Trial Outcomes & Findings for A Study to Assess Safety, Tolerability, and Immunogenicity of V591 (COVID-19 Vaccine) in Healthy Participants (V591-001) (NCT NCT04498247)
NCT ID: NCT04498247
Last Updated: 2021-12-23
Results Overview
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. Injection site AEs of pain/tenderness, swelling, and redness/erythema were assessed.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
263 participants
Primary outcome timeframe
Up to 5 days after any study intervention
Results posted on
2021-12-23
Participant Flow
Healthy adults with no prior history of confirmed Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection, or known exposure to an individual with confirmed Coronavirus Disease 2019 (COVID-19) or SARS-CoV-2 infection were enrolled in this study.
Participant milestones
| Measure |
V591 1×10^4 TCID50-1 Dose
Participants received one dose of V591 1x10\^4 tissue culture infectious dose (TCID50) on Day 1
|
V591 1×10^5 TCID50-1 Dose
Participants received one dose of V591 1×10\^5 TCID50 on Day 1.
|
V591 1x10^5 TCID50- 2 Dose
Participants received one dose of V591 1×10\^5 TCID50 on Day 1 and a second V591 1×10\^5 TCID50 dose on Day 57.
|
V591 1×10^6 TCID50-1 Dose
Participants received one dose of V591 1×10\^6 TCID50 on Day 1
|
V591 1×10^6 TCID50-2 Dose
Participants received one dose of V591 1×10\^6 TCID50 on Day 1 and a second V591 1×10\^6 TCID50 dose on Day 57.
|
V591 1×10^7 TCID50
Participants received one dose of V591 1×10\^7 TCID50 on Day 1
|
Placebo- 1 Dose
Participants received one dose of placebo on Day 1
|
Placebo- 2 Dose
Participants received one dose of placebo on Day 1 and a second dose of placebo on Day 57.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
21
|
80
|
4
|
81
|
4
|
20
|
51
|
2
|
|
Overall Study
Vaccination 1
|
20
|
80
|
4
|
81
|
4
|
20
|
51
|
2
|
|
Overall Study
Vaccination 2
|
0
|
0
|
4
|
0
|
4
|
0
|
0
|
2
|
|
Overall Study
COMPLETED
|
20
|
68
|
4
|
70
|
4
|
20
|
43
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
12
|
0
|
11
|
0
|
0
|
8
|
0
|
Reasons for withdrawal
| Measure |
V591 1×10^4 TCID50-1 Dose
Participants received one dose of V591 1x10\^4 tissue culture infectious dose (TCID50) on Day 1
|
V591 1×10^5 TCID50-1 Dose
Participants received one dose of V591 1×10\^5 TCID50 on Day 1.
|
V591 1x10^5 TCID50- 2 Dose
Participants received one dose of V591 1×10\^5 TCID50 on Day 1 and a second V591 1×10\^5 TCID50 dose on Day 57.
|
V591 1×10^6 TCID50-1 Dose
Participants received one dose of V591 1×10\^6 TCID50 on Day 1
|
V591 1×10^6 TCID50-2 Dose
Participants received one dose of V591 1×10\^6 TCID50 on Day 1 and a second V591 1×10\^6 TCID50 dose on Day 57.
|
V591 1×10^7 TCID50
Participants received one dose of V591 1×10\^7 TCID50 on Day 1
|
Placebo- 1 Dose
Participants received one dose of placebo on Day 1
|
Placebo- 2 Dose
Participants received one dose of placebo on Day 1 and a second dose of placebo on Day 57.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Mistakenly Randomized; Not Treated
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
8
|
0
|
7
|
0
|
0
|
1
|
0
|
|
Overall Study
Received a non-study COVID-19 vaccine.
|
0
|
4
|
0
|
3
|
0
|
0
|
7
|
0
|
Baseline Characteristics
A Study to Assess Safety, Tolerability, and Immunogenicity of V591 (COVID-19 Vaccine) in Healthy Participants (V591-001)
Baseline characteristics by cohort
| Measure |
V591 1×10^4 TCID50-1 Dose
n=21 Participants
Participants received one dose of V591 1x10\^4 TCID50 on Day 1
|
V591 1×10^5 TCID50- 1 Dose
n=80 Participants
Participants received one dose of V591 1×10\^5 TCID50 on Day 1.
|
V591 1x10^5 TCID50- 2 Dose
n=4 Participants
Participants received one dose of V591 1×10\^5 TCID50 on Day 1 and a second V591 1×10\^5 TCID50 dose on Day 57.
|
V591 1×10^6 TCID50-1 Dose
n=81 Participants
Participants received one dose of V591 1×10\^6 TCID50 on Day 1.
|
V591 1×10^6 TCID50-2 Dose
n=4 Participants
Participants received one dose of V591 1×10\^6 TCID50 on Day 1 and a second V591 1×10\^6 TCID50 dose on Day 57.
|
V591 1×10^7 TCID50
n=20 Participants
Participants received one dose of V591 1×10\^7 TCID50 on Day 1
|
Placebo - 1 Dose
n=51 Participants
Participants received one dose of placebo on Day 1.
|
Placebo- 2 Dose
n=2 Participants
Participants received one dose of placebo on Day 1 and a second dose of placebo on Day 57.
