Trial Outcomes & Findings for Safety, Reactogenicity, and Immunogenicity Trial of CV2CoV mRNA Vaccine Against SARS-CoV-2 in Seropositive Adult Participants (NCT NCT05260437)
NCT ID: NCT05260437
Last Updated: 2024-08-12
Results Overview
An AESI (serious or nonserious) is defined as an AE or SAE of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor could be appropriate.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
99 participants
Primary outcome timeframe
From Day 1 up to Day 180 (including Day 180)
Results posted on
2024-08-12
Participant Flow
The study was conducted at 13 centers in the United States.
Escalation to the next higher dose cohorts was based on the Safety Review Team (SRT) review of safety data from the same age group. GlaxoSmithKline Biologicals SA (GSK) and CureVac decided to stop further enrollment or vaccination in the CV2-SARS-CoV-2-002 (217741) dose escalation study. This decision was taken because the data accumulated were considered sufficient to determine next steps in vaccine platform development. Therefore, enrollment in CV2CoV Dose Cohort 5 (20 µg) was never opened.
Participant milestones
| Measure |
CV2CoV Dose Cohort 1 (Group 1a 2µg)
Participants received 2 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 1 (Group 1b 4µg)
Participants received 4 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 2 (8 µg)
Participants received 8 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 3 (12 µg)
Participants received 12 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 4 (16 µg)
Participants received 16 µg CV2CoV intramuscularly.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
24
|
23
|
20
|
21
|
11
|
|
Overall Study
COMPLETED
|
16
|
20
|
15
|
14
|
9
|
|
Overall Study
NOT COMPLETED
|
8
|
3
|
5
|
7
|
2
|
Reasons for withdrawal
| Measure |
CV2CoV Dose Cohort 1 (Group 1a 2µg)
Participants received 2 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 1 (Group 1b 4µg)
Participants received 4 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 2 (8 µg)
Participants received 8 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 3 (12 µg)
Participants received 12 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 4 (16 µg)
Participants received 16 µg CV2CoV intramuscularly.
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
2
|
1
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
4
|
5
|
0
|
|
Overall Study
Vaccine Not Administered
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Safety, Reactogenicity, and Immunogenicity Trial of CV2CoV mRNA Vaccine Against SARS-CoV-2 in Seropositive Adult Participants
Baseline characteristics by cohort
| Measure |
CV2CoV Dose Cohort 1 (Group 1a 2µg)
n=24 Participants
Participants received 2 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 1 (Group 1b 4µg)
n=23 Participants
Participants received 4 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 2 (8 µg)
n=20 Participants
Participants received 8 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 3 (12 µg)
n=21 Participants
Participants received 12 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 4 (16 µg)
n=11 Participants
Participants received 16 µg CV2CoV intramuscularly.
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
42.5 Years
STANDARD_DEVIATION 15.46 • n=5 Participants
|
44.8 Years
STANDARD_DEVIATION 14.87 • n=7 Participants
|
43.9 Years
STANDARD_DEVIATION 15.77 • n=5 Participants
|
39.7 Years
STANDARD_DEVIATION 12.37 • n=4 Participants
|
37.6 Years
STANDARD_DEVIATION 10.69 • n=21 Participants
|
42.2 Years
STANDARD_DEVIATION 14.24 • n=8 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
48 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
51 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
47 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
51 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to Day 180 (including Day 180)Population: Analysis was performed on the Safety set which excludes the participant who attended the visit on Day 1 but was not dosed.
An AESI (serious or nonserious) is defined as an AE or SAE of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor could be appropriate.
Outcome measures
| Measure |
CV2CoV Dose Cohort 1 (Group 1a 2µg)
n=24 Participants
Participants received 2 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 1 (Group 1b 4µg)
n=22 Participants
Participants received 4 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 2 (8 µg)
n=20 Participants
Participants received 8 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 3 (12 µg)
n=21 Participants
Participants received 12 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 4 (16 µg)
n=11 Participants
Participants received 16 µg CV2CoV intramuscularly.
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Events of Special Interest (AESIs) From Study Vaccination Through the End of the Study
|
1 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to Day 180 (including Day 180)Population: Analysis was performed on the Safety set which excludes the participant who attended the visit on Day 1 but was not dosed.
