Trial Outcomes & Findings for A Study to Evaluate the Safety and Immunogenicity of mRNA-1975 and mRNA-1982 Against Lyme Disease in Participants 18 Through 70 Years of Age (NCT NCT05975099)
NCT ID: NCT05975099
Last Updated: 2026-07-30
Results Overview
Solicited ARs were collected in an electronic diary (eDiary). Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered adverse events (AEs). Investigator reviewed whether the solicited AR was also to be recorded as an AE. A summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
807 participants
Primary outcome timeframe
Up to 7 days after Day 1 injection
Results posted on
2026-07-30
Participant Flow
Participant milestones
| Measure |
mRNA-1975 Dose Level 1
Participants received 3 intramuscular (IM) injections of the mRNA-1975 vaccine at 25 micrograms (μg) on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 2
Participants received 3 IM injections of the mRNA-1975 vaccine at 50 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 3
Participants received 3 IM injections of the mRNA-1975 vaccine at 100 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 4
Participants received 3 IM injections of the mRNA-1975 vaccine at 150 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 1
Participants received 3 IM injections of the mRNA-1982 vaccine at 12.5 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 2
Participants received 3 IM injections of the mRNA-1982 vaccine at 25 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 3
Participants received 3 IM injections of the mRNA-1982 vaccine at 50 μg on Days 1, 57, and 169.
|
Placebo
Participants received 3 IM injections of the vaccine matching placebo on Days 1, 57, and 169.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
100
|
101
|
99
|
102
|
99
|
100
|
104
|
102
|
|
Overall Study
Received First Injection
|
100
|
101
|
99
|
102
|
99
|
100
|
104
|
101
|
|
Overall Study
Received Second Injection
|
97
|
98
|
97
|
99
|
94
|
97
|
99
|
96
|
|
Overall Study
Received Third Injection
|
93
|
95
|
90
|
94
|
93
|
93
|
92
|
95
|
|
Overall Study
Full Analysis Set
|
100
|
101
|
99
|
102
|
99
|
100
|
104
|
101
|
|
Overall Study
Safety Analysis Set
|
100
|
101
|
99
|
102
|
98
|
100
|
105
|
101
|
|
Overall Study
Per-Protocol Set
|
99
|
99
|
99
|
99
|
96
|
99
|
102
|
100
|
|
Overall Study
COMPLETED
|
94
|
84
|
93
|
86
|
91
|
88
|
93
|
90
|
|
Overall Study
NOT COMPLETED
|
6
|
17
|
6
|
16
|
8
|
12
|
11
|
12
|
Reasons for withdrawal
| Measure |
mRNA-1975 Dose Level 1
Participants received 3 intramuscular (IM) injections of the mRNA-1975 vaccine at 25 micrograms (μg) on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 2
Participants received 3 IM injections of the mRNA-1975 vaccine at 50 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 3
Participants received 3 IM injections of the mRNA-1975 vaccine at 100 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 4
Participants received 3 IM injections of the mRNA-1975 vaccine at 150 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 1
Participants received 3 IM injections of the mRNA-1982 vaccine at 12.5 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 2
Participants received 3 IM injections of the mRNA-1982 vaccine at 25 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 3
Participants received 3 IM injections of the mRNA-1982 vaccine at 50 μg on Days 1, 57, and 169.
|
Placebo
Participants received 3 IM injections of the vaccine matching placebo on Days 1, 57, and 169.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
9
|
1
|
6
|
4
|
4
|
2
|
5
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
1
|
0
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
6
|
3
|
9
|
3
|
6
|
8
|
5
|
|
Overall Study
Death
|
0
|
1
|
0
|
1
|
0
|
1
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study to Evaluate the Safety and Immunogenicity of mRNA-1975 and mRNA-1982 Against Lyme Disease in Participants 18 Through 70 Years of Age
Baseline characteristics by cohort
| Measure |
mRNA-1975 Dose Level 1
n=100 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 25 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 2
n=101 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 50 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 3
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 100 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 4
n=102 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 150 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 1
n=99 Participants
Participants received 3 IM injections of the mRNA-1982 vaccine at 12.5 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 2
n=100 Participants
Participants received 3 IM injections of the mRNA-1982 vaccine at 25 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 3
n=104 Participants
Participants received 3 IM injections of the mRNA-1982 vaccine at 50 μg on Days 1, 57, and 169.
|
Placebo
n=101 Participants
Participants received 3 IM injections of the vaccine matching placebo on Days 1, 57, and 169.
|
Total
n=806 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
48.5 years
STANDARD_DEVIATION 13.72 • n=20 Participants
|
50.5 years
STANDARD_DEVIATION 13.76 • n=20 Participants
|
50.4 years
STANDARD_DEVIATION 14.66 • n=40 Participants
|
49.6 years
STANDARD_DEVIATION 12.81 • n=5 Participants
|
51.1 years
STANDARD_DEVIATION 13.95 • n=9 Participants
|
49.8 years
STANDARD_DEVIATION 15.05 • n=6 Participants
|
48.9 years
STANDARD_DEVIATION 14.77 • n=6 Participants
|
51.2 years
STANDARD_DEVIATION 12.93 • n=6 Participants
|
50.0 years
STANDARD_DEVIATION 13.95 • n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=20 Participants
|
53 Participants
n=20 Participants
|
57 Participants
n=40 Participants
|
56 Participants
n=5 Participants
|
53 Participants
n=9 Participants
|
50 Participants
n=6 Participants
|
54 Participants
n=6 Participants
|
58 Participants
n=6 Participants
|
423 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=20 Participants
|
48 Participants
n=20 Participants
|
42 Participants
n=40 Participants
|
46 Participants
n=5 Participants
|
46 Participants
n=9 Participants
|
50 Participants
n=6 Participants
|
50 Participants
n=6 Participants
|
43 Participants
n=6 Participants
|
383 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=9 Participants
|
9 Participants
n=6 Participants
|
13 Participants
n=6 Participants
|
8 Participants
n=6 Participants
|
63 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
91 Participants
n=20 Participants
|
86 Participants
n=20 Participants
|
91 Participants
n=40 Participants
|
95 Participants
n=5 Participants
|
90 Participants
n=9 Participants
|
90 Participants
n=6 Participants
|
90 Participants
n=6 Participants
|
93 Participants
n=6 Participants
|
726 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
78 Participants
n=20 Participants
|
74 Participants
n=20 Participants
|
76 Participants
n=40 Participants
|
84 Participants
n=5 Participants
|
77 Participants
n=9 Participants
|
79 Participants
n=6 Participants
|
73 Participants
n=6 Participants
|
79 Participants
n=6 Participants
|
620 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
15 Participants
n=20 Participants
|
21 Participants
n=20 Participants
|
20 Participants
n=40 Participants
|
13 Participants
n=5 Participants
|
17 Participants
n=9 Participants
|
13 Participants
n=6 Participants
|
22 Participants
n=6 Participants
|
18 Participants
n=6 Participants
|
139 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=9 Participants
|
5 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 7 days after Day 1 injectionPopulation: The First Injection Solicited Safety Set included all randomly assigned participants who received the study vaccine and contributed any solicited AR data.
Solicited ARs were collected in an electronic diary (eDiary). Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered adverse events (AEs). Investigator reviewed whether the solicited AR was also to be recorded as an AE. A summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Outcome measures
| Measure |
mRNA-1975 Dose Level 3
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 100 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 4
n=102 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 150 μg on Days 1, 57, and 169.
|
Placebo
n=97 Participants
Participants received 3 IM injections of the vaccine matching placebo on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 1
n=100 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 25 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 2
n=101 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 50 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 2
n=100 Participants
Participants received 3 IM injections of the mRNA-1982 vaccine at 25 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 3
n=105 Participants
Participants received 3 IM injections of the mRNA-1982 vaccine at 50 μg on Days 1, 57, and 169.
|
Placebo
n=101 Participants
Participants received 3 IM injections of the vaccine matching placebo on Days 1, 57, and 169.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Within 7 Days After Day 1 Injection
|
82 Participants
|
91 Participants
|
64 Participants
|
70 Participants
|
80 Participants
|
77 Participants
|
86 Participants
|
33 Participants
|
PRIMARY outcome
Timeframe: Up to 7 days after Day 57 injectionPopulation: The Second Injection Solicited Safety Set included all randomly assigned participants who received the study vaccine and contributed any solicited AR data.
