_DEVIATION NA • n=107 Participants
|
42.7 years
STANDARD_DEVIATION 10.77 • n=206 Participants
|
52.3 years
STANDARD_DEVIATION 12.36 • n=7 Participants
|
43.7 years
STANDARD_DEVIATION 11.69 • n=31 Participants
|
58.3 years
STANDARD_DEVIATION 9.21 • n=30 Participants
|
39.0 years
STANDARD_DEVIATION 2.83 • n=3 Participants
|
46.5 years
STANDARD_DEVIATION 12.40 • n=6 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
37 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
26 Participants
n=7 Participants
|
29 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
92 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
33 Participants
n=7 Participants
|
32 Participants
n=31 Participants
|
7 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
125 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
30 Participants
n=7 Participants
|
25 Participants
n=31 Participants
|
7 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
114 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
8 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)Population: The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
Reactogenicity was assessed daily via collection of solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using paper diary cards. By definition, all solicited local AEs occurring from the time of first vaccination were considered related to trial vaccination. For solicited systemic AEs, the Investigator assessed the relationship between trial vaccine and each occurrence of each AE.
Outcome measures
| Measure |
Chronic Kidney Disease
n=1 Participants
Participants with chronic kidney disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Kidney function was ascertained from the serum creatinine measurement within the last 6 months, converted into eGFR using the CKD-EPI equation, with impaired kidney function defined as eGFR \<60 mL/min/1.73m².
|
COPD
n=1 Participants
Participants with COPD received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. COPD included emphysema and chronic bronchitis.
|
Obesity
n=52 Participants
Participants with obesity received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Obesity was defined as a BMI \>32 kg/m².
|
Chronic Cardiovascular Disease
n=33 Participants
Participants with chronic cardiovascular disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Chronic cardiovascular disease included heart failure, structural heart disorder, coronary artery disease, cardiomyopathies and arterial hypertension.
|
Chronic HIV Infection
n=33 Participants
Participants with chronic HIV infection received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with chronic HIV infection required stable aviremia (\<50 copies/mL) and CD4 count \>350/mL as documented by blood samples taken within 12 months before enrollment. Viral load \<50 copies/mL over 12 months with transient changes of 50-350 copies/mL was allowed.
|
Type 2 Diabetes Mellitus
n=7 Participants
Participants with type 2 diabetes mellitus received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with type 2 diabetes mellitus required diabetes mellitus to be controlled with medication \[HbA1c \<58 mmol/mol (7.45%)\].
|
Renal Transplant
n=2 Participants
Participants with renal transplant received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants had a renal transplant at least a year ago under stable conditions for at least 6 months with medications, categorized as low risk of rejection.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Any Dose
Any solicited local AEs
|
1 Participants
|
0 Participants
|
40 Participants
|
28 Participants
|
26 Participants
|
6 Participants
|
2 Participants
|
|
Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Any Dose
Any solicited systemic AEs
|
1 Participants
|
0 Participants
|
46 Participants
|
29 Participants
|
31 Participants
|
7 Participants
|
2 Participants
|
|
Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Any Dose
Any related solicited systemic AEs
|
0 Participants
|
0 Participants
|
44 Participants
|
26 Participants
|
28 Participants
|
6 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)Population: The SAS including only participants who experienced solicited local and systemic AEs.
Reactogenicity was assessed daily via collection of solicited local AEs (injection site pain, redness, swelling, and itching) and 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 |
Chronic Kidney Disease
n=1 Participants
Participants with chronic kidney disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Kidney function was ascertained from the serum creatinine measurement within the last 6 months, converted into eGFR using the CKD-EPI equation, with impaired kidney function defined as eGFR \<60 mL/min/1.73m².
|
COPD
Participants with COPD received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. COPD included emphysema and chronic bronchitis.
|
Obesity
n=46 Participants
Participants with obesity received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Obesity was defined as a BMI \>32 kg/m².
|
Chronic Cardiovascular Disease
n=29 Participants
Participants with chronic cardiovascular disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Chronic cardiovascular disease included heart failure, structural heart disorder, coronary artery disease, cardiomyopathies and arterial hypertension.
|
Chronic HIV Infection
n=31 Participants
Participants with chronic HIV infection received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with chronic HIV infection required stable aviremia (\<50 copies/mL) and CD4 count \>350/mL as documented by blood samples taken within 12 months before enrollment. Viral load \<50 copies/mL over 12 months with transient changes of 50-350 copies/mL was allowed.
|
Type 2 Diabetes Mellitus
n=7 Participants
Participants with type 2 diabetes mellitus received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with type 2 diabetes mellitus required diabetes mellitus to be controlled with medication \[HbA1c \<58 mmol/mol (7.45%)\].
|
Renal Transplant
n=2 Participants
Participants with renal transplant received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants had a renal transplant at least a year ago under stable conditions for at least 6 months with medications, categorized as low risk of rejection.
|
|---|---|---|---|---|---|---|---|
|
Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose
Any solicited local AEs · Grade 1
|
1 Participants
|
0 Participants
|
30 Participants
|
23 Participants
|
20 Participants
|
6 Participants
|
2 Participants
|
|
Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose
Any solicited local AEs · Grade 2
|
0 Participants
|
0 Participants
|
9 Participants
|
4 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose
Any solicited local AEs · Grade 3
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose
Any solicited systemic AEs · Grade 1
|
1 Participants
|
0 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
2 Participants
|
0 Participants
|
|
Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose
Any solicited systemic AEs · Grade 2
|
0 Participants
|
0 Participants
|
19 Participants
|
12 Participants
|
14 Participants
|
3 Participants
|
2 Participants
|
|
Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose
Any solicited systemic AEs · Grade 3
|
0 Participants
|
0 Participants
|
19 Participants
|
9 Participants
|
9 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 7 days after vaccination (Days 1 to 8 and Days 29 to 36)Population: The SAS including only participants who experienced solicited local and systemic AEs.