An SAE is defined as any event that: • Results in death • Is immediately life-threatening • Requires inpatient hospitalization or prolongation of existing hospitalization • Results in persistent or significant disability/incapacity • Is a congenital anomaly/birth defect • Is a spontaneous miscarriage Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered SAEs when, based upon appropriate medical judgment, they may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of drug dependency or drug abuse.
Outcome measures
| Measure |
CV2CoV Dose Cohort 1 (Group 1a 2µg)
n=24 Participants
Participants received 2 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 1 (Group 1b 4µg)
n=22 Participants
Participants received 4 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 2 (8 µg)
n=20 Participants
Participants received 8 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 3 (12 µg)
n=21 Participants
Participants received 12 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 4 (16 µg)
n=11 Participants
Participants received 16 µg CV2CoV intramuscularly.
|
|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) From Study Vaccination Through the End of the Study
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to Day 180 (including Day 180)Population: Analysis was performed on the Safety set which excludes the participant who attended the visit on Day 1 but was not dosed.
An MAAE is defined as an AE that results in a visit to a medical professional. Medically attended visits are defined as a telemedicine visit, physician's office visit, urgent care visit, emergency room visit, hospitalization, or death.
Outcome measures
| Measure |
CV2CoV Dose Cohort 1 (Group 1a 2µg)
n=24 Participants
Participants received 2 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 1 (Group 1b 4µg)
n=22 Participants
Participants received 4 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 2 (8 µg)
n=20 Participants
Participants received 8 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 3 (12 µg)
n=21 Participants
Participants received 12 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 4 (16 µg)
n=11 Participants
Participants received 16 µg CV2CoV intramuscularly.
|
|---|---|---|---|---|---|
|
Number of Participants With Medically Attended Adverse Events (MAAEs) From Study Vaccination Through the End of the Study
|
3 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to Day 7 (including Day 7)Population: Analysis was performed on the Safety set which excludes the participant who attended the visit on Day 1 but was not dosed.
Assessed solicited local reactions were injection site pain, redness, swelling, and lymphadenopathy.
Outcome measures
| Measure |
CV2CoV Dose Cohort 1 (Group 1a 2µg)
n=24 Participants
Participants received 2 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 1 (Group 1b 4µg)
n=22 Participants
Participants received 4 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 2 (8 µg)
n=20 Participants
Participants received 8 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 3 (12 µg)
n=21 Participants
Participants received 12 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 4 (16 µg)
n=11 Participants
Participants received 16 µg CV2CoV intramuscularly.
|
|---|---|---|---|---|---|
|
Number of Participants With Solicited Local Adverse Events (AEs) up to 7 Days After Study Vaccination
Redness
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local Adverse Events (AEs) up to 7 Days After Study Vaccination
Lymphadenopathy
|
1 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Solicited Local Adverse Events (AEs) up to 7 Days After Study Vaccination
Injection Site Pain
|
7 Participants
|
11 Participants
|
10 Participants
|
13 Participants
|
7 Participants
|
|
Number of Participants With Solicited Local Adverse Events (AEs) up to 7 Days After Study Vaccination
Swelling
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to Day 7 (including Day 7)Population: Analysis was performed on the Safety set which excludes the participant who attended the visit on Day 1 but was not dosed.
Assessed solicited systemic reactions were fever, headache, fatigue, myalgia, arthralgia, and chills.
Outcome measures
| Measure |
CV2CoV Dose Cohort 1 (Group 1a 2µg)
n=24 Participants
Participants received 2 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 1 (Group 1b 4µg)
n=22 Participants
Participants received 4 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 2 (8 µg)
n=20 Participants
Participants received 8 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 3 (12 µg)
n=21 Participants
Participants received 12 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 4 (16 µg)
n=11 Participants
Participants received 16 µg CV2CoV intramuscularly.