|
Total
n=263 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
39.7 Years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
59.7 Years
STANDARD_DEVIATION 14.8 • n=7 Participants
|
45.0 Years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
58.4 Years
STANDARD_DEVIATION 15.2 • n=4 Participants
|
40.3 Years
STANDARD_DEVIATION 13.2 • n=21 Participants
|
26.6 Years
STANDARD_DEVIATION 6.8 • n=8 Participants
|
56.2 Years
STANDARD_DEVIATION 17.9 • n=8 Participants
|
34.5 Years
STANDARD_DEVIATION 0.7 • n=24 Participants
|
53.8 Years
STANDARD_DEVIATION 17.6 • n=42 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
27 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
148 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
24 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
115 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
37 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
48 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
226 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
78 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
50 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
254 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Up to 5 days after any study interventionPopulation: All randomized participants who received at least one dose of study intervention and received the dose relevant to the data collection time point. Participants were pooled by dose of study intervention administered due to the study's termination prior to most participants receiving their planned second dose.
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. Injection site AEs of pain/tenderness, swelling, and redness/erythema were assessed.
Outcome measures
| Measure |
V591 1×10^4 TCID50
n=20 Participants
Participants received one dose of V591 1x10\^4 TCID50 on Day 1
|
V591 1×10^5 TCID50
n=84 Participants
All participants received one dose of V591 1×10\^5 TCID50 on Day 1; Some participants received a second V591 1×10\^5 TCID50 dose on Day 57.
|
V591 1×10^6 TCID50
n=85 Participants
All participants received one dose of V591 1×10\^6 TCID50 on Day 1; Some participants received a second V591 1×10\^6 TCID50 dose on Day 57.
|
V591 1×10^7 TCID50
n=20 Participants
Participants received one dose of V591 1×10\^7 TCID50 on Day 1
|
Placebo
n=53 Participants
Participants received one dose of placebo on Day 1; Some participants received a second dose of placebo on Day 57.
|
|---|---|---|---|---|---|
|
Percentage of Participants With at Least One Solicited Injection Site Adverse Event (AE) After Any Study Intervention
Following Vaccination 1
|
25.0 Percentage of participants
|
6.0 Percentage of participants
|
15.3 Percentage of participants
|
55.0 Percentage of participants
|
7.5 Percentage of participants
|
|
Percentage of Participants With at Least One Solicited Injection Site Adverse Event (AE) After Any Study Intervention
Following Vaccination 2
|
—
|
0.0 Percentage of participants
|
25.0 Percentage of participants
|
—
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to 14 days after any study interventionPopulation: All randomized participants who received at least one dose of study intervention and received the dose relevant to the data collection time point. Participants were pooled by dose of study intervention administered due to the study's termination prior to most participants receiving their planned second dose.
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. Systemic AEs of fever, muscle pain, joint pain, headache, fatigue, rash, or nausea were assessed.
Outcome measures
| Measure |
V591 1×10^4 TCID50
n=20 Participants
Participants received one dose of V591 1x10\^4 TCID50 on Day 1
|
V591 1×10^5 TCID50
n=84 Participants
All participants received one dose of V591 1×10\^5 TCID50 on Day 1; Some participants received a second V591 1×10\^5 TCID50 dose on Day 57.
|
V591 1×10^6 TCID50
n=85 Participants
All participants received one dose of V591 1×10\^6 TCID50 on Day 1; Some participants received a second V591 1×10\^6 TCID50 dose on Day 57.
|
V591 1×10^7 TCID50
n=20 Participants
Participants received one dose of V591 1×10\^7 TCID50 on Day 1
|
Placebo
n=53 Participants
Participants received one dose of placebo on Day 1; Some participants received a second dose of placebo on Day 57.
|
|---|---|---|---|---|---|
|
Percentage of Participants With at Least One Solicited Systemic AE After Any Study Intervention
Following Vaccination 1
|
50.0 Percentage of participants
|
45.2 Percentage of participants
|
37.6 Percentage of participants
|
65.0 Percentage of participants
|
56.6 Percentage of participants
|
|
Percentage of Participants With at Least One Solicited Systemic AE After Any Study Intervention
Following Vaccination 2
|
—
|
25.0 Percentage of participants
|
75.0 Percentage of participants
|
—
|
50.0 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to 28 days after any study interventionPopulation: All randomized participants who received at least one dose of study intervention and received the dose relevant to the data collection time point. Participants were pooled by dose of study intervention administered due to the study's termination prior to most participants receiving their planned second dose.
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. All unsolicited AEs were assessed.