Reactogenicity was assessed daily via collection of solicited local AEs (injection site pain, redness, swelling, and itching) and 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. AEs ongoing after Day 8 were included.
Outcome measures
| Measure |
Chronic Kidney Disease
n=1 Participants
Participants with chronic kidney disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Kidney function was ascertained from the serum creatinine measurement within the last 6 months, converted into eGFR using the CKD-EPI equation, with impaired kidney function defined as eGFR \<60 mL/min/1.73m².
|
COPD
Participants with COPD received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. COPD included emphysema and chronic bronchitis.
|
Obesity
n=46 Participants
Participants with obesity received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Obesity was defined as a BMI \>32 kg/m².
|
Chronic Cardiovascular Disease
n=29 Participants
Participants with chronic cardiovascular disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Chronic cardiovascular disease included heart failure, structural heart disorder, coronary artery disease, cardiomyopathies and arterial hypertension.
|
Chronic HIV Infection
n=31 Participants
Participants with chronic HIV infection received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with chronic HIV infection required stable aviremia (\<50 copies/mL) and CD4 count \>350/mL as documented by blood samples taken within 12 months before enrollment. Viral load \<50 copies/mL over 12 months with transient changes of 50-350 copies/mL was allowed.
|
Type 2 Diabetes Mellitus
n=7 Participants
Participants with type 2 diabetes mellitus received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with type 2 diabetes mellitus required diabetes mellitus to be controlled with medication \[HbA1c \<58 mmol/mol (7.45%)\].
|
Renal Transplant
n=2 Participants
Participants with renal transplant received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants had a renal transplant at least a year ago under stable conditions for at least 6 months with medications, categorized as low risk of rejection.
|
|---|---|---|---|---|---|---|---|
|
Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After Any Dose
Any solicited local AEs
|
1.0 days
Standard Deviation NA
Standard deviation could not be calculated as a single participant was analyzed.
|
—
|
2.2 days
Standard Deviation 1.11
|
2.1 days
Standard Deviation 1.21
|
2.4 days
Standard Deviation 0.70
|
1.8 days
Standard Deviation 0.75
|
1.0 days
Standard Deviation 0.00
|
|
Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After Any Dose
Any solicited systemic AEs
|
1.0 days
Standard Deviation NA
Standard deviation could not be calculated as a single participant was analyzed.
|
—
|
4.4 days
Standard Deviation 5.06
|
4.1 days
Standard Deviation 2.58
|
4.3 days
Standard Deviation 3.10
|
5.4 days
Standard Deviation 4.83
|
3.0 days
Standard Deviation 1.41
|
PRIMARY outcome
Timeframe: Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57)Population: The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
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 |
Chronic Kidney Disease
n=1 Participants
Participants with chronic kidney disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Kidney function was ascertained from the serum creatinine measurement within the last 6 months, converted into eGFR using the CKD-EPI equation, with impaired kidney function defined as eGFR \<60 mL/min/1.73m².
|
COPD
n=1 Participants
Participants with COPD received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. COPD included emphysema and chronic bronchitis.
|
Obesity
n=52 Participants
Participants with obesity received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Obesity was defined as a BMI \>32 kg/m².
|
Chronic Cardiovascular Disease
n=33 Participants
Participants with chronic cardiovascular disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Chronic cardiovascular disease included heart failure, structural heart disorder, coronary artery disease, cardiomyopathies and arterial hypertension.
|
Chronic HIV Infection
n=33 Participants
Participants with chronic HIV infection received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with chronic HIV infection required stable aviremia (\<50 copies/mL) and CD4 count \>350/mL as documented by blood samples taken within 12 months before enrollment. Viral load \<50 copies/mL over 12 months with transient changes of 50-350 copies/mL was allowed.
|
Type 2 Diabetes Mellitus
n=7 Participants
Participants with type 2 diabetes mellitus received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with type 2 diabetes mellitus required diabetes mellitus to be controlled with medication \[HbA1c \<58 mmol/mol (7.45%)\].
|
Renal Transplant
n=2 Participants
Participants with renal transplant received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants had a renal transplant at least a year ago under stable conditions for at least 6 months with medications, categorized as low risk of rejection.
|
|---|---|---|---|---|---|---|---|
|
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
|
1 Participants
|
1 Participants
|
27 Participants
|
14 Participants
|
19 Participants
|
4 Participants
|
1 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
|
1 Participants
|
1 Participants
|
12 Participants
|
5 Participants
|
7 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57)Population: The SAS including only participants who experienced unsolicited AEs.
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 |
Chronic Kidney Disease
n=1 Participants
Participants with chronic kidney disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Kidney function was ascertained from the serum creatinine measurement within the last 6 months, converted into eGFR using the CKD-EPI equation, with impaired kidney function defined as eGFR \<60 mL/min/1.73m².
|
COPD
n=1 Participants
Participants with COPD received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. COPD included emphysema and chronic bronchitis.
|
Obesity
n=27 Participants
Participants with obesity received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Obesity was defined as a BMI \>32 kg/m².
|
Chronic Cardiovascular Disease
n=14 Participants
Participants with chronic cardiovascular disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Chronic cardiovascular disease included heart failure, structural heart disorder, coronary artery disease, cardiomyopathies and arterial hypertension.
|
Chronic HIV Infection
n=19 Participants
Participants with chronic HIV infection received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with chronic HIV infection required stable aviremia (\<50 copies/mL) and CD4 count \>350/mL as documented by blood samples taken within 12 months before enrollment. Viral load \<50 copies/mL over 12 months with transient changes of 50-350 copies/mL was allowed.