|
|---|---|---|---|---|---|
|
Number of Participants With Each Solicited Systemic AEs up to 7 Days After Study Vaccination
Fatigue
|
11 Participants
|
9 Participants
|
7 Participants
|
10 Participants
|
5 Participants
|
|
Number of Participants With Each Solicited Systemic AEs up to 7 Days After Study Vaccination
Headache
|
12 Participants
|
7 Participants
|
10 Participants
|
14 Participants
|
7 Participants
|
|
Number of Participants With Each Solicited Systemic AEs up to 7 Days After Study Vaccination
Fever
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Each Solicited Systemic AEs up to 7 Days After Study Vaccination
Myalgia
|
6 Participants
|
12 Participants
|
10 Participants
|
12 Participants
|
7 Participants
|
|
Number of Participants With Each Solicited Systemic AEs up to 7 Days After Study Vaccination
Chills
|
3 Participants
|
4 Participants
|
7 Participants
|
10 Participants
|
8 Participants
|
|
Number of Participants With Each Solicited Systemic AEs up to 7 Days After Study Vaccination
Arthralgia
|
2 Participants
|
5 Participants
|
4 Participants
|
7 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to Day 28 (including Day 28)Population: Analysis was performed on the Safety set which excludes the participant who attended the visit on Day 1 but was not dosed.
An unsolicited AE is defined as any AE that is volunteered from the participant and occurs within 28 days after vaccination.
Outcome measures
| Measure |
CV2CoV Dose Cohort 1 (Group 1a 2µg)
n=24 Participants
Participants received 2 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 1 (Group 1b 4µg)
n=22 Participants
Participants received 4 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 2 (8 µg)
n=20 Participants
Participants received 8 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 3 (12 µg)
n=21 Participants
Participants received 12 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 4 (16 µg)
n=11 Participants
Participants received 16 µg CV2CoV intramuscularly.
|
|---|---|---|---|---|---|
|
Number of Participants With Unsolicited AEs up to 28 Days After Study Vaccination, Including Clinically Relevant Abnormal Clinical Safety Laboratory Findings
|
4 Participants
|
4 Participants
|
5 Participants
|
5 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Day 1, Day 8, Day 15, Day 29, Day 85, and Day 180Population: The Per Protocol set included all eligible participants who received a dose of study intervention per protocol and who have values at specific timepoint for neutralizing Ab titers against pseudovirus bearing S protein from WT SARS-CoV-2.
Outcome measures
| Measure |
CV2CoV Dose Cohort 1 (Group 1a 2µg)
n=19 Participants
Participants received 2 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 1 (Group 1b 4µg)
n=19 Participants
Participants received 4 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 2 (8 µg)
n=13 Participants
Participants received 8 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 3 (12 µg)
n=15 Participants
Participants received 12 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 4 (16 µg)
n=7 Participants
Participants received 16 µg CV2CoV intramuscularly.
|
|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody Titers Against Pseudovirus Bearing Spike Protein From SARS CoV 2 Wild Type (WT)
Day 1
|
1254.1 Titers
Standard Deviation 5.54
|
757.7 Titers
Standard Deviation 8.22
|
1889.5 Titers
Standard Deviation 3.79
|
1696.6 Titers
Standard Deviation 2.99
|
1534.3 Titers
Standard Deviation 2.04
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody Titers Against Pseudovirus Bearing Spike Protein From SARS CoV 2 Wild Type (WT)
Day 8
|
1639.9 Titers
Standard Deviation 3.72
|
1342.1 Titers
Standard Deviation 5.49
|
2378.5 Titers
Standard Deviation 3.15
|
2865.5 Titers
Standard Deviation 2.43
|
3242.6 Titers
Standard Deviation 2.22
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody Titers Against Pseudovirus Bearing Spike Protein From SARS CoV 2 Wild Type (WT)
Day 85
|
2474.1 Titers
Standard Deviation 3.24
|
3152.2 Titers
Standard Deviation 2.73
|
3496.0 Titers
Standard Deviation 2.16
|
2564.0 Titers
Standard Deviation 2.26
|
2255.2 Titers
Standard Deviation 1.84
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody Titers Against Pseudovirus Bearing Spike Protein From SARS CoV 2 Wild Type (WT)
Day 180
|
2231.3 Titers
Standard Deviation 2.59
|
2206.0 Titers
Standard Deviation 3.88
|
4025.5 Titers
Standard Deviation 1.99
|
3045.5 Titers
Standard Deviation 2.82
|
2356.5 Titers
Standard Deviation 1.81
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody Titers Against Pseudovirus Bearing Spike Protein From SARS CoV 2 Wild Type (WT)
Day 15
|
1801.1 Titers
Standard Deviation 3.14
|
1651.9 Titers
Standard Deviation 3.58
|
3316.1 Titers
Standard Deviation 1.86
|
3372.1 Titers
Standard Deviation 2.15
|
2395.3 Titers
Standard Deviation 2.08
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody Titers Against Pseudovirus Bearing Spike Protein From SARS CoV 2 Wild Type (WT)
Day 29
|
2029.9 Titers
Standard Deviation 3.03
|
1784.3 Titers
Standard Deviation 3.40
|
3614.7 Titers
Standard Deviation 2.29
|
3330.6 Titers
Standard Deviation 2.21
|
2748.7 Titers
Standard Deviation 1.89
|
SECONDARY outcome
Timeframe: At Day 29 (29 days post booster dose)Population: The Per Protocol set included all eligible participants who received a dose of study intervention per protocol and who have values at specific timepoint for neutralizing Ab titers against pseudovirus bearing S protein from WT SARS-CoV-2.