Solicited ARs were collected in an eDiary. Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered AEs. Investigator reviewed whether the solicited AR was also to be recorded as an AE. A summary of SAEs and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Outcome measures
| Measure |
mRNA-1975 Dose Level 3
n=97 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 100 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 4
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 150 μg on Days 1, 57, and 169.
|
Placebo
n=93 Participants
Participants received 3 IM injections of the vaccine matching placebo on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 1
n=97 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 25 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 2
n=98 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 50 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 2
n=97 Participants
Participants received 3 IM injections of the mRNA-1982 vaccine at 25 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 3
n=100 Participants
Participants received 3 IM injections of the mRNA-1982 vaccine at 50 μg on Days 1, 57, and 169.
|
Placebo
n=96 Participants
Participants received 3 IM injections of the vaccine matching placebo on Days 1, 57, and 169.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Local and Systemic ARs Within 7 Days After Day 57 Injection
|
90 Participants
|
96 Participants
|
70 Participants
|
79 Participants
|
80 Participants
|
82 Participants
|
88 Participants
|
33 Participants
|
PRIMARY outcome
Timeframe: Up to 7 days after Day 169 injectionPopulation: The Third Injection Solicited Safety Set included all randomly assigned participants who received the study vaccine and contributed any solicited AR data.
Solicited ARs were collected in an eDiary. Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered AEs. Investigator reviewed whether the solicited AR was also to be recorded as an AE. A summary of SAEs and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Outcome measures
| Measure |
mRNA-1975 Dose Level 3
n=90 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 100 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 4
n=94 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 150 μg on Days 1, 57, and 169.
|
Placebo
n=92 Participants
Participants received 3 IM injections of the vaccine matching placebo on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 1
n=93 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 25 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 2
n=95 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 50 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 2
n=94 Participants
Participants received 3 IM injections of the mRNA-1982 vaccine at 25 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 3
n=92 Participants
Participants received 3 IM injections of the mRNA-1982 vaccine at 50 μg on Days 1, 57, and 169.
|
Placebo
n=95 Participants
Participants received 3 IM injections of the vaccine matching placebo on Days 1, 57, and 169.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Local and Systemic ARs Within 7 Days After Day 169 Injection
|
81 Participants
|
92 Participants
|
76 Participants
|
81 Participants
|
87 Participants
|
82 Participants
|
88 Participants
|
26 Participants
|
PRIMARY outcome
Timeframe: Up to 28 days post any injectionPopulation: The Safety Set included all randomly assigned participants who received the study vaccine.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time \[PT\]/partial thromboplastin time \[PTT\]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Outcome measures
| Measure |
mRNA-1975 Dose Level 3
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 100 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 4
n=102 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 150 μg on Days 1, 57, and 169.
|
Placebo
n=98 Participants
Participants received 3 IM injections of the vaccine matching placebo on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 1
n=100 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 25 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 2
n=101 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 50 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 2
n=100 Participants
Participants received 3 IM injections of the mRNA-1982 vaccine at 25 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 3
n=105 Participants
Participants received 3 IM injections of the mRNA-1982 vaccine at 50 μg on Days 1, 57, and 169.
|
Placebo
n=101 Participants
Participants received 3 IM injections of the vaccine matching placebo on Days 1, 57, and 169.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Unsolicited AEs
|
42 Participants
|
47 Participants
|
29 Participants
|
38 Participants
|
38 Participants
|
38 Participants
|
36 Participants
|
37 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to Month 18Population: The Safety Set included all randomly assigned participants who received the study vaccine.
A MAAE is an AE that led to an unscheduled visit to a healthcare practitioner. An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly/birth defect, or was an important medical event. An AESI was an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor were required. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Outcome measures
| Measure |
mRNA-1975 Dose Level 3
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 100 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 4
n=102 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 150 μg on Days 1, 57, and 169.
|
Placebo
n=98 Participants
Participants received 3 IM injections of the vaccine matching placebo on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 1
n=100 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 25 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 2
n=101 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 50 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 2
n=100 Participants
Participants received 3 IM injections of the mRNA-1982 vaccine at 25 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 3
n=105 Participants
Participants received 3 IM injections of the mRNA-1982 vaccine at 50 μg on Days 1, 57, and 169.
|
Placebo
n=101 Participants
Participants received 3 IM injections of the vaccine matching placebo on Days 1, 57, and 169.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Medically Attended AEs (MAAEs), Adverse Events of Special Interest (AESIs), SAEs, and AEs Leading to Study Discontinuation
MAAEs
|
36 Participants
|
42 Participants
|
42 Participants
|
39 Participants
|
38 Participants
|
40 Participants
|
46 Participants
|
39 Participants
|
|
Number of Participants With Medically Attended AEs (MAAEs), Adverse Events of Special Interest (AESIs), SAEs, and AEs Leading to Study Discontinuation
AESIs
|
4 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Medically Attended AEs (MAAEs), Adverse Events of Special Interest (AESIs), SAEs, and AEs Leading to Study Discontinuation
SAEs
|
6 Participants
|
4 Participants
|
6 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
7 Participants
|
|
Number of Participants With Medically Attended AEs (MAAEs), Adverse Events of Special Interest (AESIs), SAEs, and AEs Leading to Study Discontinuation
AEs Leading to Study Discontinuation
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Days 1, 29, 85 and 197Population: Per-protocol (PP) Set included all randomized participants who received at least 1 dose of study vaccine, complied with injection schedule, timing of immunogenicity blood sampling, had a baseline and at least 1 post-injection assessment, and had no major protocol deviations that impacted immune response. Number analyzed = participants assessed for specified timepoint. Not all participants were assessed for all timepoints reported.
Antibody values reported as below lower limit of quantification (LLOQ) were replaced by 0.5\*LLOQ. Values reported greater than upper limit of quantification (ULOQ) were replaced by the ULOQ. LLOQ was 41.4 nanograms (ng)/milliliter (mL) and ULOQ was 428000 ng/mL for manual assay; LLOQ was 47.6 ng/mL and 583000 ng/mL for automated assay for SR-1 IgG antibody. 95% confidence interval (CI) for GM value was calculated based on the t-distribution of the log-transformed values , then back transformed to the original scale for presentation.
Outcome measures
| Measure |
mRNA-1975 Dose Level 3
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 100 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 4
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 150 μg on Days 1, 57, and 169.
|
Placebo
n=96 Participants
Participants received 3 IM injections of the vaccine matching placebo on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 1
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 25 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 2
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 50 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 2
n=99 Participants
Participants received 3 IM injections of the mRNA-1982 vaccine at 25 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 3
n=102 Participants
Participants received 3 IM injections of the mRNA-1982 vaccine at 50 μg on Days 1, 57, and 169.
|
Placebo
n=100 Participants
Participants received 3 IM injections of the vaccine matching placebo on Days 1, 57, and 169.
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Concentration (GMC) of Anti-Outer Surface Protein (Anti-OspA) Binding Immunoglobulin (IgG) Antibodies for Serotype (SR-1) Antigen Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Day 85
|
18298.5 ng/mL
Interval 15411.6 to 21726.2
|
18793.1 ng/mL
Interval 14816.9 to 23836.3
|
10351.3 ng/mL
Interval 8109.8 to 13212.4
|
7677.6 ng/mL
Interval 6050.4 to 9742.4
|
12511.1 ng/mL
Interval 9778.6 to 16007.2
|
12207.4 ng/mL
Interval 10039.2 to 14843.8
|
14372.3 ng/mL
Interval 11741.2 to 17593.1
|
23.0 ng/mL
Interval 20.0 to 26.4
|
|
Geometric Mean Concentration (GMC) of Anti-Outer Surface Protein (Anti-OspA) Binding Immunoglobulin (IgG) Antibodies for Serotype (SR-1) Antigen Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Day 1
|
21.1 ng/mL
Interval 20.5 to 21.7
|
22.8 ng/mL
Interval 20.6 to 25.3
|
22.0 ng/mL
Interval 20.8 to 23.2
|
20.9 ng/mL
Interval 20.5 to 21.2
|
23.2 ng/mL
Interval 20.6 to 26.1
|
21.2 ng/mL
Interval 20.5 to 21.8
|
21.6 ng/mL
Interval 20.7 to 22.6
|
21.6 ng/mL
Interval 20.6 to 22.6
|
|
Geometric Mean Concentration (GMC) of Anti-Outer Surface Protein (Anti-OspA) Binding Immunoglobulin (IgG) Antibodies for Serotype (SR-1) Antigen Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Day 29
|
337.7 ng/mL
Interval 262.1 to 435.1
|
341.2 ng/mL
Interval 261.1 to 445.7
|
143.2 ng/mL
Interval 110.8 to 185.1
|
132.6 ng/mL
Interval 103.5 to 169.9
|
210.3 ng/mL
Interval 155.8 to 283.7
|
173.1 ng/mL
Interval 130.3 to 230.0
|
286.6 ng/mL
Interval 226.8 to 362.1
|
23.2 ng/mL
Interval 21.2 to 25.3
|
|
Geometric Mean Concentration (GMC) of Anti-Outer Surface Protein (Anti-OspA) Binding Immunoglobulin (IgG) Antibodies for Serotype (SR-1) Antigen Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Day 197
|
33872.8 ng/mL
Interval 28346.7 to 40476.1
|
38030.2 ng/mL
Interval 31456.3 to 45977.9
|
21896.2 ng/mL
Interval 17741.4 to 27023.9
|
18115.3 ng/mL
Interval 15351.1 to 21377.2
|
21687.1 ng/mL
Interval 17300.1 to 27186.5
|
27292.0 ng/mL
Interval 22845.8 to 32603.5
|
27325.6 ng/mL
Interval 22667.0 to 32941.7
|
24.1 ng/mL
Interval 20.8 to 27.9
|
SECONDARY outcome
Timeframe: Days 1, 29, 85, and 197Population: PP Set: randomized participants who received at least 1 dose of study vaccine, complied with injection schedule, timing of immunogenicity blood sampling, had a baseline and at least 1 post-injection assessment, and had no major protocol deviations that impacted immune response. Overall number of participants analyzed=participants assessed for overall outcome measure. Number analyzed=participants assessed for specified timepoint. Not all participants were assessed for all timepoints reported.