|
Type 2 Diabetes Mellitus
n=4 Participants
Participants with type 2 diabetes mellitus received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with type 2 diabetes mellitus required diabetes mellitus to be controlled with medication \[HbA1c \<58 mmol/mol (7.45%)\].
|
Renal Transplant
n=1 Participants
Participants with renal transplant received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants had a renal transplant at least a year ago under stable conditions for at least 6 months with medications, categorized as low risk of rejection.
|
|---|---|---|---|---|---|---|---|
|
Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Any Dose
Mild
|
1 Participants
|
0 Participants
|
6 Participants
|
4 Participants
|
8 Participants
|
2 Participants
|
1 Participants
|
|
Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Any Dose
Moderate
|
0 Participants
|
1 Participants
|
17 Participants
|
7 Participants
|
10 Participants
|
1 Participants
|
0 Participants
|
|
Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Any Dose
Severe
|
0 Participants
|
0 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 57Population: The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
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 |
Chronic Kidney Disease
n=1 Participants
Participants with chronic kidney disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Kidney function was ascertained from the serum creatinine measurement within the last 6 months, converted into eGFR using the CKD-EPI equation, with impaired kidney function defined as eGFR \<60 mL/min/1.73m².
|
COPD
n=1 Participants
Participants with COPD received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. COPD included emphysema and chronic bronchitis.
|
Obesity
n=52 Participants
Participants with obesity received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Obesity was defined as a BMI \>32 kg/m².
|
Chronic Cardiovascular Disease
n=33 Participants
Participants with chronic cardiovascular disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Chronic cardiovascular disease included heart failure, structural heart disorder, coronary artery disease, cardiomyopathies and arterial hypertension.
|
Chronic HIV Infection
n=33 Participants
Participants with chronic HIV infection received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with chronic HIV infection required stable aviremia (\<50 copies/mL) and CD4 count \>350/mL as documented by blood samples taken within 12 months before enrollment. Viral load \<50 copies/mL over 12 months with transient changes of 50-350 copies/mL was allowed.
|
Type 2 Diabetes Mellitus
n=7 Participants
Participants with type 2 diabetes mellitus received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with type 2 diabetes mellitus required diabetes mellitus to be controlled with medication \[HbA1c \<58 mmol/mol (7.45%)\].
|
Renal Transplant
n=2 Participants
Participants with renal transplant received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants had a renal transplant at least a year ago under stable conditions for at least 6 months with medications, categorized as low risk of rejection.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced a Serious Adverse Event (SAE) During the Trial
Any SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Serious Adverse Event (SAE) During the Trial
Any related SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 57Population: The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
AESIs included: * AEs with a suspected immune-mediated etiology including potential immune-mediated diseases. * Other AEs relevant to SARS-CoV-2 vaccine development or the target disease. * Non-serious intercurrent medical conditions that may affect the immune response to vaccination was collected throughout the trial. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE.
Outcome measures
| Measure |
Chronic Kidney Disease
n=1 Participants
Participants with chronic kidney disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Kidney function was ascertained from the serum creatinine measurement within the last 6 months, converted into eGFR using the CKD-EPI equation, with impaired kidney function defined as eGFR \<60 mL/min/1.73m².
|
COPD
n=1 Participants
Participants with COPD received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. COPD included emphysema and chronic bronchitis.
|
Obesity
n=52 Participants
Participants with obesity received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Obesity was defined as a BMI \>32 kg/m².
|
Chronic Cardiovascular Disease
n=33 Participants
Participants with chronic cardiovascular disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Chronic cardiovascular disease included heart failure, structural heart disorder, coronary artery disease, cardiomyopathies and arterial hypertension.
|
Chronic HIV Infection
n=33 Participants
Participants with chronic HIV infection received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with chronic HIV infection required stable aviremia (\<50 copies/mL) and CD4 count \>350/mL as documented by blood samples taken within 12 months before enrollment. Viral load \<50 copies/mL over 12 months with transient changes of 50-350 copies/mL was allowed.
|
Type 2 Diabetes Mellitus
n=7 Participants
Participants with type 2 diabetes mellitus received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with type 2 diabetes mellitus required diabetes mellitus to be controlled with medication \[HbA1c \<58 mmol/mol (7.45%)\].
|
Renal Transplant
n=2 Participants
Participants with renal transplant received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants had a renal transplant at least a year ago under stable conditions for at least 6 months with medications, categorized as low risk of rejection.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced an Adverse Event of Special Interest (AESI) During the Trial
Any AESIs
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced an Adverse Event of Special Interest (AESI) During the Trial
Any Related AESIs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 43Population: The Per Protocol Immunogenicity subset (PPI) included all participants who received both doses within the windows defined in the protocol, had no major protocol deviations expected to impact the immunogenicity outcomes, had not received medical treatments (such as blood products, immunoglobulin therapy) that may interfere with any of the immunogenicity measurements and had at least 1 blood sample collected starting at 14 days (Day 43) post-second vaccination available for analysis.
Seroconversion was defined as any increase in titer in antibodies against SARS-CoV-2 RBD versus baseline. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/ authorized vaccine.