Percentage of participants with seroresponse against antigen SARS-CoV-2 WT, Beta, Omicron BA.1, Omicron BA.2, Delta assessed were reported. Seroresponse was defined as greater than equal to (\>=) 4-fold increase from Day 1 (Baseline) to the Day 29. The fold rise was calculated as the ratio of the post-vaccination Neutralizing Antibody Titers to the pre-vaccination Neutralizing Antibody Titers.
Outcome measures
| Measure |
CV2CoV Dose Cohort 1 (Group 1a 2µg)
n=19 Participants
Participants received 2 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 1 (Group 1b 4µg)
n=19 Participants
Participants received 4 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 2 (8 µg)
n=11 Participants
Participants received 8 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 3 (12 µg)
n=15 Participants
Participants received 12 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 4 (16 µg)
n=7 Participants
Participants received 16 µg CV2CoV intramuscularly.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Seroresponse (>= 4 Fold Rise From Baseline) at Day 29 After the Booster Dose
WT
|
15.8 Percentage of participants
|
31.6 Percentage of participants
|
9.1 Percentage of participants
|
13.3 Percentage of participants
|
14.3 Percentage of participants
|
|
Percentage of Participants With Seroresponse (>= 4 Fold Rise From Baseline) at Day 29 After the Booster Dose
Beta
|
10.5 Percentage of participants
|
31.6 Percentage of participants
|
9.1 Percentage of participants
|
20.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Seroresponse (>= 4 Fold Rise From Baseline) at Day 29 After the Booster Dose
Omicron BA.1
|
15.8 Percentage of participants
|
21.1 Percentage of participants
|
9.1 Percentage of participants
|
20.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Seroresponse (>= 4 Fold Rise From Baseline) at Day 29 After the Booster Dose
Omicron BA.2
|
21.1 Percentage of participants
|
26.3 Percentage of participants
|
9.1 Percentage of participants
|
26.7 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Seroresponse (>= 4 Fold Rise From Baseline) at Day 29 After the Booster Dose
Delta
|
21.1 Percentage of participants
|
31.6 Percentage of participants
|
9.1 Percentage of participants
|
20.0 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: At Day 8, Day 15, Day 29, Day 85, and Day 180Population: The Per Protocol set included all eligible participants who received a dose of study intervention per protocol and who have values at specific timepoint for neutralizing Ab titers against pseudovirus bearing S protein from WT SARS-CoV-2.
Outcome measures
| Measure |
CV2CoV Dose Cohort 1 (Group 1a 2µg)
n=19 Participants
Participants received 2 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 1 (Group 1b 4µg)
n=19 Participants
Participants received 4 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 2 (8 µg)
n=13 Participants
Participants received 8 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 3 (12 µg)
n=15 Participants
Participants received 12 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 4 (16 µg)
n=7 Participants
Participants received 16 µg CV2CoV intramuscularly.
