Trial Outcomes & Findings for A Study of mRNA-1020 and mRNA-1030 Seasonal Influenza Vaccines in Healthy Adults (NCT NCT05333289)
NCT ID: NCT05333289
Last Updated: 2024-02-01
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. 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. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section and presented by each dose group separately.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
572 participants
Primary outcome timeframe
Up to Day 7 (7 days after vaccination)
Results posted on
2024-02-01
Participant Flow
Participant milestones
| Measure |
Flublok
Participants received Flublock by intramuscular (IM) injection on Day 1.
|
mRNA-1010
Participants received mRNA-1010 by IM injection on Day 1.
|
mRNA-1030 Dose Level A
Participants received mRNA-1030 Dose Level A by IM injection on Day 1.
|
mRNA-1020 Dose Level A
Participants received mRNA-1020 Dose Level A by IM injection on Day 1.
|
mRNA-1030 Dose Level B
Participants received mRNA-1030 Dose Level B by IM injection on Day 1.
|
mRNA-1020 Dose Level B
Participants received mRNA-1020 Dose Level B by IM injection on Day 1.
|
mRNA-1030 Dose Level C
Participants received mRNA-1030 Dose Level C by IM injection on Day 1.
|
mRNA-1020 Dose Level C
Participants received mRNA-1020 Dose Level C by IM injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
72
|
71
|
71
|
72
|
72
|
71
|
72
|
71
|
|
Overall Study
Received at Least 1 Dose of Investigational Product
|
71
|
71
|
71
|
71
|
72
|
67
|
72
|
70
|
|
Overall Study
Safety Set
|
71
|
71
|
71
|
71
|
72
|
67
|
72
|
70
|
|
Overall Study
Solicited Safety Set
|
71
|
71
|
71
|
71
|
72
|
67
|
72
|
70
|
|
Overall Study
COMPLETED
|
62
|
69
|
67
|
64
|
67
|
62
|
67
|
67
|
|
Overall Study
NOT COMPLETED
|
10
|
2
|
4
|
8
|
5
|
9
|
5
|
4
|
Reasons for withdrawal
| Measure |
Flublok
Participants received Flublock by intramuscular (IM) injection on Day 1.
|
mRNA-1010
Participants received mRNA-1010 by IM injection on Day 1.
|
mRNA-1030 Dose Level A
Participants received mRNA-1030 Dose Level A by IM injection on Day 1.
|
mRNA-1020 Dose Level A
Participants received mRNA-1020 Dose Level A by IM injection on Day 1.
|
mRNA-1030 Dose Level B
Participants received mRNA-1030 Dose Level B by IM injection on Day 1.
|
mRNA-1020 Dose Level B
Participants received mRNA-1020 Dose Level B by IM injection on Day 1.
|
mRNA-1030 Dose Level C
Participants received mRNA-1030 Dose Level C by IM injection on Day 1.
|
mRNA-1020 Dose Level C
Participants received mRNA-1020 Dose Level C by IM injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Other
|
1
|
0
|
0
|
1
|
1
|
2
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
2
|
1
|
1
|
2
|
1
|
3
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
2
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
6
|
0
|
1
|
6
|
3
|
3
|
2
|
1
|
|
Overall Study
Death
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study of mRNA-1020 and mRNA-1030 Seasonal Influenza Vaccines in Healthy Adults
Baseline characteristics by cohort
| Measure |
Flublok
n=72 Participants
Participants received Flublock by IM injection on Day 1.
|
mRNA-1010
n=71 Participants
Participants received mRNA-1010 by IM injection on Day 1.
|
mRNA-1030 Dose Level A
n=71 Participants
Participants received mRNA-1030 Dose Level A by IM injection on Day 1.
|
mRNA-1020 Dose Level A
n=72 Participants
Participants received mRNA-1020 Dose Level A by IM injection on Day 1.
|
mRNA-1030 Dose Level B
n=72 Participants
Participants received mRNA-1030 Dose Level B by IM injection on Day 1.
|
mRNA-1020 Dose Level B
n=71 Participants
Participants received mRNA-1020 Dose Level B by IM injection on Day 1.
|
mRNA-1030 Dose Level C
n=72 Participants
Participants received mRNA-1030 Dose Level C by IM injection on Day 1.
|
mRNA-1020 Dose Level C
n=71 Participants
Participants received mRNA-1020 Dose Level C by IM injection on Day 1.
|
Total
n=572 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
46.3 years
STANDARD_DEVIATION 14.51 • n=5 Participants
|
46.0 years
STANDARD_DEVIATION 15.03 • n=7 Participants
|
47.1 years
STANDARD_DEVIATION 14.40 • n=5 Participants
|
48.0 years
STANDARD_DEVIATION 16.50 • n=4 Participants
|
46.9 years
STANDARD_DEVIATION 14.11 • n=21 Participants
|
48.0 years
STANDARD_DEVIATION 14.84 • n=10 Participants
|
47.3 years
STANDARD_DEVIATION 17.13 • n=115 Participants
|
49.2 years
STANDARD_DEVIATION 15.88 • n=6 Participants
|
47.4 years
STANDARD_DEVIATION 15.27 • n=6 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
41 Participants
n=10 Participants
|
39 Participants
n=115 Participants
|
40 Participants
n=6 Participants
|
314 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
30 Participants
n=10 Participants
|
33 Participants
n=115 Participants
|
31 Participants
n=6 Participants
|
258 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
6 Participants
n=6 Participants
|
50 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
63 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
65 Participants
n=21 Participants
|
63 Participants
n=10 Participants
|
67 Participants
n=115 Participants
|
65 Participants
n=6 Participants
|
519 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
8 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
22 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
6 Participants
n=6 Participants
|
74 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
60 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
54 Participants
n=21 Participants
|
58 Participants
n=10 Participants
|
61 Participants
n=115 Participants
|
59 Participants
n=6 Participants
|
460 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Up to Day 7 (7 days after vaccination)Population: The Solicited Safety Set consisted of all participants in the Safety Set who contributed any solicited AR data.
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. 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. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section and presented by each dose group separately.
Outcome measures
| Measure |
Flublok
n=71 Participants
Participants received Flublock by IM injection on Day 1.
|
mRNA-1010
n=71 Participants
Participants received mRNA-1010 by IM injection on Day 1.
|
mRNA-1030 Dose Level A
n=71 Participants
Participants received mRNA-1030 Dose Level A by IM injection on Day 1.
|
mRNA-1020 Dose Level A
n=71 Participants
Participants received mRNA-1020 Dose Level A by IM injection on Day 1.
|
mRNA-1030 Dose Level B
n=72 Participants
Participants received mRNA-1030 Dose Level B by IM injection on Day 1.
|
mRNA-1020 Dose Level B
n=67 Participants
Participants received mRNA-1020 Dose Level B by IM injection on Day 1.
|
mRNA-1030 Dose Level C
n=72 Participants
Participants received mRNA-1030 Dose Level C by IM injection on Day 1.
|
mRNA-1020 Dose Level C
n=70 Participants
Participants received mRNA-1020 Dose Level C by IM injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Solicited Local ARs
|
37 Participants
|
63 Participants
|
59 Participants
|
60 Participants
|
57 Participants
|
58 Participants
|
67 Participants
|
67 Participants
|
|
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Solicited Systemic ARs
|
32 Participants
|
61 Participants
|
44 Participants
|
57 Participants
|
55 Participants
|
58 Participants
|
64 Participants
|
64 Participants
|
PRIMARY outcome
Timeframe: Up to Day 28 (28 days after vaccination)Population: The Safety Set consisted of all randomly assigned participants who received the investigational product.
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 dose group separately.
Outcome measures
| Measure |
Flublok
n=71 Participants
Participants received Flublock by IM injection on Day 1.
|
mRNA-1010
n=71 Participants
Participants received mRNA-1010 by IM injection on Day 1.
|
mRNA-1030 Dose Level A
n=71 Participants
Participants received mRNA-1030 Dose Level A by IM injection on Day 1.
|
mRNA-1020 Dose Level A
n=71 Participants
Participants received mRNA-1020 Dose Level A by IM injection on Day 1.
|
mRNA-1030 Dose Level B
n=72 Participants
Participants received mRNA-1030 Dose Level B by IM injection on Day 1.
|
mRNA-1020 Dose Level B
n=67 Participants
Participants received mRNA-1020 Dose Level B by IM injection on Day 1.
|
mRNA-1030 Dose Level C
n=72 Participants
Participants received mRNA-1030 Dose Level C by IM injection on Day 1.
|
mRNA-1020 Dose Level C
n=70 Participants
Participants received mRNA-1020 Dose Level C by IM injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Unsolicited Adverse Events (AEs)
|
10 Participants
|
17 Participants
|
6 Participants
|
15 Participants
|
11 Participants
|
15 Participants
|
12 Participants
|
21 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 181Population: The Safety Set consisted of all randomly assigned participants who received the investigational product.