Outcome measures
| Measure |
Chronic Kidney Disease
n=1 Participants
Participants with chronic kidney disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Kidney function was ascertained from the serum creatinine measurement within the last 6 months, converted into eGFR using the CKD-EPI equation, with impaired kidney function defined as eGFR \<60 mL/min/1.73m².
|
COPD
n=1 Participants
Participants with COPD received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. COPD included emphysema and chronic bronchitis.
|
Obesity
n=38 Participants
Participants with obesity received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Obesity was defined as a BMI \>32 kg/m².
|
Chronic Cardiovascular Disease
n=21 Participants
Participants with chronic cardiovascular disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Chronic cardiovascular disease included heart failure, structural heart disorder, coronary artery disease, cardiomyopathies and arterial hypertension.
|
Chronic HIV Infection
n=18 Participants
Participants with chronic HIV infection received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with chronic HIV infection required stable aviremia (\<50 copies/mL) and CD4 count \>350/mL as documented by blood samples taken within 12 months before enrollment. Viral load \<50 copies/mL over 12 months with transient changes of 50-350 copies/mL was allowed.
|
Type 2 Diabetes Mellitus
n=5 Participants
Participants with type 2 diabetes mellitus received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with type 2 diabetes mellitus required diabetes mellitus to be controlled with medication \[HbA1c \<58 mmol/mol (7.45%)\].
|
Renal Transplant
n=2 Participants
Participants with renal transplant received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants had a renal transplant at least a year ago under stable conditions for at least 6 months with medications, categorized as low risk of rejection.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies on Day 43
|
1 count of seroconverted participants
|
0 count of seroconverted participants
|
34 count of seroconverted participants
|
19 count of seroconverted participants
|
16 count of seroconverted participants
|
4 count of seroconverted participants
|
1 count of seroconverted participants
|
PRIMARY outcome
Timeframe: Day 43Population: The PPI included all participants who received both doses within the windows defined in the protocol, had no major protocol deviations expected to impact the immunogenicity outcomes, had not received medical treatments (such as blood products, immunoglobulin therapy) that may interfere with any of the immunogenicity measurements and had at least 1 blood sample collected starting at 14 days (Day 43) post-second vaccination available for analysis.
The SARS-CoV-2 spike RBD protein-specific antibodies are expressed as GMT (geometric mean of reciprocal duplicate dilutions). Concentration/titers marked as below the lower limit of quantification (LLOQ) were arbitrary replaced by half of the LLOQ for GMT computations purpose. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
Outcome measures
| Measure |
Chronic Kidney Disease
n=1 Participants
Participants with chronic kidney disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Kidney function was ascertained from the serum creatinine measurement within the last 6 months, converted into eGFR using the CKD-EPI equation, with impaired kidney function defined as eGFR \<60 mL/min/1.73m².
|
COPD
n=1 Participants
Participants with COPD received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. COPD included emphysema and chronic bronchitis.
|
Obesity
n=38 Participants
Participants with obesity received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Obesity was defined as a BMI \>32 kg/m².
|
Chronic Cardiovascular Disease
n=21 Participants
Participants with chronic cardiovascular disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Chronic cardiovascular disease included heart failure, structural heart disorder, coronary artery disease, cardiomyopathies and arterial hypertension.
|
Chronic HIV Infection
n=18 Participants
Participants with chronic HIV infection received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with chronic HIV infection required stable aviremia (\<50 copies/mL) and CD4 count \>350/mL as documented by blood samples taken within 12 months before enrollment. Viral load \<50 copies/mL over 12 months with transient changes of 50-350 copies/mL was allowed.
|
Type 2 Diabetes Mellitus
n=5 Participants
Participants with type 2 diabetes mellitus received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with type 2 diabetes mellitus required diabetes mellitus to be controlled with medication \[HbA1c \<58 mmol/mol (7.45%)\].
|
Renal Transplant
n=2 Participants
Participants with renal transplant received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants had a renal transplant at least a year ago under stable conditions for at least 6 months with medications, categorized as low risk of rejection.
|
|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein RBD Antibodies on Day 43
|
518.410 titers
Standard Deviation NA
Standard deviation could not be calculated as a single participant was analyzed.
|
50.000 titers
Standard Deviation NA
Standard deviation could not be calculated as a single participant was analyzed.
|
1576.121 titers
Standard Deviation 7.5115
|
1385.663 titers
Standard Deviation 5.8935
|
968.795 titers
Standard Deviation 4.7759
|
183.523 titers
Standard Deviation 2.4423
|
416.051 titers
Standard Deviation 20.0136
|
PRIMARY outcome
Timeframe: Baseline and Day 43Population: A subset of the PPI population was included in the measurement of neutralizing activity.
Seroconversion was defined as any increase in titer of SARS-CoV-2 neutralizing antibodies versus baseline. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
Outcome measures
| Measure |
Chronic Kidney Disease
n=1 Participants
Participants with chronic kidney disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Kidney function was ascertained from the serum creatinine measurement within the last 6 months, converted into eGFR using the CKD-EPI equation, with impaired kidney function defined as eGFR \<60 mL/min/1.73m².
|
COPD
n=1 Participants
Participants with COPD received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. COPD included emphysema and chronic bronchitis.
|
Obesity
n=23 Participants
Participants with obesity received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Obesity was defined as a BMI \>32 kg/m².
|
Chronic Cardiovascular Disease
n=11 Participants
Participants with chronic cardiovascular disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Chronic cardiovascular disease included heart failure, structural heart disorder, coronary artery disease, cardiomyopathies and arterial hypertension.
|
Chronic HIV Infection
n=11 Participants
Participants with chronic HIV infection received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with chronic HIV infection required stable aviremia (\<50 copies/mL) and CD4 count \>350/mL as documented by blood samples taken within 12 months before enrollment. Viral load \<50 copies/mL over 12 months with transient changes of 50-350 copies/mL was allowed.
|
Type 2 Diabetes Mellitus
n=5 Participants
Participants with type 2 diabetes mellitus received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with type 2 diabetes mellitus required diabetes mellitus to be controlled with medication \[HbA1c \<58 mmol/mol (7.45%)\].
|
Renal Transplant
n=2 Participants
Participants with renal transplant received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants had a renal transplant at least a year ago under stable conditions for at least 6 months with medications, categorized as low risk of rejection.
|
|---|---|---|---|---|---|---|---|
|
Subset Participants: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 43
|
1 count of seroconverted participants
|
0 count of seroconverted participants
|
16 count of seroconverted participants
|
6 count of seroconverted participants
|
7 count of seroconverted participants
|
0 count of seroconverted participants
|
1 count of seroconverted participants
|
PRIMARY outcome
Timeframe: Day 43Population: A subset of the PPI population was included in the measurement of neutralizing activity.