Outcome measures
| Measure |
V591 1×10^4 TCID50
n=20 Participants
Participants received one dose of V591 1x10\^4 TCID50 on Day 1
|
V591 1×10^5 TCID50
n=84 Participants
All participants received one dose of V591 1×10\^5 TCID50 on Day 1; Some participants received a second V591 1×10\^5 TCID50 dose on Day 57.
|
V591 1×10^6 TCID50
n=85 Participants
All participants received one dose of V591 1×10\^6 TCID50 on Day 1; Some participants received a second V591 1×10\^6 TCID50 dose on Day 57.
|
V591 1×10^7 TCID50
n=20 Participants
Participants received one dose of V591 1×10\^7 TCID50 on Day 1
|
Placebo
n=53 Participants
Participants received one dose of placebo on Day 1; Some participants received a second dose of placebo on Day 57.
|
|---|---|---|---|---|---|
|
Percentage of Participants With at Least One Unsolicited Adverse Event After Any Study Intervention
Following Vaccination 1
|
55.0 Percentage of participants
|
34.5 Percentage of participants
|
32.9 Percentage of participants
|
70.0 Percentage of participants
|
37.7 Percentage of participants
|
|
Percentage of Participants With at Least One Unsolicited Adverse Event After Any Study Intervention
Following Vaccination 2
|
—
|
0.0 Percentage of participants
|
25.0 Percentage of participants
|
—
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to 56 days after vaccination 1 and up to 122 days after vaccination 2 (up to 178 days)Population: All randomized participants who received at least one dose of study intervention and received the dose relevant to the data collection time point. Participants were pooled by dose of study intervention administered due to the study's termination prior to most participants receiving their planned second dose.
An SAE is defined as any untoward medical occurrence that at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
Outcome measures
| Measure |
V591 1×10^4 TCID50
n=20 Participants
Participants received one dose of V591 1x10\^4 TCID50 on Day 1
|
V591 1×10^5 TCID50
n=84 Participants
All participants received one dose of V591 1×10\^5 TCID50 on Day 1; Some participants received a second V591 1×10\^5 TCID50 dose on Day 57.
|
V591 1×10^6 TCID50
n=85 Participants
All participants received one dose of V591 1×10\^6 TCID50 on Day 1; Some participants received a second V591 1×10\^6 TCID50 dose on Day 57.
|
V591 1×10^7 TCID50
n=20 Participants
Participants received one dose of V591 1×10\^7 TCID50 on Day 1
|
Placebo
n=53 Participants
Participants received one dose of placebo on Day 1; Some participants received a second dose of placebo on Day 57.
|
|---|---|---|---|---|---|
|
Percentage of Participants With at Least 1 Serious Adverse Event
Following Vaccination 2
|
—
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
—
|
0.0 Percentage of Participants
|
|
Percentage of Participants With at Least 1 Serious Adverse Event
Following Vaccination 1
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
2.4 Percentage of Participants
|
0.0 Percentage of Participants
|
1.9 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to 57 daysPopulation: All randomized participants who received at least one dose of study intervention and received the dose relevant to the data collection time point. Participants were pooled by dose of study intervention administered due to the study's termination prior to most participants receiving their planned second dose.
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.
Outcome measures
| Measure |
V591 1×10^4 TCID50
n=20 Participants
Participants received one dose of V591 1x10\^4 TCID50 on Day 1
|
V591 1×10^5 TCID50
n=84 Participants
All participants received one dose of V591 1×10\^5 TCID50 on Day 1; Some participants received a second V591 1×10\^5 TCID50 dose on Day 57.
|
V591 1×10^6 TCID50
n=85 Participants
All participants received one dose of V591 1×10\^6 TCID50 on Day 1; Some participants received a second V591 1×10\^6 TCID50 dose on Day 57.
|
V591 1×10^7 TCID50
n=20 Participants
Participants received one dose of V591 1×10\^7 TCID50 on Day 1
|
Placebo
n=53 Participants
Participants received one dose of placebo on Day 1; Some participants received a second dose of placebo on Day 57.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Discontinued Study Treatment Due to an Adverse Event
Following Vaccination 2
|
—
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
—
|
0.0 Percentage of Participants
|
|
Percentage of Participants Who Discontinued Study Treatment Due to an Adverse Event
Following Vaccination 1
|
5.0 Percentage of Participants
|
6.0 Percentage of Participants
|
4.7 Percentage of Participants
|
0 Percentage of Participants
|
5.7 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to 56 days after vaccination 1 and up to 122 days after vaccination 2 (up to 178 days)Population: All randomized participants who received at least one dose of study intervention and received the dose relevant to the data collection time point. Participants were pooled by dose of study intervention administered due to the study's termination prior to most participants receiving their planned second dose.
A MAAE is defined as an adverse event 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.
Outcome measures
| Measure |
V591 1×10^4 TCID50
n=20 Participants
Participants received one dose of V591 1x10\^4 TCID50 on Day 1
|
V591 1×10^5 TCID50
n=84 Participants
All participants received one dose of V591 1×10\^5 TCID50 on Day 1; Some participants received a second V591 1×10\^5 TCID50 dose on Day 57.
|
V591 1×10^6 TCID50
n=85 Participants
All participants received one dose of V591 1×10\^6 TCID50 on Day 1; Some participants received a second V591 1×10\^6 TCID50 dose on Day 57.
|
V591 1×10^7 TCID50
n=20 Participants
Participants received one dose of V591 1×10\^7 TCID50 on Day 1
|
Placebo
n=53 Participants
Participants received one dose of placebo on Day 1; Some participants received a second dose of placebo on Day 57.
|
|---|---|---|---|---|---|
|
Percentage of Participants With at Least 1 Medically Attended Adverse Event (MAAE)
Following Vaccination 1
|
30.0 Percentage of Participants
|
10.7 Percentage of Participants
|
11.8 Percentage of Participants
|
40.0 Percentage of Participants
|
9.4 Percentage of Participants
|
|
Percentage of Participants With at Least 1 Medically Attended Adverse Event (MAAE)
Following Vaccination 2
|
—
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
—
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Days 1, 15, 29, 57, 71, and 85Population: All randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint, and who had available data at the indicated time point. Participants were pooled by dose of study intervention administered due to the study's termination prior to most participants receiving their planned second dose. Data were not collected for planned timepoints on days 115, 211, 365, 422, and 534 due to early termination.
Serum samples were collected and the titers of serum neutralization antibodies were assessed using PNA. Geometric mean titers were calculated using a constrained longitudinal data analysis (cLDA) method where the response vector consisted of the log transformed pre-vaccination and post-vaccination antibody titers. The point estimates were calculated by exponentiating the estimates of the mean of the natural log values; and the within-group 95% confidence intervals (CIs) were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Outcome measures
| Measure |
V591 1×10^4 TCID50
n=20 Participants
Participants received one dose of V591 1x10\^4 TCID50 on Day 1
|
V591 1×10^5 TCID50
n=84 Participants
All participants received one dose of V591 1×10\^5 TCID50 on Day 1; Some participants received a second V591 1×10\^5 TCID50 dose on Day 57.
|
V591 1×10^6 TCID50
n=85 Participants
All participants received one dose of V591 1×10\^6 TCID50 on Day 1; Some participants received a second V591 1×10\^6 TCID50 dose on Day 57.
|
V591 1×10^7 TCID50
n=20 Participants
Participants received one dose of V591 1×10\^7 TCID50 on Day 1
|
Placebo
n=53 Participants
Participants received one dose of placebo on Day 1; Some participants received a second dose of placebo on Day 57.
|
|---|---|---|---|---|---|
|
Geometric Mean Titers for Serum Neutralizing Antibodies (nAb) as Measured by Pseudo-virus Neutralization Assay (PNA)
Day 1
|
5.0 Titer
Interval 5.0 to 5.0
|
6.3 Titer
Interval 5.1 to 7.8
|
5.9 Titer
Interval 5.0 to 6.9
|
9.1 Titer
Interval 5.0 to 16.7
|
5.0 Titer
Interval 5.0 to 5.0
|
|
Geometric Mean Titers for Serum Neutralizing Antibodies (nAb) as Measured by Pseudo-virus Neutralization Assay (PNA)
Day 29
|
5.0 Titer
Interval 5.0 to 5.0
|
8.3 Titer
Interval 6.0 to 11.3
|
8.3 Titer
Interval 6.3 to 11.0
|
31.2 Titer
Interval 11.2 to 86.7
|
6.3 Titer
Interval 4.8 to 8.1
|
|
Geometric Mean Titers for Serum Neutralizing Antibodies (nAb) as Measured by Pseudo-virus Neutralization Assay (PNA)
Day 15
|
5.8 Titer
Interval 4.2 to 8.1
|
6.7 Titer
Interval 5.3 to 8.5
|
7.9 Titer
Interval 6.1 to 10.4
|
53.1 Titer
Interval 17.2 to 164.6
|
5.3 Titer
Interval 4.7 to 6.1
|
|
Geometric Mean Titers for Serum Neutralizing Antibodies (nAb) as Measured by Pseudo-virus Neutralization Assay (PNA)
Day 57
|
—
|
13.7 Titer
The 95% confidence interval is not provided when n is less than 5 participants.
|
5.0 Titer
The 95% confidence interval is not provided when n is less than 5 participants.
|
—
|
5.0 Titer
The 95% confidence interval is not provided when n is less than 5 participants.
|
|
Geometric Mean Titers for Serum Neutralizing Antibodies (nAb) as Measured by Pseudo-virus Neutralization Assay (PNA)
Day 71
|
—
|
25.7 Titer
The 95% confidence interval is not provided when n is less than 5 participants.
|
45.2 Titer
The 95% confidence interval is not provided when n is less than 5 participants.
|
—
|
5.0 Titer
The 95% confidence interval is not provided when n is less than 5 participants.
|
|
Geometric Mean Titers for Serum Neutralizing Antibodies (nAb) as Measured by Pseudo-virus Neutralization Assay (PNA)
Day 85
|
—
|
24.6 Titer
The 95% confidence interval is not provided when n is less than 5 participants.
|
54.2 Titer
The 95% confidence interval is not provided when n is less than 5 participants.
|
—
|
5.0 Titer
The 95% confidence interval is not provided when n is less than 5 participants.
|
SECONDARY outcome
Timeframe: Days 1, 15, 29, 57, 71, and 85Population: All randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint, and who had available data at the indicated time point. Participants were pooled by dose of study intervention administered due to the study's termination prior to most participants receiving their planned second dose. Data were not collected for planned timepoints on days 115, 211, 365, 422, and 534 due to early termination.
Serum samples were collected and the concentrations of total anti-spike IgG antibodies were assessed using ELISA. Geometric mean concentrations were calculated using a cLDA method where the response vector consisted of the log transformed pre-vaccination and post-vaccination antibody titers. The point estimates were calculated by exponentiating the estimates of the mean of the natural log values; and the within-group 95% confidence intervals (CIs) were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Outcome measures
| Measure |
V591 1×10^4 TCID50
n=20 Participants
Participants received one dose of V591 1x10\^4 TCID50 on Day 1
|
V591 1×10^5 TCID50
n=84 Participants
All participants received one dose of V591 1×10\^5 TCID50 on Day 1; Some participants received a second V591 1×10\^5 TCID50 dose on Day 57.
|
V591 1×10^6 TCID50
n=85 Participants
All participants received one dose of V591 1×10\^6 TCID50 on Day 1; Some participants received a second V591 1×10\^6 TCID50 dose on Day 57.
|
V591 1×10^7 TCID50
n=20 Participants
Participants received one dose of V591 1×10\^7 TCID50 on Day 1
|
Placebo
n=53 Participants
Participants received one dose of placebo on Day 1; Some participants received a second dose of placebo on Day 57.
|
|---|---|---|---|---|---|
|
Geometric Mean Concentration of Total Anti-Spike Immunoglobulin G (IgG) Antibodies as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Day 15
|
26.2 ELISA unit/mL
Interval 24.1 to 28.5
|
35.7 ELISA unit/mL
Interval 27.2 to 46.7
|
41.6 ELISA unit/mL
Interval 30.0 to 57.6
|
239.2 ELISA unit/mL
Interval 78.8 to 725.9
|
26.4 ELISA unit/mL
Interval 24.7 to 28.2
|
|
Geometric Mean Concentration of Total Anti-Spike Immunoglobulin G (IgG) Antibodies as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Day 29
|
28.6 ELISA unit/mL
Interval 23.7 to 34.6
|
44.0 ELISA unit/mL
Interval 31.6 to 61.3
|
52.6 ELISA unit/mL
Interval 36.6 to 75.6
|
294.8 ELISA unit/mL
Interval 110.3 to 788.2
|
31.5 ELISA unit/mL
Interval 25.3 to 39.3
|
|
Geometric Mean Concentration of Total Anti-Spike Immunoglobulin G (IgG) Antibodies as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Day 71
|
—
|
184.7 ELISA unit/mL
The 95% confidence interval is not provided when n is less than 5 participants.
|
336.1 ELISA unit/mL
The 95% confidence interval is not provided when n is less than 5 participants.
|
—
|
25.2 ELISA unit/mL
The 95% confidence interval is not provided when n is less than 5 participants.
|
|
Geometric Mean Concentration of Total Anti-Spike Immunoglobulin G (IgG) Antibodies as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Day 1
|
25.2 ELISA unit/mL
Interval 25.2 to 25.2
|
33.9 ELISA unit/mL
Interval 26.1 to 44.0
|
36.3 ELISA unit/mL
Interval 28.2 to 46.9
|
46.3 ELISA unit/mL
Interval 24.7 to 86.8
|
26.1 ELISA unit/mL
Interval 24.8 to 27.5
|
|
Geometric Mean Concentration of Total Anti-Spike Immunoglobulin G (IgG) Antibodies as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Day 57
|
—
|
97.7 ELISA unit/mL
The 95% confidence interval is not provided when n is less than 5 participants.
|
25.2 ELISA unit/mL
The 95% confidence interval is not provided when n is less than 5 participants.
|
—
|
25.2 ELISA unit/mL
The 95% confidence interval is not provided when n is less than 5 participants.
|
|
Geometric Mean Concentration of Total Anti-Spike Immunoglobulin G (IgG) Antibodies as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Day 85
|
—
|
180.8 ELISA unit/mL
The 95% confidence interval is not provided when n is less than 5 participants.
|
260.6 ELISA unit/mL
The 95% confidence interval is not provided when n is less than 5 participants.
|
—
|
25.2 ELISA unit/mL
The 95% confidence interval is not provided when n is less than 5 participants.
|
SECONDARY outcome
Timeframe: Days 1, 15, 29, 57, 71, and 85Population: All randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint, and who had available data at the indicated time point. Participants were pooled by dose of study intervention administered due to the study's termination prior to most participants receiving their planned second dose. Data were not collected for planned timepoints on days 115, 211, 365, 422, and 534 due to early termination.
Serum samples were collected and the titers of serum neutralization antibodies were assessed using PNA. Geometric mean titers were calculated using a cLDA method where the response vector consisted of the log transformed pre-vaccination and post-vaccination antibody titers. GMFR is defined as the geometric mean of the ratio of concentration at specified timepoints after vaccination divided by concentration at baseline (Day 1).
Outcome measures
| Measure |
V591 1×10^4 TCID50
n=20 Participants
Participants received one dose of V591 1x10\^4 TCID50 on Day 1
|
V591 1×10^5 TCID50
n=84 Participants
All participants received one dose of V591 1×10\^5 TCID50 on Day 1; Some participants received a second V591 1×10\^5 TCID50 dose on Day 57.
|
V591 1×10^6 TCID50
n=85 Participants
All participants received one dose of V591 1×10\^6 TCID50 on Day 1; Some participants received a second V591 1×10\^6 TCID50 dose on Day 57.
|
V591 1×10^7 TCID50
n=20 Participants
Participants received one dose of V591 1×10\^7 TCID50 on Day 1
|
Placebo
n=53 Participants
Participants received one dose of placebo on Day 1; Some participants received a second dose of placebo on Day 57.
|
|---|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) for Serum nAb as Measured by PNA
Day 15
|
1.1 Ratio
Interval 0.9 to 1.4
|
1.0 Ratio
Interval 1.0 to 1.1
|
1.2 Ratio
Interval 1.1 to 1.5
|
4.1 Ratio
Interval 2.0 to 8.3
|
1.1 Ratio
Interval 0.9 to 1.2
|
|
Geometric Mean Fold Rise (GMFR) for Serum nAb as Measured by PNA
Day 29
|
1.0 Ratio
Interval 1.0 to 1.0
|
1.2 Ratio
Interval 1.0 to 1.5
|
1.3 Ratio
Interval 1.1 to 1.6
|
2.6 Ratio
Interval 1.2 to 5.5
|
1.2 Ratio
Interval 1.0 to 1.5
|
|
Geometric Mean Fold Rise (GMFR) for Serum nAb as Measured by PNA
Day 57
|
—
|
2.3 Ratio
The 95% confidence interval is not provided when n is less than 5 participants.
|
1.0 Ratio
The 95% confidence interval is not provided when n is less than 5 participants.
|
—
|
1.0 Ratio
The 95% confidence interval is not provided when n is less than 5 participants.
|
|
Geometric Mean Fold Rise (GMFR) for Serum nAb as Measured by PNA
Day 85
|
—
|
3.5 Ratio
The 95% confidence interval is not provided when n is less than 5 participants.
|
5.4 Ratio
The 95% confidence interval is not provided when n is less than 5 participants.
|
—
|
1.0 Ratio
The 95% confidence interval is not provided when n is less than 5 participants.
|
|
Geometric Mean Fold Rise (GMFR) for Serum nAb as Measured by PNA
Day 71
|
—
|
3.6 Ratio
The 95% confidence interval is not provided when n is less than 5 participants.
|
4.5 Ratio
The 95% confidence interval is not provided when n is less than 5 participants.
|
—
|
1.0 Ratio
The 95% confidence interval is not provided when n is less than 5 participants.
|
SECONDARY outcome
Timeframe: Days 1, 15, 29, 57, 71, and 85Population: All randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint, and who had available data at the indicated time point. Participants were pooled by dose of study intervention administered due to the study's termination prior to most participants receiving their planned second dose. Data were not collected for planned timepoints on days 115, 211, 365, 422, and 534 due to early termination.
Serum samples were collected and the total anti-spike IgG antibodies assessed using ELISA. Geometric mean concentrations were calculated using a cLDA method where the response vector consisted of the log transformed pre-vaccination and post-vaccination antibody titers. GMFR is defined as the geometric mean of the ratio of concentration at specified timepoints after vaccination divided by concentration at baseline (Day 1).
Outcome measures
| Measure |
V591 1×10^4 TCID50
n=20 Participants
Participants received one dose of V591 1x10\^4 TCID50 on Day 1
|
V591 1×10^5 TCID50
n=84 Participants
All participants received one dose of V591 1×10\^5 TCID50 on Day 1; Some participants received a second V591 1×10\^5 TCID50 dose on Day 57.
|
V591 1×10^6 TCID50
n=85 Participants
All participants received one dose of V591 1×10\^6 TCID50 on Day 1; Some participants received a second V591 1×10\^6 TCID50 dose on Day 57.
|
V591 1×10^7 TCID50
n=20 Participants
Participants received one dose of V591 1×10\^7 TCID50 on Day 1
|
Placebo
n=53 Participants
Participants received one dose of placebo on Day 1; Some participants received a second dose of placebo on Day 57.
|
|---|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) of Total Anti-Spike IgG Antibodies as Measured by ELISA
Day 15
|
1.0 Ratio
Interval 1.0 to 1.0
|
1.0 Ratio
Interval 1.0 to 1.1
|
1.1 Ratio
Interval 1.0 to 1.3
|
3.5 Ratio
Interval 1.8 to 6.9
|
1.0 Ratio
Interval 0.9 to 1.0
|
|
Geometric Mean Fold Rise (GMFR) of Total Anti-Spike IgG Antibodies as Measured by ELISA
Day 29
|
1.1 Ratio
Interval 1.0 to 1.2
|
1.2 Ratio
Interval 1.0 to 1.4
|
1.3 Ratio
Interval 1.1 to 1.6
|
3.9 Ratio
Interval 1.8 to 8.6
|
1.2 Ratio
Interval 1.0 to 1.4
|
|
Geometric Mean Fold Rise (GMFR) of Total Anti-Spike IgG Antibodies as Measured by ELISA
Day 57
|
—
|
3.3 Ratio
The 95% confidence interval is not provided when n is less than 5 participants.
|
1.0 Ratio
The 95% confidence interval is not provided when n is less than 5 participants.
|
—
|
1.0 Ratio
The 95% confidence interval is not provided when n is less than 5 participants.
|
|
Geometric Mean Fold Rise (GMFR) of Total Anti-Spike IgG Antibodies as Measured by ELISA
Day 71
|
—
|
5.2 Ratio
The 95% confidence interval is not provided when n is less than 5 participants.
|
6.7 Ratio
The 95% confidence interval is not provided when n is less than 5 participants.
|
—
|
1.0 Ratio
The 95% confidence interval is not provided when n is less than 5 participants.
|
|
Geometric Mean Fold Rise (GMFR) of Total Anti-Spike IgG Antibodies as Measured by ELISA
Day 85
|
—
|
5.1 Ratio
The 95% confidence interval is not provided when n is less than 5 participants.
|
5.2 Ratio
The 95% confidence interval is not provided when n is less than 5 participants.
|
—
|
1.0 Ratio
The 95% confidence interval is not provided when n is less than 5 participants.
|
Adverse Events
V591 1x10⁴ TCID₅₀-Post Vaccination (Vacc) 1
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
V591 1x10⁵ TCID₅₀-Post Vacc 1
Serious events: 0 serious events
Other events: 47 other events
Deaths: 0 deaths
V591 1x10⁶ TCID₅₀-Post Vacc 1
Serious events: 2 serious events
Other events: 41 other events
Deaths: 0 deaths
V591 1x10⁷ TCID₅₀-Post Vacc 1
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Placebo-Post Vacc 1
Serious events: 1 serious events
Other events: 35 other events
Deaths: 0 deaths
V591 1x10⁵ TCID₅₀-Post Vacc 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
V591 1x10⁶ TCID₅₀-Post Vacc 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo-Post Vacc 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
V591 1x10⁴ TCID₅₀-Post Vaccination (Vacc) 1
n=20 participants at risk
Participants received one dose of 1x10\^4 TCID50 V591 on Day 1
|
V591 1x10⁵ TCID₅₀-Post Vacc 1
n=84 participants at risk
All participants received one dose of V591 1×10\^5 TCID50 on Day 1; Some participants received a second V591 1×10\^5 TCID50 dose on Day 57.
|
V591 1x10⁶ TCID₅₀-Post Vacc 1
n=85 participants at risk
All participants received one dose of V591 1×10\^6 TCID50 on Day 1; Some participants received a second V591 1×10\^6 TCID50 dose on Day 57.
|
V591 1x10⁷ TCID₅₀-Post Vacc 1
n=20 participants at risk
Participants received one dose of V591 1×10\^7 TCID50 on Day 1
|
Placebo-Post Vacc 1
n=53 participants at risk
Participants received one dose of placebo on Day 1; Some participants received a second dose of placebo on Day 57.
|
V591 1x10⁵ TCID₅₀-Post Vacc 2
n=4 participants at risk
All participants received 2 doses of V591; one dose of V591 1×10\^5 TCID50 on Day 1 and a second dose of V591 1×10\^5 TCID50 on Day 57.
|
V591 1x10⁶ TCID₅₀-Post Vacc 2
n=4 participants at risk
All participants received 2 doses of V591; one dose of V591 1×10\^6 TCID50 on Day 1 and a second dose of V591 1×10\^6 TCID50 on Day 57.
|
Placebo-Post Vacc 2
n=2 participants at risk
All participants received 2 doses of placebo; one dose of placebo on Day 1 and a second dose of placebo on Day 57.
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/20 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/84 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
1.2%
1/85 • Number of events 1 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/20 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/53 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/4 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/4 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/2 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/20 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/84 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
1.2%
1/85 • Number of events 1 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/20 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/53 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/4 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/4 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/2 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
|
Infections and infestations
COVID-19
|
0.00%
0/20 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/84 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
1.2%
1/85 • Number of events 1 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/20 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/53 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/4 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/4 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/2 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
|
Nervous system disorders
Migraine
|
0.00%
0/20 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/84 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/85 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/20 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
1.9%
1/53 • Number of events 1 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/4 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/4 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/2 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
Other adverse events
| Measure |
V591 1x10⁴ TCID₅₀-Post Vaccination (Vacc) 1
n=20 participants at risk
Participants received one dose of 1x10\^4 TCID50 V591 on Day 1
|
V591 1x10⁵ TCID₅₀-Post Vacc 1
n=84 participants at risk
All participants received one dose of V591 1×10\^5 TCID50 on Day 1; Some participants received a second V591 1×10\^5 TCID50 dose on Day 57.
|
V591 1x10⁶ TCID₅₀-Post Vacc 1
n=85 participants at risk
All participants received one dose of V591 1×10\^6 TCID50 on Day 1; Some participants received a second V591 1×10\^6 TCID50 dose on Day 57.
|
V591 1x10⁷ TCID₅₀-Post Vacc 1
n=20 participants at risk
Participants received one dose of V591 1×10\^7 TCID50 on Day 1
|
Placebo-Post Vacc 1
n=53 participants at risk
Participants received one dose of placebo on Day 1; Some participants received a second dose of placebo on Day 57.
|
V591 1x10⁵ TCID₅₀-Post Vacc 2
n=4 participants at risk
All participants received 2 doses of V591; one dose of V591 1×10\^5 TCID50 on Day 1 and a second dose of V591 1×10\^5 TCID50 on Day 57.
|
V591 1x10⁶ TCID₅₀-Post Vacc 2
n=4 participants at risk
All participants received 2 doses of V591; one dose of V591 1×10\^6 TCID50 on Day 1 and a second dose of V591 1×10\^6 TCID50 on Day 57.
|
Placebo-Post Vacc 2
n=2 participants at risk
All participants received 2 doses of placebo; one dose of placebo on Day 1 and a second dose of placebo on Day 57.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
15.0%
3/20 • Number of events 6 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
8.3%
7/84 • Number of events 9 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
2.4%
2/85 • Number of events 2 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
20.0%
4/20 • Number of events 4 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
13.2%
7/53 • Number of events 8 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/4 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
25.0%
1/4 • Number of events 1 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/2 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/20 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/84 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/85 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
10.0%
2/20 • Number of events 2 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
1.9%
1/53 • Number of events 1 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/4 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/4 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/2 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
|
General disorders
Fatigue
|
40.0%
8/20 • Number of events 14 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
26.2%
22/84 • Number of events 30 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
22.4%
19/85 • Number of events 25 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
40.0%
8/20 • Number of events 13 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
37.7%
20/53 • Number of events 26 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
25.0%
1/4 • Number of events 1 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
50.0%
2/4 • Number of events 2 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/2 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
|
General disorders
Injection site movement impairment
|
0.00%
0/20 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/84 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/85 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
10.0%
2/20 • Number of events 2 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/53 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/4 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/4 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/2 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
|
General disorders
Injection site pain
|
25.0%
5/20 • Number of events 5 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
7.1%
6/84 • Number of events 6 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
15.3%
13/85 • Number of events 14 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
55.0%
11/20 • Number of events 11 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
7.5%
4/53 • Number of events 4 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/4 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
25.0%
1/4 • Number of events 1 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/2 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
|
Infections and infestations
COVID-19
|
0.00%
0/20 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
10.7%
9/84 • Number of events 9 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
9.4%
8/85 • Number of events 8 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/20 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
9.4%
5/53 • Number of events 5 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/4 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/4 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/2 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
|
Investigations
Blood creatine phosphokinase increased
|
5.0%
1/20 • Number of events 1 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
1.2%
1/84 • Number of events 1 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
1.2%
1/85 • Number of events 1 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
10.0%
2/20 • Number of events 2 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
1.9%
1/53 • Number of events 1 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/4 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/4 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/2 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
2/20 • Number of events 3 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
9.5%
8/84 • Number of events 10 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
8.2%
7/85 • Number of events 8 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
5.0%
1/20 • Number of events 1 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
13.2%
7/53 • Number of events 8 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/4 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/4 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/2 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
2/20 • Number of events 4 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
3.6%
3/84 • Number of events 3 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/85 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
5.0%
1/20 • Number of events 1 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/53 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/4 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/4 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/2 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.0%
3/20 • Number of events 5 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
16.7%
14/84 • Number of events 15 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
16.5%
14/85 • Number of events 15 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
15.0%
3/20 • Number of events 3 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
18.9%
10/53 • Number of events 14 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/4 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
25.0%
1/4 • Number of events 2 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/2 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20 • Number of events 1 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/84 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/85 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
10.0%
2/20 • Number of events 2 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/53 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/4 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/4 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/2 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
|
Nervous system disorders
Headache
|
20.0%
4/20 • Number of events 6 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
28.6%
24/84 • Number of events 34 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
23.5%
20/85 • Number of events 31 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
45.0%
9/20 • Number of events 16 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
35.8%
19/53 • Number of events 22 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/4 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
50.0%
2/4 • Number of events 3 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
50.0%
1/2 • Number of events 1 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
10.0%
2/20 • Number of events 2 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/84 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/85 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/20 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
1.9%
1/53 • Number of events 1 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/4 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/4 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/2 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.0%
1/20 • Number of events 1 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
1.2%
1/84 • Number of events 1 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
2.4%
2/85 • Number of events 2 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
10.0%
2/20 • Number of events 2 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
5.7%
3/53 • Number of events 3 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/4 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/4 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/2 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
2/20 • Number of events 3 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/84 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
2.4%
2/85 • Number of events 2 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
5.0%
1/20 • Number of events 1 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/53 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/4 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/4 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/2 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
|
General disorders
Injection site erythema
|
0.00%
0/20 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
2.4%
2/84 • Number of events 2 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
2.4%
2/85 • Number of events 2 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/20 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/53 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
25.0%
1/4 • Number of events 1 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/4 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/2 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
|
General disorders
Puncture site haematoma
|
0.00%
0/20 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/84 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/85 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/20 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/53 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/4 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
25.0%
1/4 • Number of events 1 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/2 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
|
Injury, poisoning and procedural complications
Exposure to SARS-CoV-2
|
10.0%
2/20 • Number of events 2 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
3.6%
3/84 • Number of events 3 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
4.7%
4/85 • Number of events 4 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
10.0%
2/20 • Number of events 2 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
7.5%
4/53 • Number of events 4 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/4 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/4 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/2 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
|
Nervous system disorders
Anosmia
|
0.00%
0/20 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
6.0%
5/84 • Number of events 5 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
1.2%
1/85 • Number of events 1 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/20 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/53 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/4 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/4 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/2 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/20 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
6.0%
5/84 • Number of events 5 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
3.5%
3/85 • Number of events 3 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/20 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/53 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/4 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/4 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
0.00%
0/2 • Serious adverse events and all cause mortality were collected throughout the duration of the study (up to day 178). Non-serious adverse events were assessed up to day 146.
The analysis population for all cause mortality consists of all randomized participants. The analysis populations for serious and non-serious adverse events include all randomized participants who received at least one dose of study intervention. Adverse events were reported separately by occurrence after the first dose of study intervention or second dose of study intervention.
|
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.
- Publication restrictions are in place
Restriction type: OTHER