Trial Outcomes & Findings for A Study of mRNA-1010 Seasonal Influenza Vaccine in Healthy Adults (NCT NCT04956575)
NCT ID: NCT04956575
Last Updated: 2023-10-27
Results Overview
Solicited ARs (local and systemic) were collected in the electronic diary (eDiary). Local ARs included: pain at injection site, erythema (redness) at injection site, swelling/induration (hardness) at injection site, and localized axillary swelling or tenderness ipsilateral to the injection arm. Systemic ARs included: headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, rash, body temperature (potentially fever), and chills. Solicited ARs (local and systemic) considered causally related to injection were graded 0-4; lower score indicates lower severity and a higher score indicates greater severity. Note, not all solicited ARs were considered adverse events (AEs). The Investigator reviewed whether the solicited AR was also to be recorded as an AE. Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is in Reported "Adverse Events" section and presented by Phase/dose group.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
885 participants
Primary outcome timeframe
7 days after vaccination
Results posted on
2023-10-27
Participant Flow
This study was conducted at 20 centers in the United States. The vaccines used in the study were based on the influenza virus strains recommended by the World Health Organization for the southern and northern hemispheres.
For Phase 1/2, 1 participant who was randomly assigned to the 200 micrograms (ug) mRNA-1010 group received a dose of 100 ug and was therefore included in the 100 ug mRNA-1010 group in the Safety Set and the Solicited Safety Set. For Phase 2 Northern Hemisphere (NH), 1 participant randomly assigned to the 25 ug mRNA-1010 group received 50 ug mRNA-1010, and 1 participant randomly assigned to 50 ug mRNA-1010 received Afluria Quadrivalent.
Participant milestones
| Measure |
Phase 1/2: Placebo
Participants received placebo matching to mRNA-1010 by intramuscular (IM) injection on Day 1.
|
Phase 1/2: mRNA-1010 50 ug
Participants received mRNA-1010 50 ug by IM injection on Day 1.
|
Phase 1/2: mRNA-1010 100 ug
Participants received mRNA-1010 100 ug by IM injection on Day 1.
|
Phase 1/2: mRNA-1010 200 ug
Participants received mRNA-1010 200 ug by IM injection on Day 1.
|
Phase 2 NH: Afluria Quadrivalent 60 ug
Participants received Afluria Quadrivalent 60 ug by IM injection on Day 1.
|
Phase 2 NH: mRNA-1010 25 ug
Participants received mRNA-1010 25 ug by IM injection on Day 1.
|
Phase 2 NH: mRNA-1010 50 ug
Participants received mRNA-1010 50 ug by IM injection on Day 1.
|
Phase 2 NH: mRNA-1010 100 ug
Participants received mRNA-1010 100 ug by IM injection on Day 1.
|
Phase 2 Extension: Afluria Quadrivalent 60 ug
Participants received Afluria Quadrivalent 60 ug by IM injection on Day 1.
|
Phase 2 Extension: mRNA-1010 6.25 ug
Participants received mRNA-1010 6.25 ug by IM injection on Day 1.
|
Phase 2 Extension: mRNA-1010 12.5 ug
Participants received mRNA-1010 12.5 ug by IM injection on Day 1.
|
Phase 2 Extension: mRNA-1010 25 ug
Participants received mRNA-1010 25 ug by IM injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
45
|
45
|
45
|
45
|
53
|
153
|
149
|
148
|
51
|
50
|
51
|
50
|
|
Overall Study
Received at Least 1 Dose of Investigational Product
|
45
|
45
|
45
|
45
|
53
|
151
|
147
|
147
|
51
|
50
|
50
|
49
|
|
Overall Study
Safety Analysis Set
|
45
|
45
|
46
|
44
|
54
|
150
|
147
|
147
|
51
|
50
|
50
|
49
|
|
Overall Study
Solicited Safety Set
|
44
|
45
|
46
|
44
|
53
|
149
|
146
|
145
|
51
|
50
|
50
|
49
|
|
Overall Study
Per-Protocol (PP) Set
|
41
|
43
|
44
|
41
|
52
|
144
|
138
|
141
|
48
|
49
|
47
|
46
|
|
Overall Study
COMPLETED
|
40
|
39
|
42
|
38
|
50
|
135
|
133
|
139
|
46
|
47
|
45
|
41
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
3
|
7
|
3
|
18
|
16
|
9
|
5
|
3
|
6
|
9
|
Reasons for withdrawal
| Measure |
Phase 1/2: Placebo
Participants received placebo matching to mRNA-1010 by intramuscular (IM) injection on Day 1.
|
Phase 1/2: mRNA-1010 50 ug
Participants received mRNA-1010 50 ug by IM injection on Day 1.
|
Phase 1/2: mRNA-1010 100 ug
Participants received mRNA-1010 100 ug by IM injection on Day 1.
|
Phase 1/2: mRNA-1010 200 ug
Participants received mRNA-1010 200 ug by IM injection on Day 1.
|
Phase 2 NH: Afluria Quadrivalent 60 ug
Participants received Afluria Quadrivalent 60 ug by IM injection on Day 1.
|
Phase 2 NH: mRNA-1010 25 ug
Participants received mRNA-1010 25 ug by IM injection on Day 1.
|
Phase 2 NH: mRNA-1010 50 ug
Participants received mRNA-1010 50 ug by IM injection on Day 1.
|
Phase 2 NH: mRNA-1010 100 ug
Participants received mRNA-1010 100 ug by IM injection on Day 1.
|
Phase 2 Extension: Afluria Quadrivalent 60 ug
Participants received Afluria Quadrivalent 60 ug by IM injection on Day 1.
|
Phase 2 Extension: mRNA-1010 6.25 ug
Participants received mRNA-1010 6.25 ug by IM injection on Day 1.
|
Phase 2 Extension: mRNA-1010 12.5 ug
Participants received mRNA-1010 12.5 ug by IM injection on Day 1.
|
Phase 2 Extension: mRNA-1010 25 ug
Participants received mRNA-1010 25 ug by IM injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
2
|
3
|
1
|
10
|
11
|
7
|
4
|
2
|
3
|
8
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
1
|
4
|
2
|
8
|
5
|
1
|
1
|
0
|
3
|
1
|
Baseline Characteristics
A Study of mRNA-1010 Seasonal Influenza Vaccine in Healthy Adults
Baseline characteristics by cohort
| Measure |
Phase 1/2: Placebo
n=45 Participants
Participants received placebo matching to mRNA-1010 by IM injection on Day 1.
|
Phase 1/2: mRNA-1010 50 ug
n=45 Participants
Participants received mRNA-1010 50 ug by IM injection on Day 1.
|
Phase 1/2: mRNA-1010 100 ug
n=46 Participants
Participants received mRNA-1010 100 ug by IM injection on Day 1.
|
Phase 1/2: mRNA-1010 200 ug
n=44 Participants
Participants received mRNA-1010 200 ug by IM injection on Day 1.
|
Phase 2 NH: Afluria Quadrivalent 60 ug
n=54 Participants
Participants received Afluria Quadrivalent 60 ug by IM injection on Day 1.
|
Phase 2 NH: mRNA-1010 25 ug
n=150 Participants
Participants received mRNA-1010 25 ug by IM injection on Day 1.
|
Phase 2 NH: mRNA-1010 50 ug
n=147 Participants
Participants received mRNA-1010 50 ug by IM injection on Day 1.
|
Phase 2 NH: mRNA-1010 100 ug
n=147 Participants
Participants received mRNA-1010 100 ug by IM injection on Day 1.
|
Phase 2 Extension: Afluria Quadrivalent 60 ug
n=51 Participants
Participants received Afluria Quadrivalent 60 ug by IM injection on Day 1
|
Phase 2 Extension: mRNA-1010 6.25 ug
n=50 Participants
Participants received mRNA-1010 6.25 ug by IM injection on Day 1.
|
Phase 2 Extension: mRNA-1010 12.5 ug
n=50 Participants
Participants received mRNA-1010 12.5 ug by IM injection on Day 1.
|
Phase 2 Extension: mRNA-1010 25 ug
n=49 Participants
Participants received mRNA-1010 25 ug by IM injection on Day 1.
|
Total
n=878 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
52.0 years
n=5 Participants
|
48.2 years
n=7 Participants
|
52.2 years
n=5 Participants
|
48.9 years
n=4 Participants
|
52.4 years
n=21 Participants
|
50.4 years
n=8 Participants
|
50.3 years
n=8 Participants
|
49.9 years
n=24 Participants
|
40.8 years
n=42 Participants
|
40.4 years
n=42 Participants
|
42.8 years
n=42 Participants
|
38.9 years
n=42 Participants
|
47.3 years
n=36 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
89 Participants
n=8 Participants
|
80 Participants
n=8 Participants
|
86 Participants
n=24 Participants
|
24 Participants
n=42 Participants
|
34 Participants
n=42 Participants
|
27 Participants
n=42 Participants
|
30 Participants
n=42 Participants
|
500 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
61 Participants
n=8 Participants
|
67 Participants
n=8 Participants
|
61 Participants
n=24 Participants
|
27 Participants
n=42 Participants
|
16 Participants
n=42 Participants
|
23 Participants
n=42 Participants
|
19 Participants
n=42 Participants
|
378 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
27 Participants
n=8 Participants
|
32 Participants
n=8 Participants
|
29 Participants
n=24 Participants
|
17 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
14 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
188 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
122 Participants
n=8 Participants
|
114 Participants
n=8 Participants
|
114 Participants
n=24 Participants
|
34 Participants
n=42 Participants
|
36 Participants
n=42 Participants
|
35 Participants
n=42 Participants
|
36 Participants
n=42 Participants
|
677 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
13 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
White
|
38 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
124 Participants
n=8 Participants
|
120 Participants
n=8 Participants
|
124 Participants
n=24 Participants
|
47 Participants
n=42 Participants
|
44 Participants
n=42 Participants
|
39 Participants
n=42 Participants
|
41 Participants
n=42 Participants
|
733 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
18 Participants
n=8 Participants
|
18 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
101 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
12 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
5 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Multiple Race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
11 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Other Race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
4 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
10 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 7 days after vaccinationPopulation: Solicited Safety Set: Consisted of all participants in the Safety Set who contributed any solicited AR data. Dose groups for Phase 1/2, Phase 2 NH, and Phase 2 Extension by dose group and Afluria Quadrivalent 60 ug groups were combined for this assessment as pre-specified by the protocol. Combined data for \>= 50 ug is also presented. Number Analyzed = participants who were evaluable at specified timepoints.
Solicited ARs (local and systemic) were collected in the electronic diary (eDiary). Local ARs included: pain at injection site, erythema (redness) at injection site, swelling/induration (hardness) at injection site, and localized axillary swelling or tenderness ipsilateral to the injection arm. Systemic ARs included: headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, rash, body temperature (potentially fever), and chills. Solicited ARs (local and systemic) considered causally related to injection were graded 0-4; lower score indicates lower severity and a higher score indicates greater severity. Note, not all solicited ARs were considered adverse events (AEs). The Investigator reviewed whether the solicited AR was also to be recorded as an AE. Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is in Reported "Adverse Events" section and presented by Phase/dose group.
Outcome measures
| Measure |
Placebo
n=44 Participants
Participants received placebo matching to mRNA-1010 by IM injection on Day 1.
|
Afluria Quadrivalent 60 ug
n=104 Participants
Participants received Afluria Quadrivalent 60 ug by IM injection on Day 1.
|
mRNA-1010 6.25 ug
n=50 Participants
Participants received mRNA-1010 6.25 ug by IM injection on Day 1.
|
mRNA-1010 12.5 ug
n=50 Participants
Participants received mRNA-1010 12.5 ug by IM injection on Day 1.
|
mRNA-1010 25 ug
n=198 Participants
Participants received mRNA-1010 25 ug by IM injection on Day 1.
|
mRNA-1010 50 ug
n=191 Participants
Participants received mRNA-1010 50 ug by IM injection on Day 1.
|
mRNA-1010 100 ug
n=191 Participants
Participants received mRNA-1010 100 ug by IM injection on Day 1.
|
mRNA-1010 200 ug
n=44 Participants
Participants received mRNA-1010 200 ug by IM injection on Day 1.
|
mRNA-1010 >= 50 ug Overall
n=426 Participants
Participants received mRNA-1010 \>= 50 ug by IM injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Local and Systemic ARs
Grade 1
|
12 Participants
|
43 Participants
|
22 Participants
|
16 Participants
|
76 Participants
|
65 Participants
|
44 Participants
|
7 Participants
|
116 Participants
|
|
Number of Participants With Solicited Local and Systemic ARs
Grade 2
|
5 Participants
|
16 Participants
|
17 Participants
|
12 Participants
|
81 Participants
|
70 Participants
|
86 Participants
|
17 Participants
|
173 Participants
|
|
Number of Participants With Solicited Local and Systemic ARs
Grade 3
|
1 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
15 Participants
|
31 Participants
|
45 Participants
|
18 Participants
|
94 Participants
|
|
Number of Participants With Solicited Local and Systemic ARs
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 28 days after vaccinationPopulation: Safety Analysis Set: all randomly assigned participants who received the investigational product. Dose groups for Phase 1/2, Phase 2 NH, and Phase 2 Extension by dose group and Afluria Quadrivalent 60 ug groups were combined for this assessment as pre-specified by the protocol. Combined data for \>= 50 ug is also presented. Number Analyzed = participants who were evaluable at specified timepoints.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A treatment-emergent AE (TEAE) was defined as any event not present before exposure to vaccine or any event already present that worsens in intensity or frequency after exposure. 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 worsens from baseline and is considered clinically significant in the medical and scientific judgment of the Investigator. A summary of SAEs and all nonserious AEs ("Other") reported up to the end of the study, regardless of causality, is located in the Reported "Adverse Events" section and presented by each Phase and dose group separately.
Outcome measures
| Measure |
Placebo
n=45 Participants
Participants received placebo matching to mRNA-1010 by IM injection on Day 1.
|
Afluria Quadrivalent 60 ug
n=105 Participants
Participants received Afluria Quadrivalent 60 ug by IM injection on Day 1.
|
mRNA-1010 6.25 ug
n=50 Participants
Participants received mRNA-1010 6.25 ug by IM injection on Day 1.
|
mRNA-1010 12.5 ug
n=50 Participants
Participants received mRNA-1010 12.5 ug by IM injection on Day 1.
|
mRNA-1010 25 ug
n=199 Participants
Participants received mRNA-1010 25 ug by IM injection on Day 1.
|
mRNA-1010 50 ug
n=192 Participants
Participants received mRNA-1010 50 ug by IM injection on Day 1.
|
mRNA-1010 100 ug
n=193 Participants
Participants received mRNA-1010 100 ug by IM injection on Day 1.
|
mRNA-1010 200 ug
n=44 Participants
Participants received mRNA-1010 200 ug by IM injection on Day 1.
|
mRNA-1010 >= 50 ug Overall
n=429 Participants
Participants received mRNA-1010 \>= 50 ug by IM injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Unsolicited AEs
Nonserious
|
5 Participants
|
20 Participants
|
16 Participants
|
14 Participants
|
47 Participants
|
41 Participants
|
44 Participants
|
10 Participants
|
95 Participants
|
|
Number of Participants With Unsolicited AEs
All
|
6 Participants
|
20 Participants
|
17 Participants
|
14 Participants
|
47 Participants
|
42 Participants
|
46 Participants
|
10 Participants
|
98 Participants
|
|
Number of Participants With Unsolicited AEs
Serious
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Up to 6 months (end of study)Population: Safety Analysis Set: all randomly assigned participants who received the investigational product. Dose groups for Phase 1/2, Phase 2 NH, and Phase 2 Extension by dose group and Afluria Quadrivalent 60 ug groups were combined for this assessment as pre-specified by the protocol. Combined data for \>= 50 ug is also presented. Number Analyzed = participants who were evaluable at specified timepoints.
An SAE was defined as any AE that resulted in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AESIs included thrombocytopenia, new onset of or worsening of the protocol specified neurologic diseases, anaphylaxis, and myocarditis/pericarditis. An MAAE is an AE that leads to an unscheduled visit to an healthcare practitioner. This would include visits to a study site for unscheduled assessments (for example, abnormal laboratory follow-up, and/or COVID-19 and visits to healthcare practitioners external to the study site (for example, urgent care, primary care physician). A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section and presented by each Phase and dose group separately.
Outcome measures
| Measure |
Placebo
n=45 Participants
Participants received placebo matching to mRNA-1010 by IM injection on Day 1.
|
Afluria Quadrivalent 60 ug
n=105 Participants
Participants received Afluria Quadrivalent 60 ug by IM injection on Day 1.
|
mRNA-1010 6.25 ug
n=50 Participants
Participants received mRNA-1010 6.25 ug by IM injection on Day 1.
|
mRNA-1010 12.5 ug
n=50 Participants
Participants received mRNA-1010 12.5 ug by IM injection on Day 1.
|
mRNA-1010 25 ug
n=199 Participants
Participants received mRNA-1010 25 ug by IM injection on Day 1.
|
mRNA-1010 50 ug
n=192 Participants
Participants received mRNA-1010 50 ug by IM injection on Day 1.
|
mRNA-1010 100 ug
n=193 Participants
Participants received mRNA-1010 100 ug by IM injection on Day 1.
|
mRNA-1010 200 ug
n=44 Participants
Participants received mRNA-1010 200 ug by IM injection on Day 1.
|
mRNA-1010 >= 50 ug Overall
n=429 Participants
Participants received mRNA-1010 \>= 50 ug by IM injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs)
SAE
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
1 Participants
|
10 Participants
|
|
Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs)
AESI
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs)
MAAE
|
10 Participants
|
27 Participants
|
18 Participants
|
15 Participants
|
58 Participants
|
50 Participants
|
62 Participants
|
12 Participants
|
124 Participants
|
PRIMARY outcome
Timeframe: Day 29Population: Per-Protocol (PP) Set: consisted of all participants who received the investigational product and who complied with the injection schedule and timing of immunogenicity blood sampling, did not have influenza infection at baseline through Day 29, and had no major protocol deviations that impacted the immune response. Number Analyzed = participants who were evaluable at specified timepoints.
Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. GMT 95% confidence interval (CI) was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
Outcome measures
| Measure |
Placebo
n=41 Participants
Participants received placebo matching to mRNA-1010 by IM injection on Day 1.
|
Afluria Quadrivalent 60 ug
n=43 Participants
Participants received Afluria Quadrivalent 60 ug by IM injection on Day 1.
|
mRNA-1010 6.25 ug
n=44 Participants
Participants received mRNA-1010 6.25 ug by IM injection on Day 1.
|
mRNA-1010 12.5 ug
n=41 Participants
Participants received mRNA-1010 12.5 ug by IM injection on Day 1.
|
mRNA-1010 25 ug
Participants received mRNA-1010 25 ug by IM injection on Day 1.
|
mRNA-1010 50 ug
Participants received mRNA-1010 50 ug by IM injection on Day 1.
|
mRNA-1010 100 ug
Participants received mRNA-1010 100 ug by IM injection on Day 1.
|
mRNA-1010 200 ug
Participants received mRNA-1010 200 ug by IM injection on Day 1.
|
mRNA-1010 >= 50 ug Overall
Participants received mRNA-1010 \>= 50 ug by IM injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Phase 1/2: Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains
H1N1
|
58.50 Titer
Interval 39.17 to 87.38
|
410.71 Titer
Interval 262.55 to 642.47
|
331.06 Titer
Interval 214.34 to 511.34
|
598.22 Titer
Interval 370.14 to 966.84
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1/2: Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains
H3N2
|
56.49 Titer
Interval 38.27 to 83.36
|
376.02 Titer
Interval 272.52 to 518.81
|
325.07 Titer
Interval 234.58 to 450.47
|
537.26 Titer
Interval 386.28 to 747.26
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1/2: Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Victoria-lineage
|
111.14 Titer
Interval 75.41 to 163.8
|
237.44 Titer
Interval 178.78 to 315.34
|
169.92 Titer
Interval 122.03 to 236.6
|
281.00 Titer
Interval 213.37 to 370.06
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1/2: Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Yamagata-lineage
|
103.94 Titer
Interval 66.83 to 161.65
|
379.02 Titer
Interval 277.02 to 518.57
|
319.07 Titer
Interval 218.6 to 465.73
|
456.36 Titer
Interval 341.14 to 610.5
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 29Population: PP Set: consisted of all participants who received the investigational product and who complied with the injection schedule and timing of immunogenicity blood sampling, did not have influenza infection at baseline through Day 29, and had no major protocol deviations that impacted the immune response. Number Analyzed = participants who were evaluable at specified timepoints.
Humoral immunogenicity relative to that of the active comparator (afluria quadrivalent) was assessed against vaccine-matched Influenza A and B strains at Day 29. Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. GMT 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
Outcome measures
| Measure |
Placebo
n=52 Participants
Participants received placebo matching to mRNA-1010 by IM injection on Day 1.
|
Afluria Quadrivalent 60 ug
n=144 Participants
Participants received Afluria Quadrivalent 60 ug by IM injection on Day 1.
|
mRNA-1010 6.25 ug
n=138 Participants
Participants received mRNA-1010 6.25 ug by IM injection on Day 1.
|
mRNA-1010 12.5 ug
n=141 Participants
Participants received mRNA-1010 12.5 ug by IM injection on Day 1.
|
mRNA-1010 25 ug
Participants received mRNA-1010 25 ug by IM injection on Day 1.
|
mRNA-1010 50 ug
Participants received mRNA-1010 50 ug by IM injection on Day 1.
|
mRNA-1010 100 ug
Participants received mRNA-1010 100 ug by IM injection on Day 1.
|
mRNA-1010 200 ug
Participants received mRNA-1010 200 ug by IM injection on Day 1.
|
mRNA-1010 >= 50 ug Overall
Participants received mRNA-1010 \>= 50 ug by IM injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 NH: GMT of HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
H1N1
|
164.00 titer
Interval 120.18 to 223.81
|
298.88 titer
Interval 247.21 to 361.36
|
422.24 titer
Interval 347.72 to 512.73
|
443.62 titer
Interval 366.58 to 536.85
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 NH: GMT of HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
H3N2
|
85.54 titer
Interval 64.33 to 113.74
|
153.43 titer
Interval 128.99 to 182.5
|
187.08 titer
Interval 156.64 to 223.43
|
215.23 titer
Interval 180.75 to 256.28
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 NH: GMT of HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Victoria-lineage
|
147.47 titer
Interval 119.98 to 181.24
|
100.51 titer
Interval 88.63 to 114.0
|
129.56 titer
Interval 113.92 to 147.36
|
123.17 titer
Interval 108.47 to 139.85
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 NH: GMT of HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Yamagata-lineage
|
193.08 titer
Interval 155.16 to 240.27
|
215.19 titer
Interval 188.3 to 245.92
|
230.66 titer
Interval 201.23 to 264.4
|
231.44 titer
Interval 202.38 to 264.68
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 29Population: PP Set: consisted of all participants who received the investigational product and who complied with the injection schedule and timing of immunogenicity blood sampling, did not have influenza infection at baseline through Day 29, and had no major protocol deviations that impacted the immune response. Number Analyzed = participants who were evaluable at specified timepoints.
Humoral immunogenicity relative to that of the active comparator (afluria quadrivalent) was assessed against vaccine-matched Influenza A and B strains at Day 29. Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. GMT 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
Outcome measures
| Measure |
Placebo
n=48 Participants
Participants received placebo matching to mRNA-1010 by IM injection on Day 1.
|
Afluria Quadrivalent 60 ug
n=49 Participants
Participants received Afluria Quadrivalent 60 ug by IM injection on Day 1.
|
mRNA-1010 6.25 ug
n=47 Participants
Participants received mRNA-1010 6.25 ug by IM injection on Day 1.
|
mRNA-1010 12.5 ug
n=46 Participants
Participants received mRNA-1010 12.5 ug by IM injection on Day 1.
|
mRNA-1010 25 ug
Participants received mRNA-1010 25 ug by IM injection on Day 1.
|
mRNA-1010 50 ug
Participants received mRNA-1010 50 ug by IM injection on Day 1.
|
mRNA-1010 100 ug
Participants received mRNA-1010 100 ug by IM injection on Day 1.
|
mRNA-1010 200 ug
Participants received mRNA-1010 200 ug by IM injection on Day 1.
|
mRNA-1010 >= 50 ug Overall
Participants received mRNA-1010 \>= 50 ug by IM injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 Extension: GMT of HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
H1N1
|
253.07 Titer
Interval 180.86 to 354.12
|
228.02 Titer
Interval 163.17 to 318.64
|
316.53 Titer
Interval 225.12 to 445.06
|
471.56 Titer
Interval 334.39 to 664.99
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Extension: GMT of HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
H3N2
|
114.21 Titer
Interval 82.8 to 157.55
|
161.58 Titer
Interval 117.46 to 222.27
|
216.32 Titer
Interval 156.34 to 299.3
|
301.53 Titer
Interval 217.28 to 418.45
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Extension: GMT of HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Victoria-lineage
|
155.07 Titer
Interval 121.65 to 197.66
|
55.76 Titer
Interval 43.81 to 70.97
|
71.12 Titer
Interval 55.51 to 91.11
|
83.46 Titer
Interval 65.16 to 106.9
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Extension: GMT of HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Yamagata-lineage
|
193.16 Titer
Interval 147.41 to 253.12
|
119.54 Titer
Interval 91.34 to 156.45
|
178.43 Titer
Interval 135.33 to 235.26
|
144.13 Titer
Interval 109.16 to 190.29
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 29Population: PP Set: consisted of all participants who received the investigational product and who complied with the injection schedule and timing of immunogenicity blood sampling, did not have influenza infection at baseline through Day 29, and had no major protocol deviations that impacted the immune response. Number Analyzed = participants who were evaluable at specified timepoints.
Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. Seroconversion at a participant level was defined as (a) if lower limit of quantification (LLOQ) was 1:10, a post-baseline titer ≥1:40 if baseline was \<1:10 or a 4-fold or greater rise from baseline if baseline was ≥1:10 in anti-HA antibodies; or (b) if LLOQ was \>1:10, a post-baseline titer ≥4 x LLOQ if baseline was \<LLOQ, or 4-fold or greater increase from baseline if baseline was ≥LLOQ in anti-HA antibodies.
Outcome measures
| Measure |
Placebo
n=41 Participants
Participants received placebo matching to mRNA-1010 by IM injection on Day 1.
|
Afluria Quadrivalent 60 ug
n=43 Participants
Participants received Afluria Quadrivalent 60 ug by IM injection on Day 1.
|
mRNA-1010 6.25 ug
n=44 Participants
Participants received mRNA-1010 6.25 ug by IM injection on Day 1.
|
mRNA-1010 12.5 ug
n=41 Participants
Participants received mRNA-1010 12.5 ug by IM injection on Day 1.
|
mRNA-1010 25 ug
Participants received mRNA-1010 25 ug by IM injection on Day 1.
|
mRNA-1010 50 ug
Participants received mRNA-1010 50 ug by IM injection on Day 1.
|
mRNA-1010 100 ug
Participants received mRNA-1010 100 ug by IM injection on Day 1.
|
mRNA-1010 200 ug
Participants received mRNA-1010 200 ug by IM injection on Day 1.
|
mRNA-1010 >= 50 ug Overall
Participants received mRNA-1010 \>= 50 ug by IM injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Phase 1/2: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B
H1N1
|
4.9 percentage of participants
Interval 0.6 to 16.53
|
67.4 percentage of participants
Interval 51.46 to 80.92
|
81.8 percentage of participants
Interval 67.29 to 91.81
|
90.2 percentage of participants
Interval 76.87 to 97.28
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1/2: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B
H3N2
|
2.4 percentage of participants
Interval 0.06 to 12.86
|
81.4 percentage of participants
Interval 66.6 to 91.61
|
75.0 percentage of participants
Interval 59.66 to 86.81
|
75.6 percentage of participants
Interval 59.7 to 87.64
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1/2: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B
Victoria-lineage
|
2.4 percentage of participants
Interval 0.06 to 12.86
|
14.0 percentage of participants
Interval 5.3 to 27.93
|
15.9 percentage of participants
Interval 6.64 to 30.07
|
25.0 percentage of participants
Interval 12.69 to 41.2
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1/2: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B
Yamagata-lineage
|
2.4 percentage of participants
Interval 0.06 to 12.86
|
41.9 percentage of participants
Interval 27.01 to 57.87
|
50.0 percentage of participants
Interval 34.56 to 65.44
|
51.2 percentage of participants
Interval 35.13 to 67.12
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (Baseline), Day 29Population: PP Set: consisted of all participants who received the investigational product and who complied with the injection schedule and timing of immunogenicity blood sampling, did not have influenza infection at baseline through Day 29, and had no major protocol deviations that impacted the immune response.
The GMFR measures the changes in immunogenicity titers or levels from Baseline within participants. Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. 95% CI was calculated based on the difference in the log-transformed values for GMFR, then back transformed to the original scale for presentation.
Outcome measures
| Measure |
Placebo
n=41 Participants
Participants received placebo matching to mRNA-1010 by IM injection on Day 1.
|
Afluria Quadrivalent 60 ug
n=43 Participants
Participants received Afluria Quadrivalent 60 ug by IM injection on Day 1.
|
mRNA-1010 6.25 ug
n=44 Participants
Participants received mRNA-1010 6.25 ug by IM injection on Day 1.
|
mRNA-1010 12.5 ug
n=41 Participants
Participants received mRNA-1010 12.5 ug by IM injection on Day 1.
|
mRNA-1010 25 ug
Participants received mRNA-1010 25 ug by IM injection on Day 1.
|
mRNA-1010 50 ug
Participants received mRNA-1010 50 ug by IM injection on Day 1.
|
mRNA-1010 100 ug
Participants received mRNA-1010 100 ug by IM injection on Day 1.
|
mRNA-1010 200 ug
Participants received mRNA-1010 200 ug by IM injection on Day 1.
|
mRNA-1010 >= 50 ug Overall
Participants received mRNA-1010 \>= 50 ug by IM injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Phase 1/2: Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
H1N1
|
1.08 ratio
Interval 0.91 to 1.29
|
7.50 ratio
Interval 5.0 to 11.26
|
8.69 ratio
Interval 6.03 to 12.5
|
11.05 ratio
Interval 7.59 to 16.11
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1/2: Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
H3N2
|
1.05 ratio
Interval 0.8 to 1.39
|
7.16 ratio
Interval 5.19 to 9.88
|
6.43 ratio
Interval 4.54 to 9.1
|
7.13 ratio
Interval 5.12 to 9.93
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1/2: Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Victoria-lineage
|
0.98 ratio
Interval 0.8 to 1.2
|
1.95 ratio
Interval 1.61 to 2.37
|
1.86 ratio
Interval 1.36 to 2.53
|
2.03 ratio
Interval 1.5 to 2.75
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1/2: Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Yamagata-lineage
|
0.92 ratio
Interval 0.81 to 1.05
|
3.04 ratio
Interval 2.34 to 3.96
|
3.78 ratio
Interval 2.7 to 5.28
|
3.55 ratio
Interval 2.47 to 5.11
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 29Population: PP Set: consisted of all participants who received the investigational product and who complied with the injection schedule and timing of immunogenicity blood sampling, did not have influenza infection at baseline through Day 29, and had no major protocol deviations that impacted the immune response. Number Analyzed = participants who were evaluable at specified timepoints.
Humoral immunogenicity relative to that of the active comparator (afluria quadrivalent) was assessed against vaccine-matched Influenza A and B strains at Day 29. Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. Seroconversion at a participant level was defined as (a) if LLOQ was 1:10, a post-baseline titer ≥1:40 if baseline was \<1:10 or a 4-fold or greater rise from baseline if baseline was ≥1:10 in anti-HA antibodies; or (b) if LLOQ was \>1:10, a post-baseline titer ≥4 x LLOQ if baseline was \<LLOQ, or 4-fold or greater increase from baseline if baseline was ≥LLOQ in anti-HA antibodies. 95% CI was calculated using the Clopper-Pearson method
Outcome measures
| Measure |
Placebo
n=52 Participants
Participants received placebo matching to mRNA-1010 by IM injection on Day 1.
|
Afluria Quadrivalent 60 ug
n=144 Participants
Participants received Afluria Quadrivalent 60 ug by IM injection on Day 1.
|
mRNA-1010 6.25 ug
n=138 Participants
Participants received mRNA-1010 6.25 ug by IM injection on Day 1.
|
mRNA-1010 12.5 ug
n=141 Participants
Participants received mRNA-1010 12.5 ug by IM injection on Day 1.
|
mRNA-1010 25 ug
Participants received mRNA-1010 25 ug by IM injection on Day 1.
|
mRNA-1010 50 ug
Participants received mRNA-1010 50 ug by IM injection on Day 1.
|
mRNA-1010 100 ug
Participants received mRNA-1010 100 ug by IM injection on Day 1.
|
mRNA-1010 200 ug
Participants received mRNA-1010 200 ug by IM injection on Day 1.
|
mRNA-1010 >= 50 ug Overall
Participants received mRNA-1010 \>= 50 ug by IM injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 NH: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B
H1N1
|
59.6 percentage of participants
Interval 45.1 to 72.99
|
72.2 percentage of participants
Interval 64.15 to 79.36
|
84.8 percentage of participants
Interval 77.68 to 90.33
|
85.8 percentage of participants
Interval 78.95 to 91.12
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 NH: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B
H3N2
|
40.4 percentage of participants
Interval 27.01 to 54.9
|
66.0 percentage of participants
Interval 57.62 to 73.65
|
71.7 percentage of participants
Interval 63.45 to 79.07
|
78.7 percentage of participants
Interval 71.04 to 85.16
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 NH: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B
Victoria-lineage
|
32.7 percentage of participants
Interval 20.33 to 47.11
|
22.9 percentage of participants
Interval 16.33 to 30.65
|
33.3 percentage of participants
Interval 25.54 to 41.86
|
37.1 percentage of participants
Interval 29.13 to 45.71
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 NH: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B
Yamagata-lineage
|
32.7 percentage of participants
Interval 20.33 to 47.11
|
41.7 percentage of participants
Interval 33.52 to 50.17
|
47.8 percentage of participants
Interval 39.26 to 56.49
|
51.8 percentage of participants
Interval 43.21 to 60.26
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 29Population: PP Set: consisted of all participants who received the investigational product and who complied with the injection schedule and timing of immunogenicity blood sampling, did not have influenza infection at baseline through Day 29, and had no major protocol deviations that impacted the immune response. Number Analyzed = participants who were evaluable at specified timepoints.
Humoral immunogenicity relative to that of the active comparator (afluria quadrivalent) was assessed against vaccine-matched Influenza A and B strains at Day 29. Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. Seroconversion at a participant level was defined as (a) if LLOQ was 1:10, a post-baseline titer ≥1:40 if baseline was \<1:10 or a 4-fold or greater rise from baseline if baseline was ≥1:10 in anti-HA antibodies; or (b) if LLOQ was \>1:10, a post-baseline titer ≥4 x LLOQ if baseline was \<LLOQ, or 4-fold or greater increase from baseline if baseline was ≥LLOQ in anti-HA antibodies. 95% CI was calculated using the Clopper-Pearson method
Outcome measures
| Measure |
Placebo
n=48 Participants
Participants received placebo matching to mRNA-1010 by IM injection on Day 1.
|
Afluria Quadrivalent 60 ug
n=49 Participants
Participants received Afluria Quadrivalent 60 ug by IM injection on Day 1.
|
mRNA-1010 6.25 ug
n=47 Participants
Participants received mRNA-1010 6.25 ug by IM injection on Day 1.
|
mRNA-1010 12.5 ug
n=46 Participants
Participants received mRNA-1010 12.5 ug by IM injection on Day 1.
|
mRNA-1010 25 ug
Participants received mRNA-1010 25 ug by IM injection on Day 1.
|
mRNA-1010 50 ug
Participants received mRNA-1010 50 ug by IM injection on Day 1.
|
mRNA-1010 100 ug
Participants received mRNA-1010 100 ug by IM injection on Day 1.
|
mRNA-1010 200 ug
Participants received mRNA-1010 200 ug by IM injection on Day 1.
|
mRNA-1010 >= 50 ug Overall
Participants received mRNA-1010 \>= 50 ug by IM injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B
H1N1
|
50.0 percentage of participants
Interval 35.23 to 64.77
|
59.2 percentage of participants
Interval 44.21 to 73.0
|
68.1 percentage of participants
Interval 52.88 to 80.91
|
73.9 percentage of participants
Interval 58.87 to 85.73
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B
H3N2
|
43.8 percentage of participants
Interval 29.48 to 58.82
|
44.9 percentage of participants
Interval 30.67 to 59.77
|
66.0 percentage of participants
Interval 50.69 to 79.14
|
80.4 percentage of participants
Interval 66.09 to 90.64
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B
Victoria-lineage
|
47.9 percentage of participants
Interval 33.29 to 62.81
|
10.2 percentage of participants
Interval 3.4 to 22.23
|
21.7 percentage of participants
Interval 10.95 to 36.36
|
28.3 percentage of participants
Interval 15.99 to 43.46
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B
Yamagata-lineage
|
47.9 percentage of participants
Interval 33.29 to 62.81
|
24.5 percentage of participants
Interval 13.34 to 38.87
|
43.5 percentage of participants
Interval 28.93 to 58.89
|
39.1 percentage of participants
Interval 25.09 to 54.63
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Baseline), Day 8 and Day 181Population: PP Set: consisted of all participants who received the investigational product and who complied with the injection schedule and timing of immunogenicity blood sampling, did not have influenza infection at baseline through Day 29, and had no major protocol deviations that impacted the immune response. Number Analyzed = participants who were evaluable at specified timepoints.
Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. GMT 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
Outcome measures
| Measure |
Placebo
n=41 Participants
Participants received placebo matching to mRNA-1010 by IM injection on Day 1.
|
Afluria Quadrivalent 60 ug
n=43 Participants
Participants received Afluria Quadrivalent 60 ug by IM injection on Day 1.
|
mRNA-1010 6.25 ug
n=44 Participants
Participants received mRNA-1010 6.25 ug by IM injection on Day 1.
|
mRNA-1010 12.5 ug
n=41 Participants
Participants received mRNA-1010 12.5 ug by IM injection on Day 1.
|
mRNA-1010 25 ug
Participants received mRNA-1010 25 ug by IM injection on Day 1.
|
mRNA-1010 50 ug
Participants received mRNA-1010 50 ug by IM injection on Day 1.
|
mRNA-1010 100 ug
Participants received mRNA-1010 100 ug by IM injection on Day 1.
|
mRNA-1010 200 ug
Participants received mRNA-1010 200 ug by IM injection on Day 1.
|
mRNA-1010 >= 50 ug Overall
Participants received mRNA-1010 \>= 50 ug by IM injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Day 1 (Baseline): H1N1
|
54.16 titer
Interval 35.85 to 81.83
|
54.73 titer
Interval 37.76 to 79.31
|
38.12 titer
Interval 28.35 to 51.26
|
54.12 titer
Interval 37.26 to 78.61
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Day 8: H1N1
|
42.05 titer
Interval 27.89 to 63.4
|
185.61 titer
Interval 125.31 to 274.92
|
163.84 titer
Interval 101.76 to 263.81
|
319.86 titer
Interval 208.59 to 490.5
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Day 181: H1N1
|
67.55 titer
Interval 41.88 to 108.96
|
167.28 titer
Interval 121.35 to 230.59
|
74.14 titer
Interval 52.08 to 105.54
|
159.95 titer
Interval 104.34 to 245.2
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Day 1 (Baseline): H3N2
|
53.68 titer
Interval 36.84 to 78.22
|
52.52 titer
Interval 37.35 to 73.85
|
50.59 titer
Interval 37.9 to 67.53
|
75.31 titer
Interval 50.06 to 113.3
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Day 8: H3N2
|
51.46 titer
Interval 37.34 to 70.91
|
211.76 titer
Interval 148.46 to 302.04
|
220.95 titer
Interval 155.08 to 314.81
|
345.29 titer
Interval 262.51 to 454.16
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Day 181: H3N2
|
67.50 titer
Interval 45.07 to 101.09
|
186.06 titer
Interval 136.0 to 254.55
|
158.74 titer
Interval 116.46 to 216.37
|
235.10 titer
Interval 167.17 to 330.64
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Day 1 (Baseline): Victoria-lineage
|
113.97 titer
Interval 76.71 to 169.33
|
121.61 titer
Interval 86.46 to 171.06
|
91.41 titer
Interval 64.64 to 129.27
|
137.99 titer
Interval 95.73 to 198.91
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Day 8: Victoria-lineage
|
34.65 titer
Interval 23.93 to 50.17
|
91.27 titer
Interval 68.41 to 121.78
|
113.14 titer
Interval 81.85 to 156.4
|
122.10 titer
Interval 88.63 to 168.2
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Day 181: Victoria-lineage
|
37.59 titer
Interval 26.09 to 54.17
|
76.56 titer
Interval 55.37 to 105.87
|
72.27 titer
Interval 53.7 to 97.26
|
70.62 titer
Interval 48.32 to 103.19
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Day 1 (Baseline): Yamagata-lineage
|
113.13 titer
Interval 70.09 to 182.6
|
124.60 titer
Interval 86.34 to 179.83
|
84.47 titer
Interval 55.85 to 127.75
|
128.43 titer
Interval 81.44 to 202.53
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Day 8: Yamagata-lineage
|
54.68 titer
Interval 36.21 to 82.59
|
118.85 titer
Interval 90.96 to 155.29
|
116.79 titer
Interval 81.49 to 167.37
|
194.38 titer
Interval 141.31 to 267.38
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1/2: GMT of Anti-HA Antibodies at Days 1, 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Day 181: Yamagata-lineage
|
55.08 titer
Interval 36.3 to 83.57
|
106.23 titer
Interval 79.98 to 141.08
|
69.87 titer
Interval 52.76 to 92.54
|
112.06 titer
Interval 73.69 to 170.39
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Baseline), Day 8 and Day 181Population: PP Set: consisted of all participants who received the investigational product and who complied with the injection schedule and timing of immunogenicity blood sampling, did not have influenza infection at baseline through Day 29, and had no major protocol deviations that impacted the immune response. Number Analyzed = participants who were evaluable at specified timepoints.
The GMFR measures the changes in immunogenicity titers or levels from Baseline within participants. Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. 95% CI was calculated based on the difference in the log-transformed values for GMT, then back transformed to the original scale for presentation.
Outcome measures
| Measure |
Placebo
n=41 Participants
Participants received placebo matching to mRNA-1010 by IM injection on Day 1.
|
Afluria Quadrivalent 60 ug
n=42 Participants
Participants received Afluria Quadrivalent 60 ug by IM injection on Day 1.
|
mRNA-1010 6.25 ug
n=44 Participants
Participants received mRNA-1010 6.25 ug by IM injection on Day 1.
|
mRNA-1010 12.5 ug
n=41 Participants
Participants received mRNA-1010 12.5 ug by IM injection on Day 1.
|
mRNA-1010 25 ug
Participants received mRNA-1010 25 ug by IM injection on Day 1.
|
mRNA-1010 50 ug
Participants received mRNA-1010 50 ug by IM injection on Day 1.
|
mRNA-1010 100 ug
Participants received mRNA-1010 100 ug by IM injection on Day 1.
|
mRNA-1010 200 ug
Participants received mRNA-1010 200 ug by IM injection on Day 1.
|
mRNA-1010 >= 50 ug Overall
Participants received mRNA-1010 \>= 50 ug by IM injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Phase 1/2: GMFR of Anti-HA Antibodies at Days 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Day 8: H1N1
|
0.78 ratio
Interval 0.62 to 0.98
|
3.48 ratio
Interval 2.35 to 5.14
|
4.30 ratio
Interval 2.76 to 6.69
|
5.91 ratio
Interval 3.83 to 9.11
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1/2: GMFR of Anti-HA Antibodies at Days 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Day 181: H1N1
|
1.21 ratio
Interval 0.87 to 1.67
|
2.99 ratio
Interval 1.95 to 4.57
|
2.18 ratio
Interval 1.51 to 3.14
|
2.92 ratio
Interval 2.11 to 4.04
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1/2: GMFR of Anti-HA Antibodies at Days 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Day 8: H3N2
|
0.96 ratio
Interval 0.73 to 1.25
|
4.21 ratio
Interval 2.77 to 6.4
|
4.37 ratio
Interval 2.73 to 6.99
|
4.58 ratio
Interval 2.9 to 7.25
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1/2: GMFR of Anti-HA Antibodies at Days 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Day 181: H3N2
|
1.27 ratio
Interval 0.89 to 1.82
|
3.24 ratio
Interval 2.37 to 4.41
|
3.27 ratio
Interval 2.28 to 4.7
|
3.09 ratio
Interval 2.14 to 4.46
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1/2: GMFR of Anti-HA Antibodies at Days 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Day 8: Victoria-lineage
|
0.30 ratio
Interval 0.22 to 0.41
|
0.77 ratio
Interval 0.54 to 1.1
|
1.24 ratio
Interval 0.86 to 1.77
|
0.85 ratio
Interval 0.55 to 1.3
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1/2: GMFR of Anti-HA Antibodies at Days 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Day 181: Victoria-lineage
|
0.34 ratio
Interval 0.25 to 0.48
|
0.54 ratio
Interval 0.37 to 0.8
|
0.82 ratio
Interval 0.59 to 1.15
|
0.48 ratio
Interval 0.32 to 0.7
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1/2: GMFR of Anti-HA Antibodies at Days 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Day 8: Yamagata-lineage
|
0.48 ratio
Interval 0.37 to 0.63
|
0.98 ratio
Interval 0.72 to 1.32
|
1.38 ratio
Interval 1.0 to 1.9
|
1.51 ratio
Interval 1.05 to 2.17
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1/2: GMFR of Anti-HA Antibodies at Days 8 and 181, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Day 181: Yamagata-lineage
|
0.53 ratio
Interval 0.4 to 0.69
|
0.77 ratio
Interval 0.56 to 1.07
|
0.96 ratio
Interval 0.67 to 1.37
|
0.85 ratio
Interval 0.66 to 1.09
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 29Population: PP Set: consisted of all participants who received the investigational product and who complied with the injection schedule and timing of immunogenicity blood sampling, did not have influenza infection at baseline through Day 29, and had no major protocol deviations that impacted the immune response. Number Analyzed = participants who were evaluable at specified timepoints.
Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. Seroconversion at a participant level was defined as (a) if lower limit of quantification (LLOQ) was 1:10, a post-baseline titer ≥1:40 if baseline was \<1:10 or a 4-fold or greater rise from baseline if baseline was ≥1:10 in anti-HA antibodies; or (b) if LLOQ was \>1:10, a post-baseline titer ≥4 x LLOQ if baseline was \<LLOQ, or 4-fold or greater increase from baseline if baseline was ≥LLOQ in anti-HA antibodies.
Outcome measures
| Measure |
Placebo
n=52 Participants
Participants received placebo matching to mRNA-1010 by IM injection on Day 1.
|
Afluria Quadrivalent 60 ug
n=144 Participants
Participants received Afluria Quadrivalent 60 ug by IM injection on Day 1.
|
mRNA-1010 6.25 ug
n=138 Participants
Participants received mRNA-1010 6.25 ug by IM injection on Day 1.
|
mRNA-1010 12.5 ug
n=141 Participants
Participants received mRNA-1010 12.5 ug by IM injection on Day 1.
|
mRNA-1010 25 ug
n=48 Participants
Participants received mRNA-1010 25 ug by IM injection on Day 1.
|
mRNA-1010 50 ug
n=49 Participants
Participants received mRNA-1010 50 ug by IM injection on Day 1.
|
mRNA-1010 100 ug
n=47 Participants
Participants received mRNA-1010 100 ug by IM injection on Day 1.
|
mRNA-1010 200 ug
n=46 Participants
Participants received mRNA-1010 200 ug by IM injection on Day 1.
|
mRNA-1010 >= 50 ug Overall
Participants received mRNA-1010 \>= 50 ug by IM injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 NH and Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B
H1N1
|
59.6 Percentage of participants
Interval 45.1 to 72.99
|
72.2 Percentage of participants
Interval 64.15 to 79.36
|
84.8 Percentage of participants
Interval 77.68 to 90.33
|
85.8 Percentage of participants
Interval 78.95 to 91.12
|
50.0 Percentage of participants
Interval 35.23 to 64.77
|
59.2 Percentage of participants
Interval 44.21 to 73.0
|
68.1 Percentage of participants
Interval 52.88 to 80.91
|
73.9 Percentage of participants
Interval 58.87 to 85.73
|
—
|
|
Phase 2 NH and Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B
H3N2
|
40.4 Percentage of participants
Interval 27.01 to 54.9
|
66.0 Percentage of participants
Interval 57.62 to 73.65
|
71.7 Percentage of participants
Interval 63.45 to 79.07
|
78.7 Percentage of participants
Interval 71.04 to 85.16
|
43.8 Percentage of participants
Interval 29.48 to 58.82
|
44.9 Percentage of participants
Interval 30.67 to 59.77
|
66.0 Percentage of participants
Interval 50.69 to 79.14
|
80.4 Percentage of participants
Interval 66.09 to 90.64
|
—
|
|
Phase 2 NH and Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B
Victoria-lineage
|
32.7 Percentage of participants
Interval 20.33 to 47.11
|
22.9 Percentage of participants
Interval 16.33 to 30.65
|
33.3 Percentage of participants
Interval 25.54 to 41.86
|
37.1 Percentage of participants
Interval 29.13 to 45.71
|
47.9 Percentage of participants
Interval 33.29 to 62.81
|
10.2 Percentage of participants
Interval 3.4 to 22.23
|
21.7 Percentage of participants
Interval 10.95 to 36.36
|
28.3 Percentage of participants
Interval 15.99 to 43.46
|
—
|
|
Phase 2 NH and Phase 2 Extension: Percentage of Participants With Seroconversion, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B
Yamagata-lineage
|
32.7 Percentage of participants
Interval 20.33 to 47.11
|
41.7 Percentage of participants
Interval 33.52 to 50.17
|
47.8 Percentage of participants
Interval 39.26 to 56.49
|
51.8 Percentage of participants
Interval 43.21 to 60.26
|
47.9 Percentage of participants
Interval 33.29 to 62.81
|
24.5 Percentage of participants
Interval 13.34 to 38.87
|
43.5 Percentage of participants
Interval 28.93 to 58.89
|
39.1 Percentage of participants
Interval 25.09 to 54.63
|
—
|
SECONDARY outcome
Timeframe: Day 29Population: PP Set: consisted of all participants who received the investigational product and who complied with the injection schedule and timing of immunogenicity blood sampling, did not have influenza infection at baseline through Day 29, and had no major protocol deviations that impacted the immune response. Number Analyzed = participants who were evaluable at specified timepoints. Number Analyzed = participants who were evaluable at specified timepoints.
The GMFR measures the changes in immunogenicity titers or levels from Baseline within participants. Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. 95% CI was calculated based on the difference in the log-transformed values for GMFR, then back transformed to the original scale for presentation.
Outcome measures
| Measure |
Placebo
n=52 Participants
Participants received placebo matching to mRNA-1010 by IM injection on Day 1.
|
Afluria Quadrivalent 60 ug
n=144 Participants
Participants received Afluria Quadrivalent 60 ug by IM injection on Day 1.
|
mRNA-1010 6.25 ug
n=138 Participants
Participants received mRNA-1010 6.25 ug by IM injection on Day 1.
|
mRNA-1010 12.5 ug
n=141 Participants
Participants received mRNA-1010 12.5 ug by IM injection on Day 1.
|
mRNA-1010 25 ug
n=48 Participants
Participants received mRNA-1010 25 ug by IM injection on Day 1.
|
mRNA-1010 50 ug
n=49 Participants
Participants received mRNA-1010 50 ug by IM injection on Day 1.
|
mRNA-1010 100 ug
n=47 Participants
Participants received mRNA-1010 100 ug by IM injection on Day 1.
|
mRNA-1010 200 ug
n=46 Participants
Participants received mRNA-1010 200 ug by IM injection on Day 1.
|
mRNA-1010 >= 50 ug Overall
Participants received mRNA-1010 \>= 50 ug by IM injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 NH and Phase 2 Extension: GMFR of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
H1N1
|
4.19 ratio
Interval 2.82 to 6.23
|
7.64 ratio
Interval 6.22 to 9.38
|
12.15 ratio
Interval 9.38 to 15.73
|
11.96 ratio
Interval 9.81 to 14.58
|
6.08 ratio
Interval 3.84 to 9.64
|
6.03 ratio
Interval 4.22 to 8.61
|
7.21 ratio
Interval 4.9 to 10.63
|
12.58 ratio
Interval 7.95 to 19.9
|
—
|
|
Phase 2 NH and Phase 2 Extension: GMFR of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
H3N2
|
3.17 ratio
Interval 2.2 to 4.58
|
6.28 ratio
Interval 5.02 to 7.84
|
8.17 ratio
Interval 6.63 to 10.06
|
8.70 ratio
Interval 7.22 to 10.48
|
3.78 ratio
Interval 2.56 to 5.58
|
4.51 ratio
Interval 3.15 to 6.46
|
6.66 ratio
Interval 4.57 to 9.69
|
9.30 ratio
Interval 6.11 to 14.17
|
—
|
|
Phase 2 NH and Phase 2 Extension: GMFR of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Victoria-lineage
|
3.30 ratio
Interval 2.13 to 5.11
|
2.27 ratio
Interval 2.0 to 2.58
|
3.06 ratio
Interval 2.6 to 3.6
|
2.79 ratio
Interval 2.47 to 3.15
|
3.91 ratio
Interval 2.66 to 5.76
|
1.69 ratio
Interval 1.3 to 2.2
|
1.84 ratio
Interval 1.39 to 2.43
|
2.47 ratio
Interval 1.76 to 3.46
|
—
|
|
Phase 2 NH and Phase 2 Extension: GMFR of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Yamagata-lineage
|
3.07 ratio
Interval 2.19 to 4.29
|
3.33 ratio
Interval 2.85 to 3.9
|
3.73 ratio
Interval 3.09 to 4.51
|
3.67 ratio
Interval 3.15 to 4.27
|
3.72 ratio
Interval 2.7 to 5.15
|
2.29 ratio
Interval 1.67 to 3.14
|
3.03 ratio
Interval 2.18 to 4.21
|
3.08 ratio
Interval 2.08 to 4.55
|
—
|
SECONDARY outcome
Timeframe: Day 29Population: PP Set: consisted of all participants who received the investigational product and who complied with the injection schedule and timing of immunogenicity blood sampling, did not have influenza infection at baseline through Day 29, and had no major protocol deviations that impacted the immune response. Number Analyzed = participants who were evaluable at specified timepoints.
Outcome measures
| Measure |
Placebo
n=52 Participants
Participants received placebo matching to mRNA-1010 by IM injection on Day 1.
|
Afluria Quadrivalent 60 ug
n=144 Participants
Participants received Afluria Quadrivalent 60 ug by IM injection on Day 1.
|
mRNA-1010 6.25 ug
n=138 Participants
Participants received mRNA-1010 6.25 ug by IM injection on Day 1.
|
mRNA-1010 12.5 ug
n=141 Participants
Participants received mRNA-1010 12.5 ug by IM injection on Day 1.
|
mRNA-1010 25 ug
n=48 Participants
Participants received mRNA-1010 25 ug by IM injection on Day 1.
|
mRNA-1010 50 ug
n=49 Participants
Participants received mRNA-1010 50 ug by IM injection on Day 1.
|
mRNA-1010 100 ug
n=47 Participants
Participants received mRNA-1010 100 ug by IM injection on Day 1.
|
mRNA-1010 200 ug
n=46 Participants
Participants received mRNA-1010 200 ug by IM injection on Day 1.
|
mRNA-1010 >= 50 ug Overall
Participants received mRNA-1010 \>= 50 ug by IM injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 NH and Phase 2 Extension: Percentage of Participants With HAI Titer ≥1:40 at Day 29
H1N1
|
92.3 percentage of participants
Interval 81.46 to 97.86
|
97.2 percentage of participants
Interval 93.04 to 99.24
|
97.1 percentage of participants
Interval 92.74 to 99.2
|
98.6 percentage of participants
Interval 94.97 to 99.83
|
95.8 percentage of participants
Interval 85.75 to 99.49
|
93.9 percentage of participants
Interval 83.13 to 98.72
|
95.7 percentage of participants
Interval 85.46 to 99.48
|
97.8 percentage of participants
Interval 88.47 to 99.94
|
—
|
|
Phase 2 NH and Phase 2 Extension: Percentage of Participants With HAI Titer ≥1:40 at Day 29
Victoria-lineage
|
96.2 percentage of participants
Interval 86.79 to 99.53
|
91.7 percentage of participants
Interval 85.9 to 95.62
|
90.6 percentage of participants
Interval 84.43 to 94.89
|
91.4 percentage of participants
Interval 85.51 to 95.49
|
100.0 percentage of participants
Interval 92.6 to 100.0
|
75.5 percentage of participants
Interval 61.13 to 86.66
|
89.1 percentage of participants
Interval 76.43 to 96.38
|
82.6 percentage of participants
Interval 68.58 to 92.18
|
—
|
|
Phase 2 NH and Phase 2 Extension: Percentage of Participants With HAI Titer ≥1:40 at Day 29
H3N2
|
90.4 percentage of participants
Interval 78.97 to 96.8
|
91.0 percentage of participants
Interval 85.06 to 95.11
|
91.3 percentage of participants
Interval 85.3 to 95.43
|
91.5 percentage of participants
Interval 85.61 to 95.52
|
81.3 percentage of participants
Interval 67.37 to 91.05
|
89.8 percentage of participants
Interval 77.77 to 96.6
|
93.6 percentage of participants
Interval 82.46 to 98.66
|
97.8 percentage of participants
Interval 88.47 to 99.94
|
—
|
|
Phase 2 NH and Phase 2 Extension: Percentage of Participants With HAI Titer ≥1:40 at Day 29
Yamagata-lineage
|
96.2 percentage of participants
Interval 86.79 to 99.51
|
99.3 percentage of participants
Interval 96.19 to 99.98
|
96.4 percentage of participants
Interval 91.75 to 98.81
|
97.2 percentage of participants
Interval 92.9 to 99.22
|
97.9 percentage of participants
Interval 88.93 to 99.95
|
93.9 percentage of participants
Interval 83.13 to 98.72
|
95.7 percentage of participants
Interval 85.16 to 99.47
|
91.3 percentage of participants
Interval 79.21 to 97.58
|
—
|
Adverse Events
Phase 1/2: Placebo
Serious events: 2 serious events
Other events: 26 other events
Deaths: 1 deaths
Phase 1/2: mRNA-1010 50 ug
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Phase 1/2: mRNA-1010 100 ug
Serious events: 0 serious events
Other events: 44 other events
Deaths: 0 deaths
Phase 1/2: mRNA-1010 200 ug
Serious events: 1 serious events
Other events: 42 other events
Deaths: 0 deaths
Phase 2 NH: Afluria Quadrivalent 60 ug
Serious events: 1 serious events
Other events: 37 other events
Deaths: 0 deaths
Phase 2 NH: mRNA-1010 25 ug
Serious events: 3 serious events
Other events: 130 other events
Deaths: 0 deaths
Phase 2 NH: mRNA-1010 50 ug
Serious events: 5 serious events
Other events: 133 other events
Deaths: 0 deaths
Phase 2 NH: mRNA-1010 100 ug
Serious events: 4 serious events
Other events: 133 other events
Deaths: 1 deaths
Phase 2 Extension: Afluria Quadrivalent 60 ug
Serious events: 1 serious events
Other events: 33 other events
Deaths: 0 deaths
Phase 2 Extension: mRNA-1010 6.25 ug
Serious events: 2 serious events
Other events: 45 other events
Deaths: 1 deaths
Phase 2 Extension: mRNA-1010 12.5 ug
Serious events: 0 serious events
Other events: 38 other events
Deaths: 0 deaths
Phase 2 Extension: mRNA-1010 25 ug
Serious events: 0 serious events
Other events: 45 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1/2: Placebo
n=45 participants at risk
Participants received placebo matching to mRNA-1010 by IM injection on Day 1.
|
Phase 1/2: mRNA-1010 50 ug
n=45 participants at risk
Participants received mRNA-1010 50 ug by IM injection on Day 1.
|
Phase 1/2: mRNA-1010 100 ug
n=46 participants at risk
Participants received mRNA-1010 100 ug by IM injection on Day 1.
|
Phase 1/2: mRNA-1010 200 ug
n=44 participants at risk
Participants received mRNA-1010 200 ug by IM injection on Day 1.
|
Phase 2 NH: Afluria Quadrivalent 60 ug
n=54 participants at risk
Participants received Afluria Quadrivalent 60 ug by IM injection on Day 1.
|
Phase 2 NH: mRNA-1010 25 ug
n=150 participants at risk
Participants received mRNA-1010 25 ug by IM injection on Day 1.
|
Phase 2 NH: mRNA-1010 50 ug
n=147 participants at risk
Participants received mRNA-1010 50 ug by IM injection on Day 1.
|
Phase 2 NH: mRNA-1010 100 ug
n=147 participants at risk
Participants received mRNA-1010 100 ug by IM injection on Day 1.
|
Phase 2 Extension: Afluria Quadrivalent 60 ug
n=51 participants at risk
Participants received Afluria Quadrivalent 60 ug by IM injection on Day 1.
|
Phase 2 Extension: mRNA-1010 6.25 ug
n=50 participants at risk
Participants received mRNA-1010 6.25 ug by IM injection on Day 1.
|
Phase 2 Extension: mRNA-1010 12.5 ug
n=50 participants at risk
Participants received mRNA-1010 12.5 ug by IM injection on Day 1.
|
Phase 2 Extension: mRNA-1010 25 ug
n=49 participants at risk
Participants received mRNA-1010 25 ug by IM injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.68%
1/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Cystitis
|
2.2%
1/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.68%
1/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma benign
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.9%
1/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer Stage IV
|
2.2%
1/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.67%
1/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.2%
1/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Psychiatric disorders
Post-traumatic amnestic disorder
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.3%
1/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.68%
1/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.68%
1/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.68%
1/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.68%
1/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.68%
1/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.67%
1/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Vascular disorders
Distributive shock
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.3%
1/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.68%
1/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.68%
1/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.68%
1/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.67%
1/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.68%
1/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
1/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Renal and urinary disorders
Urinary retention
|
2.2%
1/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.68%
1/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.3%
1/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.3%
1/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Kidney contusion
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.3%
1/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.3%
1/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.3%
1/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.3%
1/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
1/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.3%
1/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Traumatic liver injury
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.3%
1/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
1/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
Other adverse events
| Measure |
Phase 1/2: Placebo
n=45 participants at risk
Participants received placebo matching to mRNA-1010 by IM injection on Day 1.
|
Phase 1/2: mRNA-1010 50 ug
n=45 participants at risk
Participants received mRNA-1010 50 ug by IM injection on Day 1.
|
Phase 1/2: mRNA-1010 100 ug
n=46 participants at risk
Participants received mRNA-1010 100 ug by IM injection on Day 1.
|
Phase 1/2: mRNA-1010 200 ug
n=44 participants at risk
Participants received mRNA-1010 200 ug by IM injection on Day 1.
|
Phase 2 NH: Afluria Quadrivalent 60 ug
n=54 participants at risk
Participants received Afluria Quadrivalent 60 ug by IM injection on Day 1.
|
Phase 2 NH: mRNA-1010 25 ug
n=150 participants at risk
Participants received mRNA-1010 25 ug by IM injection on Day 1.
|
Phase 2 NH: mRNA-1010 50 ug
n=147 participants at risk
Participants received mRNA-1010 50 ug by IM injection on Day 1.
|
Phase 2 NH: mRNA-1010 100 ug
n=147 participants at risk
Participants received mRNA-1010 100 ug by IM injection on Day 1.
|
Phase 2 Extension: Afluria Quadrivalent 60 ug
n=51 participants at risk
Participants received Afluria Quadrivalent 60 ug by IM injection on Day 1.
|
Phase 2 Extension: mRNA-1010 6.25 ug
n=50 participants at risk
Participants received mRNA-1010 6.25 ug by IM injection on Day 1.
|
Phase 2 Extension: mRNA-1010 12.5 ug
n=50 participants at risk
Participants received mRNA-1010 12.5 ug by IM injection on Day 1.
|
Phase 2 Extension: mRNA-1010 25 ug
n=49 participants at risk
Participants received mRNA-1010 25 ug by IM injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Mouth injury
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.3%
1/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Investigations
Blood alkaline phosphatase increased
|
2.2%
1/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.2%
1/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.2%
1/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.2%
1/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.2%
1/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.3%
1/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.68%
1/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
1/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
1/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Investigations
Prostatic specific antigen increased
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.3%
1/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
2.2%
1/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.3%
1/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
4.1%
2/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.3%
1/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.2%
1/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.2%
1/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.68%
1/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Endocrine disorders
Hypothyroidism
|
2.2%
1/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.3%
1/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Eye disorders
Epiretinal membrane
|
2.2%
1/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.2%
1/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.3%
1/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.2%
1/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.68%
1/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.3%
1/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.7%
4/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.4%
2/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
3/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
1/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
17.8%
8/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
39.1%
18/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
38.6%
17/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
9.3%
5/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
15.3%
23/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
21.1%
31/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
20.4%
30/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
5.9%
3/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
8.0%
4/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
12.0%
6/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
22.4%
11/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
General disorders
Chills
|
4.4%
2/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
31.1%
14/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
56.5%
26/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
70.5%
31/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
11.1%
6/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
29.3%
44/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
35.4%
52/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
49.7%
73/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
15.7%
8/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
18.0%
9/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
10.0%
5/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
36.7%
18/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
General disorders
Fatigue
|
22.2%
10/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
53.3%
24/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
87.0%
40/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
79.5%
35/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
29.6%
16/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
52.7%
79/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
58.5%
86/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
65.3%
96/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
31.4%
16/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
46.0%
23/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
40.0%
20/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
55.1%
27/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
General disorders
Influenza like illness
|
2.2%
1/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.9%
1/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
4.0%
6/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.7%
4/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.7%
4/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
3.9%
2/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
1/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
General disorders
Injection site dermatitis
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.3%
1/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
General disorders
Injection site erythema
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
4.4%
2/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
13.0%
6/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.3%
1/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.9%
1/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
5.3%
8/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
3.4%
5/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
7.5%
11/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
1/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
6.0%
3/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
General disorders
Injection site induration
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
6.7%
3/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
8.7%
4/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.3%
1/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.9%
1/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
6.0%
9/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
8.2%
12/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
9.5%
14/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
1/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
8.0%
4/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
4.1%
2/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
General disorders
Injection site lymphadenopathy
|
6.7%
3/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
24.4%
11/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
34.8%
16/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
50.0%
22/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
18.5%
10/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
26.7%
40/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
30.6%
45/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
35.4%
52/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
13.7%
7/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
26.0%
13/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
28.0%
14/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
32.7%
16/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
General disorders
Injection site pain
|
15.6%
7/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
73.3%
33/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
87.0%
40/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
90.9%
40/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
31.5%
17/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
73.3%
110/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
81.6%
120/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
83.0%
122/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
49.0%
25/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
74.0%
37/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
64.0%
32/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
83.7%
41/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
General disorders
Pyrexia
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
4.4%
2/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
23.9%
11/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
29.5%
13/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
3.7%
2/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
6.7%
10/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
9.5%
14/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
17.0%
25/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
4.0%
2/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
6.1%
3/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Immune system disorders
Seasonal allergy
|
2.2%
1/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.2%
1/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.68%
1/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
1/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Acute sinusitis
|
2.2%
1/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.2%
1/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.3%
1/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.68%
1/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Asymptomatic COVID-19
|
2.2%
1/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.4%
2/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
COVID-19
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
4.4%
2/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
4.3%
2/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
6.8%
3/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
14.8%
8/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
11.3%
17/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
12.9%
19/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
14.3%
21/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
1/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
10.0%
5/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
6.0%
3/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
6.1%
3/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Cystitis
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.2%
1/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.2%
1/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.9%
1/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.3%
2/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.4%
2/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.68%
1/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
1/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Gastrointestinal bacterial infection
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.3%
1/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Influenza
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.3%
1/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.9%
1/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.3%
2/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.68%
1/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
1/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
1/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
1/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Laryngitis
|
2.2%
1/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.68%
1/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Otitis media
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
4.4%
2/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.2%
1/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
3.7%
2/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
3/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.2%
1/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
3/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
3/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.7%
4/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
4.0%
2/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
1/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
1/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Sinusitis
|
2.2%
1/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.2%
1/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.67%
1/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
3/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
6.0%
3/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Sinusitis bacterial
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.2%
1/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.67%
1/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.68%
1/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.68%
1/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
6.7%
3/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
4.3%
2/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.3%
1/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
9.3%
5/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
5.3%
8/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
5.4%
8/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
5.4%
8/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
6.0%
3/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
4.0%
2/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
1/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.2%
1/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.2%
1/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
4.5%
2/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.67%
1/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.68%
1/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
6.0%
3/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
1/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
3/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.3%
1/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.2%
1/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
1/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
2.2%
1/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Heat stroke
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.2%
1/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
2.2%
1/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.68%
1/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
1/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
1/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.2%
1/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
2.2%
1/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.3%
2/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.2%
1/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
1/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
2.2%
1/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.2%
1/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.2%
1/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.3%
1/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.67%
1/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.3%
1/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.9%
1/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.4%
2/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.68%
1/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.2%
1/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.2%
1/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.2%
1/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.2%
1/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.3%
1/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.67%
1/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.2%
1/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.9%
1/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.67%
1/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.4%
2/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
3/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
22.2%
10/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
60.9%
28/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
61.4%
27/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
20.4%
11/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
38.0%
57/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
46.3%
68/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
49.7%
73/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
19.6%
10/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
24.0%
12/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
26.0%
13/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
51.0%
25/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.3%
1/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.9%
1/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Musculoskeletal and connective tissue disorders
Fracture pain
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.3%
1/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.2%
1/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.2%
1/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.6%
7/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
40.0%
18/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
78.3%
36/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
70.5%
31/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
22.2%
12/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
48.0%
72/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
59.9%
88/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
66.7%
98/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
27.5%
14/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
32.0%
16/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
32.0%
16/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
57.1%
28/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.2%
1/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
2.2%
1/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.2%
1/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.2%
1/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.3%
1/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Nervous system disorders
Headache
|
17.8%
8/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
42.2%
19/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
63.0%
29/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
75.0%
33/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
18.5%
10/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
52.0%
78/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
53.7%
79/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
55.8%
82/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
39.2%
20/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
42.0%
21/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
36.0%
18/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
49.0%
24/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Nervous system disorders
Migraine
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.3%
1/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Nervous system disorders
Post-traumatic headache
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.3%
1/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
4.5%
2/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.4%
2/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
1/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.3%
1/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Psychiatric disorders
Depression
|
2.2%
1/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.2%
1/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.67%
1/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
3/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.67%
1/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.68%
1/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
1/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.3%
1/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Psychiatric disorders
Substance abuse
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.3%
1/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.3%
1/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Reproductive system and breast disorders
Endometriosis
|
2.2%
1/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.68%
1/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.2%
1/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.3%
1/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
3.7%
2/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.3%
2/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
3/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
4.8%
7/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
1/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
1/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
3.7%
2/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
3/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.68%
1/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
3.4%
5/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
4.0%
2/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.2%
1/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.3%
1/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
3.3%
5/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.7%
4/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
4.8%
7/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
1/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
1/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
4.1%
2/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
3.7%
2/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.7%
4/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.68%
1/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.7%
4/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
6.0%
3/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.2%
1/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.2%
1/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.68%
1/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
1/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
2.2%
1/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
1/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.3%
1/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.67%
1/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
1/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.3%
1/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
4.0%
2/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Vascular disorders
Haematoma
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.2%
1/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.68%
1/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Vascular disorders
Hypertension
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.2%
1/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.9%
1/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.3%
2/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.4%
2/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.7%
4/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
1/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
6.0%
3/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
4.1%
2/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Vascular disorders
Subgaleal haematoma
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/45 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/46 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.3%
1/44 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/54 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/150 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/147 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/51 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/50 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/49 • Up to 6 months (Day 181, end of study)
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
Additional Information
Moderna Clinical Trials Support Center
ModernaTX, Inc
Phone: 1-877-777-7187
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place