The SARS-CoV-2 neutralizing antibodies are expressed as GMT (geometric mean of reciprocal duplicate dilutions). Concentrations/titers marked as below the LLOQ were arbitrary replaced by half of the LLOQ for GMT computations purpose. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
Outcome measures
| Measure |
Chronic Kidney Disease
n=1 Participants
Participants with chronic kidney disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Kidney function was ascertained from the serum creatinine measurement within the last 6 months, converted into eGFR using the CKD-EPI equation, with impaired kidney function defined as eGFR \<60 mL/min/1.73m².
|
COPD
n=1 Participants
Participants with COPD received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. COPD included emphysema and chronic bronchitis.
|
Obesity
n=23 Participants
Participants with obesity received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Obesity was defined as a BMI \>32 kg/m².
|
Chronic Cardiovascular Disease
n=11 Participants
Participants with chronic cardiovascular disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Chronic cardiovascular disease included heart failure, structural heart disorder, coronary artery disease, cardiomyopathies and arterial hypertension.
|
Chronic HIV Infection
n=11 Participants
Participants with chronic HIV infection received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with chronic HIV infection required stable aviremia (\<50 copies/mL) and CD4 count \>350/mL as documented by blood samples taken within 12 months before enrollment. Viral load \<50 copies/mL over 12 months with transient changes of 50-350 copies/mL was allowed.
|
Type 2 Diabetes Mellitus
n=5 Participants
Participants with type 2 diabetes mellitus received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with type 2 diabetes mellitus required diabetes mellitus to be controlled with medication \[HbA1c \<58 mmol/mol (7.45%)\].
|
Renal Transplant
n=2 Participants
Participants with renal transplant received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants had a renal transplant at least a year ago under stable conditions for at least 6 months with medications, categorized as low risk of rejection.
|
|---|---|---|---|---|---|---|---|
|
Subset Participants: GMTs of Serum SARS-CoV-2 Neutralizing Antibodies on Day 43
|
14.140 titers
Standard Deviation NA
Standard deviation could not be calculated as a single participant was analyzed.
|
5.000 titers
Standard Deviation NA
Standard deviation could not be calculated as a single participant was analyzed.
|
57.426 titers
Standard Deviation 9.1427
|
16.042 titers
Standard Deviation 4.0790
|
18.778 titers
Standard Deviation 3.9937
|
5.000 titers
Standard Deviation 1.0000
|
10.000 titers
Standard Deviation 2.6651
|
SECONDARY outcome
Timeframe: Baseline and Days 29, 120, 211 and 393Population: The PPI. No data was collected for Days 211 and 393 due to early study termination.
Seroconversion was defined as any increase in titer in antibodies against SARS-CoV-2 RBD versus baseline. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/ authorized vaccine.
Outcome measures
| Measure |
Chronic Kidney Disease
n=1 Participants
Participants with chronic kidney disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Kidney function was ascertained from the serum creatinine measurement within the last 6 months, converted into eGFR using the CKD-EPI equation, with impaired kidney function defined as eGFR \<60 mL/min/1.73m².
|
COPD
n=1 Participants
Participants with COPD received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. COPD included emphysema and chronic bronchitis.
|
Obesity
n=39 Participants
Participants with obesity received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Obesity was defined as a BMI \>32 kg/m².
|
Chronic Cardiovascular Disease
n=21 Participants
Participants with chronic cardiovascular disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Chronic cardiovascular disease included heart failure, structural heart disorder, coronary artery disease, cardiomyopathies and arterial hypertension.
|
Chronic HIV Infection
n=18 Participants
Participants with chronic HIV infection received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with chronic HIV infection required stable aviremia (\<50 copies/mL) and CD4 count \>350/mL as documented by blood samples taken within 12 months before enrollment. Viral load \<50 copies/mL over 12 months with transient changes of 50-350 copies/mL was allowed.
|
Type 2 Diabetes Mellitus
n=5 Participants
Participants with type 2 diabetes mellitus received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with type 2 diabetes mellitus required diabetes mellitus to be controlled with medication \[HbA1c \<58 mmol/mol (7.45%)\].
|
Renal Transplant
n=2 Participants
Participants with renal transplant received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants had a renal transplant at least a year ago under stable conditions for at least 6 months with medications, categorized as low risk of rejection.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Seroconverting for SARS-CoV-2 Spike Protein RBD Antibodies on Days 29, 120, 211 and 393
Day 29
|
0 count of seroconverted participants
|
0 count of seroconverted participants
|
13 count of seroconverted participants
|
7 count of seroconverted participants
|
3 count of seroconverted participants
|
1 count of seroconverted participants
|
0 count of seroconverted participants
|
|
Number of Participants Seroconverting for SARS-CoV-2 Spike Protein RBD Antibodies on Days 29, 120, 211 and 393
Day 120
|
—
|
0 count of seroconverted participants
|
6 count of seroconverted participants
|
1 count of seroconverted participants
|
2 count of seroconverted participants
|
1 count of seroconverted participants
|
—
|
SECONDARY outcome
Timeframe: Days 29, 120, 211 and 393Population: The PPI. No data was collected for Days 211 and 393 due to early study termination.