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 dose group separately.
Outcome measures
| Measure |
Flublok
n=71 Participants
Participants received Flublock by IM injection on Day 1.
|
mRNA-1010
n=71 Participants
Participants received mRNA-1010 by IM injection on Day 1.
|
mRNA-1030 Dose Level A
n=71 Participants
Participants received mRNA-1030 Dose Level A by IM injection on Day 1.
|
mRNA-1020 Dose Level A
n=71 Participants
Participants received mRNA-1020 Dose Level A by IM injection on Day 1.
|
mRNA-1030 Dose Level B
n=72 Participants
Participants received mRNA-1030 Dose Level B by IM injection on Day 1.
|
mRNA-1020 Dose Level B
n=67 Participants
Participants received mRNA-1020 Dose Level B by IM injection on Day 1.
|
mRNA-1030 Dose Level C
n=72 Participants
Participants received mRNA-1030 Dose Level C by IM injection on Day 1.
|
mRNA-1020 Dose Level C
n=70 Participants
Participants received mRNA-1020 Dose Level C by IM injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Medically-Attended AEs (MAAEs), Adverse Event of Special Interest (AESI), AEs Leading to Withdrawal and Serious Adverse Events (SAEs)
Medically-Attended AEs
|
23 Participants
|
20 Participants
|
16 Participants
|
24 Participants
|
18 Participants
|
19 Participants
|
17 Participants
|
23 Participants
|
|
Number of Participants With Medically-Attended AEs (MAAEs), Adverse Event of Special Interest (AESI), AEs Leading to Withdrawal and Serious Adverse Events (SAEs)
Adverse Event of Special Interest
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Medically-Attended AEs (MAAEs), Adverse Event of Special Interest (AESI), AEs Leading to Withdrawal and Serious Adverse Events (SAEs)
AEs Leading to Withdrawal
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Medically-Attended AEs (MAAEs), Adverse Event of Special Interest (AESI), AEs Leading to Withdrawal and Serious Adverse Events (SAEs)
Serious Adverse Events
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Day 29Population: PP Set consisted of all participants in the FAS who complied with injection schedule, complied with timings of immunogenicity blood sampling to have a baseline and at least 1 post-injection assessment, did not had influenza infection at baseline through Day 29, and had no major protocol deviations that impacted immune response. Number of participants analyzed signifies those who were evaluable for this outcome measure and number analyzed signifies those who were evaluable for specified category.
Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage.
Outcome measures
| Measure |
Flublok
n=65 Participants
Participants received Flublock by IM injection on Day 1.
|
mRNA-1010
n=61 Participants
Participants received mRNA-1010 by IM injection on Day 1.
|
mRNA-1030 Dose Level A
n=67 Participants
Participants received mRNA-1030 Dose Level A by IM injection on Day 1.
|
mRNA-1020 Dose Level A
n=63 Participants
Participants received mRNA-1020 Dose Level A by IM injection on Day 1.
|
mRNA-1030 Dose Level B
n=63 Participants
Participants received mRNA-1030 Dose Level B by IM injection on Day 1.
|
mRNA-1020 Dose Level B
n=60 Participants
Participants received mRNA-1020 Dose Level B by IM injection on Day 1.
|
mRNA-1030 Dose Level C
n=66 Participants
Participants received mRNA-1030 Dose Level C by IM injection on Day 1.
|
mRNA-1020 Dose Level C
n=61 Participants
Participants received mRNA-1020 Dose Level C by IM injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29 as Measured by Hemagglutination Inhibition (HAI) Assay Vaccine-Matched Seasonal Influenza A and B Strains
Influenza B/Victoria Lineage
|
151.68 titer
Interval 116.74 to 197.06
|
88.57 titer
Interval 69.14 to 113.47
|
86.86 titer
Interval 70.52 to 106.99
|
86.88 titer
Interval 68.9 to 109.55
|
105.92 titer
Interval 85.24 to 131.6
|
82.86 titer
Interval 64.68 to 106.13
|
91.71 titer
Interval 73.63 to 114.23
|
75.56 titer
Interval 58.47 to 97.65
|
|
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29 as Measured by Hemagglutination Inhibition (HAI) Assay Vaccine-Matched Seasonal Influenza A and B Strains
Influenza A H1N1 Antibody
|
724.69 titer
Interval 527.41 to 995.78
|
498.43 titer
Interval 392.33 to 633.22
|
328.44 titer
Interval 243.71 to 442.62
|
472.81 titer
Interval 345.73 to 646.61
|
387.92 titer
Interval 291.94 to 515.47
|
378.34 titer
Interval 267.06 to 535.99
|
431.61 titer
Interval 325.8 to 571.78
|
527.55 titer
Interval 404.11 to 688.7
|
|
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29 as Measured by Hemagglutination Inhibition (HAI) Assay Vaccine-Matched Seasonal Influenza A and B Strains
Influenza A H3N2 Antibody
|
354.11 titer
Interval 269.13 to 465.92
|
316.36 titer
Interval 243.84 to 410.45
|
239.78 titer
Interval 180.19 to 319.07
|
263.95 titer
Interval 206.13 to 338.0
|
211.86 titer
Interval 152.96 to 293.44
|
255.44 titer
Interval 181.2 to 360.09
|
283.59 titer
Interval 222.4 to 361.62
|
300.62 titer
Interval 228.6 to 395.34
|
|
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29 as Measured by Hemagglutination Inhibition (HAI) Assay Vaccine-Matched Seasonal Influenza A and B Strains
Influenza B/Yamagata Lineage
|
277.06 titer
Interval 225.13 to 340.96
|
245.01 titer
Interval 196.73 to 305.41
|
191.74 titer
Interval 157.35 to 233.65
|
249.81 titer
Interval 199.09 to 313.45
|
237.78 titer
Interval 194.08 to 291.31
|
246.78 titer
Interval 196.09 to 310.57
|
255.31 titer
Interval 216.23 to 301.44
|
243.62 titer
Interval 196.35 to 302.26
|
PRIMARY outcome
Timeframe: Day 29Population: The Per Protocol (PP) Set consisted of all participants in the Full analysis set (FAS) who complied with injection schedule, complied with timings of immunogenicity blood sampling to have a baseline and at least 1 post-injection assessment, did not had influenza infection at baseline through Day 29, and had no major protocol deviations that impacted immune response. Here, Number analyzed signifies those who were evaluable for specified category.
Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage.
Outcome measures
| Measure |
Flublok
n=67 Participants
Participants received Flublock by IM injection on Day 1.
|
mRNA-1010
n=63 Participants
Participants received mRNA-1010 by IM injection on Day 1.
|
mRNA-1030 Dose Level A
n=67 Participants
Participants received mRNA-1030 Dose Level A by IM injection on Day 1.
|
mRNA-1020 Dose Level A
n=66 Participants
Participants received mRNA-1020 Dose Level A by IM injection on Day 1.
|
mRNA-1030 Dose Level B
n=66 Participants
Participants received mRNA-1030 Dose Level B by IM injection on Day 1.
|
mRNA-1020 Dose Level B
n=64 Participants
Participants received mRNA-1020 Dose Level B by IM injection on Day 1.
|
mRNA-1030 Dose Level C
n=67 Participants
Participants received mRNA-1030 Dose Level C by IM injection on Day 1.
