Trial Outcomes & Findings for Safety and Immunogenicity Study of a Booster Dose of the Investigational CV0501 mRNA COVID-19 Vaccine in Adults at Least 18 Years Old (NCT NCT05477186)
NCT ID: NCT05477186
Last Updated: 2025-02-21
Results Overview
Assessed solicited local adverse events were injection site pain, redness, swelling, and Lymphadenopathy.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
185 participants
Primary outcome timeframe
From Day 1 to Day 7 (including Day 7)
Results posted on
2025-02-21
Participant Flow
The study was conducted at 20 centers in Australia, Philippines and 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.
Participant milestones
| Measure |
Part B: CV0501 Dose Cohort 6 (3 μg)
Healthy participants received a single dose of 3 microgram (μg) CV0501 vaccine intramuscularly at Day 1.
|
Part B: CV0501 Dose Cohort 7 (6 μg)
Healthy participants received a single dose of 6 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 1 (12 μg)
Healthy participants received a single dose of 12 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 2 (25 μg)
Healthy participants received a single dose of 25 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 3 (50 μg)
Healthy participants received a single dose of 50 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 4 (100 μg)
Healthy participants received a single dose of 100 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 5 (200 μg)
Healthy participants received a single dose of 200 μg CV0501 vaccine intramuscularly at Day 1.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
17
|
31
|
30
|
31
|
31
|
30
|
|
Overall Study
Safety Set
|
15
|
15
|
30
|
30
|
30
|
30
|
30
|
|
Overall Study
Per Protocol Immunogenicity (PPI)
|
15
|
14
|
28
|
27
|
28
|
29
|
26
|
|
Overall Study
COMPLETED
|
13
|
15
|
28
|
29
|
29
|
30
|
28
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
3
|
1
|
2
|
1
|
2
|
Reasons for withdrawal
| Measure |
Part B: CV0501 Dose Cohort 6 (3 μg)
Healthy participants received a single dose of 3 microgram (μg) CV0501 vaccine intramuscularly at Day 1.
|
Part B: CV0501 Dose Cohort 7 (6 μg)
Healthy participants received a single dose of 6 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 1 (12 μg)
Healthy participants received a single dose of 12 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 2 (25 μg)
Healthy participants received a single dose of 25 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 3 (50 μg)
Healthy participants received a single dose of 50 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 4 (100 μg)
Healthy participants received a single dose of 100 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 5 (200 μg)
Healthy participants received a single dose of 200 μg CV0501 vaccine intramuscularly at Day 1.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Vaccine not administered
|
0
|
2
|
1
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
2
|
1
|
1
|
0
|
2
|
Baseline Characteristics
Safety and Immunogenicity Study of a Booster Dose of the Investigational CV0501 mRNA COVID-19 Vaccine in Adults at Least 18 Years Old
Baseline characteristics by cohort
| Measure |
Part B: CV0501 Dose Cohort 6 (3 μg)
n=15 Participants
Healthy participants received a single dose of 3 microgram (μg) CV0501 vaccine intramuscularly at Day 1.
|
Part B: CV0501 Dose Cohort 7 (6 μg)
n=17 Participants
Healthy participants received a single dose of 6 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 1 (12 μg)
n=31 Participants
Healthy participants received a single dose of 12 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 2 (25 μg)
n=30 Participants
Healthy participants received a single dose of 25 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 3 (50 μg)
n=31 Participants
Healthy participants received a single dose of 50 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 4 (100 μg)
n=31 Participants
Healthy participants received a single dose of 100 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 5 (200 μg)
n=30 Participants
Healthy participants received a single dose of 200 μg CV0501 vaccine intramuscularly at Day 1.
|
Total
n=185 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
36.8 Years
STANDARD_DEVIATION 12.18 • n=5 Participants
|
35.8 Years
STANDARD_DEVIATION 12.66 • n=7 Participants
|
50.9 Years
STANDARD_DEVIATION 16.43 • n=5 Participants
|
48.9 Years
STANDARD_DEVIATION 17.99 • n=4 Participants
|
54.5 Years
STANDARD_DEVIATION 15.69 • n=21 Participants
|
55.2 Years
STANDARD_DEVIATION 16.15 • n=8 Participants
|
49.8 Years
STANDARD_DEVIATION 19.23 • n=8 Participants
|
49.2 Years
STANDARD_DEVIATION 17.37 • n=24 Participants
|
|
Sex/Gender, Customized
Male
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
18 Participants
n=8 Participants
|
78 Participants
n=24 Participants
|
|
Sex/Gender, Customized
Female
|
4 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
107 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
38 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
25 Participants
n=8 Participants
|
27 Participants
n=8 Participants
|
147 Participants
n=24 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to Day 7 (including Day 7)Population: Analysis was performed on the Safety set who received 1 dose of investigational product. Only participants in the Safety Set with at least one day of eDiary entry within each dose group and at each level of summarization were included in this analysis; one participant in the 25 μg group did not complete the eDiary and was excluded from the summary.
Assessed solicited local adverse events were injection site pain, redness, swelling, and Lymphadenopathy.
Outcome measures
| Measure |
Part B: CV0501 Dose Cohort 6 (3 μg)
n=15 Participants
Healthy participants received a single dose of 3 microgram (μg) CV0501 vaccine intramuscularly at Day 1.
|
Part B: CV0501 Dose Cohort 7 (6 μg)
n=15 Participants
Healthy participants received a single dose of 6 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 1 (12 μg)
n=30 Participants
Healthy participants received a single dose of 12 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 2 (25 μg)
n=29 Participants
Healthy participants received a single dose of 25 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 3 (50 μg)
n=30 Participants
Healthy participants received a single dose of 50 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 4 (100 μg)
n=30 Participants
Healthy participants received a single dose of 100 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 5 (200 μg)
n=30 Participants
Healthy participants received a single dose of 200 μg CV0501 vaccine intramuscularly at Day 1.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination
Overall
|
5 Participants
|
9 Participants
|
16 Participants
|
19 Participants
|
16 Participants
|
19 Participants
|
22 Participants
|
|
Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination
Injection site pain
|
5 Participants
|
9 Participants
|
14 Participants
|
19 Participants
|
15 Participants
|
19 Participants
|
22 Participants
|
|
Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination
Redness
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
9 Participants
|
|
Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination
Swelling
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
6 Participants
|
|
Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination
Lymphadenopathy
|
0 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to Day 7 (including Day 7)Population: Analysis was performed on the Safety set who received 1 dose of investigational product. Only participants in the Safety Set with at least one day of eDiary entry within each dose group and at each level of summarization were included in this analysis; one participant in the 25 μg group did not complete the eDiary and was excluded from the summary.