The SARS-CoV-2 spike RBD protein-specific antibodies are expressed as GMT (geometric mean of reciprocal duplicate dilutions). Concentrations/titers marked as below the LLOQ were arbitrary replaced by half of the LLOQ for GMT computations purpose. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
Outcome measures
| Measure |
Chronic Kidney Disease
n=1 Participants
Participants with chronic kidney disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Kidney function was ascertained from the serum creatinine measurement within the last 6 months, converted into eGFR using the CKD-EPI equation, with impaired kidney function defined as eGFR \<60 mL/min/1.73m².
|
COPD
n=1 Participants
Participants with COPD received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. COPD included emphysema and chronic bronchitis.
|
Obesity
n=39 Participants
Participants with obesity received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Obesity was defined as a BMI \>32 kg/m².
|
Chronic Cardiovascular Disease
n=21 Participants
Participants with chronic cardiovascular disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Chronic cardiovascular disease included heart failure, structural heart disorder, coronary artery disease, cardiomyopathies and arterial hypertension.
|
Chronic HIV Infection
n=18 Participants
Participants with chronic HIV infection received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with chronic HIV infection required stable aviremia (\<50 copies/mL) and CD4 count \>350/mL as documented by blood samples taken within 12 months before enrollment. Viral load \<50 copies/mL over 12 months with transient changes of 50-350 copies/mL was allowed.
|
Type 2 Diabetes Mellitus
n=5 Participants
Participants with type 2 diabetes mellitus received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with type 2 diabetes mellitus required diabetes mellitus to be controlled with medication \[HbA1c \<58 mmol/mol (7.45%)\].
|
Renal Transplant
n=2 Participants
Participants with renal transplant received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants had a renal transplant at least a year ago under stable conditions for at least 6 months with medications, categorized as low risk of rejection.
|
|---|---|---|---|---|---|---|---|
|
GMTs of Serum SARS-CoV-2 Spike Protein RBD Antibodies on Days 29, 120, 211 and 393
Day 29
|
50.000 titers
Standard Deviation NA
Standard deviation could not be calculated as a single participant was analyzed.
|
50.000 titers
Standard Deviation NA
Standard deviation could not be calculated as a single participant was analyzed.
|
234.464 titers
Standard Deviation 9.4598
|
153.351 titers
Standard Deviation 5.6201
|
104.230 titers
Standard Deviation 5.4583
|
90.306 titers
Standard Deviation 3.7506
|
50.000 titers
Standard Deviation 1.0000
|
|
GMTs of Serum SARS-CoV-2 Spike Protein RBD Antibodies on Days 29, 120, 211 and 393
Day 120
|
—
|
50.000 titers
Standard Deviation NA
Standard deviation could not be calculated as a single participant was analyzed.
|
1861.522 titers
Standard Deviation 7.3966
|
179.992 titers
Standard Deviation 6.1193
|
174.749 titers
Standard Deviation 1.1589
|
554.010 titers
Standard Deviation NA
Standard deviation could not be calculated as a single participant was analyzed.
|
—
|
SECONDARY outcome
Timeframe: Baseline and Days 29 and 120Population: A subset of the PPI population was included in the measurement of neutralizing activity.
Seroconversion was defined as any increase in titer of SARS-CoV-2 neutralizing antibodies versus baseline. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
Outcome measures
| Measure |
Chronic Kidney Disease
n=1 Participants
Participants with chronic kidney disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Kidney function was ascertained from the serum creatinine measurement within the last 6 months, converted into eGFR using the CKD-EPI equation, with impaired kidney function defined as eGFR \<60 mL/min/1.73m².
|
COPD
n=1 Participants
Participants with COPD received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. COPD included emphysema and chronic bronchitis.
|
Obesity
n=24 Participants
Participants with obesity received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Obesity was defined as a BMI \>32 kg/m².
|
Chronic Cardiovascular Disease
n=11 Participants
Participants with chronic cardiovascular disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Chronic cardiovascular disease included heart failure, structural heart disorder, coronary artery disease, cardiomyopathies and arterial hypertension.
|
Chronic HIV Infection
n=11 Participants
Participants with chronic HIV infection received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with chronic HIV infection required stable aviremia (\<50 copies/mL) and CD4 count \>350/mL as documented by blood samples taken within 12 months before enrollment. Viral load \<50 copies/mL over 12 months with transient changes of 50-350 copies/mL was allowed.
|
Type 2 Diabetes Mellitus
n=5 Participants
Participants with type 2 diabetes mellitus received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with type 2 diabetes mellitus required diabetes mellitus to be controlled with medication \[HbA1c \<58 mmol/mol (7.45%)\].
|
Renal Transplant
n=2 Participants
Participants with renal transplant received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants had a renal transplant at least a year ago under stable conditions for at least 6 months with medications, categorized as low risk of rejection.
|
|---|---|---|---|---|---|---|---|
|
Subset Participants: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Days 29 and 120
Day 29
|
0 count of seroconverted participants
|
0 count of seroconverted participants
|
7 count of seroconverted participants
|
2 count of seroconverted participants
|
1 count of seroconverted participants
|
0 count of seroconverted participants
|
0 count of seroconverted participants
|
|
Subset Participants: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Days 29 and 120
Day 120
|
—
|
0 count of seroconverted participants
|
2 count of seroconverted participants
|
0 count of seroconverted participants
|
1 count of seroconverted participants
|
0 count of seroconverted participants
|
—
|
SECONDARY outcome
Timeframe: Days 29 and 120Population: A subset of the PPI population was included in the measurement of neutralizing activity.