|
mRNA-1020 Dose Level C
n=63 Participants
Participants received mRNA-1020 Dose Level C by IM injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
GMT of Anti-Neuraminidase (NA) Antibodies at Day 29 as Measured by Neuraminidase Inhibition (NAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Influenza B/Yamagata Lineage
|
183.03 titer
Interval 146.21 to 229.13
|
215.34 titer
Interval 174.21 to 266.19
|
837.52 titer
Interval 718.85 to 975.8
|
1293.51 titer
Interval 1099.7 to 1521.48
|
953.89 titer
Interval 823.81 to 1104.52
|
1441.95 titer
Interval 1215.88 to 1710.05
|
998.57 titer
Interval 857.69 to 1162.59
|
1428.87 titer
Interval 1186.31 to 1721.02
|
|
GMT of Anti-Neuraminidase (NA) Antibodies at Day 29 as Measured by Neuraminidase Inhibition (NAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Influenza A H1N1 Antibody
|
103.61 titer
Interval 91.5 to 117.33
|
97.52 titer
Interval 88.13 to 107.91
|
163.35 titer
Interval 134.09 to 198.99
|
219.26 titer
Interval 174.9 to 274.86
|
195.34 titer
Interval 159.57 to 239.11
|
198.70 titer
Interval 160.51 to 245.98
|
170.25 titer
Interval 141.09 to 205.43
|
268.35 titer
Interval 210.93 to 341.4
|
|
GMT of Anti-Neuraminidase (NA) Antibodies at Day 29 as Measured by Neuraminidase Inhibition (NAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Influenza A H3N2 Antibody
|
20.49 titer
Interval 16.47 to 25.51
|
21.09 titer
Interval 16.44 to 27.05
|
69.21 titer
Interval 50.36 to 95.12
|
105.23 titer
Interval 78.54 to 141.0
|
79.56 titer
Interval 57.45 to 110.18
|
127.60 titer
Interval 92.74 to 175.55
|
92.57 titer
Interval 70.53 to 121.49
|
139.16 titer
Interval 104.11 to 186.0
|
|
GMT of Anti-Neuraminidase (NA) Antibodies at Day 29 as Measured by Neuraminidase Inhibition (NAI) Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Influenza B/Victoria Lineage
|
69.93 titer
Interval 60.15 to 81.31
|
78.26 titer
Interval 66.5 to 92.1
|
268.39 titer
Interval 232.82 to 309.4
|
416.08 titer
Interval 354.45 to 488.42
|
316.66 titer
Interval 269.21 to 372.46
|
477.73 titer
Interval 402.55 to 566.95
|
316.71 titer
Interval 270.66 to 370.58
|
470.32 titer
Interval 390.92 to 565.83
|
PRIMARY outcome
Timeframe: Day 29Population: PP Set consisted of all participants in the FAS who complied with injection schedule, complied with timings of immunogenicity blood sampling to have a baseline and at least 1 post-injection assessment, did not had influenza infection at baseline through Day 29, and had no major protocol deviations that impacted immune response. Number of participants analyzed signifies those who were evaluable for this outcome measure and number analyzed signifies those who were evaluable for specified category.
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. Fold-rise was calculated by dividing post-vaccination results by the baseline value. 95% CI for GMFR was calculated based on the t distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation.
Outcome measures
| Measure |
Flublok
n=65 Participants
Participants received Flublock by IM injection on Day 1.
|
mRNA-1010
n=61 Participants
Participants received mRNA-1010 by IM injection on Day 1.
|
mRNA-1030 Dose Level A
n=67 Participants
Participants received mRNA-1030 Dose Level A by IM injection on Day 1.
|
mRNA-1020 Dose Level A
n=63 Participants
Participants received mRNA-1020 Dose Level A by IM injection on Day 1.
|
mRNA-1030 Dose Level B
n=63 Participants
Participants received mRNA-1030 Dose Level B by IM injection on Day 1.
|
mRNA-1020 Dose Level B
n=60 Participants
Participants received mRNA-1020 Dose Level B by IM injection on Day 1.
|
mRNA-1030 Dose Level C
n=66 Participants
Participants received mRNA-1030 Dose Level C by IM injection on Day 1.
|
mRNA-1020 Dose Level C
n=61 Participants
Participants received mRNA-1020 Dose Level C by IM injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29 as Measured by HAI Assay Vaccine-Matched Seasonal Influenza A and B Strains
Influenza A H1N1 Antibody
|
9.93 ratio
Interval 6.6 to 14.94
|
9.12 ratio
Interval 6.63 to 12.55
|
5.29 ratio
Interval 3.77 to 7.42
|
8.56 ratio
Interval 6.03 to 12.15
|
6.83 ratio
Interval 4.96 to 9.39
|
8.39 ratio
Interval 5.93 to 11.88
|
6.73 ratio
Interval 5.01 to 9.04
|
6.79 ratio
Interval 4.86 to 9.48
|
|
Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29 as Measured by HAI Assay Vaccine-Matched Seasonal Influenza A and B Strains
Influenza A H3N2 Antibody
|
6.97 ratio
Interval 5.05 to 9.61
|
7.73 ratio
Interval 5.9 to 10.13
|
4.44 ratio
Interval 3.28 to 6.01
|
6.53 ratio
Interval 4.74 to 9.0
|
5.45 ratio
Interval 4.12 to 7.2
|
7.68 ratio
Interval 5.75 to 10.28
|
5.93 ratio
Interval 4.42 to 7.96
|
6.98 ratio
Interval 5.58 to 8.73
|
|
Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29 as Measured by HAI Assay Vaccine-Matched Seasonal Influenza A and B Strains
Influenza B/Victoria Lineage
|
3.45 ratio
Interval 2.62 to 4.54
|
2.48 ratio
Interval 1.98 to 3.12
|
1.93 ratio
Interval 1.6 to 2.32
|
2.37 ratio
Interval 2.01 to 2.8
|
2.40 ratio
Interval 1.92 to 3.01
|
2.35 ratio
Interval 1.99 to 2.78
|
2.50 ratio
Interval 2.08 to 3.0
|
2.37 ratio
Interval 1.94 to 2.9
|
|
Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29 as Measured by HAI Assay Vaccine-Matched Seasonal Influenza A and B Strains
Influenza B/Yamagata Lineage
|
3.75 ratio
Interval 2.89 to 4.88
|
3.12 ratio
Interval 2.49 to 3.9
|
2.83 ratio
Interval 2.31 to 3.47
|
3.62 ratio
Interval 2.88 to 4.57
|
3.18 ratio
Interval 2.64 to 3.81
|
3.65 ratio
Interval 2.94 to 4.53
|
2.98 ratio
Interval 2.46 to 3.61
|
4.05 ratio
Interval 3.25 to 5.04
|
PRIMARY outcome
Timeframe: Day 29Population: PP Set consisted of all participants in the FAS who complied with injection schedule, complied with timings of immunogenicity blood sampling to have a baseline and at least 1 post-injection assessment, did not had influenza infection at baseline through Day 29, and had no major protocol deviations that impacted immune response. Here, Number analyzed signifies those who were evaluable for specified category.
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. Fold-rise was calculated by dividing post-vaccination results by the baseline value. 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 |
Flublok
n=67 Participants
Participants received Flublock by IM injection on Day 1.
|
mRNA-1010
n=63 Participants
Participants received mRNA-1010 by IM injection on Day 1.
|
mRNA-1030 Dose Level A
n=67 Participants
Participants received mRNA-1030 Dose Level A by IM injection on Day 1.
|
mRNA-1020 Dose Level A
n=66 Participants
Participants received mRNA-1020 Dose Level A by IM injection on Day 1.
|
mRNA-1030 Dose Level B
n=66 Participants
Participants received mRNA-1030 Dose Level B by IM injection on Day 1.
|
mRNA-1020 Dose Level B
n=64 Participants
Participants received mRNA-1020 Dose Level B by IM injection on Day 1.
|
mRNA-1030 Dose Level C
n=67 Participants
Participants received mRNA-1030 Dose Level C by IM injection on Day 1.
|
mRNA-1020 Dose Level C
n=63 Participants
Participants received mRNA-1020 Dose Level C by IM injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
GMFR of Anti-NA Antibodies at Day 29 as Measured by NAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Influenza A H1N1 Antibody
|
1.01 ratio
Interval 0.93 to 1.1
|
1.00 ratio
Interval 0.96 to 1.05
|
1.42 ratio
Interval 1.23 to 1.65
|
2.18 ratio
Interval 1.8 to 2.63
|
1.82 ratio
Interval 1.57 to 2.11
|
2.35 ratio
Interval 1.92 to 2.89
|
1.75 ratio
Interval 1.49 to 2.05
|
2.38 ratio
Interval 1.96 to 2.9
|
|
GMFR of Anti-NA Antibodies at Day 29 as Measured by NAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Influenza A H3N2 Antibody
|
0.94 ratio
Interval 0.84 to 1.05
|
1.07 ratio
Interval 0.92 to 1.24
|
3.18 ratio
Interval 2.41 to 4.21
|
4.61 ratio
Interval 3.64 to 5.84
|
3.65 ratio
Interval 2.79 to 4.79
|
6.29 ratio
Interval 4.8 to 8.23
|
4.47 ratio
Interval 3.43 to 5.83
|
8.01 ratio
Interval 6.04 to 10.64
|
|
GMFR of Anti-NA Antibodies at Day 29 as Measured by NAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Influenza B/Victoria Lineage
|
0.93 ratio
Interval 0.86 to 1.01
|
0.99 ratio
Interval 0.9 to 1.08
|
3.57 ratio
Interval 2.95 to 4.32
|
5.78 ratio
Interval 4.8 to 6.95
|
4.31 ratio
Interval 3.63 to 5.1
|
6.80 ratio
Interval 5.67 to 8.16
|
4.30 ratio
Interval 3.64 to 5.08
|
6.49 ratio
Interval 5.43 to 7.76
|
|
GMFR of Anti-NA Antibodies at Day 29 as Measured by NAI Assay for Vaccine-Matched Seasonal Influenza A and B Strains
Influenza B/Yamagata Lineage
|
1.00 ratio
Interval 0.92 to 1.09
|
0.95 ratio
Interval 0.86 to 1.05
|
4.21 ratio
Interval 3.48 to 5.1
|
6.76 ratio
Interval 5.41 to 8.46
|
4.54 ratio
Interval 3.79 to 5.43
|
7.74 ratio
Interval 6.35 to 9.45
|
4.87 ratio
Interval 4.07 to 5.82
|
8.36 ratio
Interval 6.82 to 10.24
|
PRIMARY outcome
Timeframe: Day 29Population: PP Set consisted of all participants in the FAS who complied with injection schedule, complied with timings of immunogenicity blood sampling to have a baseline and at least 1 post-injection assessment, did not had influenza infection at baseline through Day 29, and had no major protocol deviations that impacted immune response. Number of participants analyzed signifies those who were evaluable for this outcome measure and number analyzed signifies those who were evaluable for specified category.
Seroconversion at a participant level is defined as corresponding visit titer ≥ 4\*LLOQ (lower limit of quantification) if baseline is \< LLOQ or a 4-fold or greater rise if baseline is ≥ LLOQ in anti-HA antibodies. When LLOQ is 1:10, seroconversion is defined as a corresponding visit titer ≥ 1:40 if baseline is \< 1:10 or a 4-fold or greater rise if baseline is ≥ 1:10 in anti- HA antibodies measured by HAI assay. 95% CI was calculated using the Clopper-Pearson method.
Outcome measures
| Measure |
Flublok
n=65 Participants
Participants received Flublock by IM injection on Day 1.
|
mRNA-1010
n=61 Participants
Participants received mRNA-1010 by IM injection on Day 1.
|
mRNA-1030 Dose Level A
n=67 Participants
Participants received mRNA-1030 Dose Level A by IM injection on Day 1.
|
mRNA-1020 Dose Level A
n=63 Participants
Participants received mRNA-1020 Dose Level A by IM injection on Day 1.
|
mRNA-1030 Dose Level B
n=63 Participants
Participants received mRNA-1030 Dose Level B by IM injection on Day 1.
|
mRNA-1020 Dose Level B
n=60 Participants
Participants received mRNA-1020 Dose Level B by IM injection on Day 1.
|
mRNA-1030 Dose Level C
n=66 Participants
Participants received mRNA-1030 Dose Level C by IM injection on Day 1.
|
mRNA-1020 Dose Level C
n=61 Participants
Participants received mRNA-1020 Dose Level C by IM injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroconversion as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B
Influenza A H1N1 Antibody
|
66.2 percentage of participants
Interval 53.35 to 77.43
|
75.4 percentage of participants
Interval 62.71 to 85.54
|
56.7 percentage of participants
Interval 44.04 to 68.78
|
74.6 percentage of participants
Interval 62.06 to 84.73
|
71.4 percentage of participants
Interval 58.65 to 82.11
|
71.7 percentage of participants
Interval 58.56 to 82.55
|
69.7 percentage of participants
Interval 57.15 to 80.41
|
67.2 percentage of participants
Interval 54.0 to 78.69
|
|
Percentage of Participants With Seroconversion as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B
Influenza A H3N2 Antibody
|
69.2 percentage of participants
Interval 56.55 to 80.09
|
73.8 percentage of participants
Interval 60.93 to 84.2
|
50.0 percentage of participants
Interval 37.43 to 62.57
|
65.1 percentage of participants
Interval 52.03 to 76.66
|
60.3 percentage of participants
Interval 47.2 to 72.43
|
76.7 percentage of participants
Interval 63.96 to 86.62
|
65.2 percentage of participants
Interval 52.42 to 76.47
|
82.0 percentage of participants
Interval 70.02 to 90.64
|
|
Percentage of Participants With Seroconversion as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B
Influenza B/Victoria Lineage
|
46.2 percentage of participants
Interval 33.7 to 58.97
|
19.7 percentage of participants
Interval 10.6 to 31.84
|
14.9 percentage of participants
Interval 7.4 to 25.74
|
28.6 percentage of participants
Interval 17.89 to 41.35
|
30.2 percentage of participants
Interval 19.23 to 43.02
|
25.0 percentage of participants
Interval 14.72 to 37.86
|
25.8 percentage of participants
Interval 15.78 to 38.01
|
23.0 percentage of participants
Interval 13.15 to 35.5
|
|
Percentage of Participants With Seroconversion as Measured by HAI Assay for Vaccine-Matched Seasonal Influenza A and B
Influenza B/Yamagata Lineage
|
47.7 percentage of participants
Interval 35.15 to 60.46
|
36.1 percentage of participants
Interval 24.16 to 49.37
|
37.3 percentage of participants
Interval 25.8 to 49.99
|
52.4 percentage of participants
Interval 39.41 to 65.12
|
41.3 percentage of participants
Interval 29.01 to 54.38
|
45.0 percentage of participants
Interval 32.12 to 58.39
|
40.9 percentage of participants
Interval 28.95 to 53.71
|
54.1 percentage of participants
Interval 40.85 to 66.94
|
PRIMARY outcome
Timeframe: Baseline (Day 1), Day 29Population: PP Set consisted of all participants in the FAS who complied with injection schedule, complied with timings of immunogenicity blood sampling to have a baseline and at least 1 post-injection assessment, did not had influenza infection at baseline through Day 29, and had no major protocol deviations that impacted immune response.Number of participants analyzed signifies those who were evaluable for this outcome measure. Number analyzed signifies those who were evaluable for specified category.
≥ z-fold rise from baseline at participant level is defined as a ≥ z x LLOQ for participants with baseline antibody level \< LLOQ, or a z-times or higher antibody level ratio in participants with baseline antibody level ≥ LLOQ. 95% CI was calculated using the Clopper-Pearson method.