|
|---|---|---|---|---|---|
|
Geometric Mean Increase (GMI) From Baseline of Neutralizing Antibody Titers Against Pseudovirus Bearing Spike Protein From SARS CoV 2 WT at Each Collection Time Point
Day 8
|
1.31 Titers
Standard Deviation 1.960
|
1.52 Titers
Standard Deviation 2.068
|
1.30 Titers
Standard Deviation 1.631
|
1.69 Titers
Standard Deviation 2.003
|
1.83 Titers
Standard Deviation 1.725
|
|
Geometric Mean Increase (GMI) From Baseline of Neutralizing Antibody Titers Against Pseudovirus Bearing Spike Protein From SARS CoV 2 WT at Each Collection Time Point
Day 15
|
1.44 Titers
Standard Deviation 2.048
|
2.35 Titers
Standard Deviation 3.197
|
1.68 Titers
Standard Deviation 2.380
|
1.95 Titers
Standard Deviation 2.300
|
1.56 Titers
Standard Deviation 1.569
|
|
Geometric Mean Increase (GMI) From Baseline of Neutralizing Antibody Titers Against Pseudovirus Bearing Spike Protein From SARS CoV 2 WT at Each Collection Time Point
Day 29
|
1.62 Titers
Standard Deviation 2.541
|
2.35 Titers
Standard Deviation 3.410
|
1.31 Titers
Standard Deviation 1.872
|
1.96 Titers
Standard Deviation 2.183
|
1.79 Titers
Standard Deviation 1.969
|
|
Geometric Mean Increase (GMI) From Baseline of Neutralizing Antibody Titers Against Pseudovirus Bearing Spike Protein From SARS CoV 2 WT at Each Collection Time Point
Day 85
|
1.46 Titers
Standard Deviation 2.318
|
2.07 Titers
Standard Deviation 3.429
|
1.15 Titers
Standard Deviation 2.086
|
1.33 Titers
Standard Deviation 1.976
|
1.08 Titers
Standard Deviation 1.429
|
|
Geometric Mean Increase (GMI) From Baseline of Neutralizing Antibody Titers Against Pseudovirus Bearing Spike Protein From SARS CoV 2 WT at Each Collection Time Point
Day 180
|
0.85 Titers
Standard Deviation 2.128
|
1.67 Titers
Standard Deviation 2.903
|
1.48 Titers
Standard Deviation 1.955
|
1.44 Titers
Standard Deviation 1.765
|
1.13 Titers
Standard Deviation 1.893
|
SECONDARY outcome
Timeframe: At Day 8, Day 15, Day 29, Day 85 and Day 180Population: The Per Protocol set included all eligible participants who received a dose of study intervention per protocol and who have values at specific timepoint for neutralizing Ab titers against pseudovirus bearing S protein from WT SARS-CoV-2.
Outcome measures
| Measure |
CV2CoV Dose Cohort 1 (Group 1a 2µg)
n=19 Participants
Participants received 2 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 1 (Group 1b 4µg)
n=19 Participants
Participants received 4 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 2 (8 µg)
n=13 Participants
Participants received 8 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 3 (12 µg)
n=15 Participants
Participants received 12 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 4 (16 µg)
n=7 Participants
Participants received 16 µg CV2CoV intramuscularly.