The SARS-CoV-2 neutralizing antibodies are expressed as GMT (geometric mean of reciprocal duplicate dilutions). Concentrations/titers marked as below the LLOQ were arbitrary replaced by half of the LLOQ for GMT computations purpose. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
Outcome measures
| Measure |
Chronic Kidney Disease
n=1 Participants
Participants with chronic kidney disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Kidney function was ascertained from the serum creatinine measurement within the last 6 months, converted into eGFR using the CKD-EPI equation, with impaired kidney function defined as eGFR \<60 mL/min/1.73m².
|
COPD
n=1 Participants
Participants with COPD received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. COPD included emphysema and chronic bronchitis.
|
Obesity
n=24 Participants
Participants with obesity received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Obesity was defined as a BMI \>32 kg/m².
|
Chronic Cardiovascular Disease
n=11 Participants
Participants with chronic cardiovascular disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Chronic cardiovascular disease included heart failure, structural heart disorder, coronary artery disease, cardiomyopathies and arterial hypertension.
|
Chronic HIV Infection
n=11 Participants
Participants with chronic HIV infection received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with chronic HIV infection required stable aviremia (\<50 copies/mL) and CD4 count \>350/mL as documented by blood samples taken within 12 months before enrollment. Viral load \<50 copies/mL over 12 months with transient changes of 50-350 copies/mL was allowed.
|
Type 2 Diabetes Mellitus
n=5 Participants
Participants with type 2 diabetes mellitus received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with type 2 diabetes mellitus required diabetes mellitus to be controlled with medication \[HbA1c \<58 mmol/mol (7.45%)\].
|
Renal Transplant
n=2 Participants
Participants with renal transplant received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants had a renal transplant at least a year ago under stable conditions for at least 6 months with medications, categorized as low risk of rejection.
|
|---|---|---|---|---|---|---|---|
|
Subset Participants: GMTs of Serum SARS-CoV-2 Neutralizing Antibodies on Days 29 and 120
Day 120
|
—
|
5.000 titers
Standard Deviation NA
Standard deviation could not be calculated as a single participant was analyzed.
|
26.389 titers
Standard Deviation 7.0380
|
5.000 titers
Standard Deviation NA
Standard deviation could not be calculated as a single participant was analyzed.
|
7.071 titers
Standard Deviation 1.6325
|
5.000 titers
Standard Deviation NA
Standard deviation could not be calculated as a single participant was analyzed.
|
—
|
|
Subset Participants: GMTs of Serum SARS-CoV-2 Neutralizing Antibodies on Days 29 and 120
Day 29
|
5.000 titers
Standard Deviation NA
Standard deviation could not be calculated as a single participant was analyzed.
|
5.000 titers
Standard Deviation NA
Standard deviation could not be calculated as a single participant was analyzed.
|
17.311 titers
Standard Deviation 7.4073
|
7.297 titers
Standard Deviation 2.3521
|
6.234 titers
Standard Deviation 2.0782
|
5.000 titers
Standard Deviation 1.0000
|
5.000 titers
Standard Deviation 1.0000
|
Adverse Events
Chronic Kidney Disease
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
COPD
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Obesity
Serious events: 0 serious events
Other events: 50 other events
Deaths: 0 deaths
Chronic Cardiovascular Disease
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Chronic HIV Infection
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Type 2 Diabetes Mellitus
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Renal Transplant
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Chronic Kidney Disease
n=1 participants at risk
Participants with chronic kidney disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Kidney function was ascertained from the serum creatinine measurement within the last 6 months, converted into eGFR using the CKD-EPI equation, with impaired kidney function defined as eGFR \<60 mL/min/1.73m².
|
COPD
n=1 participants at risk
Participants with COPD received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. COPD included emphysema and chronic bronchitis.
|
Obesity
n=52 participants at risk
Participants with obesity received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Obesity was defined as a BMI \>32 kg/m².
|
Chronic Cardiovascular Disease
n=33 participants at risk
Participants with chronic cardiovascular disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Chronic cardiovascular disease included heart failure, structural heart disorder, coronary artery disease, cardiomyopathies and arterial hypertension.
|
Chronic HIV Infection
n=33 participants at risk
Participants with chronic HIV infection received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with chronic HIV infection required stable aviremia (\<50 copies/mL) and CD4 count \>350/mL as documented by blood samples taken within 12 months before enrollment. Viral load \<50 copies/mL over 12 months with transient changes of 50-350 copies/mL was allowed.
|
Type 2 Diabetes Mellitus
n=7 participants at risk
Participants with type 2 diabetes mellitus received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with type 2 diabetes mellitus required diabetes mellitus to be controlled with medication \[HbA1c \<58 mmol/mol (7.45%)\].
|
Renal Transplant
n=2 participants at risk
Participants with renal transplant received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants had a renal transplant at least a year ago under stable conditions for at least 6 months with medications, categorized as low risk of rejection.
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Empyema
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/52 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/33 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/33 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
14.3%
1/7 • Number of events 1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/2 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
Other adverse events
| Measure |
Chronic Kidney Disease
n=1 participants at risk
Participants with chronic kidney disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Kidney function was ascertained from the serum creatinine measurement within the last 6 months, converted into eGFR using the CKD-EPI equation, with impaired kidney function defined as eGFR \<60 mL/min/1.73m².
|
COPD
n=1 participants at risk
Participants with COPD received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. COPD included emphysema and chronic bronchitis.
|
Obesity
n=52 participants at risk
Participants with obesity received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Obesity was defined as a BMI \>32 kg/m².
|
Chronic Cardiovascular Disease
n=33 participants at risk
Participants with chronic cardiovascular disease received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Chronic cardiovascular disease included heart failure, structural heart disorder, coronary artery disease, cardiomyopathies and arterial hypertension.
|
Chronic HIV Infection
n=33 participants at risk
Participants with chronic HIV infection received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with chronic HIV infection required stable aviremia (\<50 copies/mL) and CD4 count \>350/mL as documented by blood samples taken within 12 months before enrollment. Viral load \<50 copies/mL over 12 months with transient changes of 50-350 copies/mL was allowed.
|
Type 2 Diabetes Mellitus
n=7 participants at risk
Participants with type 2 diabetes mellitus received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants with type 2 diabetes mellitus required diabetes mellitus to be controlled with medication \[HbA1c \<58 mmol/mol (7.45%)\].