Antibody values reported as below LLOQ were replaced by 0.5\*LLOQ. Values reported greater than ULOQ were replaced by the ULOQ. LLOQ was 30 ng/mL and ULOQ was 214000 ng/mL for manual assay; LLOQ was 66.6 ng/mL and 215000 ng/mL for automated assay for SR-2 IgG antibody. 95% CI for GM value was calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation. Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
Outcome measures
| Measure |
mRNA-1975 Dose Level 3
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 100 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 4
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 150 μg on Days 1, 57, and 169.
|
Placebo
n=50 Participants
Participants received 3 IM injections of the vaccine matching placebo on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 1
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 25 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 2
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 50 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 2
Participants received 3 IM injections of the mRNA-1982 vaccine at 25 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 3
Participants received 3 IM injections of the mRNA-1982 vaccine at 50 μg on Days 1, 57, and 169.
|
Placebo
Participants received 3 IM injections of the vaccine matching placebo on Days 1, 57, and 169.
|
|---|---|---|---|---|---|---|---|---|
|
GMC of Anti-OspA Binding IgG Antibodies for SR-2 Antigen Measured by ELISA
Day 1
|
17.1 ng/mL
Interval 15.4 to 19.0
|
17.0 ng/mL
Interval 15.3 to 18.9
|
18.0 ng/mL
Interval 15.4 to 21.2
|
16.5 ng/mL
Interval 15.3 to 17.7
|
17.5 ng/mL
Interval 15.4 to 19.8
|
—
|
—
|
—
|
|
GMC of Anti-OspA Binding IgG Antibodies for SR-2 Antigen Measured by ELISA
Day 29
|
963.1 ng/mL
Interval 750.9 to 1235.4
|
1051.5 ng/mL
Interval 812.8 to 1360.2
|
17.5 ng/mL
Interval 15.1 to 20.1
|
462.4 ng/mL
Interval 361.2 to 591.9
|
517.0 ng/mL
Interval 390.2 to 684.9
|
—
|
—
|
—
|
|
GMC of Anti-OspA Binding IgG Antibodies for SR-2 Antigen Measured by ELISA
Day 85
|
25840.4 ng/mL
Interval 22010.1 to 30337.3
|
24519.3 ng/mL
Interval 19478.4 to 30864.6
|
20.8 ng/mL
Interval 15.2 to 28.4
|
11868.7 ng/mL
Interval 9422.5 to 14949.9
|
15853.4 ng/mL
Interval 12610.0 to 19931.0
|
—
|
—
|
—
|
|
GMC of Anti-OspA Binding IgG Antibodies for SR-2 Antigen Measured by ELISA
Day 197
|
36464.7 ng/mL
Interval 31067.1 to 42800.0
|
38402.4 ng/mL
Interval 32552.4 to 45303.7
|
21.5 ng/mL
Interval 15.5 to 29.9
|
19183.3 ng/mL
Interval 16351.5 to 22505.6
|
21827.7 ng/mL
Interval 17422.6 to 27346.6
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 29, 85 and 197Population: PP Set: randomized participants who received at least 1 dose of study vaccine, complied with injection schedule, timing of immunogenicity blood sampling, had a baseline and at least 1 post-injection assessment, and had no major protocol deviations that impacted immune response. Overall number of participants analyzed=participants assessed for overall outcome measure. Number analyzed=participants assessed for specified timepoint. Not all participants were assessed for all timepoints reported.
Antibody values reported as below LLOQ were replaced by 0.5\*LLOQ. Values reported greater than ULOQ were replaced by the ULOQ. LLOQ was 14.5 ng/mL and ULOQ was 299000 ng/mL for manual assay; LLOQ was 62.5 ng/mL and 296000 ng/mL for automated assay for SR-3 IgG antibody. 95% CI for GM value was calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation. Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
Outcome measures
| Measure |
mRNA-1975 Dose Level 3
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 100 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 4
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 150 μg on Days 1, 57, and 169.
|
Placebo
n=50 Participants
Participants received 3 IM injections of the vaccine matching placebo on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 1
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 25 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 2
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 50 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 2
Participants received 3 IM injections of the mRNA-1982 vaccine at 25 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 3
Participants received 3 IM injections of the mRNA-1982 vaccine at 50 μg on Days 1, 57, and 169.
|
Placebo
Participants received 3 IM injections of the vaccine matching placebo on Days 1, 57, and 169.
|
|---|---|---|---|---|---|---|---|---|
|
GMC of Anti-OspA Binding IgG Antibodies for SR-3 Antigen Measured by ELISA
Day 1
|
8.6 ng/mL
Interval 7.8 to 9.5
|
9.3 ng/mL
Interval 8.0 to 10.8
|
10.4 ng/mL
Interval 8.6 to 12.5
|
10.0 ng/mL
Interval 8.2 to 12.1
|
9.4 ng/mL
Interval 7.9 to 11.2
|
—
|
—
|
—
|
|
GMC of Anti-OspA Binding IgG Antibodies for SR-3 Antigen Measured by ELISA
Day 29
|
451.0 ng/mL
Interval 351.9 to 577.9
|
499.7 ng/mL
Interval 380.1 to 657.0
|
9.7 ng/mL
Interval 8.1 to 11.5
|
281.2 ng/mL
Interval 220.1 to 359.4
|
265.1 ng/mL
Interval 198.6 to 354.0
|
—
|
—
|
—
|
|
GMC of Anti-OspA Binding IgG Antibodies for SR-3 Antigen Measured by ELISA
Day 85
|
39496.9 ng/mL
Interval 33493.5 to 46576.4
|
38397.6 ng/mL
Interval 30110.4 to 48965.7
|
12.2 ng/mL
Interval 8.4 to 17.7
|
18879.1 ng/mL
Interval 14955.0 to 23833.0
|
24744.5 ng/mL
Interval 19231.0 to 31838.6
|
—
|
—
|
—
|
|
GMC of Anti-OspA Binding IgG Antibodies for SR-3 Antigen Measured by ELISA
Day 197
|
53775.7 ng/mL
Interval 45890.0 to 63016.5
|
59961.2 ng/mL
Interval 51353.0 to 70012.3
|
10.5 ng/mL
Interval 7.9 to 13.9
|
30597.1 ng/mL
Interval 26195.4 to 35738.5
|
34358.4 ng/mL
Interval 27397.3 to 43088.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 29, 85 and 197Population: PP Set: randomized participants who received at least 1 dose of study vaccine, complied with injection schedule, timing of immunogenicity blood sampling, had a baseline and at least 1 post-injection assessment, and had no major protocol deviations that impacted immune response. Overall number of participants analyzed=participants assessed for overall outcome measure. Number analyzed=participants assessed for specified timepoint. Not all participants were assessed for all timepoints reported.
Antibody values reported as below LLOQ were replaced by 0.5\*LLOQ. Values reported greater than ULOQ were replaced by the ULOQ. LLOQ was 32.6 ng/mL and ULOQ was 292000 ng/mL for manual assay; LLOQ was 59.7 ng/mL and 264000 ng/mL for automated assay for SR-4 IgG antibody. 95% CI for GM value was calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation. Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
Outcome measures
| Measure |
mRNA-1975 Dose Level 3
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 100 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 4
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 150 μg on Days 1, 57, and 169.
|
Placebo
n=50 Participants
Participants received 3 IM injections of the vaccine matching placebo on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 1
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 25 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 2
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 50 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 2
Participants received 3 IM injections of the mRNA-1982 vaccine at 25 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 3
Participants received 3 IM injections of the mRNA-1982 vaccine at 50 μg on Days 1, 57, and 169.
|
Placebo
Participants received 3 IM injections of the vaccine matching placebo on Days 1, 57, and 169.
|
|---|---|---|---|---|---|---|---|---|
|
GMC of Anti-OspA Binding IgG Antibodies for SR-4 Antigen Measured by ELISA
Day 1
|
17.5 ng/mL
Interval 16.4 to 18.8
|
18.9 ng/mL
Interval 16.9 to 21.1
|
17.4 ng/mL
Interval 16.1 to 18.9
|
17.5 ng/mL
Interval 16.4 to 18.8
|
18.4 ng/mL
Interval 16.5 to 20.5
|
—
|
—
|
—
|
|
GMC of Anti-OspA Binding IgG Antibodies for SR-4 Antigen Measured by ELISA
Day 29
|
461.7 ng/mL
Interval 367.1 to 580.8
|
673.4 ng/mL
Interval 512.3 to 885.1
|
16.8 ng/mL
Interval 15.8 to 17.7
|
278.3 ng/mL
Interval 216.7 to 357.4
|
311.2 ng/mL
Interval 233.9 to 414.0
|
—
|
—
|
—
|
|
GMC of Anti-OspA Binding IgG Antibodies for SR-4 Antigen Measured by ELISA
Day 85
|
16893.9 ng/mL
Interval 14300.6 to 19957.5
|
17014.8 ng/mL
Interval 13540.2 to 21381.0
|
19.1 ng/mL
Interval 14.7 to 24.8
|
7657.5 ng/mL
Interval 6041.3 to 9706.0
|
10956.1 ng/mL
Interval 8618.8 to 13927.4
|
—
|
—
|
—
|
|
GMC of Anti-OspA Binding IgG Antibodies for SR-4 Antigen Measured by ELISA
Day 197
|
30140.4 ng/mL
Interval 25139.1 to 36136.6
|
33650.8 ng/mL
Interval 28045.2 to 40376.9
|
21.0 ng/mL
Interval 15.7 to 28.1
|
16321.2 ng/mL
Interval 13797.4 to 19306.7
|
18558.6 ng/mL
Interval 14731.0 to 23380.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 29, 85 and 197Population: PP Set: randomized participants who received at least 1 dose of study vaccine, complied with injection schedule, timing of immunogenicity blood sampling, had a baseline and at least 1 post-injection assessment, and had no major protocol deviations that impacted immune response. Overall number of participants analyzed=participants assessed for overall outcome measure. Number analyzed=participants assessed for specified timepoint. Not all participants were assessed for all timepoints reported.
Antibody values reported as below LLOQ were replaced by 0.5\*LLOQ. Values reported greater than ULOQ were replaced by the ULOQ. LLOQ was 45.5 ng/mL and ULOQ was 298000 ng/mL for manual assay; LLOQ was 84.2 ng/mL and 319000 ng/mL for automated assay for SR-5 IgG antibody. 95% CI for GM value was calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation. Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
Outcome measures
| Measure |
mRNA-1975 Dose Level 3
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 100 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 4
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 150 μg on Days 1, 57, and 169.
|
Placebo
n=50 Participants
Participants received 3 IM injections of the vaccine matching placebo on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 1
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 25 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 2
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 50 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 2
Participants received 3 IM injections of the mRNA-1982 vaccine at 25 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 3
Participants received 3 IM injections of the mRNA-1982 vaccine at 50 μg on Days 1, 57, and 169.
|
Placebo
Participants received 3 IM injections of the vaccine matching placebo on Days 1, 57, and 169.
|
|---|---|---|---|---|---|---|---|---|
|
GMC of Anti-OspA Binding IgG Antibodies for SR-5 Antigen Measured by ELISA
Day 1
|
23.2 ng/mL
Interval 22.6 to 23.7
|
24.1 ng/mL
Interval 22.2 to 26.2
|
23.5 ng/mL
Interval 22.4 to 24.7
|
23.1 ng/mL
Interval 22.6 to 23.7
|
24.8 ng/mL
Interval 22.5 to 27.4
|
—
|
—
|
—
|
|
GMC of Anti-OspA Binding IgG Antibodies for SR-5 Antigen Measured by ELISA
Day 29
|
429.2 ng/mL
Interval 342.0 to 538.7
|
574.3 ng/mL
Interval 447.4 to 737.3
|
23.5 ng/mL
Interval 22.4 to 24.6
|
227.8 ng/mL
Interval 181.1 to 286.7
|
312.8 ng/mL
Interval 237.5 to 411.9
|
—
|
—
|
—
|
|
GMC of Anti-OspA Binding IgG Antibodies for SR-5 Antigen Measured by ELISA
Day 85
|
28935.8 ng/mL
Interval 24549.3 to 34106.2
|
29379.4 ng/mL
Interval 23500.4 to 36729.0
|
26.5 ng/mL
Interval 20.2 to 34.9
|
12397.8 ng/mL
Interval 9776.0 to 15722.8
|
18278.8 ng/mL
Interval 14417.0 to 23175.1
|
—
|
—
|
—
|
|
GMC of Anti-OspA Binding IgG Antibodies for SR-5 Antigen Measured by ELISA
Day 197
|
48316.4 ng/mL
Interval 40666.4 to 57405.4
|
55926.3 ng/mL
Interval 47330.2 to 66083.6
|
28.8 ng/mL
Interval 21.3 to 38.8
|
25936.7 ng/mL
Interval 22160.8 to 30355.9
|
30441.9 ng/mL
Interval 24264.0 to 38192.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 29, 85 and 197Population: PP Set: randomized participants who received at least 1 dose of study vaccine, complied with injection schedule, timing of immunogenicity blood sampling, had a baseline and at least 1 post-injection assessment, and had no major protocol deviations that impacted immune response. Overall number of participants analyzed=participants assessed for overall outcome measure. Number analyzed=participants assessed for specified timepoint. Not all participants were assessed for all timepoints reported.
Antibody values reported as below LLOQ were replaced by 0.5\*LLOQ. Values reported greater than ULOQ were replaced by the ULOQ. LLOQ was 18.1 ng/mL and ULOQ was 203000 ng/mL for manual assay; LLOQ was 68.7 ng/mL and 248000 ng/mL for automated assay for SR-6 IgG antibody. 95% CI for GM value was calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation. Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
Outcome measures
| Measure |
mRNA-1975 Dose Level 3
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 100 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 4
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 150 μg on Days 1, 57, and 169.
|
Placebo
n=50 Participants
Participants received 3 IM injections of the vaccine matching placebo on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 1
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 25 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 2
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 50 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 2
Participants received 3 IM injections of the mRNA-1982 vaccine at 25 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 3
Participants received 3 IM injections of the mRNA-1982 vaccine at 50 μg on Days 1, 57, and 169.
|
Placebo
Participants received 3 IM injections of the vaccine matching placebo on Days 1, 57, and 169.
|
|---|---|---|---|---|---|---|---|---|
|
GMC of Anti-OspA Binding IgG Antibodies for SR-6 Antigen Measured by ELISA
Day 85
|
24822.5 ng/mL
Interval 20955.4 to 29403.1
|
24350.5 ng/mL
Interval 19698.1 to 30101.7
|
19.1 ng/mL
Interval 13.2 to 27.6
|
10562.2 ng/mL
Interval 8398.7 to 13283.0
|
15196.8 ng/mL
Interval 12110.6 to 19069.5
|
—
|
—
|
—
|
|
GMC of Anti-OspA Binding IgG Antibodies for SR-6 Antigen Measured by ELISA
Day 197
|
40282.3 ng/mL
Interval 33744.1 to 48087.4
|
45703.0 ng/mL
Interval 38542.2 to 54194.3
|
20.5 ng/mL
Interval 13.8 to 30.5
|
21974.2 ng/mL
Interval 18498.7 to 26102.8
|
24469.9 ng/mL
Interval 19561.2 to 30610.5
|
—
|
—
|
—
|
|
GMC of Anti-OspA Binding IgG Antibodies for SR-6 Antigen Measured by ELISA
Day 1
|
17.4 ng/mL
Interval 14.0 to 21.7
|
16.5 ng/mL
Interval 13.3 to 20.6
|
16.1 ng/mL
Interval 12.4 to 20.8
|
15.7 ng/mL
Interval 12.9 to 19.0
|
17.8 ng/mL
Interval 14.2 to 22.5
|
—
|
—
|
—
|
|
GMC of Anti-OspA Binding IgG Antibodies for SR-6 Antigen Measured by ELISA
Day 29
|
1455.3 ng/mL
Interval 1098.3 to 1928.3
|
2053.0 ng/mL
Interval 1519.8 to 2773.3
|
17.4 ng/mL
Interval 12.8 to 23.7
|
908.6 ng/mL
Interval 686.7 to 1202.2
|
966.1 ng/mL
Interval 707.5 to 1319.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 29, 85 and 197Population: PP Set: randomized participants who received at least 1 dose of study vaccine, complied with injection schedule, timing of immunogenicity blood sampling, had a baseline and at least 1 post-injection assessment, and had no major protocol deviations that impacted immune response. Overall number of participants analyzed=participants assessed for overall outcome measure. Number analyzed=participants assessed for specified timepoint. Not all participants were assessed for all timepoints reported.
Antibody values reported as below LLOQ were replaced by 0.5\*LLOQ. Values reported greater than ULOQ were replaced by the ULOQ. LLOQ was 13 ng/mL and ULOQ was 197000 ng/mL for manual assay; LLOQ was 78.9 ng/mL and 174000 ng/mL for automated assay for SR-7 IgG antibody. 95% CI for GM value was calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation. Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
Outcome measures
| Measure |
mRNA-1975 Dose Level 3
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 100 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 4
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 150 μg on Days 1, 57, and 169.
|
Placebo
n=50 Participants
Participants received 3 IM injections of the vaccine matching placebo on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 1
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 25 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 2
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 50 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 2
Participants received 3 IM injections of the mRNA-1982 vaccine at 25 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 3
Participants received 3 IM injections of the mRNA-1982 vaccine at 50 μg on Days 1, 57, and 169.
|
Placebo
Participants received 3 IM injections of the vaccine matching placebo on Days 1, 57, and 169.
|
|---|---|---|---|---|---|---|---|---|
|
GMC of Anti-OspA Binding IgG Antibodies for SR-7 Antigen Measured by ELISA
Day 1
|
8.9 ng/mL
Interval 7.7 to 10.3
|
9.3 ng/mL
Interval 7.8 to 11.0
|
9.9 ng/mL
Interval 8.0 to 12.3
|
9.5 ng/mL
Interval 7.8 to 11.4
|
9.4 ng/mL
Interval 7.8 to 11.3
|
—
|
—
|
—
|
|
GMC of Anti-OspA Binding IgG Antibodies for SR-7 Antigen Measured by ELISA
Day 29
|
567.4 ng/mL
Interval 444.9 to 723.7
|
730.4 ng/mL
Interval 533.6 to 999.7
|
9.3 ng/mL
Interval 7.6 to 11.3
|
360.8 ng/mL
Interval 281.2 to 462.8
|
314.7 ng/mL
Interval 226.3 to 437.6
|
—
|
—
|
—
|
|
GMC of Anti-OspA Binding IgG Antibodies for SR-7 Antigen Measured by ELISA
Day 85
|
32934.0 ng/mL
Interval 27492.3 to 39452.9
|
28756.5 ng/mL
Interval 22583.1 to 36617.5
|
11.4 ng/mL
Interval 7.8 to 16.6
|
15651.7 ng/mL
Interval 12231.7 to 20028.0
|
18865.4 ng/mL
Interval 14538.3 to 24480.3
|
—
|
—
|
—
|
|
GMC of Anti-OspA Binding IgG Antibodies for SR-7 Antigen Measured by ELISA
Day 197
|
44179.6 ng/mL
Interval 37498.2 to 52051.3
|
47777.3 ng/mL
Interval 40846.7 to 55883.8
|
11.0 ng/mL
Interval 7.9 to 15.4
|
27210.2 ng/mL
Interval 23148.9 to 31984.0
|
26425.1 ng/mL
Interval 21070.6 to 33140.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 29, 85 and 197Population: PP Set: randomized participants who received at least 1 dose of study vaccine, complied with injection schedule, timing of immunogenicity blood sampling, had a baseline and at least 1 post-injection assessment, and had no major protocol deviations that impacted immune response. Number analyzed = participants assessed for specified timepoint. Not all participants were assessed for all timepoints reported.
Antibody values reported as below LLOQ were replaced by 0.5\*LLOQ. Values reported greater than ULOQ were replaced by the ULOQ. LLOQ was 41.4 ng/mL and ULOQ was 428000 ng/mL for manual assay; LLOQ was 47.6 ng/mL and 583000 ng/mL for automated assay for SR-1 IgG antibody. 95% CI for GMFR value was calculated based on the t-distribution of the difference in the log-transformed values, then back transformed to the original scale for presentation.
Outcome measures
| Measure |
mRNA-1975 Dose Level 3
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 100 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 4
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 150 μg on Days 1, 57, and 169.
|
Placebo
n=96 Participants
Participants received 3 IM injections of the vaccine matching placebo on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 1
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 25 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 2
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 50 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 2
n=99 Participants
Participants received 3 IM injections of the mRNA-1982 vaccine at 25 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 3
n=102 Participants
Participants received 3 IM injections of the mRNA-1982 vaccine at 50 μg on Days 1, 57, and 169.
|
Placebo
n=100 Participants
Participants received 3 IM injections of the vaccine matching placebo on Days 1, 57, and 169.
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) of Anti-OspA Binding IgG Antibody Concentration for SR-1 Antigen
Day 29
|
16.00 ratio
Interval 12.45 to 20.56
|
15.13 ratio
Interval 11.87 to 19.28
|
6.52 ratio
Interval 5.09 to 8.35
|
6.36 ratio
Interval 4.96 to 8.15
|
9.07 ratio
Interval 6.97 to 11.81
|
8.18 ratio
Interval 6.18 to 10.83
|
13.24 ratio
Interval 10.45 to 16.77
|
1.07 ratio
Interval 0.99 to 1.16
|
|
Geometric Mean Fold Rise (GMFR) of Anti-OspA Binding IgG Antibody Concentration for SR-1 Antigen
Day 85
|
866.31 ratio
Interval 728.39 to 1030.33
|
822.95 ratio
Interval 651.97 to 1038.75
|
470.15 ratio
Interval 366.95 to 602.37
|
367.86 ratio
Interval 289.59 to 467.29
|
543.18 ratio
Interval 424.67 to 694.76
|
581.89 ratio
Interval 480.79 to 704.25
|
662.04 ratio
Interval 540.01 to 811.66
|
1.06 ratio
Interval 0.93 to 1.22
|
|
Geometric Mean Fold Rise (GMFR) of Anti-OspA Binding IgG Antibody Concentration for SR-1 Antigen
Day 197
|
1601.46 ratio
Interval 1338.41 to 1916.2
|
1658.31 ratio
Interval 1352.59 to 2033.15
|
993.15 ratio
Interval 794.82 to 1240.96
|
867.49 ratio
Interval 733.47 to 1026.0
|
938.35 ratio
Interval 744.25 to 1183.07
|
1300.55 ratio
Interval 1088.8 to 1553.5
|
1253.29 ratio
Interval 1036.49 to 1515.44
|
1.11 ratio
Interval 0.96 to 1.26
|
SECONDARY outcome
Timeframe: Days 29, 85 and 197Population: PP Set: randomized participants who received at least 1 dose of study vaccine, complied with injection schedule, timing of immunogenicity blood sampling, had a baseline and at least 1 post-injection assessment, and had no major protocol deviations that impacted immune response. Overall number of participants analyzed=participants assessed for overall outcome measure. Number analyzed=participants assessed for specified timepoint. Not all participants were assessed for all timepoints reported.
Antibody values reported as below LLOQ were replaced by 0.5\*LLOQ. Values reported greater than ULOQ were replaced by the ULOQ. LLOQ was 30 ng/mL and ULOQ was 214000 ng/mL for manual assay; LLOQ was 66.6 ng/mL and 215000 ng/mL for automated assay for SR-2 IgG antibody. 95% CI for GMFR value was calculated based on the t-distribution of the difference in the log-transformed values, then back transformed to the original scale for presentation. Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
Outcome measures
| Measure |
mRNA-1975 Dose Level 3
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 100 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 4
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 150 μg on Days 1, 57, and 169.
|
Placebo
n=50 Participants
Participants received 3 IM injections of the vaccine matching placebo on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 1
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 25 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 2
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 50 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 2
Participants received 3 IM injections of the mRNA-1982 vaccine at 25 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 3
Participants received 3 IM injections of the mRNA-1982 vaccine at 50 μg on Days 1, 57, and 169.
|
Placebo
Participants received 3 IM injections of the vaccine matching placebo on Days 1, 57, and 169.
|
|---|---|---|---|---|---|---|---|---|
|
GMFR of Anti-OspA Binding IgG Antibody Concentration for SR-2 Antigen
Day 29
|
56.25 ratio
Interval 44.0 to 71.91
|
61.84 ratio
Interval 47.73 to 80.11
|
0.97 ratio
Interval 0.93 to 1.01
|
28.03 ratio
Interval 22.24 to 35.34
|
29.49 ratio
Interval 22.81 to 38.12
|
—
|
—
|
—
|
|
GMFR of Anti-OspA Binding IgG Antibody Concentration for SR-2 Antigen
Day 85
|
1500.72 ratio
Interval 1221.09 to 1844.39
|
1438.92 ratio
Interval 1128.33 to 1835.01
|
1.15 ratio
Interval 0.86 to 1.53
|
718.13 ratio
Interval 566.61 to 910.17
|
902.85 ratio
Interval 704.35 to 1157.29
|
—
|
—
|
—
|
|
GMFR of Anti-OspA Binding IgG Antibody Concentration for SR-2 Antigen
Day 197
|
2188.32 ratio
Interval 1824.82 to 2624.23
|
2316.91 ratio
Interval 1920.38 to 2795.31
|
1.19 ratio
Interval 0.89 to 1.59
|
1165.32 ratio
Interval 984.17 to 1379.8
|
1236.85 ratio
Interval 958.68 to 1595.74
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 29, 85 and 197Population: PP Set: randomized participants who received at least 1 dose of study vaccine, complied with injection schedule, timing of immunogenicity blood sampling, had a baseline and at least 1 post-injection assessment, and had no major protocol deviations that impacted immune response. Overall number of participants analyzed=participants assessed for overall outcome measure. Number analyzed=participants assessed for specified timepoint. Not all participants were assessed for all timepoints reported.
Antibody values reported as below LLOQ were replaced by 0.5\*LLOQ. Values reported greater than ULOQ were replaced by the ULOQ. LLOQ was 14.5 ng/mL and ULOQ was 299000 ng/mL for manual assay; LLOQ was 62.5 ng/mL and 296000 ng/mL for automated assay for SR-3 IgG antibody. 95% CI for GMFR value was calculated based on the t-distribution of the difference in the log-transformed values, then back transformed to the original scale for presentation. Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
Outcome measures
| Measure |
mRNA-1975 Dose Level 3
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 100 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 4
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 150 μg on Days 1, 57, and 169.
|
Placebo
n=50 Participants
Participants received 3 IM injections of the vaccine matching placebo on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 1
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 25 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 2
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 50 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 2
Participants received 3 IM injections of the mRNA-1982 vaccine at 25 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 3
Participants received 3 IM injections of the mRNA-1982 vaccine at 50 μg on Days 1, 57, and 169.
|
Placebo
Participants received 3 IM injections of the vaccine matching placebo on Days 1, 57, and 169.
|
|---|---|---|---|---|---|---|---|---|
|
GMFR of Anti-OspA Binding IgG Antibody Concentration for SR-3 Antigen
Day 29
|
52.58 ratio
Interval 40.16 to 68.84
|
53.48 ratio
Interval 40.99 to 69.76
|
0.93 ratio
Interval 0.86 to 1.01
|
27.98 ratio
Interval 21.92 to 35.7
|
28.19 ratio
Interval 21.73 to 36.57
|
—
|
—
|
—
|
|
GMFR of Anti-OspA Binding IgG Antibody Concentration for SR-3 Antigen
Day 85
|
4651.11 ratio
Interval 3749.37 to 5769.72
|
4106.89 ratio
Interval 3104.97 to 5432.1
|
1.18 ratio
Interval 0.83 to 1.68
|
1871.56 ratio
Interval 1397.22 to 2506.93
|
2677.78 ratio
Interval 2008.72 to 3569.68
|
—
|
—
|
—
|
|
GMFR of Anti-OspA Binding IgG Antibody Concentration for SR-3 Antigen
Day 197
|
6328.99 ratio
Interval 5160.22 to 7762.48
|
6487.62 ratio
Interval 5164.85 to 8149.16
|
1.02 ratio
Interval 0.77 to 1.36
|
3249.93 ratio
Interval 2735.98 to 3860.42
|
3689.50 ratio
Interval 2820.14 to 4826.86
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 29, 85 and 197Population: PP Set: randomized participants who received at least 1 dose of study vaccine, complied with injection schedule, timing of immunogenicity blood sampling, had a baseline and at least 1 post-injection assessment, and had no major protocol deviations that impacted immune response. Overall number of participants analyzed=participants assessed for overall outcome measure. Number analyzed=participants assessed for specified timepoint. Not all participants were assessed for all timepoints reported.
Antibody values reported as below LLOQ were replaced by 0.5\*LLOQ. Values reported greater than ULOQ were replaced by the ULOQ. LLOQ was 32.6 ng/mL and ULOQ was 292000 ng/mL for manual assay; LLOQ was 59.7 ng/mL and 264000 ng/mL for automated assay for SR-4 IgG antibody. 95% CI for GMFR value was calculated based on the t-distribution of the difference in the log-transformed values, then back transformed to the original scale for presentation. Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
Outcome measures
| Measure |
mRNA-1975 Dose Level 3
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 100 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 4
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 150 μg on Days 1, 57, and 169.
|
Placebo
n=50 Participants
Participants received 3 IM injections of the vaccine matching placebo on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 1
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 25 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 2
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 50 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 2
Participants received 3 IM injections of the mRNA-1982 vaccine at 25 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 3
Participants received 3 IM injections of the mRNA-1982 vaccine at 50 μg on Days 1, 57, and 169.
|
Placebo
Participants received 3 IM injections of the vaccine matching placebo on Days 1, 57, and 169.
|
|---|---|---|---|---|---|---|---|---|
|
GMFR of Anti-OspA Binding IgG Antibody Concentration for SR-4 Antigen
Day 29
|
26.32 ratio
Interval 20.83 to 33.25
|
36.26 ratio
Interval 27.78 to 47.32
|
0.96 ratio
Interval 0.91 to 1.01
|
15.84 ratio
Interval 12.51 to 20.05
|
16.90 ratio
Interval 13.17 to 21.67
|
—
|
—
|
—
|
|
GMFR of Anti-OspA Binding IgG Antibody Concentration for SR-4 Antigen
Day 85
|
960.06 ratio
Interval 795.84 to 1158.16
|
901.26 ratio
Interval 709.46 to 1144.93
|
1.09 ratio
Interval 0.84 to 1.42
|
435.52 ratio
Interval 341.99 to 554.63
|
600.04 ratio
Interval 470.06 to 765.97
|
—
|
—
|
—
|
|
GMFR of Anti-OspA Binding IgG Antibody Concentration for SR-4 Antigen
Day 197
|
1704.02 ratio
Interval 1391.81 to 2086.25
|
1784.54 ratio
Interval 1452.04 to 2193.18
|
1.20 ratio
Interval 0.9 to 1.61
|
923.60 ratio
Interval 773.02 to 1103.5
|
1012.74 ratio
Interval 796.67 to 1287.41
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 29, 85 and 197Population: PP Set: randomized participants who received at least 1 dose of study vaccine, complied with injection schedule, timing of immunogenicity blood sampling, had a baseline and at least 1 post-injection assessment, and had no major protocol deviations that impacted immune response. Overall number of participants analyzed=participants assessed for overall outcome measure. Number analyzed=participants assessed for specified timepoint. Not all participants were assessed for all timepoints reported.
Antibody values reported as below LLOQ were replaced by 0.5\*LLOQ. Values reported greater than ULOQ were replaced by the ULOQ. LLOQ was 45.5 ng/mL and ULOQ was 298000 ng/mL for manual assay; LLOQ was 84.2 ng/mL and 319000 ng/mL for automated assay for SR-5 IgG antibody. 95% CI for GMFR value was calculated based on the t-distribution of the difference in the log-transformed values, then back transformed to the original scale for presentation. Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
Outcome measures
| Measure |
mRNA-1975 Dose Level 3
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 100 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 4
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 150 μg on Days 1, 57, and 169.
|
Placebo
n=50 Participants
Participants received 3 IM injections of the vaccine matching placebo on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 1
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 25 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 2
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 50 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 2
Participants received 3 IM injections of the mRNA-1982 vaccine at 25 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 3
Participants received 3 IM injections of the mRNA-1982 vaccine at 50 μg on Days 1, 57, and 169.
|
Placebo
Participants received 3 IM injections of the vaccine matching placebo on Days 1, 57, and 169.
|
|---|---|---|---|---|---|---|---|---|
|
GMFR of Anti-OspA Binding IgG Antibody Concentration for SR-5 Antigen
Day 29
|
18.53 ratio
Interval 14.72 to 23.33
|
23.79 ratio
Interval 18.92 to 29.91
|
1.00 ratio
Interval 0.96 to 1.05
|
9.84 ratio
Interval 7.86 to 12.32
|
12.58 ratio
Interval 9.76 to 16.22
|
—
|
—
|
—
|
|
GMFR of Anti-OspA Binding IgG Antibody Concentration for SR-5 Antigen
Day 85
|
1248.40 ratio
Interval 1051.92 to 1481.58
|
1221.90 ratio
Interval 977.12 to 1528.01
|
1.13 ratio
Interval 0.86 to 1.48
|
535.26 ratio
Interval 422.24 to 678.54
|
734.72 ratio
Interval 574.47 to 939.67
|
—
|
—
|
—
|
|
GMFR of Anti-OspA Binding IgG Antibody Concentration for SR-5 Antigen
Day 197
|
2081.93 ratio
Interval 1742.35 to 2487.7
|
2313.13 ratio
Interval 1937.15 to 2762.07
|
1.22 ratio
Interval 0.9 to 1.65
|
1118.45 ratio
Interval 957.19 to 1306.88
|
1220.14 ratio
Interval 964.85 to 1542.97
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 29, 85 and 197Population: PP Set: randomized participants who received at least 1 dose of study vaccine, complied with injection schedule, timing of immunogenicity blood sampling, had a baseline and at least 1 post-injection assessment, and had no major protocol deviations that impacted immune response. Overall number of participants analyzed=participants assessed for overall outcome measure. Number analyzed=participants assessed for specified timepoint. Not all participants were assessed for all timepoints reported.
Antibody values reported as below LLOQ were replaced by 0.5\*LLOQ. Values reported greater than ULOQ were replaced by the ULOQ. LLOQ was 18.1 ng/mL and ULOQ was 203000 ng/mL for manual assay; LLOQ was 68.7 ng/mL and 248000 ng/mL for automated assay for SR-6 IgG antibody. 95% CI for GMFR value was calculated based on the t-distribution of the difference in the log-transformed values, then back transformed to the original scale for presentation. Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
Outcome measures
| Measure |
mRNA-1975 Dose Level 3
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 100 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 4
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 150 μg on Days 1, 57, and 169.
|
Placebo
n=50 Participants
Participants received 3 IM injections of the vaccine matching placebo on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 1
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 25 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 2
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 50 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 2
Participants received 3 IM injections of the mRNA-1982 vaccine at 25 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 3
Participants received 3 IM injections of the mRNA-1982 vaccine at 50 μg on Days 1, 57, and 169.
|
Placebo
Participants received 3 IM injections of the vaccine matching placebo on Days 1, 57, and 169.
|
|---|---|---|---|---|---|---|---|---|
|
GMFR of Anti-OspA Binding IgG Antibody Concentration for SR-6 Antigen
Day 29
|
83.55 ratio
Interval 61.4 to 113.68
|
126.77 ratio
Interval 92.88 to 173.02
|
1.08 ratio
Interval 0.88 to 1.34
|
57.36 ratio
Interval 44.3 to 74.28
|
54.45 ratio
Interval 40.29 to 73.59
|
—
|
—
|
—
|
|
GMFR of Anti-OspA Binding IgG Antibody Concentration for SR-6 Antigen
Day 85
|
1448.42 ratio
Interval 1066.27 to 1967.54
|
1459.96 ratio
Interval 1098.19 to 1940.9
|
1.20 ratio
Interval 0.97 to 1.47
|
687.70 ratio
Interval 530.8 to 890.99
|
858.93 ratio
Interval 628.91 to 1173.07
|
—
|
—
|
—
|
|
GMFR of Anti-OspA Binding IgG Antibody Concentration for SR-6 Antigen
Day 197
|
2444.57 ratio
Interval 1849.48 to 3231.14
|
2811.21 ratio
Interval 2119.73 to 3728.26
|
1.29 ratio
Interval 0.94 to 1.76
|
1422.17 ratio
Interval 1110.28 to 1821.67
|
1353.77 ratio
Interval 980.02 to 1870.04
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 29, 85 and 197Population: PP Set: randomized participants who received at least 1 dose of study vaccine, complied with injection schedule, timing of immunogenicity blood sampling, had a baseline and at least 1 post-injection assessment, and had no major protocol deviations that impacted immune response. Overall number of participants analyzed=participants assessed for overall outcome measure. Number analyzed=participants assessed for specified timepoint. Not all participants were assessed for all timepoints reported.
Antibody values reported as below LLOQ were replaced by 0.5\*LLOQ. Values reported greater than ULOQ were replaced by the ULOQ. LLOQ was 13 ng/mL and ULOQ was 197000 ng/mL for manual assay; LLOQ was 78.9 ng/mL and 174000 ng/mL for automated assay for SR-7 IgG antibody. 95% CI for GMFR value was calculated based on the t-distribution of the difference in the log-transformed values, then back transformed to the original scale for presentation. Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
Outcome measures
| Measure |
mRNA-1975 Dose Level 3
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 100 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 4
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 150 μg on Days 1, 57, and 169.
|
Placebo
n=50 Participants
Participants received 3 IM injections of the vaccine matching placebo on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 1
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 25 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 2
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 50 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 2
Participants received 3 IM injections of the mRNA-1982 vaccine at 25 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 3
Participants received 3 IM injections of the mRNA-1982 vaccine at 50 μg on Days 1, 57, and 169.
|
Placebo
Participants received 3 IM injections of the vaccine matching placebo on Days 1, 57, and 169.
|
|---|---|---|---|---|---|---|---|---|
|
GMFR of Anti-OspA Binding IgG Antibody Concentration for SR-7 Antigen
Day 85
|
3764.69 ratio
Interval 2894.54 to 4896.43
|
3085.38 ratio
Interval 2305.2 to 4129.62
|
1.17 ratio
Interval 0.82 to 1.65
|
1634.53 ratio
Interval 1211.14 to 2205.93
|
2059.80 ratio
Interval 1545.71 to 2744.87
|
—
|
—
|
—
|
|
GMFR of Anti-OspA Binding IgG Antibody Concentration for SR-7 Antigen
Day 29
|
63.76 ratio
Interval 48.29 to 84.18
|
79.96 ratio
Interval 58.39 to 109.51
|
0.93 ratio
Interval 0.88 to 1.0
|
37.83 ratio
Interval 29.46 to 48.57
|
33.46 ratio
Interval 24.91 to 44.95
|
—
|
—
|
—
|
|
GMFR of Anti-OspA Binding IgG Antibody Concentration for SR-7 Antigen
Day 197
|
5113.85 ratio
Interval 4044.21 to 6466.39
|
5235.80 ratio
Interval 4102.95 to 6681.44
|
1.13 ratio
Interval 0.84 to 1.51
|
2989.02 ratio
Interval 2414.14 to 3700.8
|
2882.41 ratio
Interval 2191.5 to 3791.14
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 up to Month 18Population: The randomization set consisted of all participants who were randomly assigned.
A death that occurred during the study or that came to the attention of the investigator during the study was reported to the Sponsor, whether or not it was considered related to study drug. The investigator assessed causality (that is, whether there is a reasonable possibility that the study drug caused the death). The relationship was characterized using the following classifications: Not related: There was not a reasonable possibility of a relationship to the study drug. The temporal sequence of the death relative to administration of the study drug was not reasonable AND/OR the death was more likely explained by a cause other than the study drug. Related: There was a reasonable possibility of a relationship to the study drug. There was evidence of exposure to the study drug. The temporal sequence of the death relative to the administration of the study drug was reasonable. The death was more likely explained by the study drug than by another cause.
Outcome measures
| Measure |
mRNA-1975 Dose Level 3
n=99 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 100 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 4
n=102 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 150 μg on Days 1, 57, and 169.
|
Placebo
n=99 Participants
Participants received 3 IM injections of the vaccine matching placebo on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 1
n=100 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 25 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 2
n=101 Participants
Participants received 3 IM injections of the mRNA-1975 vaccine at 50 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 2
n=100 Participants
Participants received 3 IM injections of the mRNA-1982 vaccine at 25 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 3
n=104 Participants
Participants received 3 IM injections of the mRNA-1982 vaccine at 50 μg on Days 1, 57, and 169.
|
Placebo
n=102 Participants
Participants received 3 IM injections of the vaccine matching placebo on Days 1, 57, and 169.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Deaths Related to Study Drug
Deaths
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Deaths Related to Study Drug
Deaths related to study drug
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
mRNA-1982 Dose Level 3
Serious events: 4 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo
Serious events: 7 serious events
Other events: 12 other events
Deaths: 1 deaths
mRNA-1975 Dose Level 1
Serious events: 4 serious events
Other events: 12 other events
Deaths: 0 deaths
mRNA-1975 Dose Level 2
Serious events: 4 serious events
Other events: 16 other events
Deaths: 1 deaths
mRNA-1975 Dose Level 3
Serious events: 6 serious events
Other events: 6 other events
Deaths: 0 deaths
mRNA-1975 Dose Level 4
Serious events: 4 serious events
Other events: 13 other events
Deaths: 1 deaths
mRNA-1982 Dose Level 1
Serious events: 6 serious events
Other events: 15 other events
Deaths: 0 deaths
mRNA-1982 Dose Level 2
Serious events: 3 serious events
Other events: 14 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
mRNA-1982 Dose Level 3
n=105 participants at risk
Participants received 3 IM injections of the mRNA-1982 vaccine at 50 μg on Days 1, 57, and 169.
|
Placebo
n=101 participants at risk
Participants received 3 IM injections of vaccine matching placebo on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 1
n=100 participants at risk
Participants received 3 IM injections of the mRNA-1975 vaccine at 25 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 2
n=101 participants at risk
Participants received 3 IM injections of the mRNA-1975 vaccine at 50 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 3
n=99 participants at risk
Participants received 3 IM injections of the mRNA-1975 vaccine at 100 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 4
n=102 participants at risk
Participants received 3 IM injections of the mRNA-1975 vaccine at 150 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 1
n=98 participants at risk
Participants received 3 IM injections of the mRNA-1982 vaccine at 12.5 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 2
n=100 participants at risk
Participants received 3 IM injections of the mRNA-1982 vaccine at 25 μg on Days 1, 57, and 169.
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/105 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/99 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/102 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
1.0%
1/98 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
|
Infections and infestations
COVID-19
|
0.00%
0/105 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/99 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/102 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
1.0%
1/98 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
|
Infections and infestations
Cystitis klebsiella
|
0.00%
0/105 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/99 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.98%
1/102 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/98 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/105 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/99 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.98%
1/102 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/98 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
1.0%
1/100 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/105 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
1.0%
1/100 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/99 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/102 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/98 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/105 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
1.0%
1/99 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/102 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/98 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/105 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/99 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/102 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
1.0%
1/98 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/105 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
2.0%
2/99 • Number of events 2 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/102 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/98 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/105 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.99%
1/101 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/99 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/102 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/98 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/105 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
1.0%
1/99 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/102 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/98 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal neoplasm
|
0.00%
0/105 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/99 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/102 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/98 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
1.0%
1/100 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/105 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/99 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.98%
1/102 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/98 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.00%
0/105 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/99 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/102 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
1.0%
1/98 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.00%
0/105 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
1.0%
1/100 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/99 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/102 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/98 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma recurrent
|
0.00%
0/105 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.99%
1/101 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/99 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/102 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/98 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/105 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
1.0%
1/99 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/102 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/98 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
|
Metabolism and nutrition disorders
Euglycaemic diabetic ketoacidosis
|
0.00%
0/105 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.99%
1/101 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/99 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/102 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/98 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/105 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
1.0%
1/99 • Number of events 2 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/102 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/98 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/105 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
1.0%
1/99 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/102 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/98 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
|
Nervous system disorders
Middle cerebral artery stroke
|
0.00%
0/105 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
1.0%
1/100 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/99 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/102 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/98 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/105 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
1.0%
1/99 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/102 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/98 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/105 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/99 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/102 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/98 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
1.0%
1/100 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
|
Nervous system disorders
Syncope
|
0.00%
0/105 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.99%
1/101 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
1.0%
1/99 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/102 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/98 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/105 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.99%
1/101 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/99 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/102 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/98 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/105 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/99 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/102 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
1.0%
1/98 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/105 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
1.0%
1/100 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/99 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/102 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/98 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/105 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
1.0%
1/100 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/99 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/102 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/98 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
|
Vascular disorders
Deep vein thrombosis
|
0.95%
1/105 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/99 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/102 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/98 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
|
Vascular disorders
Subclavian steal syndrome
|
0.00%
0/105 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/99 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/102 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
1.0%
1/98 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/105 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/99 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/102 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
1.0%
1/98 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/105 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.99%
1/101 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/99 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/102 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/98 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/105 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.99%
1/101 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/99 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/102 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/98 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.00%
0/105 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/99 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.98%
1/102 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/98 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/105 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
1.0%
1/100 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/99 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/102 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/98 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/105 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/99 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/102 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/98 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
1.0%
1/100 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/105 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
1.0%
1/99 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/102 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/98 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/105 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/99 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.98%
1/102 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/98 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
1.0%
1/100 • Number of events 2 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.95%
1/105 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
1.0%
1/99 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/102 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/98 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/105 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.99%
1/101 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/99 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/102 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/98 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.95%
1/105 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.99%
1/101 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/99 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/102 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/98 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/105 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
1.0%
1/99 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/102 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/98 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.95%
1/105 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/99 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/102 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/98 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/105 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/99 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/102 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
1.0%
1/98 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
|
General disorders
Death
|
0.00%
0/105 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/99 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.98%
1/102 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/98 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/105 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
1.0%
1/99 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/102 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/98 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/105 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/99 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.98%
1/102 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/98 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/105 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.99%
1/101 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/99 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/102 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/98 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/105 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.99%
1/101 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/99 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/102 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/98 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/105 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.99%
1/101 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/101 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/99 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/102 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/98 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.00%
0/100 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
Other adverse events
| Measure |
mRNA-1982 Dose Level 3
n=105 participants at risk
Participants received 3 IM injections of the mRNA-1982 vaccine at 50 μg on Days 1, 57, and 169.
|
Placebo
n=101 participants at risk
Participants received 3 IM injections of vaccine matching placebo on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 1
n=100 participants at risk
Participants received 3 IM injections of the mRNA-1975 vaccine at 25 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 2
n=101 participants at risk
Participants received 3 IM injections of the mRNA-1975 vaccine at 50 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 3
n=99 participants at risk
Participants received 3 IM injections of the mRNA-1975 vaccine at 100 μg on Days 1, 57, and 169.
|
mRNA-1975 Dose Level 4
n=102 participants at risk
Participants received 3 IM injections of the mRNA-1975 vaccine at 150 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 1
n=98 participants at risk
Participants received 3 IM injections of the mRNA-1982 vaccine at 12.5 μg on Days 1, 57, and 169.
|
mRNA-1982 Dose Level 2
n=100 participants at risk
Participants received 3 IM injections of the mRNA-1982 vaccine at 25 μg on Days 1, 57, and 169.
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
1.9%
2/105 • Number of events 2 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
5.9%
6/101 • Number of events 6 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
5.0%
5/100 • Number of events 5 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
7.9%
8/101 • Number of events 8 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
2.0%
2/99 • Number of events 2 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
6.9%
7/102 • Number of events 7 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
6.1%
6/98 • Number of events 6 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
5.0%
5/100 • Number of events 5 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.7%
6/105 • Number of events 6 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
5.0%
5/101 • Number of events 5 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
7.0%
7/100 • Number of events 8 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
7.9%
8/101 • Number of events 8 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
3.0%
3/99 • Number of events 3 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
5.9%
6/102 • Number of events 6 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
8.2%
8/98 • Number of events 9 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
8.0%
8/100 • Number of events 9 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.95%
1/105 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.99%
1/101 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
1.0%
1/100 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
2.0%
2/101 • Number of events 2 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
1.0%
1/99 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
0.98%
1/102 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
5.1%
5/98 • Number of events 5 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
3.0%
3/100 • Number of events 3 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected from Day 1 up to Month 18. Other (non-serious) adverse events were collected from the time of injection through 28 days after each injection, unless they met the criteria for SAEs, AESIs, MAAEs, or AEs led to study discontinuation.
All-cause mortality data was based on the randomization Set, which consisted of all randomized participants. The serious and other (not including serious) adverse events were based on the safety set, which included all randomly assigned participants who received the study vaccine. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place