|
|---|---|---|---|---|---|
|
GMTs of Binding Immunoglobulin G (IgG) Against SARS CoV-2 S Protein and Receptor-Binding Domain (RBD)
Day 8
|
85721.0 Titers
Standard Deviation 4.00
|
63602.3 Titers
Standard Deviation 3.55
|
100471.0 Titers
Standard Deviation 2.66
|
139859.4 Titers
Standard Deviation 1.88
|
163686.8 Titers
Standard Deviation 2.14
|
|
GMTs of Binding Immunoglobulin G (IgG) Against SARS CoV-2 S Protein and Receptor-Binding Domain (RBD)
Day 15
|
103076.4 Titers
Standard Deviation 3.36
|
80210.9 Titers
Standard Deviation 2.24
|
132016.5 Titers
Standard Deviation 2.80
|
172621.3 Titers
Standard Deviation 1.65
|
167769.4 Titers
Standard Deviation 1.99
|
|
GMTs of Binding Immunoglobulin G (IgG) Against SARS CoV-2 S Protein and Receptor-Binding Domain (RBD)
Day 29
|
103702.2 Titers
Standard Deviation 3.23
|
101635.2 Titers
Standard Deviation 2.34
|
137232.9 Titers
Standard Deviation 2.49
|
136088.9 Titers
Standard Deviation 1.86
|
112702.8 Titers
Standard Deviation 2.12
|
|
GMTs of Binding Immunoglobulin G (IgG) Against SARS CoV-2 S Protein and Receptor-Binding Domain (RBD)
Day 85
|
171980.7 Titers
Standard Deviation 2.57
|
120609.1 Titers
Standard Deviation 2.73
|
121543.7 Titers
Standard Deviation 2.92
|
63229.7 Titers
Standard Deviation 2.15
|
110797.5 Titers
Standard Deviation 1.51
|
|
GMTs of Binding Immunoglobulin G (IgG) Against SARS CoV-2 S Protein and Receptor-Binding Domain (RBD)
Day 180
|
76009.5 Titers
Standard Deviation 2.58
|
70208.3 Titers
Standard Deviation 3.58
|
140651.1 Titers
Standard Deviation 2.42
|
101287.9 Titers
Standard Deviation 2.02
|
96157.6 Titers
Standard Deviation 1.78
|
SECONDARY outcome
Timeframe: At Day 8, Day 15, Day 29, Day 85, and Day 180Population: The Per Protocol set included all eligible participants who received a dose of study intervention per protocol and who have values at specific timepoint for neutralizing Ab titers against pseudovirus bearing S protein from WT SARS-CoV-2.
Outcome measures
| Measure |
CV2CoV Dose Cohort 1 (Group 1a 2µg)
n=19 Participants
Participants received 2 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 1 (Group 1b 4µg)
n=19 Participants
Participants received 4 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 2 (8 µg)
n=13 Participants
Participants received 8 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 3 (12 µg)
n=15 Participants
Participants received 12 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 4 (16 µg)
n=7 Participants
Participants received 16 µg CV2CoV intramuscularly.
|
|---|---|---|---|---|---|
|
GMI From Baseline of Binding IgG Against SARS CoV-2 S Protein and RBD
Day 29
|
1.59 Titers
Standard Deviation 2.711
|
2.48 Titers
Standard Deviation 2.990
|
1.29 Titers
Standard Deviation 1.530
|
1.53 Titers
Standard Deviation 1.741
|
0.96 Titers
Standard Deviation 1.345
|
|
GMI From Baseline of Binding IgG Against SARS CoV-2 S Protein and RBD
Day 85
|
0.95 Titers
Standard Deviation 1.317
|
1.88 Titers
Standard Deviation 3.111
|
1.34 Titers
Standard Deviation 2.730
|
0.71 Titers
Standard Deviation 1.732
|
0.71 Titers
Standard Deviation 1.417
|
|
GMI From Baseline of Binding IgG Against SARS CoV-2 S Protein and RBD
Day 180
|
0.78 Titers
Standard Deviation 1.801
|
1.52 Titers
Standard Deviation 3.789
|
1.38 Titers
Standard Deviation 1.938
|
1.18 Titers
Standard Deviation 1.711
|
0.62 Titers
Standard Deviation 2.535
|
|
GMI From Baseline of Binding IgG Against SARS CoV-2 S Protein and RBD
Day 8
|
1.32 Titers
Standard Deviation 1.671
|
1.44 Titers
Standard Deviation 1.575
|
1.48 Titers
Standard Deviation 1.859
|
1.57 Titers
Standard Deviation 1.623
|
1.28 Titers
Standard Deviation 1.421
|
|
GMI From Baseline of Binding IgG Against SARS CoV-2 S Protein and RBD
Day 15
|
1.58 Titers
Standard Deviation 2.181
|
2.51 Titers
Standard Deviation 2.936
|
1.62 Titers
Standard Deviation 2.107
|
1.88 Titers
Standard Deviation 1.856
|
1.44 Titers
Standard Deviation 1.435
|
Adverse Events
CV2CoV Dose Cohort 1 (Group 1a 2µg)
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
CV2CoV Dose Cohort 1 (Group 1b 4µg)
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
CV2CoV Dose Cohort 2 (8 µg)
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
CV2CoV Dose Cohort 3 (12 µg)
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
CV2CoV Dose Cohort 4 (16 µg)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CV2CoV Dose Cohort 1 (Group 1a 2µg)
n=24 participants at risk
Participants received 2 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 1 (Group 1b 4µg)
n=22 participants at risk
Participants received 4 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 2 (8 µg)
n=20 participants at risk
Participants received 8 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 3 (12 µg)
n=21 participants at risk
Participants received 12 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 4 (16 µg)
n=11 participants at risk
Participants received 16 µg CV2CoV intramuscularly.