|
Renal Transplant
n=2 participants at risk
Participants with renal transplant received SARS-CoV-2 mRNA vaccine CVnCoV 12 µg on Day 1 and Day 29. Participants had a renal transplant at least a year ago under stable conditions for at least 6 months with medications, categorized as low risk of rejection.
|
|---|---|---|---|---|---|---|---|
|
Eye disorders
Eye pain
|
100.0%
1/1 • Number of events 2 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/52 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/33 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/33 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/7 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/2 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
50.0%
26/52 • Number of events 56 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
33.3%
11/33 • Number of events 18 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
27.3%
9/33 • Number of events 17 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
42.9%
3/7 • Number of events 3 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/2 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
17.3%
9/52 • Number of events 11 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
18.2%
6/33 • Number of events 6 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
30.3%
10/33 • Number of events 14 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
28.6%
2/7 • Number of events 2 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
50.0%
1/2 • Number of events 2 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
|
General disorders
Chills
|
100.0%
1/1 • Number of events 2 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
46.2%
24/52 • Number of events 34 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
60.6%
20/33 • Number of events 23 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
42.4%
14/33 • Number of events 23 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
14.3%
1/7 • Number of events 1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
50.0%
1/2 • Number of events 2 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
|
General disorders
Fatigue
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
84.6%
44/52 • Number of events 142 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
75.8%
25/33 • Number of events 56 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
66.7%
22/33 • Number of events 58 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
100.0%
7/7 • Number of events 15 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
100.0%
2/2 • Number of events 10 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
|
General disorders
Feeling abnormal
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/52 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/33 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/33 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
14.3%
1/7 • Number of events 2 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/2 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
|
General disorders
Pain
|
100.0%
1/1 • Number of events 1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
75.0%
39/52 • Number of events 59 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
81.8%
27/33 • Number of events 40 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
81.8%
27/33 • Number of events 41 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
85.7%
6/7 • Number of events 8 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
100.0%
2/2 • Number of events 3 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
26.9%
14/52 • Number of events 20 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
30.3%
10/33 • Number of events 11 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
18.2%
6/33 • Number of events 8 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
28.6%
2/7 • Number of events 2 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
50.0%
1/2 • Number of events 2 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
|
General disorders
Swelling
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
7.7%
4/52 • Number of events 4 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/33 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
6.1%
2/33 • Number of events 2 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/7 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/2 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
|
General disorders
Vaccination site pain
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/52 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
6.1%
2/33 • Number of events 2 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
6.1%
2/33 • Number of events 3 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/7 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/2 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
5.8%
3/52 • Number of events 5 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/33 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/33 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/7 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/2 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/52 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/33 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
6.1%
2/33 • Number of events 2 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/7 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/2 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
|
Infections and infestations
Syphilis
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/52 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/33 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
9.1%
3/33 • Number of events 3 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/7 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/2 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
1.9%
1/52 • Number of events 1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/33 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/33 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
14.3%
1/7 • Number of events 1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/2 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/52 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/33 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/33 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
14.3%
1/7 • Number of events 1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/2 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
100.0%
1/1 • Number of events 1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
51.9%
27/52 • Number of events 54 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
45.5%
15/33 • Number of events 31 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
27.3%
9/33 • Number of events 16 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
85.7%
6/7 • Number of events 15 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
50.0%
1/2 • Number of events 2 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
5.8%
3/52 • Number of events 3 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
3.0%
1/33 • Number of events 1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/33 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/7 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/2 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
100.0%
1/1 • Number of events 1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
67.3%
35/52 • Number of events 68 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
63.6%
21/33 • Number of events 39 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
57.6%
19/33 • Number of events 41 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
100.0%
7/7 • Number of events 14 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
100.0%
2/2 • Number of events 4 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
75.0%
39/52 • Number of events 106 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
63.6%
21/33 • Number of events 44 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
63.6%
21/33 • Number of events 42 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
85.7%
6/7 • Number of events 9 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
100.0%
2/2 • Number of events 8 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
|
Nervous system disorders
Parosmia
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/52 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/33 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/33 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
14.3%
1/7 • Number of events 1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/2 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/52 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/33 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/33 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
14.3%
1/7 • Number of events 1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/2 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/52 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/33 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
6.1%
2/33 • Number of events 2 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/7 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/2 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
100.0%
1/1 • Number of events 1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/52 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/33 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/33 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/7 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/2 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/52 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/33 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/33 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
14.3%
1/7 • Number of events 2 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/2 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
100.0%
1/1 • Number of events 1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
3.8%
2/52 • Number of events 2 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/33 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
9.1%
3/33 • Number of events 3 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/7 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/2 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
100.0%
1/1 • Number of events 2 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/52 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/33 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/33 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/7 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/2 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
3.8%
2/52 • Number of events 2 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
3.0%
1/33 • Number of events 1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
6.1%
2/33 • Number of events 2 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/7 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/2 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
9.6%
5/52 • Number of events 5 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
15.2%
5/33 • Number of events 6 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
12.1%
4/33 • Number of events 4 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/7 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/2 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
|
Vascular disorders
Hot flush
|
100.0%
1/1 • Number of events 1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/52 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/33 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
3.0%
1/33 • Number of events 1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/7 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/2 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
|
Infections and infestations
COVID-19
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
5.8%
3/52 • Number of events 3 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
3.0%
1/33 • Number of events 1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/33 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/7 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/2 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/52 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
3.0%
1/33 • Number of events 1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
6.1%
2/33 • Number of events 2 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/7 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/2 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/52 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/33 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
6.1%
2/33 • Number of events 2 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/7 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/2 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
|
General disorders
Malaise
|
100.0%
1/1 • Number of events 1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/1 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/52 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/33 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/33 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/7 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
0.00%
0/2 • Up to Day 57
The SAS consisted of all participants who received at least 1 dose of CVnCoV and for whom any post-vaccination safety data were available.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place