Assessed solicited systemic AEs were fever, headache, fatigue, myalgia, arthralgia, and chills.
Outcome measures
| Measure |
Part B: CV0501 Dose Cohort 6 (3 μg)
n=15 Participants
Healthy participants received a single dose of 3 microgram (μg) CV0501 vaccine intramuscularly at Day 1.
|
Part B: CV0501 Dose Cohort 7 (6 μg)
n=15 Participants
Healthy participants received a single dose of 6 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 1 (12 μg)
n=30 Participants
Healthy participants received a single dose of 12 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 2 (25 μg)
n=29 Participants
Healthy participants received a single dose of 25 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 3 (50 μg)
n=30 Participants
Healthy participants received a single dose of 50 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 4 (100 μg)
n=30 Participants
Healthy participants received a single dose of 100 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 5 (200 μg)
n=30 Participants
Healthy participants received a single dose of 200 μg CV0501 vaccine intramuscularly at Day 1.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Systemic AE During 7 Days After Vaccination
Fever
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Solicited Systemic AE During 7 Days After Vaccination
Chills
|
1 Participants
|
0 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
11 Participants
|
11 Participants
|
|
Number of Participants With Solicited Systemic AE During 7 Days After Vaccination
Overall
|
4 Participants
|
4 Participants
|
11 Participants
|
17 Participants
|
15 Participants
|
18 Participants
|
21 Participants
|
|
Number of Participants With Solicited Systemic AE During 7 Days After Vaccination
Headache
|
3 Participants
|
4 Participants
|
5 Participants
|
9 Participants
|
9 Participants
|
13 Participants
|
13 Participants
|
|
Number of Participants With Solicited Systemic AE During 7 Days After Vaccination
Fatigue
|
1 Participants
|
0 Participants
|
5 Participants
|
14 Participants
|
10 Participants
|
15 Participants
|
14 Participants
|
|
Number of Participants With Solicited Systemic AE During 7 Days After Vaccination
Myalgia
|
2 Participants
|
3 Participants
|
8 Participants
|
10 Participants
|
10 Participants
|
16 Participants
|
17 Participants
|
|
Number of Participants With Solicited Systemic AE During 7 Days After Vaccination
Arthralgia
|
0 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to day 28 (including day 28)Population: Analysis was performed on the Safety set who received 1 dose of investigational product.
An unsolicited AE is defined as any AE that is volunteered from the participant and occurs within 28 days after vaccination.
Outcome measures
| Measure |
Part B: CV0501 Dose Cohort 6 (3 μg)
n=15 Participants
Healthy participants received a single dose of 3 microgram (μg) CV0501 vaccine intramuscularly at Day 1.
|
Part B: CV0501 Dose Cohort 7 (6 μg)
n=15 Participants
Healthy participants received a single dose of 6 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 1 (12 μg)
n=30 Participants
Healthy participants received a single dose of 12 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 2 (25 μg)
n=30 Participants
Healthy participants received a single dose of 25 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 3 (50 μg)
n=30 Participants
Healthy participants received a single dose of 50 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 4 (100 μg)
n=30 Participants
Healthy participants received a single dose of 100 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 5 (200 μg)
n=30 Participants
Healthy participants received a single dose of 200 μg CV0501 vaccine intramuscularly at Day 1.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Unsolicited AEs for 28 Days After Study Vaccination
|
4 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to Day 180 (including Day 180)Population: Analysis was performed on the Safety set who received 1 dose of investigational product.
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 |
Part B: CV0501 Dose Cohort 6 (3 μg)
n=15 Participants
Healthy participants received a single dose of 3 microgram (μg) CV0501 vaccine intramuscularly at Day 1.
|
Part B: CV0501 Dose Cohort 7 (6 μg)
n=15 Participants
Healthy participants received a single dose of 6 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 1 (12 μg)
n=30 Participants
Healthy participants received a single dose of 12 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 2 (25 μg)
n=30 Participants
Healthy participants received a single dose of 25 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 3 (50 μg)
n=30 Participants
Healthy participants received a single dose of 50 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 4 (100 μg)
n=30 Participants
Healthy participants received a single dose of 100 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 5 (200 μg)
n=30 Participants
Healthy participants received a single dose of 200 μg CV0501 vaccine intramuscularly at Day 1.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Medically Attended Adverse Events (MAAEs) From Study Vaccination Through the End of the Study
|
2 Participants
|
2 Participants
|
9 Participants
|
2 Participants
|
5 Participants
|
6 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to Day 180 (including Day 180)Population: Analysis was performed on the Safety set who received 1 dose of investigational product.
An AESI (serious or nonserious) is defined as an AE or serious adverse event (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 |
Part B: CV0501 Dose Cohort 6 (3 μg)
n=15 Participants
Healthy participants received a single dose of 3 microgram (μg) CV0501 vaccine intramuscularly at Day 1.
|
Part B: CV0501 Dose Cohort 7 (6 μg)
n=15 Participants
Healthy participants received a single dose of 6 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 1 (12 μg)
n=30 Participants
Healthy participants received a single dose of 12 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 2 (25 μg)
n=30 Participants
Healthy participants received a single dose of 25 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 3 (50 μg)
n=30 Participants
Healthy participants received a single dose of 50 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 4 (100 μg)
n=30 Participants
Healthy participants received a single dose of 100 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 5 (200 μg)
n=30 Participants
Healthy participants received a single dose of 200 μg CV0501 vaccine intramuscularly at Day 1.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events of Special Interest (AESIs) From Study Vaccination Through the End of the Study
|
2 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to Day 180 (including Day 180)Population: Analysis was performed on the Safety set who received 1 dose of investigational product.
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 |
Part B: CV0501 Dose Cohort 6 (3 μg)
n=15 Participants
Healthy participants received a single dose of 3 microgram (μg) CV0501 vaccine intramuscularly at Day 1.
|
Part B: CV0501 Dose Cohort 7 (6 μg)
n=15 Participants
Healthy participants received a single dose of 6 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 1 (12 μg)
n=30 Participants
Healthy participants received a single dose of 12 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 2 (25 μg)
n=30 Participants
Healthy participants received a single dose of 25 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 3 (50 μg)
n=30 Participants
Healthy participants received a single dose of 50 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 4 (100 μg)
n=30 Participants
Healthy participants received a single dose of 100 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 5 (200 μg)
n=30 Participants
Healthy participants received a single dose of 200 μg CV0501 vaccine intramuscularly at Day 1.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) From Study Vaccination Through the End of the Study
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 8 days from vaccination at Day 1Population: Analysis was performed on the Safety set who received 1 dose of investigational product.
An abnormal laboratory is defined as any value outside of the normal range. Normal ranges were: Alanine Aminotransferase: (Female: 10-32 micro (u)/ liter (L); Male: 10-40 u/L); Alkaline Phosphatase: (Female: 30-115 u/L; Male: 43-115 u/L); Aspartate Aminotransferase: (Female: 10-36 u/L; Male: 10-43 u/L); Bilirubin total: 0.1-1.1 milligram (mg)/deciliter (dL); Bilirubin, Direct: 0-0.4 mg/dL ;Creatinine:0.7-1.4 mg/dL; Eosinophils: 0%-7%; Eosinophils/Leukocytes: 0.00-0.80 x 10\^3/uL ; Erythrocytes: (Female: 3.70-5.20 x 10\^6/uL; Male: 4.63-6.08x 10\^6/uL); Hemoglobin: (Female: 11.0-15.5 gram (g)/dL; Male: 12.5-17.0 g/dL); Leukocytes: 3.70-11.00 x 10\^3/uL; Lymphocytes 12.0%-46.0%; Lymphocytes/Leukocytes: 0.90-3.60 x 10\^3/uL; Monocytes/Leukocytes: 0.00-1.20 x 10\^3/uL; Neutrophils: 4.0% - 71.0%; Neutrophils/Leukocytes:1.70-7.90x 10\^3/uL; Platelets: 163-375 x 10\^3/uL; Urea Nitrogen: 5-20 mg/dL.
Outcome measures
| Measure |
Part B: CV0501 Dose Cohort 6 (3 μg)
n=15 Participants
Healthy participants received a single dose of 3 microgram (μg) CV0501 vaccine intramuscularly at Day 1.
|
Part B: CV0501 Dose Cohort 7 (6 μg)
n=15 Participants
Healthy participants received a single dose of 6 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 1 (12 μg)
n=30 Participants
Healthy participants received a single dose of 12 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 2 (25 μg)
n=30 Participants
Healthy participants received a single dose of 25 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 3 (50 μg)
n=30 Participants
Healthy participants received a single dose of 50 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 4 (100 μg)
n=30 Participants
Healthy participants received a single dose of 100 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 5 (200 μg)
n=30 Participants
Healthy participants received a single dose of 200 μg CV0501 vaccine intramuscularly at Day 1.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination
Alanine Aminotransferase (High)
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
6 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination
Alanine Aminotransferase (Low)
|
0 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination
Alkaline Phosphatase (High)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination
Aspartate Aminotransferase (High)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination
Bilirubin (High)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination
Creatinine (High)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination
Eosinophils (High)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination
Eosinophils/Leukocytes (High)
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination
Leukocytes (Low)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination
Erythrocytes (High)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination
Erythrocytes (Low)
|
4 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
8 Participants
|
5 Participants
|
8 Participants
|
|
Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination
Hemoglobin (High)
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination
Hemoglobin (Low)
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination
Leukocytes (High)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination
Lymphocytes (High)
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination
Lymphocytes/Leukocytes (High)
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination
Monocytes/Leukocytes (High)
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination
Neutrophils (High)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination
Neutrophils (Low)
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination
Neutrophils/Leukocytes (High)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination
Neutrophils/Leukocytes (Low)
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination
Platelets (High)
|
3 Participants
|
5 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination
Platelets (Low)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination
Urea Nitrogen (High)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At Day 1, Day 15, Day 29, Day 91, and Day 181Population: The Per Protocol Immunogenicity (PPI) Set includes all eligible participants who received a dose of investigational product per protocol and who have values at specific timepoint for neutralizing Ab titers against pseudovirus bearing S protein from the Omicron variant of SARS-CoV-2.
Outcome measures
| Measure |
Part B: CV0501 Dose Cohort 6 (3 μg)
n=15 Participants
Healthy participants received a single dose of 3 microgram (μg) CV0501 vaccine intramuscularly at Day 1.
|
Part B: CV0501 Dose Cohort 7 (6 μg)
n=14 Participants
Healthy participants received a single dose of 6 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 1 (12 μg)
n=28 Participants
Healthy participants received a single dose of 12 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 2 (25 μg)
n=27 Participants
Healthy participants received a single dose of 25 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 3 (50 μg)
n=28 Participants
Healthy participants received a single dose of 50 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 4 (100 μg)
n=29 Participants
Healthy participants received a single dose of 100 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 5 (200 μg)
n=26 Participants
Healthy participants received a single dose of 200 μg CV0501 vaccine intramuscularly at Day 1.
|
|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint
WT, Day 29
|
3065.6 Titers
Standard Deviation 2.66
|
2865.2 Titers
Standard Deviation 2.59
|
6188.1 Titers
Standard Deviation 2.25
|
5869.7 Titers
Standard Deviation 2.64
|
12148.6 Titers
Standard Deviation 2.42
|
8356.7 Titers
Standard Deviation 2.36
|
15717.3 Titers
Standard Deviation 2.62
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint
Omicron BA.1, Day 15
|
2357.5 Titers
Standard Deviation 2.88
|
2723.1 Titers
Standard Deviation 2.28
|
4770.9 Titers
Standard Deviation 3.28
|
2180.5 Titers
Standard Deviation 3.27
|
4997.7 Titers
Standard Deviation 2.76
|
4767.7 Titers
Standard Deviation 2.05
|
10237.9 Titers
Standard Deviation 2.73
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint
Omicron BA.1, Day 181
|
1568.7 Titers
Standard Deviation 2.96
|
2070.4 Titers
Standard Deviation 2.78
|
1832.4 Titers
Standard Deviation 3.63
|
1004.8 Titers
Standard Deviation 4.54
|
1647.4 Titers
Standard Deviation 2.59
|
1401.6 Titers
Standard Deviation 3.35
|
2040.9 Titers
Standard Deviation 4.05
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint
Omicron BA.2, Day 15
|
2262.6 Titers
Standard Deviation 3.03
|
2643.6 Titers
Standard Deviation 2.14
|
5348.4 Titers
Standard Deviation 3.24
|
2383.0 Titers
Standard Deviation 2.77
|
5587.0 Titers
Standard Deviation 2.89
|
5046.6 Titers
Standard Deviation 2.01
|
7229.7 Titers
Standard Deviation 4.90
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint
Omicron BA.2, Day 29
|
1426.0 Titers
Standard Deviation 3.24
|
2128.8 Titers
Standard Deviation 2.16
|
4590.7 Titers
Standard Deviation 3.15
|
2134.2 Titers
Standard Deviation 2.84
|
5148.6 Titers
Standard Deviation 3.02
|
3364.4 Titers
Standard Deviation 2.55
|
7440.6 Titers
Standard Deviation 2.99
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint
Omicron BA.2, Day 91
|
1672.7 Titers
Standard Deviation 2.43
|
1580.6 Titers
Standard Deviation 2.49
|
2430.5 Titers
Standard Deviation 3.25
|
1399.4 Titers
Standard Deviation 3.06
|
2931.6 Titers
Standard Deviation 3.16
|
1723.1 Titers
Standard Deviation 2.68
|
3094.9 Titers
Standard Deviation 2.76
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint
Omicron BA.2, Day 181
|
1525.3 Titers
Standard Deviation 3.56
|
1359.2 Titers
Standard Deviation 2.45
|
1362.4 Titers
Standard Deviation 4.18
|
903.8 Titers
Standard Deviation 3.81
|
1801.2 Titers
Standard Deviation 2.74
|
1151.5 Titers
Standard Deviation 3.23
|
1823.2 Titers
Standard Deviation 3.56
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint
Wild Type (WT), Day 1
|
1311.5 Titers
Standard Deviation 5.36
|
1154.5 Titers
Standard Deviation 3.01
|
1678.3 Titers
Standard Deviation 3.81
|
884.4 Titers
Standard Deviation 3.67
|
1752.1 Titers
Standard Deviation 3.25
|
1248.6 Titers
Standard Deviation 4.14
|
1556.0 Titers
Standard Deviation 4.83
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint
WT, Day 15
|
3478.1 Titers
Standard Deviation 2.67
|
3663.7 Titers
Standard Deviation 2.04
|
7344.4 Titers
Standard Deviation 2.22
|
4651.9 Titers
Standard Deviation 2.44
|
9679.4 Titers
Standard Deviation 2.19
|
11321.4 Titers
Standard Deviation 2.01
|
20966.2 Titers
Standard Deviation 2.49
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint
WT, Day 91
|
2233.9 Titers
Standard Deviation 2.38
|
2606.6 Titers
Standard Deviation 2.43
|
5793.7 Titers
Standard Deviation 2.76
|
3917.9 Titers
Standard Deviation 2.55
|
8607.5 Titers
Standard Deviation 2.42
|
4050.6 Titers
Standard Deviation 2.41
|
6861.6 Titers
Standard Deviation 2.71
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint
WT, Day 181
|
2662.1 Titers
Standard Deviation 2.42
|
2105.0 Titers
Standard Deviation 2.39
|
3138.8 Titers
Standard Deviation 2.68
|
2088.1 Titers
Standard Deviation 3.33
|
4413.8 Titers
Standard Deviation 1.98
|
2126.5 Titers
Standard Deviation 2.64
|
3018.1 Titers
Standard Deviation 3.28
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint
Omicron BA.1, Day 1
|
399.6 Titers
Standard Deviation 8.15
|
545.1 Titers
Standard Deviation 4.46
|
500.0 Titers
Standard Deviation 4.83
|
188.7 Titers
Standard Deviation 5.86
|
410.2 Titers
Standard Deviation 4.91
|
366.8 Titers
Standard Deviation 5.77
|
445.8 Titers
Standard Deviation 5.20
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint
Omicron BA.1, Day 29
|
2317.0 Titers
Standard Deviation 3.16
|
2270.5 Titers
Standard Deviation 2.62
|
4263.8 Titers
Standard Deviation 3.37
|
1876.5 Titers
Standard Deviation 3.48
|
4395.3 Titers
Standard Deviation 2.54
|
3859.4 Titers
Standard Deviation 2.43
|
7582.7 Titers
Standard Deviation 2.98
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint
Omicron BA.1, Day 91
|
2207.8 Titers
Standard Deviation 2.56
|
2536.0 Titers
Standard Deviation 3.11
|
2864.4 Titers
Standard Deviation 3.58
|
1619.9 Titers
Standard Deviation 3.60
|
3244.6 Titers
Standard Deviation 3.70
|
2009.2 Titers
Standard Deviation 2.79
|
3410.5 Titers
Standard Deviation 2.80
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint
Omicron BA.2, Day 1
|
435.6 Titers
Standard Deviation 7.06
|
497.7 Titers
Standard Deviation 4.14
|
503.5 Titers
Standard Deviation 5.36
|
205.4 Titers
Standard Deviation 5.13
|
513.1 Titers
Standard Deviation 5.14
|
432.5 Titers
Standard Deviation 6.49
|
527.6 Titers
Standard Deviation 5.47
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint
Omicron BA.5, Day 1
|
263.2 Titers
Standard Deviation 7.74
|
374.9 Titers
Standard Deviation 5.04
|
254.4 Titers
Standard Deviation 6.17
|
100.0 Titers
Standard Deviation 5.24
|
276.8 Titers
Standard Deviation 5.69
|
253.6 Titers
Standard Deviation 5.89
|
381.9 Titers
Standard Deviation 5.21
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint
Omicron BA.5, Day 15
|
1336.7 Titers
Standard Deviation 2.87
|
1442.8 Titers
Standard Deviation 2.04
|
1985.9 Titers
Standard Deviation 3.05
|
1017.1 Titers
Standard Deviation 3.13
|
2756.7 Titers
Standard Deviation 3.26
|
2354.2 Titers
Standard Deviation 2.79
|
5956.0 Titers
Standard Deviation 3.27
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint
Omicron BA.5, Day 29
|
1213.4 Titers
Standard Deviation 3.28
|
1364.1 Titers
Standard Deviation 1.97
|
1613.8 Titers
Standard Deviation 3.47
|
832.2 Titers
Standard Deviation 3.01
|
2304.2 Titers
Standard Deviation 3.27
|
1532.3 Titers
Standard Deviation 2.91
|
4310.4 Titers
Standard Deviation 3.37
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint
Omicron BA.5, Day 91
|
1024.5 Titers
Standard Deviation 2.63
|
1072.0 Titers
Standard Deviation 2.21
|
1027.9 Titers
Standard Deviation 4.06
|
618.5 Titers
Standard Deviation 3.37
|
1341.2 Titers
Standard Deviation 3.93
|
1002.9 Titers
Standard Deviation 3.58
|
1923.5 Titers
Standard Deviation 3.17
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint
Omicron BA.5, Day 181
|
928.1 Titers
Standard Deviation 4.27
|
908.0 Titers
Standard Deviation 2.05
|
822.1 Titers
Standard Deviation 4.54
|
383.7 Titers
Standard Deviation 4.74
|
957.2 Titers
Standard Deviation 3.49
|
483.9 Titers
Standard Deviation 4.56
|
1108.4 Titers
Standard Deviation 4.33
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint
Delta, Day 1
|
496.3 Titers
Standard Deviation 5.55
|
494.9 Titers
Standard Deviation 3.73
|
587.7 Titers
Standard Deviation 4.46
|
249.4 Titers
Standard Deviation 3.78
|
591.6 Titers
Standard Deviation 3.53
|
474.0 Titers
Standard Deviation 5.12
|
500.2 Titers
Standard Deviation 5.21
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint
Delta, Day 15
|
1584.4 Titers
Standard Deviation 2.84
|
1907.8 Titers
Standard Deviation 2.38
|
3478.6 Titers
Standard Deviation 2.59
|
2066.0 Titers
Standard Deviation 2.28
|
4606.8 Titers
Standard Deviation 2.32
|
3455.8 Titers
Standard Deviation 2.24
|
9241.4 Titers
Standard Deviation 2.55
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint
Delta, Day 29
|
1449.8 Titers
Standard Deviation 2.70
|
1641.1 Titers
Standard Deviation 2.74
|
3253.1 Titers
Standard Deviation 2.75
|
1865.1 Titers
Standard Deviation 2.49
|
3810.1 Titers
Standard Deviation 2.33
|
3295.5 Titers
Standard Deviation 2.36
|
5906.9 Titers
Standard Deviation 2.66
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint
Delta, Day 91
|
1200.2 Titers
Standard Deviation 2.58
|
1212.4 Titers
Standard Deviation 3.33
|
2020.3 Titers
Standard Deviation 3.87
|
1249.9 Titers
Standard Deviation 2.94
|
2627.1 Titers
Standard Deviation 2.72
|
1685.9 Titers
Standard Deviation 2.87
|
2393.6 Titers
Standard Deviation 2.71
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint
Delta, Day 181
|
1210.5 Titers
Standard Deviation 2.84
|
1064.9 Titers
Standard Deviation 2.99
|
1300.1 Titers
Standard Deviation 3.16
|
896.5 Titers
Standard Deviation 2.93
|
1482.6 Titers
Standard Deviation 2.20
|
841.7 Titers
Standard Deviation 2.93
|
1277.6 Titers
Standard Deviation 3.37
|
SECONDARY outcome
Timeframe: At Day 15, Day 29, Day 91, and Day 181Population: The Per Protocol Immunogenicity (PPI) Set includes all eligible participants who received a dose of investigational product per protocol and who have values at specific timepoint for neutralizing Ab titers against pseudovirus bearing S protein from the Omicron variant of SARS-CoV-2.
Outcome measures
| Measure |
Part B: CV0501 Dose Cohort 6 (3 μg)
n=13 Participants
Healthy participants received a single dose of 3 microgram (μg) CV0501 vaccine intramuscularly at Day 1.
|
Part B: CV0501 Dose Cohort 7 (6 μg)
n=14 Participants
Healthy participants received a single dose of 6 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 1 (12 μg)
n=27 Participants
Healthy participants received a single dose of 12 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 2 (25 μg)
n=27 Participants
Healthy participants received a single dose of 25 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 3 (50 μg)
n=26 Participants
Healthy participants received a single dose of 50 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 4 (100 μg)
n=26 Participants
Healthy participants received a single dose of 100 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 5 (200 μg)
n=24 Participants
Healthy participants received a single dose of 200 μg CV0501 vaccine intramuscularly at Day 1.
|
|---|---|---|---|---|---|---|---|
|
Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point
WT, Day 91
|
1.06 Fold increase
Standard Deviation 1.938
|
2.25 Fold increase
Standard Deviation 2.948
|
3.28 Fold increase
Standard Deviation 2.709
|
4.83 Fold increase
Standard Deviation 2.721
|
4.42 Fold increase
Standard Deviation 2.883
|
3.61 Fold increase
Standard Deviation 2.792
|
4.14 Fold increase
Standard Deviation 2.928
|
|
Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point
WT, Day 181
|
1.02 Fold increase
Standard Deviation 2.201
|
1.83 Fold increase
Standard Deviation 2.917
|
1.82 Fold increase
Standard Deviation 3.000
|
2.79 Fold increase
Standard Deviation 2.204
|
1.86 Fold increase
Standard Deviation 2.586
|
1.98 Fold increase
Standard Deviation 2.636
|
1.83 Fold increase
Standard Deviation 3.615
|
|
Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point
Omicron BA.1, Day 15
|
3.72 Fold increase
Standard Deviation 3.328
|
5.00 Fold increase
Standard Deviation 5.923
|
8.64 Fold increase
Standard Deviation 3.575
|
11.56 Fold increase
Standard Deviation 3.789
|
12.04 Fold increase
Standard Deviation 3.518
|
11.09 Fold increase
Standard Deviation 4.294
|
23.51 Fold increase
Standard Deviation 4.705
|
|
Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point
Omicron BA.1, Day 29
|
3.66 Fold increase
Standard Deviation 2.794
|
4.17 Fold increase
Standard Deviation 6.567
|
7.71 Fold increase
Standard Deviation 3.348
|
10.54 Fold increase
Standard Deviation 3.314
|
11.12 Fold increase
Standard Deviation 3.793
|
11.05 Fold increase
Standard Deviation 3.888
|
20.89 Fold increase
Standard Deviation 4.123
|
|
Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point
Wild Type (WT), Day 15
|
2.14 Fold increase
Standard Deviation 2.500
|
3.16 Fold increase
Standard Deviation 2.765
|
4.10 Fold increase
Standard Deviation 2.687
|
5.25 Fold increase
Standard Deviation 3.292
|
4.89 Fold increase
Standard Deviation 3.329
|
8.10 Fold increase
Standard Deviation 3.171
|
13.31 Fold increase
Standard Deviation 4.397
|
|
Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point
Omicron BA.1, Day 91
|
2.37 Fold increase
Standard Deviation 2.675
|
4.64 Fold increase
Standard Deviation 7.041
|
5.31 Fold increase
Standard Deviation 3.180
|
8.94 Fold increase
Standard Deviation 3.448
|
7.76 Fold increase
Standard Deviation 3.798
|
6.55 Fold increase
Standard Deviation 3.411
|
7.39 Fold increase
Standard Deviation 3.460
|
|
Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point
Omicron BA.1, Day 181
|
1.39 Fold increase
Standard Deviation 2.863
|
3.81 Fold increase
Standard Deviation 6.801
|
3.40 Fold increase
Standard Deviation 3.165
|
6.30 Fold increase
Standard Deviation 3.695
|
3.22 Fold increase
Standard Deviation 3.122
|
4.27 Fold increase
Standard Deviation 3.411
|
4.38 Fold increase
Standard Deviation 4.698
|
|
Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point
Omicron BA.2, Day 15
|
3.64 Fold increase
Standard Deviation 3.177
|
5.31 Fold increase
Standard Deviation 5.736
|
9.50 Fold increase
Standard Deviation 3.567
|
11.63 Fold increase
Standard Deviation 3.182
|
10.51 Fold increase
Standard Deviation 3.586
|
9.77 Fold increase
Standard Deviation 4.246
|
13.44 Fold increase
Standard Deviation 6.178
|
|
Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point
Omicron BA.2, Day 29
|
2.30 Fold increase
Standard Deviation 3.466
|
4.27 Fold increase
Standard Deviation 5.859
|
8.16 Fold increase
Standard Deviation 3.503
|
10.80 Fold increase
Standard Deviation 3.391
|
10.59 Fold increase
Standard Deviation 3.758
|
8.00 Fold increase
Standard Deviation 5.258
|
16.01 Fold increase
Standard Deviation 4.056
|
|
Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point
Omicron BA.2, Day 91
|
1.81 Fold increase
Standard Deviation 2.668
|
3.17 Fold increase
Standard Deviation 6.083
|
4.52 Fold increase
Standard Deviation 3.098
|
6.88 Fold increase
Standard Deviation 3.823
|
5.44 Fold increase
Standard Deviation 3.831
|
4.76 Fold increase
Standard Deviation 4.024
|
5.48 Fold increase
Standard Deviation 3.018
|
|
Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point
Omicron BA.2, Day 181
|
1.30 Fold increase
Standard Deviation 2.624
|
2.73 Fold increase
Standard Deviation 5.862
|
2.57 Fold increase
Standard Deviation 4.061
|
4.96 Fold increase
Standard Deviation 2.984
|
2.77 Fold increase
Standard Deviation 3.565
|
2.90 Fold increase
Standard Deviation 3.669
|
3.06 Fold increase
Standard Deviation 4.172
|
|
Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point
Omicron BA.5, Day 15
|
3.64 Fold increase
Standard Deviation 3.370
|
3.85 Fold increase
Standard Deviation 6.017
|
6.94 Fold increase
Standard Deviation 3.677
|
10.16 Fold increase
Standard Deviation 3.210
|
9.57 Fold increase
Standard Deviation 3.709
|
7.86 Fold increase
Standard Deviation 3.871
|
15.67 Fold increase
Standard Deviation 3.821
|
|
Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point
Omicron BA.5, Day 29
|
3.30 Fold increase
Standard Deviation 3.031
|
3.63 Fold increase
Standard Deviation 5.877
|
5.64 Fold increase
Standard Deviation 3.458
|
8.72 Fold increase
Standard Deviation 3.011
|
8.99 Fold increase
Standard Deviation 3.658
|
5.93 Fold increase
Standard Deviation 3.645
|
12.69 Fold increase
Standard Deviation 3.418
|
|
Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point
Omicron BA.5, Day 181
|
1.25 Fold increase
Standard Deviation 2.678
|
2.42 Fold increase
Standard Deviation 6.001
|
3.14 Fold increase
Standard Deviation 3.293
|
4.16 Fold increase
Standard Deviation 2.728
|
2.75 Fold increase
Standard Deviation 3.822
|
2.13 Fold increase
Standard Deviation 2.808
|
2.62 Fold increase
Standard Deviation 3.846
|
|
Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point
WT, Day 29
|
1.89 Fold increase
Standard Deviation 2.337
|
2.48 Fold increase
Standard Deviation 2.934
|
3.47 Fold increase
Standard Deviation 2.557
|
7.16 Fold increase
Standard Deviation 2.456
|
7.20 Fold increase
Standard Deviation 3.118
|
6.86 Fold increase
Standard Deviation 3.792
|
11.74 Fold increase
Standard Deviation 3.453
|
|
Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point
Omicron BA.5, Day 91
|
1.93 Fold increase
Standard Deviation 3.136
|
2.87 Fold increase
Standard Deviation 6.515
|
3.78 Fold increase
Standard Deviation 3.451
|
5.94 Fold increase
Standard Deviation 2.791
|
4.55 Fold increase
Standard Deviation 3.842
|
4.03 Fold increase
Standard Deviation 2.932
|
4.60 Fold increase
Standard Deviation 2.654
|
|
Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point
Delta, Day 15
|
2.32 Fold increase
Standard Deviation 2.100
|
3.86 Fold increase
Standard Deviation 3.575
|
5.50 Fold increase
Standard Deviation 3.041
|
8.28 Fold increase
Standard Deviation 2.837
|
7.23 Fold increase
Standard Deviation 3.225
|
6.27 Fold increase
Standard Deviation 3.502
|
18.44 Fold increase
Standard Deviation 5.067
|
|
Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point
Delta, Day 29
|
2.12 Fold increase
Standard Deviation 2.002
|
3.31 Fold increase
Standard Deviation 3.919
|
5.16 Fold increase
Standard Deviation 2.783
|
7.76 Fold increase
Standard Deviation 2.982
|
6.73 Fold increase
Standard Deviation 3.424
|
7.12 Fold increase
Standard Deviation 3.677
|
13.62 Fold increase
Standard Deviation 4.023
|
|
Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point
Delta, Day 91
|
1.26 Fold increase
Standard Deviation 1.717
|
2.45 Fold increase
Standard Deviation 3.973
|
3.26 Fold increase
Standard Deviation 2.973
|
5.27 Fold increase
Standard Deviation 2.817
|
4.12 Fold increase
Standard Deviation 3.235
|
4.16 Fold increase
Standard Deviation 3.198
|
4.41 Fold increase
Standard Deviation 3.020
|
|
Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point
Delta, Day 181
|
0.97 Fold increase
Standard Deviation 2.131
|
2.15 Fold increase
Standard Deviation 3.829
|
2.16 Fold increase
Standard Deviation 3.188
|
4.14 Fold increase
Standard Deviation 2.414
|
1.96 Fold increase
Standard Deviation 3.087
|
2.10 Fold increase
Standard Deviation 2.982
|
2.37 Fold increase
Standard Deviation 3.394
|
SECONDARY outcome
Timeframe: At day 29 (28 days after the booster dose)Population: The Per Protocol Immunogenicity (PPI) Set includes all eligible participants who received a dose of investigational product per protocol and who have values at specific timepoint for neutralizing Ab titers against pseudovirus bearing S protein from the Omicron variant of SARS-CoV-2.
Seroresponse was defined as post-boost titers \>= 4 times pre-boost (baseline) titers for participants with titer \>= LLOQ at pre-vaccination and as post-booster titer \>= 4 times LLOQ for participants with titer \< LLOQ at pre vaccination.
Outcome measures
| Measure |
Part B: CV0501 Dose Cohort 6 (3 μg)
n=13 Participants
Healthy participants received a single dose of 3 microgram (μg) CV0501 vaccine intramuscularly at Day 1.
|
Part B: CV0501 Dose Cohort 7 (6 μg)
n=14 Participants
Healthy participants received a single dose of 6 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 1 (12 μg)
n=27 Participants
Healthy participants received a single dose of 12 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 2 (25 μg)
n=26 Participants
Healthy participants received a single dose of 25 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 3 (50 μg)
n=26 Participants
Healthy participants received a single dose of 50 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 4 (100 μg)
n=26 Participants
Healthy participants received a single dose of 100 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 5 (200 μg)
n=21 Participants
Healthy participants received a single dose of 200 μg CV0501 vaccine intramuscularly at Day 1.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Neutralizing Seroresponse of Serum SARS-CoV-2 WT, Omicron BA.1, BA.2 and BA.5 Variants Specific Ab at Day 29
Ancestral WT
|
15.4 Percentage of participants
Interval 1.9 to 45.4
|
21.4 Percentage of participants
Interval 4.7 to 50.8
|
33.3 Percentage of participants
Interval 16.5 to 54.0
|
69.2 Percentage of participants
Interval 48.2 to 85.7
|
69.2 Percentage of participants
Interval 48.2 to 85.7
|
50.0 Percentage of participants
Interval 29.9 to 70.1
|
76.2 Percentage of participants
Interval 52.8 to 91.8
|
|
Percentage of Participants With Neutralizing Seroresponse of Serum SARS-CoV-2 WT, Omicron BA.1, BA.2 and BA.5 Variants Specific Ab at Day 29
Omicron BA.1
|
38.5 Percentage of participants
Interval 13.9 to 68.4
|
21.4 Percentage of participants
Interval 4.7 to 50.8
|
74.1 Percentage of participants
Interval 53.7 to 88.9
|
65.4 Percentage of participants
Interval 44.3 to 82.8
|
84.6 Percentage of participants
Interval 65.1 to 95.6
|
76.9 Percentage of participants
Interval 56.4 to 91.0
|
95.2 Percentage of participants
Interval 76.2 to 99.9
|
|
Percentage of Participants With Neutralizing Seroresponse of Serum SARS-CoV-2 WT, Omicron BA.1, BA.2 and BA.5 Variants Specific Ab at Day 29
Omicron BA.5
|
38.5 Percentage of participants
Interval 13.9 to 68.4
|
28.6 Percentage of participants
Interval 8.4 to 58.1
|
48.1 Percentage of participants
Interval 28.7 to 68.1
|
73.1 Percentage of participants
Interval 52.2 to 88.4
|
73.1 Percentage of participants
Interval 52.2 to 88.4
|
50.0 Percentage of participants
Interval 29.9 to 70.1
|
81.0 Percentage of participants
Interval 58.1 to 95.6
|
|
Percentage of Participants With Neutralizing Seroresponse of Serum SARS-CoV-2 WT, Omicron BA.1, BA.2 and BA.5 Variants Specific Ab at Day 29
Omicron BA.2
|
30.8 Percentage of participants
Interval 9.1 to 61.4
|
28.6 Percentage of participants
Interval 8.4 to 58.1
|
77.8 Percentage of participants
Interval 57.7 to 91.4
|
73.1 Percentage of participants
Interval 52.2 to 88.4
|
73.1 Percentage of participants
Interval 52.2 to 88.4
|
61.5 Percentage of participants
Interval 40.6 to 79.8
|
90.5 Percentage of participants
Interval 69.9 to 98.8
|
Adverse Events
Part B: CV0501 Dose Cohort 6 (3 μg)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Part B: CV0501 Dose Cohort 7 (6 μg)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Part A: CV0501 Dose Cohort 1 (12 μg)
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Part A: CV0501 Dose Cohort 2 (25 μg)
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Part A: CV0501 Dose Cohort 3 (50 μg)
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Part A: CV0501 Dose Cohort 4 (100 μg)
Serious events: 2 serious events
Other events: 22 other events
Deaths: 0 deaths
Part A: CV0501 Dose Cohort 5 (200 μg)
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part B: CV0501 Dose Cohort 6 (3 μg)
n=15 participants at risk
Healthy participants received a single dose of 3 microgram (μg) CV0501 vaccine intramuscularly at Day 1.
|
Part B: CV0501 Dose Cohort 7 (6 μg)
n=15 participants at risk
Healthy participants received a single dose of 6 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 1 (12 μg)
n=30 participants at risk
Healthy participants received a single dose of 12 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 2 (25 μg)
n=30 participants at risk
Healthy participants received a single dose of 25 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 3 (50 μg)
n=30 participants at risk
Healthy participants received a single dose of 50 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 4 (100 μg)
n=30 participants at risk
Healthy participants received a single dose of 100 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 5 (200 μg)
n=30 participants at risk
Healthy participants received a single dose of 200 μg CV0501 vaccine intramuscularly at Day 1.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/15 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/15 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
3.3%
1/30 • Number of events 1 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/15 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/15 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
3.3%
1/30 • Number of events 1 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
|
Nervous system disorders
Syncope
|
0.00%
0/15 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/15 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
3.3%
1/30 • Number of events 1 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
Other adverse events
| Measure |
Part B: CV0501 Dose Cohort 6 (3 μg)
n=15 participants at risk
Healthy participants received a single dose of 3 microgram (μg) CV0501 vaccine intramuscularly at Day 1.
|
Part B: CV0501 Dose Cohort 7 (6 μg)
n=15 participants at risk
Healthy participants received a single dose of 6 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 1 (12 μg)
n=30 participants at risk
Healthy participants received a single dose of 12 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 2 (25 μg)
n=30 participants at risk
Healthy participants received a single dose of 25 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 3 (50 μg)
n=30 participants at risk
Healthy participants received a single dose of 50 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 4 (100 μg)
n=30 participants at risk
Healthy participants received a single dose of 100 μg CV0501 vaccine intramuscularly at Day 1.
|
Part A: CV0501 Dose Cohort 5 (200 μg)
n=30 participants at risk
Healthy participants received a single dose of 200 μg CV0501 vaccine intramuscularly at Day 1.
|
|---|---|---|---|---|---|---|---|
|
General disorders
Injection site pain
|
33.3%
5/15 • Number of events 5 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
60.0%
9/15 • Number of events 9 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
46.7%
14/30 • Number of events 14 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
63.3%
19/30 • Number of events 19 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
50.0%
15/30 • Number of events 15 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
63.3%
19/30 • Number of events 19 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
73.3%
22/30 • Number of events 22 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
|
General disorders
Fatigue
|
6.7%
1/15 • Number of events 1 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/15 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
16.7%
5/30 • Number of events 5 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
46.7%
14/30 • Number of events 14 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
33.3%
10/30 • Number of events 10 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
50.0%
15/30 • Number of events 16 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
46.7%
14/30 • Number of events 14 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
|
General disorders
Chills
|
6.7%
1/15 • Number of events 1 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/15 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
10.0%
3/30 • Number of events 3 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
16.7%
5/30 • Number of events 5 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
10.0%
3/30 • Number of events 3 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
36.7%
11/30 • Number of events 11 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
36.7%
11/30 • Number of events 11 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
|
General disorders
Injection site erythema
|
0.00%
0/15 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/15 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
3.3%
1/30 • Number of events 1 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
6.7%
2/30 • Number of events 2 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
6.7%
2/30 • Number of events 2 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
3.3%
1/30 • Number of events 1 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
30.0%
9/30 • Number of events 10 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
|
General disorders
Injection site swelling
|
6.7%
1/15 • Number of events 1 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
6.7%
1/15 • Number of events 1 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
3.3%
1/30 • Number of events 1 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
10.0%
3/30 • Number of events 3 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
3.3%
1/30 • Number of events 1 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
20.0%
6/30 • Number of events 6 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
|
General disorders
Fever
|
0.00%
0/15 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/15 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
6.7%
2/30 • Number of events 2 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
10.0%
3/30 • Number of events 3 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
6.7%
2/30 • Number of events 2 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
|
General disorders
Administration site pain
|
0.00%
0/15 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/15 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
3.3%
1/30 • Number of events 1 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
|
General disorders
Chest pain
|
0.00%
0/15 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/15 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
3.3%
1/30 • Number of events 1 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.3%
2/15 • Number of events 2 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
20.0%
3/15 • Number of events 3 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
26.7%
8/30 • Number of events 8 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
33.3%
10/30 • Number of events 10 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
33.3%
10/30 • Number of events 10 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
53.3%
16/30 • Number of events 16 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
56.7%
17/30 • Number of events 17 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/15 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
6.7%
1/15 • Number of events 1 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
6.7%
2/30 • Number of events 2 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
16.7%
5/30 • Number of events 5 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
10.0%
3/30 • Number of events 3 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
20.0%
6/30 • Number of events 6 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
10.0%
3/30 • Number of events 3 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
1/15 • Number of events 1 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/15 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
|
Nervous system disorders
Headache
|
26.7%
4/15 • Number of events 4 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
26.7%
4/15 • Number of events 4 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
16.7%
5/30 • Number of events 5 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
30.0%
9/30 • Number of events 9 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
30.0%
9/30 • Number of events 9 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
43.3%
13/30 • Number of events 13 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
43.3%
13/30 • Number of events 13 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
|
Infections and infestations
COVID-19
|
13.3%
2/15 • Number of events 2 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/15 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
3.3%
1/30 • Number of events 1 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
10.0%
3/30 • Number of events 3 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
6.7%
2/30 • Number of events 2 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
13.3%
4/30 • Number of events 4 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
10.0%
3/30 • Number of events 3 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/15 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
6.7%
1/15 • Number of events 1 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
3.3%
1/30 • Number of events 1 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
10.0%
3/30 • Number of events 3 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/15 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/15 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
3.3%
1/30 • Number of events 1 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
3.3%
1/30 • Number of events 1 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/15 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/15 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
3.3%
1/30 • Number of events 1 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/15 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/15 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
3.3%
1/30 • Number of events 1 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/15 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/15 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
3.3%
1/30 • Number of events 1 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/15 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/15 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
3.3%
1/30 • Number of events 1 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/15 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
13.3%
2/15 • Number of events 2 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
13.3%
4/30 • Number of events 4 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
6.7%
2/30 • Number of events 2 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
16.7%
5/30 • Number of events 5 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
13.3%
4/30 • Number of events 4 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
20.0%
6/30 • Number of events 6 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/15 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/15 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
3.3%
1/30 • Number of events 1 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/15 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/15 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
3.3%
1/30 • Number of events 1 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/15 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/15 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
3.3%
1/30 • Number of events 1 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.00%
0/15 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/15 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
3.3%
1/30 • Number of events 1 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/15 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/15 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
3.3%
1/30 • Number of events 1 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/15 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/15 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
3.3%
1/30 • Number of events 1 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
|
Vascular disorders
Hypertension
|
0.00%
0/15 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/15 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
3.3%
1/30 • Number of events 1 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
0.00%
0/30 • Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) 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 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. 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 included all participants that received the study intervention administration.
|
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