|
|---|---|---|---|---|---|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/24 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
4.5%
1/22 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/20 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/21 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/11 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/24 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
4.5%
1/22 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/20 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/21 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/11 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
Other adverse events
| Measure |
CV2CoV Dose Cohort 1 (Group 1a 2µg)
n=24 participants at risk
Participants received 2 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 1 (Group 1b 4µg)
n=22 participants at risk
Participants received 4 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 2 (8 µg)
n=20 participants at risk
Participants received 8 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 3 (12 µg)
n=21 participants at risk
Participants received 12 µg CV2CoV intramuscularly.
|
CV2CoV Dose Cohort 4 (16 µg)
n=11 participants at risk
Participants received 16 µg CV2CoV intramuscularly.
|
|---|---|---|---|---|---|
|
General disorders
Injection site pain
|
29.2%
7/24 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
50.0%
11/22 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
50.0%
10/20 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
61.9%
13/21 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
63.6%
7/11 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
|
General disorders
Fatigue
|
45.8%
11/24 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
40.9%
9/22 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
35.0%
7/20 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
47.6%
10/21 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
45.5%
5/11 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
|
General disorders
Chills
|
12.5%
3/24 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
18.2%
4/22 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
35.0%
7/20 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
47.6%
10/21 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
72.7%
8/11 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
|
General disorders
Fever
|
0.00%
0/24 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/22 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
5.0%
1/20 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
14.3%
3/21 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
27.3%
3/11 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
|
General disorders
Injection site swelling
|
0.00%
0/24 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/22 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
5.0%
1/20 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
4.8%
1/21 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
9.1%
1/11 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
|
General disorders
Injection site erythema
|
0.00%
0/24 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
9.1%
2/22 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/20 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/21 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/11 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
|
General disorders
Chest discomfort
|
0.00%
0/24 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/22 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/20 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
4.8%
1/21 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/11 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
|
General disorders
Injection site bruising
|
4.2%
1/24 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/22 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/20 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/21 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/11 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
|
Nervous system disorders
Headache
|
50.0%
12/24 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
31.8%
7/22 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
50.0%
10/20 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
66.7%
14/21 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
63.6%
7/11 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/24 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
4.5%
1/22 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/20 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/21 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/11 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
6/24 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
54.5%
12/22 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
50.0%
10/20 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
57.1%
12/21 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
63.6%
7/11 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
2/24 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
22.7%
5/22 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
20.0%
4/20 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
38.1%
8/21 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
18.2%
2/11 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
4.2%
1/24 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
13.6%
3/22 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
10.0%
2/20 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
9.5%
2/21 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
9.1%
1/11 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/24 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/22 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
5.0%
1/20 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/21 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/11 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/24 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/22 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/20 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
4.8%
1/21 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/11 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
|
Infections and infestations
COVID-19
|
4.2%
1/24 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
13.6%
3/22 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
10.0%
2/20 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/21 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/11 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/24 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
4.5%
1/22 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/20 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/21 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/11 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/24 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/22 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/20 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
4.8%
1/21 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/11 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
4.2%
1/24 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/22 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/20 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/21 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/11 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/24 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/22 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/20 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
4.8%
1/21 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/11 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/24 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/22 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/20 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
4.8%
1/21 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/11 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
4.2%
1/24 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/22 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/20 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/21 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/11 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
|
Vascular disorders
Hypertension
|
0.00%
0/24 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/22 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/20 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
4.8%
1/21 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
0.00%
0/11 • Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7, unsolicited adverse events from Day 1-30, Abnormal Clinical Safety Laboratory Findings from Day 1-28, Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination
Adverse events were assessed in safety set which exclude participant who attended the visit on Day 1 but was not dosed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER