Trial Outcomes & Findings for Dose Ranging Trial to Assess Safety and Immunogenicity of V590 (COVID-19 Vaccine) in Healthy Adults (V590-001) (NCT NCT04569786)
NCT ID: NCT04569786
Last Updated: 2021-12-29
Results Overview
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Solicited injection site AEs (injection site redness/erythema, pain, swelling) were assessed.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
232 participants
Primary outcome timeframe
Up to 5 days post-vaccination
Results posted on
2021-12-29
Participant Flow
The planned enrollment total was approximately 252 participants.
Participant milestones
| Measure |
V590 5.00x10^5 Plaque Forming Units (Pfu)
Participants received a single dose of V590 5.00x10\^5 pfu on Day 1.
|
V590 2.40x10^6 Pfu
Participants received a single dose of V590 2.40x10\^6 pfu on Day 1.
|
V590 1.15x10^7 Pfu
Participants received a single dose of V590 1.15x10\^7 pfu on Day 1.
|
V590 5.55x10^7 Pfu
Participants received a single dose of V590 5.55x10\^7 pfu on Day 1.
|
Placebo
Participants received single dose placebo administered via intramuscular (IM) injection on Day 1.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
39
|
39
|
42
|
56
|
56
|
|
Overall Study
COMPLETED
|
38
|
39
|
38
|
49
|
55
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
4
|
7
|
1
|
Reasons for withdrawal
| Measure |
V590 5.00x10^5 Plaque Forming Units (Pfu)
Participants received a single dose of V590 5.00x10\^5 pfu on Day 1.
|
V590 2.40x10^6 Pfu
Participants received a single dose of V590 2.40x10\^6 pfu on Day 1.
|
V590 1.15x10^7 Pfu
Participants received a single dose of V590 1.15x10\^7 pfu on Day 1.
|
V590 5.55x10^7 Pfu
Participants received a single dose of V590 5.55x10\^7 pfu on Day 1.
|
Placebo
Participants received single dose placebo administered via intramuscular (IM) injection on Day 1.
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
4
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
5
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Dose Ranging Trial to Assess Safety and Immunogenicity of V590 (COVID-19 Vaccine) in Healthy Adults (V590-001)
Baseline characteristics by cohort
| Measure |
V590 5.00x10^5 Plaque Forming Units (Pfu)
n=39 Participants
Participants received a single dose of V590 5.00x10\^5 pfu on Day 1.
|
V590 2.40x10^6 Pfu
n=39 Participants
Participants received a single dose of V590 2.40x10\^6 pfu on Day 1.
|
V590 1.15x10^7 Pfu
n=42 Participants
Participants received a single dose of V590 1.15x10\^7 pfu on Day 1.
|
V590 5.55x10^7 Pfu
n=56 Participants
Participants received a single dose of V590 5.55x10\^7 pfu on Day 1.
|
Placebo
n=56 Participants
Participants received single dose placebo administered via intramuscular (IM) injection on Day 1.
|
Total
n=232 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
48.9 Years
STANDARD_DEVIATION 18.8 • n=5 Participants
|
50.9 Years
STANDARD_DEVIATION 16.0 • n=7 Participants
|
51.0 Years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
48.0 Years
STANDARD_DEVIATION 16.1 • n=4 Participants
|
47.3 Years
STANDARD_DEVIATION 16.9 • n=21 Participants
|
49.0 Years
STANDARD_DEVIATION 16.3 • n=10 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
118 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
114 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
96 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
136 Participants
n=10 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=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
27 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
197 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race (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=10 Participants
|
PRIMARY outcome
Timeframe: Up to 5 days post-vaccinationPopulation: The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Solicited injection site AEs (injection site redness/erythema, pain, swelling) were assessed.
Outcome measures
| Measure |
V590 5.00x10^5 Plaque Forming Units (Pfu)
n=39 Participants
Participants received a single dose of V590 5.00x10\^5 pfu on Day 1.
|
V590 2.40x10^6 Pfu
n=39 Participants
Participants received a single dose of V590 2.40x10\^6 pfu on Day 1.
|
V590 1.15x10^7 Pfu
n=42 Participants
Participants received a single dose of V590 1.15x10\^7 pfu on Day 1.
|
V590 5.55x10^7 Pfu
n=56 Participants
Participants received a single dose of V590 5.55x10\^7 pfu on Day 1.
|
Placebo
n=56 Participants
Participants received single dose placebo administered via intramuscular (IM) injection on Day 1.
|
|---|---|---|---|---|---|
|
Percentage of Participants With at Least 1 Solicited Injection Site Adverse Event
Injection site redness/erythema
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
1.8 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants With at Least 1 Solicited Injection Site Adverse Event
Injection site pain
|
28.2 Percentage of Participants
|
35.9 Percentage of Participants
|
31.0 Percentage of Participants
|
42.9 Percentage of Participants
|
46.4 Percentage of Participants
|
|
Percentage of Participants With at Least 1 Solicited Injection Site Adverse Event
Injection site swelling
|
0.0 Percentage of Participants
|
2.6 Percentage of Participants
|
2.4 Percentage of Participants
|
3.6 Percentage of Participants
|
0.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to 28 days post-vaccinationPopulation: The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Solicited systemic AEs (joint stiffness/arthralgia, tiredness/fatigue, headache, joint swelling, muscle pain/myalgia, nausea, oral disorder, and rash) were assessed.
Outcome measures
| Measure |
V590 5.00x10^5 Plaque Forming Units (Pfu)
n=39 Participants
Participants received a single dose of V590 5.00x10\^5 pfu on Day 1.
|
V590 2.40x10^6 Pfu
n=39 Participants
Participants received a single dose of V590 2.40x10\^6 pfu on Day 1.
|
V590 1.15x10^7 Pfu
n=42 Participants
Participants received a single dose of V590 1.15x10\^7 pfu on Day 1.
|
V590 5.55x10^7 Pfu
n=56 Participants
Participants received a single dose of V590 5.55x10\^7 pfu on Day 1.
|
Placebo
n=56 Participants
Participants received single dose placebo administered via intramuscular (IM) injection on Day 1.
|
|---|---|---|---|---|---|
|
Percentage of Participants With at Least 1 Solicited Systemic Adverse Event
Joint stiffness/arthralgia
|
5.1 Percentage of Participants
|
7.7 Percentage of Participants
|
0.0 Percentage of Participants
|
12.5 Percentage of Participants
|
8.9 Percentage of Participants
|
|
Percentage of Participants With at Least 1 Solicited Systemic Adverse Event
Tiredness/fatigue
|
10.3 Percentage of Participants
|
15.4 Percentage of Participants
|
11.9 Percentage of Participants
|
12.5 Percentage of Participants
|
16.1 Percentage of Participants
|
|
Percentage of Participants With at Least 1 Solicited Systemic Adverse Event
Headache
|
15.4 Percentage of Participants
|
12.8 Percentage of Participants
|
9.5 Percentage of Participants
|
16.1 Percentage of Participants
|
19.6 Percentage of Participants
|
|
Percentage of Participants With at Least 1 Solicited Systemic Adverse Event
Joint swelling
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
1.8 Percentage of Participants
|
3.6 Percentage of Participants
|
|
Percentage of Participants With at Least 1 Solicited Systemic Adverse Event
Muscle pain/myalgia
|
10.3 Percentage of Participants
|
7.7 Percentage of Participants
|
0.0 Percentage of Participants
|
10.7 Percentage of Participants
|
7.1 Percentage of Participants
|
|
Percentage of Participants With at Least 1 Solicited Systemic Adverse Event
Nausea
|
5.1 Percentage of Participants
|
5.1 Percentage of Participants
|
0.0 Percentage of Participants
|
3.6 Percentage of Participants
|
8.9 Percentage of Participants
|
|
Percentage of Participants With at Least 1 Solicited Systemic Adverse Event
Oral disorder
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
1.8 Percentage of Participants
|
1.8 Percentage of Participants
|
|
Percentage of Participants With at Least 1 Solicited Systemic Adverse Event
Rash
|
10.3 Percentage of Participants
|
0.0 Percentage of Participants
|
2.4 Percentage of Participants
|
3.6 Percentage of Participants
|
0.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to ~28 days post-vaccinationPopulation: The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Participants with reported unsolicited AEs were assessed.
Outcome measures
| Measure |
V590 5.00x10^5 Plaque Forming Units (Pfu)
n=39 Participants
Participants received a single dose of V590 5.00x10\^5 pfu on Day 1.
|
V590 2.40x10^6 Pfu
n=39 Participants
Participants received a single dose of V590 2.40x10\^6 pfu on Day 1.
|
V590 1.15x10^7 Pfu
n=42 Participants
Participants received a single dose of V590 1.15x10\^7 pfu on Day 1.
|
V590 5.55x10^7 Pfu
n=56 Participants
Participants received a single dose of V590 5.55x10\^7 pfu on Day 1.
|
Placebo
n=56 Participants
Participants received single dose placebo administered via intramuscular (IM) injection on Day 1.
|
|---|---|---|---|---|---|
|
Percentage of Participants With at Least 1 Unsolicited Adverse Event
|
6 Percentage of Participants
|
10 Percentage of Participants
|
13 Percentage of Participants
|
21 Percentage of Participants
|
16 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to 28 days post-vaccinationPopulation: The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
A medically attended adverse event (MAAE) is an AE in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency room visit, office visit, or an urgent care visit with any medical personnel for any reason. Any MAAE was assessed.
Outcome measures
| Measure |
V590 5.00x10^5 Plaque Forming Units (Pfu)
n=39 Participants
Participants received a single dose of V590 5.00x10\^5 pfu on Day 1.
|
V590 2.40x10^6 Pfu
n=39 Participants
Participants received a single dose of V590 2.40x10\^6 pfu on Day 1.
|
V590 1.15x10^7 Pfu
n=42 Participants
Participants received a single dose of V590 1.15x10\^7 pfu on Day 1.
|
V590 5.55x10^7 Pfu
n=56 Participants
Participants received a single dose of V590 5.55x10\^7 pfu on Day 1.
|
Placebo
n=56 Participants
Participants received single dose placebo administered via intramuscular (IM) injection on Day 1.
|
|---|---|---|---|---|---|
|
Percentage of Participants With at Least 1 Medically Attended Adverse Event
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
5.4 Percentage of Participants
|
0.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Active monitoring through Day 28 post-vaccination (Up to a maximum of ~90 days post-vaccination)Population: The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
A serious adverse event (SAE) is "life threatening," requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or other important medical event. Any SAE was assessed. Active monitoring of SAEs occurred through Day 28 but were collected per protocol till study completion/termination or \~90 days post-vaccination.
Outcome measures
| Measure |
V590 5.00x10^5 Plaque Forming Units (Pfu)
n=39 Participants
Participants received a single dose of V590 5.00x10\^5 pfu on Day 1.
|
V590 2.40x10^6 Pfu
n=39 Participants
Participants received a single dose of V590 2.40x10\^6 pfu on Day 1.
|
V590 1.15x10^7 Pfu
n=42 Participants
Participants received a single dose of V590 1.15x10\^7 pfu on Day 1.
|
V590 5.55x10^7 Pfu
n=56 Participants
Participants received a single dose of V590 5.55x10\^7 pfu on Day 1.
|
Placebo
n=56 Participants
Participants received single dose placebo administered via intramuscular (IM) injection on Day 1.
|
|---|---|---|---|---|---|
|
Percentage of Participants With at Least 1 Serious Adverse Event
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
1.8 Percentage of Participants
|
0.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: 28 days post-vaccinationPopulation: The analysis population consisted of all randomized participants who were seronegative for anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleocapsid antibody through Day 28 with exclusions for important deviations from the protocol that may substantially affect the results of this immunogenicity endpoint.
Serum samples were collected and the presence of serum neutralization antibodies (SNAs) were assessed using plaque reduction neutralization test (PRNT). Geometric mean titers (GMTs) and 95% confidence intervals (CIs), GMT ratios and 90% CIs, and p-values are estimated from a longitudinal data analysis (LDA) model and are provided in accordance with the statistical analysis plan.
Outcome measures
| Measure |
V590 5.00x10^5 Plaque Forming Units (Pfu)
n=39 Participants
Participants received a single dose of V590 5.00x10\^5 pfu on Day 1.
|
V590 2.40x10^6 Pfu
n=37 Participants
Participants received a single dose of V590 2.40x10\^6 pfu on Day 1.
|
V590 1.15x10^7 Pfu
n=41 Participants
Participants received a single dose of V590 1.15x10\^7 pfu on Day 1.
|
V590 5.55x10^7 Pfu
n=42 Participants
Participants received a single dose of V590 5.55x10\^7 pfu on Day 1.
|
Placebo
n=50 Participants
Participants received single dose placebo administered via intramuscular (IM) injection on Day 1.
|
|---|---|---|---|---|---|
|
Geometric Mean Titers for Serum Neutralizing Antibodies as Measured by Plaque Reduction Neutralization Test
|
6.39 Titer
Interval 4.54 to 8.99
|
7.00 Titer
Interval 4.93 to 9.92
|
7.67 Titer
Interval 5.5 to 10.7
|
15.78 Titer
Interval 11.37 to 21.91
|
6.98 Titer
Interval 5.17 to 9.42
|
SECONDARY outcome
Timeframe: 7 days post-vaccinationPopulation: The analysis population consisted of a subset of all randomized participants who received at least one dose of study intervention and had at least 1 result for the analysis endpoint. Due to the early termination of the study, testing was prioritized and data were not generated for all samples and timepoints.
Serum samples were collected and analyzed on a subset of participants but assays were not conducted on all samples that were collected. Due to the early termination of the study, testing was prioritized for the key samples and timepoints that would provide the required safety and immunogenicity data to support programmatic decision-making and subsequent clinical studies. Blank cells indicate that data were not generated and no data were available. The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Outcome measures
| Measure |
V590 5.00x10^5 Plaque Forming Units (Pfu)
n=20 Participants
Participants received a single dose of V590 5.00x10\^5 pfu on Day 1.
|
V590 2.40x10^6 Pfu
n=7 Participants
Participants received a single dose of V590 2.40x10\^6 pfu on Day 1.
|
V590 1.15x10^7 Pfu
n=5 Participants
Participants received a single dose of V590 1.15x10\^7 pfu on Day 1.
|
V590 5.55x10^7 Pfu
Participants received a single dose of V590 5.55x10\^7 pfu on Day 1.
|
Placebo
n=7 Participants
Participants received single dose placebo administered via intramuscular (IM) injection on Day 1.
|
|---|---|---|---|---|---|
|
Geometric Mean Titers for SNAs as Measured by PRNT- 7 Days
|
5.32 Titers
Interval 4.68 to 6.04
|
17.07 Titers
Interval 1.96 to 148.6
|
5.0 Titers
Interval 5.0 to 5.0
|
—
|
9.78 Titers
Interval 1.89 to 50.47
|
SECONDARY outcome
Timeframe: 14 days post vaccinationPopulation: The analysis population consisted of all randomized participants who were seronegative for anti-SARS-CoV-2 nucleocapsid antibody through Day 14 with exclusions for important deviations from the protocol that may substantially affect the results of this immunogenicity endpoint.
Serum samples were collected for all participants and the presence of SNAs was assessed using PRNT. The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Outcome measures
| Measure |
V590 5.00x10^5 Plaque Forming Units (Pfu)
n=39 Participants
Participants received a single dose of V590 5.00x10\^5 pfu on Day 1.
|
V590 2.40x10^6 Pfu
n=37 Participants
Participants received a single dose of V590 2.40x10\^6 pfu on Day 1.
|
V590 1.15x10^7 Pfu
n=41 Participants
Participants received a single dose of V590 1.15x10\^7 pfu on Day 1.
|
V590 5.55x10^7 Pfu
n=42 Participants
Participants received a single dose of V590 5.55x10\^7 pfu on Day 1.
|
Placebo
n=50 Participants
Participants received single dose placebo administered via intramuscular (IM) injection on Day 1.
|
|---|---|---|---|---|---|
|
Geometric Mean Titers for SNAs as Measured by PRNT- 14 Days
|
5.94 Titers
Interval 4.66 to 7.56
|
6.64 Titers
Interval 4.58 to 9.62
|
7.32 Titers
Interval 5.84 to 9.18
|
15.26 Titers
Interval 9.73 to 23.95
|
6.45 Titers
Interval 4.67 to 8.91
|
SECONDARY outcome
Timeframe: 7, 14, and 28 days post vaccinationPopulation: The analysis population consisted of all randomized participants who were seronegative for anti-SARS-CoV-2 nucleocapsid antibody on Days 7, 14 or 28 with exclusions for important deviations from the protocol that may substantially affect the results of this immunogenicity endpoint.
Serum samples were collected and the total anti-spike immunoglobulin G (IgG) antibodies were assessed using enzyme-linked immunosorbent assay (ELISA). The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Outcome measures
| Measure |
V590 5.00x10^5 Plaque Forming Units (Pfu)
n=39 Participants
Participants received a single dose of V590 5.00x10\^5 pfu on Day 1.
|
V590 2.40x10^6 Pfu
n=39 Participants
Participants received a single dose of V590 2.40x10\^6 pfu on Day 1.
|
V590 1.15x10^7 Pfu
n=42 Participants
Participants received a single dose of V590 1.15x10\^7 pfu on Day 1.
|
V590 5.55x10^7 Pfu
n=42 Participants
Participants received a single dose of V590 5.55x10\^7 pfu on Day 1.
|
Placebo
n=52 Participants
Participants received single dose placebo administered via intramuscular (IM) injection on Day 1.
|
|---|---|---|---|---|---|
|
Geometric Mean Titers for Total Anti-Spike Immunoglobulin G Antibodies as Measured by Enzyme-Linked Immunosorbent Assay
Day 7
|
56.60 Titers
Interval 44.04 to 72.75
|
65.78 Titers
Interval 43.63 to 99.15
|
51.90 Titers
Interval 48.13 to 55.97
|
58.06 Titers
Interval 45.7 to 73.77
|
68.36 Titers
Interval 47.01 to 99.39
|
|
Geometric Mean Titers for Total Anti-Spike Immunoglobulin G Antibodies as Measured by Enzyme-Linked Immunosorbent Assay
Day 14
|
56.01 Titers
Interval 44.51 to 70.47
|
65.10 Titers
Interval 43.75 to 96.86
|
63.63 Titers
Interval 52.31 to 77.39
|
104.12 Titers
Interval 72.27 to 150.01
|
67.13 Titers
Interval 47.26 to 95.36
|
|
Geometric Mean Titers for Total Anti-Spike Immunoglobulin G Antibodies as Measured by Enzyme-Linked Immunosorbent Assay
Day 28
|
62.82 Titers
Interval 45.48 to 86.77
|
69.78 Titers
Interval 47.31 to 102.93
|
69.14 Titers
Interval 53.0 to 90.2
|
107.58 Titers
Interval 75.93 to 152.41
|
71.13 Titers
Interval 49.82 to 101.57
|
SECONDARY outcome
Timeframe: 1, 2, 3, 4, 5, 6, 7, 14 and 28 days post-vaccinationPopulation: The analysis population consisted of all randomized participants who received study intervention with data available for Days 1, 2, 3, 4, 5, 6, 7, 14, or 28.
Positive viremia was defined as detectable reverse transcription polymerase chain reaction (RT-PCR) results greater than or equal to the lower limit of detection (≥ LLOD); results were deemed quantifiable if the result was greater than or equal to the lower limit of quantification (≥ LLOQ). The number of participants who have a positive V590 RT-PCR result greater than or equal to the lowest limit of detection (≥LLOD) were assessed.
Outcome measures
| Measure |
V590 5.00x10^5 Plaque Forming Units (Pfu)
n=39 Participants
Participants received a single dose of V590 5.00x10\^5 pfu on Day 1.
|
V590 2.40x10^6 Pfu
n=39 Participants
Participants received a single dose of V590 2.40x10\^6 pfu on Day 1.
|
V590 1.15x10^7 Pfu
n=42 Participants
Participants received a single dose of V590 1.15x10\^7 pfu on Day 1.
|
V590 5.55x10^7 Pfu
n=56 Participants
Participants received a single dose of V590 5.55x10\^7 pfu on Day 1.
|
Placebo
n=56 Participants
Participants received single dose placebo administered via intramuscular (IM) injection on Day 1.
|
|---|---|---|---|---|---|
|
Number of Participants With Vaccine Viremia as Measured by Reverse Transcription-Polymerase Chain Reaction
Day 3
|
4 Participants
|
5 Participants
|
22 Participants
|
48 Participants
|
0 Participants
|
|
Number of Participants With Vaccine Viremia as Measured by Reverse Transcription-Polymerase Chain Reaction
Day 6
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vaccine Viremia as Measured by Reverse Transcription-Polymerase Chain Reaction
Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vaccine Viremia as Measured by Reverse Transcription-Polymerase Chain Reaction
Day 28
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vaccine Viremia as Measured by Reverse Transcription-Polymerase Chain Reaction
Day 14
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vaccine Viremia as Measured by Reverse Transcription-Polymerase Chain Reaction
Day 1
|
4 Participants
|
5 Participants
|
9 Participants
|
8 Participants
|
0 Participants
|
|
Number of Participants With Vaccine Viremia as Measured by Reverse Transcription-Polymerase Chain Reaction
Day 2
|
6 Participants
|
8 Participants
|
24 Participants
|
54 Participants
|
0 Participants
|
|
Number of Participants With Vaccine Viremia as Measured by Reverse Transcription-Polymerase Chain Reaction
Day 4
|
1 Participants
|
6 Participants
|
9 Participants
|
30 Participants
|
0 Participants
|
|
Number of Participants With Vaccine Viremia as Measured by Reverse Transcription-Polymerase Chain Reaction
Day 5
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1, 2, 3, 4, 5, 6, 7, 14, and 28 days post-vaccinationPopulation: The analysis population consisted of all randomized participants who received study intervention. Due to the early termination of the study, testing was prioritized and data were not generated for all samples and timepoints.
The number of participants with viral shedding detected by RT-PCR in saliva specimens was assessed. Only Day 7 samples were assayed for all participants. Day 14 and 28 samples for a participant were assayed if the Day 7 result was positive (≥LLOD). Due to the early termination of the study, testing was prioritized for the key samples and timepoints that would provide the required safety and immunogenicity data to support programmatic decision-making and subsequent clinical studies. Blank cells indicate data were not generated and no data were available. Additional sample testing is not possible because the viral shedding assay is not qualified for samples that have been stored for this length of time.
Outcome measures
| Measure |
V590 5.00x10^5 Plaque Forming Units (Pfu)
n=39 Participants
Participants received a single dose of V590 5.00x10\^5 pfu on Day 1.
|
V590 2.40x10^6 Pfu
n=39 Participants
Participants received a single dose of V590 2.40x10\^6 pfu on Day 1.
|
V590 1.15x10^7 Pfu
n=42 Participants
Participants received a single dose of V590 1.15x10\^7 pfu on Day 1.
|
V590 5.55x10^7 Pfu
n=56 Participants
Participants received a single dose of V590 5.55x10\^7 pfu on Day 1.
|
Placebo
n=56 Participants
Participants received single dose placebo administered via intramuscular (IM) injection on Day 1.
|
|---|---|---|---|---|---|
|
Number of Participants With Viral Shedding in Saliva as Measured by RT-PCR
Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Viral Shedding in Saliva as Measured by RT-PCR
Day 14
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Number of Participants With Viral Shedding in Saliva as Measured by RT-PCR
Day 28
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1, 2, 3, 4, 5, 6, 7, 14, and 28 days post-vaccinationPopulation: The analysis population consisted of all randomized participants who received study intervention. Due to the early termination of the study, testing was prioritized and data were not generated for all samples and timepoints.
The number of participants with viral shedding detected by RT-PCR in urine specimens was assessed. Due to the early termination of the study, testing was prioritized for the key samples and timepoints that would provide the required safety and immunogenicity data to support programmatic decision-making and subsequent clinical studies. Only Day 7 samples were assayed for all participants. Day 14 and 28 samples for a participant were assayed if the Day 7 result was positive (≥LLOD). Blank cells indicate data were not generated and no data were available.
Outcome measures
| Measure |
V590 5.00x10^5 Plaque Forming Units (Pfu)
n=39 Participants
Participants received a single dose of V590 5.00x10\^5 pfu on Day 1.
|
V590 2.40x10^6 Pfu
n=39 Participants
Participants received a single dose of V590 2.40x10\^6 pfu on Day 1.
|
V590 1.15x10^7 Pfu
n=42 Participants
Participants received a single dose of V590 1.15x10\^7 pfu on Day 1.
|
V590 5.55x10^7 Pfu
n=56 Participants
Participants received a single dose of V590 5.55x10\^7 pfu on Day 1.
|
Placebo
n=56 Participants
Participants received single dose placebo administered via intramuscular (IM) injection on Day 1.
|
|---|---|---|---|---|---|
|
Number of Participants With Viral Shedding in Urine as Measured by RT-PCR
Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2-4, 5-7 days post-vaccinationPopulation: The study was terminated based on an interim assessment of immunogenicity and V590 stool samples for viral shedding were not assayed.
The study was terminated and V590 stool samples for viral shedding (considered optional per protocol) were not assayed. Due to the early termination of the study, testing was prioritized for the key samples and timepoints that would provide the required safety and immunogenicity data to support programmatic decision-making and subsequent clinical studies. Blank cells indicate that data were not generated and no data were available.
Outcome measures
Outcome data not reported
Adverse Events
V590 5.00x10^5 Plaque Forming Units (Pfu)
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
V590 2.40x10^6 Pfu
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
V590 1.15x10^7 Pfu
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
V590 5.55x10^7 Pfu
Serious events: 1 serious events
Other events: 39 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
V590 5.00x10^5 Plaque Forming Units (Pfu)
n=39 participants at risk
Participants received a single dose of V590 5.00x10\^5 pfu on Day 1.
|
V590 2.40x10^6 Pfu
n=39 participants at risk
Participants received a single dose of V590 2.40x10\^6 pfu on Day 1.
|
V590 1.15x10^7 Pfu
n=42 participants at risk
Participants received a single dose of V590 1.15x10\^7 pfu on Day 1.
|
V590 5.55x10^7 Pfu
n=56 participants at risk
Participants received a single dose of V590 5.55x10\^7 pfu on Day 1.
|
Placebo
n=56 participants at risk
Participants received single dose placebo administered via intramuscular (IM) injection on Day 1.
|
|---|---|---|---|---|---|
|
Eye disorders
Amaurosis fugax
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
Other adverse events
| Measure |
V590 5.00x10^5 Plaque Forming Units (Pfu)
n=39 participants at risk
Participants received a single dose of V590 5.00x10\^5 pfu on Day 1.
|
V590 2.40x10^6 Pfu
n=39 participants at risk
Participants received a single dose of V590 2.40x10\^6 pfu on Day 1.
|
V590 1.15x10^7 Pfu
n=42 participants at risk
Participants received a single dose of V590 1.15x10\^7 pfu on Day 1.
|
V590 5.55x10^7 Pfu
n=56 participants at risk
Participants received a single dose of V590 5.55x10\^7 pfu on Day 1.
|
Placebo
n=56 participants at risk
Participants received single dose placebo administered via intramuscular (IM) injection on Day 1.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
3.6%
2/56 • Number of events 2 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Eye disorders
Asthenopia
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
2.6%
1/39 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
2.4%
1/42 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Gastrointestinal disorders
Constipation
|
2.6%
1/39 • Number of events 2 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
2.6%
1/39 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
2.4%
1/42 • Number of events 2 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
3.6%
2/56 • Number of events 3 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.1%
2/39 • Number of events 3 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Gastrointestinal disorders
Nausea
|
5.1%
2/39 • Number of events 4 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
5.1%
2/39 • Number of events 2 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
3.6%
2/56 • Number of events 3 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
8.9%
5/56 • Number of events 7 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Gastrointestinal disorders
Oral disorder
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Gastrointestinal disorders
Tongue disorder
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
General disorders
Chest discomfort
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
5.4%
3/56 • Number of events 4 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
General disorders
Fatigue
|
10.3%
4/39 • Number of events 8 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
15.4%
6/39 • Number of events 7 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
11.9%
5/42 • Number of events 6 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
12.5%
7/56 • Number of events 13 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
16.1%
9/56 • Number of events 13 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
General disorders
Feeling cold
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
2.6%
1/39 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
General disorders
Feeling hot
|
2.6%
1/39 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
General disorders
Hypothermia
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
2.6%
1/39 • Number of events 4 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
General disorders
Injection site bruising
|
2.6%
1/39 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
2.6%
1/39 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
2.4%
1/42 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
General disorders
Injection site erythema
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
General disorders
Injection site induration
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
2.6%
1/39 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
General disorders
Injection site movement impairment
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
General disorders
Injection site pain
|
28.2%
11/39 • Number of events 13 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
35.9%
14/39 • Number of events 16 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
31.0%
13/42 • Number of events 14 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
42.9%
24/56 • Number of events 28 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
48.2%
27/56 • Number of events 35 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
General disorders
Injection site swelling
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
2.6%
1/39 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
2.4%
1/42 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
3.6%
2/56 • Number of events 2 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
General disorders
Injection site warmth
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
2.6%
1/39 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
General disorders
Malaise
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
General disorders
Pain
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
3.6%
2/56 • Number of events 2 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
General disorders
Peripheral swelling
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
2.6%
1/39 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
General disorders
Pyrexia
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Infections and infestations
Asymptomatic COVID-19
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
2.6%
1/39 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Infections and infestations
COVID-19
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
2.6%
1/39 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Infections and infestations
Nasopharyngitis
|
2.6%
1/39 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
2.4%
1/42 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Infections and infestations
Urethritis
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
2.6%
1/39 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
2.4%
1/42 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
2.6%
1/39 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Investigations
Blood fibrinogen increased
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
2.6%
1/39 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
2.4%
1/42 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Investigations
Liver function test increased
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Investigations
SARS-CoV-2 antibody test positive
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.1%
2/39 • Number of events 3 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
7.7%
3/39 • Number of events 3 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
12.5%
7/56 • Number of events 8 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
8.9%
5/56 • Number of events 7 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.1%
2/39 • Number of events 2 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
7.1%
4/56 • Number of events 4 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 3 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
3.6%
2/56 • Number of events 2 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.6%
1/39 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
2.4%
1/42 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
2.6%
1/39 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.3%
4/39 • Number of events 5 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
7.7%
3/39 • Number of events 5 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
10.7%
6/56 • Number of events 9 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
7.1%
4/56 • Number of events 7 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
2.6%
1/39 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Nervous system disorders
Ageusia
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Nervous system disorders
Anosmia
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
3.6%
2/56 • Number of events 2 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
4.8%
2/42 • Number of events 2 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Nervous system disorders
Headache
|
15.4%
6/39 • Number of events 6 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
12.8%
5/39 • Number of events 8 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
9.5%
4/42 • Number of events 4 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
16.1%
9/56 • Number of events 17 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
19.6%
11/56 • Number of events 20 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
2.4%
1/42 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Nervous system disorders
Poor quality sleep
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Nervous system disorders
Presyncope
|
2.6%
1/39 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
2.6%
1/39 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 2 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Psychiatric disorders
Fear
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
5.4%
3/56 • Number of events 3 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
2.4%
1/42 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract congestion
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
2.6%
1/39 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
2.6%
1/39 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
2.4%
1/42 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
2.6%
1/39 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
2.4%
1/42 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 2 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
5.1%
2/39 • Number of events 2 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
2.4%
1/42 • Number of events 2 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.3%
4/39 • Number of events 4 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
2.4%
1/42 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
3.6%
2/56 • Number of events 2 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
2.4%
1/42 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Vascular disorders
Flushing
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
|
Vascular disorders
Hot flush
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/39 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/42 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
0.00%
0/56 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
1.8%
1/56 • Number of events 1 • Non-serious adverse events were reported up to Day 28 following vaccination. Serious adverse events (SAEs) and the all cause mortality were reported throughout the duration of an individual's study participation (active monitoring through Day 28 post-vaccination [Up to a maximum of ~90 days post-vaccination])
The analysis population consisted of all randomized participants who received at least one dose of study vaccination.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments. Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors authorship requirements.
- Publication restrictions are in place
Restriction type: OTHER