Outcome measures
| Measure |
Flublok
n=65 Participants
Participants received Flublock by IM injection on Day 1.
|
mRNA-1010
n=61 Participants
Participants received mRNA-1010 by IM injection on Day 1.
|
mRNA-1030 Dose Level A
n=67 Participants
Participants received mRNA-1030 Dose Level A by IM injection on Day 1.
|
mRNA-1020 Dose Level A
n=63 Participants
Participants received mRNA-1020 Dose Level A by IM injection on Day 1.
|
mRNA-1030 Dose Level B
n=63 Participants
Participants received mRNA-1030 Dose Level B by IM injection on Day 1.
|
mRNA-1020 Dose Level B
n=60 Participants
Participants received mRNA-1020 Dose Level B by IM injection on Day 1.
|
mRNA-1030 Dose Level C
n=66 Participants
Participants received mRNA-1030 Dose Level C by IM injection on Day 1.
|
mRNA-1020 Dose Level C
n=61 Participants
Participants received mRNA-1020 Dose Level C by IM injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay
Influenza A H1N1 Antibody: ≥ 2-fold Rise from Baseline
|
84.6 Percentage of Participants
Interval 73.52 to 92.37
|
93.4 Percentage of Participants
Interval 84.05 to 98.18
|
80.6 Percentage of Participants
Interval 69.11 to 89.24
|
84.1 Percentage of Participants
Interval 72.74 to 92.12
|
92.1 Percentage of Participants
Interval 82.44 to 97.37
|
93.3 Percentage of Participants
Interval 83.3 to 98.15
|
92.4 Percentage of Participants
Interval 83.2 to 97.49
|
95.1 Percentage of Participants
Interval 86.29 to 98.97
|
|
Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay
Influenza A H1N1 Antibody: ≥ 3-fold Rise from Baseline
|
67.7 Percentage of Participants
Interval 54.95 to 78.77
|
77.0 Percentage of Participants
Interval 64.5 to 86.85
|
56.7 Percentage of Participants
Interval 44.04 to 68.78
|
74.6 Percentage of Participants
Interval 62.06 to 84.73
|
71.4 Percentage of Participants
Interval 58.65 to 82.11
|
71.7 Percentage of Participants
Interval 58.56 to 82.55
|
69.7 Percentage of Participants
Interval 57.15 to 80.41
|
68.9 Percentage of Participants
Interval 55.71 to 80.1
|
|
Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay
Influenza A H1N1 Antibody: ≥ 4-fold Rise from Baseline
|
66.2 Percentage of Participants
Interval 53.35 to 77.43
|
75.4 Percentage of Participants
Interval 62.71 to 85.54
|
56.7 Percentage of Participants
Interval 44.04 to 68.78
|
74.6 Percentage of Participants
Interval 62.06 to 84.73
|
71.4 Percentage of Participants
Interval 58.65 to 82.11
|
71.7 Percentage of Participants
Interval 58.56 to 82.55
|
69.7 Percentage of Participants
Interval 57.15 to 80.41
|
67.2 Percentage of Participants
Interval 54.0 to 78.69
|
|
Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay
Influenza A H3N2 Antibody: ≥ 2-fold Rise from Baseline
|
87.7 Percentage of Participants
Interval 77.18 to 94.53
|
96.7 Percentage of Participants
Interval 88.65 to 99.6
|
80.3 Percentage of Participants
Interval 68.68 to 89.07
|
90.5 Percentage of Participants
Interval 80.41 to 96.42
|
88.9 Percentage of Participants
Interval 78.44 to 95.41
|
91.7 Percentage of Participants
Interval 81.61 to 97.24
|
92.4 Percentage of Participants
Interval 83.2 to 97.49
|
98.4 Percentage of Participants
Interval 91.2 to 99.96
|
|
Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay
Influenza A H3N2 Antibody: ≥ 3-fold Rise from Baseline
|
69.2 Percentage of Participants
Interval 56.55 to 80.09
|
75.4 Percentage of Participants
Interval 62.71 to 85.54
|
51.5 Percentage of Participants
Interval 38.88 to 64.01
|
65.1 Percentage of Participants
Interval 52.03 to 76.66
|
60.3 Percentage of Participants
Interval 47.2 to 72.43
|
76.7 Percentage of Participants
Interval 63.96 to 86.62
|
65.2 Percentage of Participants
Interval 52.42 to 76.47
|
82.0 Percentage of Participants
Interval 70.02 to 90.64
|
|
Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay
Influenza A H3N2 Antibody: ≥ 4-fold Rise from Baseline
|
69.2 Percentage of Participants
Interval 56.55 to 80.09
|
73.8 Percentage of Participants
Interval 60.93 to 84.2
|
50.0 Percentage of Participants
Interval 37.43 to 62.57
|
65.1 Percentage of Participants
Interval 52.03 to 76.66
|
60.3 Percentage of Participants
Interval 47.2 to 72.43
|
76.7 Percentage of Participants
Interval 63.96 to 86.62
|
65.2 Percentage of Participants
Interval 52.42 to 76.47
|
82.0 Percentage of Participants
Interval 70.02 to 90.64
|
|
Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay
Influenza B/Victoria Lineage: ≥ 2-fold Rise from Baseline
|
78.5 Percentage of Participants
Interval 66.51 to 87.69
|
65.6 Percentage of Participants
Interval 52.31 to 77.27
|
46.3 Percentage of Participants
Interval 34.0 to 58.88
|
68.3 Percentage of Participants
Interval 55.31 to 79.42
|
66.7 Percentage of Participants
Interval 53.66 to 78.05
|
71.7 Percentage of Participants
Interval 58.56 to 82.55
|
71.2 Percentage of Participants
Interval 58.75 to 81.7
|
68.9 Percentage of Participants
Interval 55.71 to 80.1
|
|
Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay
Influenza B/Victoria Lineage: ≥ 3-fold Rise from Baseline
|
47.7 Percentage of Participants
Interval 35.15 to 60.46
|
19.7 Percentage of Participants
Interval 10.6 to 31.84
|
14.9 Percentage of Participants
Interval 7.4 to 25.74
|
28.6 Percentage of Participants
Interval 17.89 to 41.35
|
30.2 Percentage of Participants
Interval 19.23 to 43.02
|
25.0 Percentage of Participants
Interval 14.72 to 37.86
|
25.8 Percentage of Participants
Interval 15.78 to 38.01
|
23.0 Percentage of Participants
Interval 13.15 to 35.5
|
|
Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay
Influenza B/Victoria Lineage: ≥ 4-fold Rise from Baseline
|
46.2 Percentage of Participants
Interval 33.7 to 58.97
|
19.7 Percentage of Participants
Interval 10.6 to 31.84
|
14.9 Percentage of Participants
Interval 7.4 to 25.74
|
28.6 Percentage of Participants
Interval 17.89 to 41.35
|
30.2 Percentage of Participants
Interval 19.23 to 43.02
|
25.0 Percentage of Participants
Interval 14.72 to 37.86
|
25.8 Percentage of Participants
Interval 15.78 to 38.01
|
23.0 Percentage of Participants
Interval 13.15 to 35.5
|
|
Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay
Influenza B/Yamagata Lineage: ≥ 2-fold Rise from Baseline
|
75.4 Percentage of Participants
Interval 63.13 to 85.23
|
85.2 Percentage of Participants
Interval 73.83 to 93.02
|
77.6 Percentage of Participants
Interval 65.78 to 86.89
|
84.1 Percentage of Participants
Interval 72.74 to 92.12
|
87.3 Percentage of Participants
Interval 76.5 to 94.35
|
93.3 Percentage of Participants
Interval 83.3 to 98.15
|
87.9 Percentage of Participants
Interval 77.51 to 94.62
|
93.4 Percentage of Participants
Interval 84.05 to 98.18
|
|
Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay
Influenza B/Yamagata Lineage: ≥ 3-fold Rise from Baseline
|
47.7 Percentage of Participants
Interval 35.15 to 60.46
|
36.1 Percentage of Participants
Interval 24.16 to 49.37
|
37.3 Percentage of Participants
Interval 25.8 to 49.99
|
52.4 Percentage of Participants
Interval 39.41 to 65.12
|
41.3 Percentage of Participants
Interval 29.01 to 54.38
|
45.0 Percentage of Participants
Interval 32.12 to 58.39
|
40.9 Percentage of Participants
Interval 28.95 to 53.71
|
54.1 Percentage of Participants
Interval 40.85 to 66.94
|
|
Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise by HAI Assay
Influenza B/Yamagata Lineage: ≥ 4-fold Rise from Baseline
|
47.7 Percentage of Participants
Interval 35.15 to 60.46
|
36.1 Percentage of Participants
Interval 24.16 to 49.37
|
37.3 Percentage of Participants
Interval 25.8 to 49.99
|
52.4 Percentage of Participants
Interval 39.41 to 65.12
|
41.3 Percentage of Participants
Interval 29.01 to 54.38
|
45.0 Percentage of Participants
Interval 32.12 to 58.39
|
40.9 Percentage of Participants
Interval 28.95 to 53.71
|
54.1 Percentage of Participants
Interval 40.85 to 66.94
|
SECONDARY outcome
Timeframe: Days 8 and 181Population: PP Set consisted of all participants in the FAS who comply with injection schedule, comply with timings of immunogenicity blood sampling to have a baseline and at least 1 post-injection assessment, do not have influenza infection at baseline through Day 29, and have no major protocol deviations that impact immune response. Number of participants analyzed signifies those who were evaluable for this outcome measure and number analyzed signifies those who were evaluable for specified category.
Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage.
Outcome measures
| Measure |
Flublok
n=66 Participants
Participants received Flublock by IM injection on Day 1.
|
mRNA-1010
n=63 Participants
Participants received mRNA-1010 by IM injection on Day 1.
|
mRNA-1030 Dose Level A
n=67 Participants
Participants received mRNA-1030 Dose Level A by IM injection on Day 1.
|
mRNA-1020 Dose Level A
n=66 Participants
Participants received mRNA-1020 Dose Level A by IM injection on Day 1.
|
mRNA-1030 Dose Level B
n=66 Participants
Participants received mRNA-1030 Dose Level B by IM injection on Day 1.
|
mRNA-1020 Dose Level B
n=64 Participants
Participants received mRNA-1020 Dose Level B by IM injection on Day 1.
|
mRNA-1030 Dose Level C
n=67 Participants
Participants received mRNA-1030 Dose Level C by IM injection on Day 1.
|
mRNA-1020 Dose Level C
n=63 Participants
Participants received mRNA-1020 Dose Level C by IM injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains
Day 8: Influenza A H1N1 Antibody (titer) by HAI Assay
|
348.67 titer
Interval 236.32 to 514.44
|
242.49 titer
Interval 181.0 to 324.88
|
167.43 titer
Interval 122.81 to 228.25
|
207.90 titer
Interval 151.25 to 285.77
|
195.65 titer
Interval 141.71 to 270.11
|
186.93 titer
Interval 136.89 to 255.26
|
281.89 titer
Interval 212.63 to 373.72
|
344.86 titer
Interval 256.99 to 462.78
|
|
GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains
Day 181: Influenza A H1N1 Antibody (titer) by HAI Assay
|
203.10 titer
Interval 145.63 to 283.25
|
170.30 titer
Interval 129.94 to 223.2
|
138.97 titer
Interval 101.24 to 190.77
|
171.47 titer
Interval 124.45 to 236.24
|
141.74 titer
Interval 103.95 to 193.27
|
120.48 titer
Interval 84.4 to 171.97
|
149.60 titer
Interval 113.99 to 196.33
|
164.66 titer
Interval 121.59 to 222.99
|
|
GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains
Day 8: Influenza A H3N2 Antibody (titer) by HAI Assay
|
193.05 titer
Interval 140.03 to 266.14
|
164.69 titer
Interval 123.53 to 219.55
|
151.14 titer
Interval 112.49 to 203.09
|
121.39 titer
Interval 88.43 to 166.65
|
139.91 titer
Interval 101.3 to 193.22
|
138.63 titer
Interval 97.3 to 197.5
|
190.79 titer
Interval 146.44 to 248.58
|
181.63 titer
Interval 134.14 to 245.94
|
|
GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains
Day 181: Influenza A H3N2 Antibody (titer) by HAI Assay
|
178.85 titer
Interval 126.64 to 252.58
|
131.90 titer
Interval 97.43 to 178.57
|
149.90 titer
Interval 111.76 to 201.04
|
116.43 titer
Interval 88.3 to 153.51
|
134.16 titer
Interval 97.23 to 185.12
|
111.81 titer
Interval 78.03 to 160.2
|
146.30 titer
Interval 112.22 to 190.74
|
131.15 titer
Interval 98.53 to 174.58
|
|
GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains
Day 8: Influenza B/Victoria Lineage (titer) by HAI Assay
|
140.58 titer
Interval 106.39 to 185.76
|
80.91 titer
Interval 60.9 to 107.49
|
93.28 titer
Interval 73.73 to 117.99
|
83.35 titer
Interval 63.73 to 109.0
|
114.40 titer
Interval 91.42 to 143.16
|
101.00 titer
Interval 79.71 to 127.98
|
100.25 titer
Interval 82.12 to 122.4
|
91.30 titer
Interval 71.16 to 117.13
|
|
GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains
Day 181: Influenza B/Victoria Lineage (titer) by HAI Assay
|
98.26 titer
Interval 73.8 to 130.81
|
64.82 titer
Interval 49.01 to 85.73
|
83.56 titer
Interval 65.97 to 105.82
|
80.49 titer
Interval 61.62 to 105.14
|
91.80 titer
Interval 72.47 to 116.28
|
74.64 titer
Interval 56.65 to 98.34
|
63.97 titer
Interval 50.2 to 81.52
|
55.26 titer
Interval 42.76 to 71.41
|
|
GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains
Day 8: Influenza B/Yamagata Lineage (titer) by HAI Assay
|
250.04 titer
Interval 195.63 to 319.58
|
188.07 titer
Interval 141.6 to 249.8
|
138.81 titer
Interval 111.32 to 173.07
|
171.63 titer
Interval 132.14 to 222.91
|
195.70 titer
Interval 153.33 to 249.78
|
227.71 titer
Interval 181.02 to 286.45
|
216.55 titer
Interval 176.59 to 265.56
|
209.90 titer
Interval 162.24 to 271.56
|
|
GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains
Day 181: Influenza B/Yamagata Lineage (titer) by HAI Assay
|
134.94 titer
Interval 103.17 to 176.51
|
104.47 titer
Interval 82.63 to 132.09
|
90.12 titer
Interval 69.17 to 117.42
|
113.17 titer
Interval 87.9 to 145.7
|
105.33 titer
Interval 84.91 to 130.68
|
113.74 titer
Interval 88.6 to 146.02
|
106.39 titer
Interval 86.72 to 130.52
|
93.22 titer
Interval 72.19 to 120.38
|
|
GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains
Day 8: Influenza A H1N1 Antibody (titer) by NAI Assay
|
109.63 titer
Interval 92.53 to 129.89
|
96.45 titer
Interval 86.45 to 107.62
|
119.76 titer
Interval 102.45 to 140.0
|
145.36 titer
Interval 119.15 to 177.33
|
124.35 titer
Interval 108.21 to 142.9
|
136.01 titer
Interval 114.31 to 161.83
|
114.91 titer
Interval 100.62 to 131.23
|
184.60 titer
Interval 148.17 to 229.99
|
|
GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains
Day 181: Influenza A H1N1 Antibody (titer) by NAI Assay
|
104.82 titer
Interval 88.93 to 123.55
|
93.55 titer
Interval 85.29 to 102.62
|
136.01 titer
Interval 112.81 to 163.97
|
149.29 titer
Interval 118.89 to 187.46
|
151.44 titer
Interval 125.37 to 182.92
|
126.99 titer
Interval 108.93 to 148.05
|
135.30 titer
Interval 114.76 to 159.51
|
161.83 titer
Interval 130.05 to 201.37
|
|
GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains
Day 8: Influenza A H3N2 Antibody (titer) by NAI Assay
|
26.70 titer
Interval 20.25 to 35.21
|
19.59 titer
Interval 15.71 to 24.42
|
55.15 titer
Interval 39.9 to 76.24
|
64.20 titer
Interval 44.15 to 93.35
|
62.87 titer
Interval 45.0 to 87.83
|
74.58 titer
Interval 51.72 to 107.55
|
73.44 titer
Interval 53.46 to 100.89
|
79.31 titer
Interval 57.39 to 109.59
|
|
GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains
Day 181: Influenza A H3N2 Antibody (titer) by NAI Assay
|
21.34 titer
Interval 16.79 to 27.12
|
19.13 titer
Interval 15.27 to 23.97
|
50.91 titer
Interval 37.88 to 68.41
|
50.43 titer
Interval 35.78 to 71.07
|
50.86 titer
Interval 35.48 to 72.91
|
64.15 titer
Interval 46.15 to 89.18
|
69.34 titer
Interval 49.33 to 97.47
|
64.08 titer
Interval 45.54 to 90.17
|
|
GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains
Day 8: Influenza B/Victoria Lineage (titer) by NAI Assay
|
73.55 titer
Interval 63.06 to 85.79
|
80.00 titer
Interval 67.77 to 94.44
|
209.38 titer
Interval 176.83 to 247.92
|
281.56 titer
Interval 226.25 to 350.4
|
238.47 titer
Interval 196.0 to 290.15
|
330.57 titer
Interval 267.9 to 407.9
|
282.64 titer
Interval 238.72 to 334.64
|
365.16 titer
Interval 293.96 to 453.61
|
|
GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains
Day 181: Influenza B/Victoria Lineage (titer) by NAI Assay
|
82.87 titer
Interval 69.08 to 99.41
|
79.11 titer
Interval 67.14 to 93.21
|
161.64 titer
Interval 136.79 to 191.24
|
236.98 titer
Interval 194.79 to 288.3
|
195.04 titer
Interval 161.84 to 235.06
|
251.07 titer
Interval 205.54 to 306.67
|
182.97 titer
Interval 150.4 to 222.6
|
214.99 titer
Interval 173.21 to 266.86
|
|
GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains
Day 8: Influenza B/Yamagata Lineage (titer) by NAI Assay
|
208.04 titer
Interval 162.96 to 265.59
|
220.14 titer
Interval 180.17 to 268.96
|
640.00 titer
Interval 546.19 to 749.92
|
914.65 titer
Interval 749.75 to 1115.83
|
823.47 titer
Interval 696.04 to 974.22
|
1064.75 titer
Interval 879.83 to 1288.55
|
828.90 titer
Interval 698.48 to 983.68
|
1085.27 titer
Interval 873.94 to 1347.7
|
|
GMT of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains
Day 181: Influenza B/Yamagata Lineage (titer) by NAI Assay
|
193.09 titer
Interval 150.62 to 247.53
|
212.57 titer
Interval 173.0 to 261.18
|
414.99 titer
Interval 343.55 to 501.28
|
625.38 titer
Interval 517.53 to 755.7
|
536.70 titer
Interval 450.77 to 639.0
|
693.91 titer
Interval 561.72 to 857.2
|
529.22 titer
Interval 436.91 to 641.05
|
604.65 titer
Interval 489.74 to 746.53
|
SECONDARY outcome
Timeframe: Days 8 and 181Population: PP Set consisted of all participants in the FAS who comply with injection schedule, comply with timings of immunogenicity blood sampling to have a baseline and at least 1 post-injection assessment, do not have influenza infection at baseline through Day 29, and have no major protocol deviations that impact immune response. Number of participants analyzed signifies those who were evaluable for this outcome measure and number analyzed signifies those who were evaluable for specified category.
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. Fold-rise was calculated by dividing post-vaccination results by the baseline value. 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 |
Flublok
n=66 Participants
Participants received Flublock by IM injection on Day 1.
|
mRNA-1010
n=63 Participants
Participants received mRNA-1010 by IM injection on Day 1.
|
mRNA-1030 Dose Level A
n=67 Participants
Participants received mRNA-1030 Dose Level A by IM injection on Day 1.
|
mRNA-1020 Dose Level A
n=66 Participants
Participants received mRNA-1020 Dose Level A by IM injection on Day 1.
|
mRNA-1030 Dose Level B
n=66 Participants
Participants received mRNA-1030 Dose Level B by IM injection on Day 1.
|
mRNA-1020 Dose Level B
n=64 Participants
Participants received mRNA-1020 Dose Level B by IM injection on Day 1.
|
mRNA-1030 Dose Level C
n=67 Participants
Participants received mRNA-1030 Dose Level C by IM injection on Day 1.
|
mRNA-1020 Dose Level C
n=63 Participants
Participants received mRNA-1020 Dose Level C by IM injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains
Day 8: Influenza A H3N2 Antibody (titer) by NAI Assay
|
1.21 ratio
Interval 1.01 to 1.46
|
0.99 ratio
Interval 0.9 to 1.09
|
2.54 ratio
Interval 1.97 to 3.26
|
2.81 ratio
Interval 2.17 to 3.64
|
2.89 ratio
Interval 2.2 to 3.78
|
3.67 ratio
Interval 2.69 to 5.01
|
3.57 ratio
Interval 2.72 to 4.69
|
4.57 ratio
Interval 3.32 to 6.28
|
|
GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains
Day 8: Influenza A H1N1 Antibody (titer) by HAI Assay
|
4.37 ratio
Interval 2.79 to 6.87
|
4.32 ratio
Interval 3.18 to 5.89
|
2.78 ratio
Interval 2.04 to 3.79
|
3.97 ratio
Interval 2.89 to 5.47
|
3.18 ratio
Interval 2.24 to 4.54
|
4.16 ratio
Interval 3.0 to 5.78
|
4.65 ratio
Interval 3.43 to 6.3
|
4.32 ratio
Interval 3.11 to 6.0
|
|
GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains
Day 181: Influenza A H1N1 Antibody (titer) by HAI Assay
|
2.71 ratio
Interval 1.88 to 3.9
|
3.07 ratio
Interval 2.25 to 4.19
|
2.24 ratio
Interval 1.59 to 3.16
|
3.34 ratio
Interval 2.3 to 4.85
|
2.64 ratio
Interval 1.88 to 3.7
|
2.63 ratio
Interval 1.91 to 3.63
|
2.36 ratio
Interval 1.82 to 3.06
|
2.08 ratio
Interval 1.55 to 2.81
|
|
GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains
Day 8: Influenza A H3N2 Antibody (titer) by HAI Assay
|
3.25 ratio
Interval 2.33 to 4.54
|
3.84 ratio
Interval 2.79 to 5.27
|
2.78 ratio
Interval 2.12 to 3.64
|
3.22 ratio
Interval 2.34 to 4.43
|
3.58 ratio
Interval 2.68 to 4.78
|
3.75 ratio
Interval 2.79 to 5.05
|
4.02 ratio
Interval 2.95 to 5.49
|
4.07 ratio
Interval 3.07 to 5.4
|
|
GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains
Day 181: Influenza A H3N2 Antibody (titer) by HAI Assay
|
3.37 ratio
Interval 2.44 to 4.67
|
3.29 ratio
Interval 2.49 to 4.34
|
2.69 ratio
Interval 2.04 to 3.55
|
3.01 ratio
Interval 2.27 to 3.98
|
3.65 ratio
Interval 2.71 to 4.92
|
3.46 ratio
Interval 2.64 to 4.52
|
2.80 ratio
Interval 2.11 to 3.71
|
3.12 ratio
Interval 2.5 to 3.9
|
|
GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains
Day 8: Influenza B/Victoria Lineage (titer) by HAI Assay
|
2.92 ratio
Interval 2.08 to 4.09
|
2.25 ratio
Interval 1.75 to 2.91
|
2.28 ratio
Interval 1.86 to 2.8
|
2.31 ratio
Interval 1.89 to 2.81
|
2.55 ratio
Interval 2.04 to 3.18
|
2.69 ratio
Interval 2.12 to 3.42
|
2.83 ratio
Interval 2.21 to 3.63
|
2.73 ratio
Interval 2.19 to 3.41
|
|
GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains
Day 181: Influenza B/Victoria Lineage (titer) by HAI Assay
|
2.13 ratio
Interval 1.67 to 2.71
|
1.88 ratio
Interval 1.45 to 2.43
|
1.83 ratio
Interval 1.47 to 2.26
|
2.05 ratio
Interval 1.67 to 2.53
|
2.14 ratio
Interval 1.7 to 2.7
|
2.03 ratio
Interval 1.71 to 2.4
|
1.78 ratio
Interval 1.51 to 2.08
|
1.79 ratio
Interval 1.45 to 2.22
|
|
GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains
Day 8: Influenza B/Yamagata Lineage (titer) by HAI Assay
|
3.03 ratio
Interval 2.17 to 4.22
|
2.31 ratio
Interval 1.76 to 3.03
|
2.17 ratio
Interval 1.77 to 2.65
|
2.73 ratio
Interval 2.06 to 3.6
|
2.52 ratio
Interval 1.94 to 3.26
|
3.12 ratio
Interval 2.38 to 4.1
|
2.68 ratio
Interval 2.17 to 3.3
|
3.41 ratio
Interval 2.62 to 4.44
|
|
GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains
Day 181: Influenza B/Yamagata Lineage (titer) by HAI Assay
|
1.62 ratio
Interval 1.25 to 2.1
|
1.36 ratio
Interval 1.06 to 1.74
|
1.36 ratio
Interval 1.05 to 1.76
|
1.67 ratio
Interval 1.35 to 2.06
|
1.45 ratio
Interval 1.16 to 1.8
|
1.57 ratio
Interval 1.31 to 1.88
|
1.26 ratio
Interval 1.05 to 1.51
|
1.53 ratio
Interval 1.22 to 1.92
|
|
GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains
Day 8: Influenza A H1N1 Antibody (titer) by NAI Assay
|
1.07 ratio
Interval 0.96 to 1.18
|
0.99 ratio
Interval 0.94 to 1.04
|
1.04 ratio
Interval 0.98 to 1.1
|
1.44 ratio
Interval 1.26 to 1.64
|
1.16 ratio
Interval 1.08 to 1.24
|
1.61 ratio
Interval 1.37 to 1.9
|
1.18 ratio
Interval 1.09 to 1.28
|
1.64 ratio
Interval 1.39 to 1.93
|
|
GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains
Day 181: Influenza A H1N1 Antibody (titer) by NAI Assay
|
1.00 ratio
Interval 0.94 to 1.07
|
0.97 ratio
Interval 0.92 to 1.02
|
1.20 ratio
Interval 1.07 to 1.36
|
1.52 ratio
Interval 1.26 to 1.82
|
1.39 ratio
Interval 1.22 to 1.58
|
1.50 ratio
Interval 1.3 to 1.73
|
1.43 ratio
Interval 1.25 to 1.64
|
1.47 ratio
Interval 1.28 to 1.69
|
|
GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains
Day 181: Influenza A H3N2 Antibody (titer) by NAI Assay
|
1.03 ratio
Interval 0.85 to 1.24
|
0.98 ratio
Interval 0.85 to 1.14
|
2.28 ratio
Interval 1.8 to 2.87
|
2.33 ratio
Interval 1.75 to 3.1
|
2.27 ratio
Interval 1.77 to 2.92
|
3.20 ratio
Interval 2.46 to 4.16
|
3.43 ratio
Interval 2.45 to 4.81
|
3.65 ratio
Interval 2.68 to 4.96
|
|
GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains
Day 8: Influenza B/Victoria Lineage (titer) by NAI Assay
|
0.97 ratio
Interval 0.88 to 1.06
|
1.01 ratio
Interval 0.92 to 1.11
|
2.78 ratio
Interval 2.27 to 3.41
|
3.96 ratio
Interval 3.18 to 4.93
|
3.24 ratio
Interval 2.65 to 3.97
|
4.71 ratio
Interval 3.79 to 5.85
|
3.84 ratio
Interval 3.15 to 4.67
|
5.04 ratio
Interval 3.95 to 6.43
|
|
GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains
Day 181: Influenza B/Victoria Lineage (titer) by NAI Assay
|
1.06 ratio
Interval 0.93 to 1.21
|
1.00 ratio
Interval 0.92 to 1.08
|
2.16 ratio
Interval 1.79 to 2.6
|
3.36 ratio
Interval 2.78 to 4.07
|
2.69 ratio
Interval 2.33 to 3.12
|
3.52 ratio
Interval 2.89 to 4.3
|
2.45 ratio
Interval 2.12 to 2.82
|
3.01 ratio
Interval 2.48 to 3.66
|
|
GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains
Day 8: Influenza B/Yamagata Lineage (titer) by NAI Assay
|
1.12 ratio
Interval 0.97 to 1.3
|
0.97 ratio
Interval 0.87 to 1.08
|
3.22 ratio
Interval 2.64 to 3.92
|
4.78 ratio
Interval 3.72 to 6.14
|
3.92 ratio
Interval 3.13 to 4.91
|
5.72 ratio
Interval 4.45 to 7.35
|
4.04 ratio
Interval 3.27 to 4.99
|
6.35 ratio
Interval 4.76 to 8.46
|
|
GMFR of Anti-HA or Anti-NA Antibodies at Days 8 and 181 as Measured by HAI and NAI Assays for Vaccine-Matched Seasonal Influenza A and B Strains
Day 181: Influenza B/Yamagata Lineage (titer) by NAI Assay
|
1.02 ratio
Interval 0.89 to 1.18
|
0.96 ratio
Interval 0.85 to 1.07
|
2.11 ratio
Interval 1.81 to 2.47
|
3.44 ratio
Interval 2.75 to 4.31
|
2.63 ratio
Interval 2.25 to 3.09
|
3.65 ratio
Interval 3.03 to 4.39
|
2.53 ratio
Interval 2.17 to 2.95
|
3.61 ratio
Interval 2.9 to 4.5
|
Adverse Events
Flublok
Serious events: 2 serious events
Other events: 58 other events
Deaths: 1 deaths
mRNA-1010
Serious events: 1 serious events
Other events: 67 other events
Deaths: 0 deaths
mRNA-1030 Dose Level A
Serious events: 1 serious events
Other events: 62 other events
Deaths: 0 deaths
mRNA-1020 Dose Level A
Serious events: 1 serious events
Other events: 66 other events
Deaths: 0 deaths
mRNA-1030 Dose Level B
Serious events: 1 serious events
Other events: 63 other events
Deaths: 0 deaths
mRNA-1020 Dose Level B
Serious events: 0 serious events
Other events: 62 other events
Deaths: 0 deaths
mRNA-1030 Dose Level C
Serious events: 2 serious events
Other events: 70 other events
Deaths: 0 deaths
mRNA-1020 Dose Level C
Serious events: 4 serious events
Other events: 69 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Flublok
n=71 participants at risk
Participants received Flublock by IM injection on Day 1.
|
mRNA-1010
n=71 participants at risk
Participants received mRNA-1010 by IM injection on Day 1.
|
mRNA-1030 Dose Level A
n=71 participants at risk
Participants received mRNA-1030 Dose Level A by IM injection on Day 1.
|
mRNA-1020 Dose Level A
n=71 participants at risk
Participants received mRNA-1020 Dose Level A by IM injection on Day 1.
|
mRNA-1030 Dose Level B
n=72 participants at risk
Participants received mRNA-1030 Dose Level B by IM injection on Day 1.
|
mRNA-1020 Dose Level B
n=67 participants at risk
Participants received mRNA-1020 Dose Level B by IM injection on Day 1.
|
mRNA-1030 Dose Level C
n=72 participants at risk
Participants received mRNA-1030 Dose Level C by IM injection on Day 1.
|
mRNA-1020 Dose Level C
n=70 participants at risk
Participants received mRNA-1020 Dose Level C by IM injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Sepsis
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/67 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
1.4%
1/70 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
|
Psychiatric disorders
Depression
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
1.4%
1/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/67 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/70 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/67 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
1.4%
1/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/70 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/67 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
1.4%
1/70 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
|
Gastrointestinal disorders
Abdominal wall cyst
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/67 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
1.4%
1/70 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
|
Gastrointestinal disorders
Epiploic appendagitis
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
1.4%
1/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/67 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/70 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
1.4%
1/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/67 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/70 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/67 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
1.4%
1/70 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/67 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
1.4%
1/70 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
1.4%
1/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/67 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
1.4%
1/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/70 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
1.4%
1/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/67 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/70 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
1.4%
1/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/67 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/70 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
Other adverse events
| Measure |
Flublok
n=71 participants at risk
Participants received Flublock by IM injection on Day 1.
|
mRNA-1010
n=71 participants at risk
Participants received mRNA-1010 by IM injection on Day 1.
|
mRNA-1030 Dose Level A
n=71 participants at risk
Participants received mRNA-1030 Dose Level A by IM injection on Day 1.
|
mRNA-1020 Dose Level A
n=71 participants at risk
Participants received mRNA-1020 Dose Level A by IM injection on Day 1.
|
mRNA-1030 Dose Level B
n=72 participants at risk
Participants received mRNA-1030 Dose Level B by IM injection on Day 1.
|
mRNA-1020 Dose Level B
n=67 participants at risk
Participants received mRNA-1020 Dose Level B by IM injection on Day 1.
|
mRNA-1030 Dose Level C
n=72 participants at risk
Participants received mRNA-1030 Dose Level C by IM injection on Day 1.
|
mRNA-1020 Dose Level C
n=70 participants at risk
Participants received mRNA-1020 Dose Level C by IM injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
2.8%
2/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/67 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/70 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
|
Infections and infestations
COVID-19
|
7.0%
5/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
2.8%
2/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
1.4%
1/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
8.5%
6/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
9.7%
7/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
6.0%
4/67 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
6.9%
5/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
7.1%
5/70 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.8%
2/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
1.4%
1/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
7.0%
5/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
2.8%
2/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
4.5%
3/67 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
1.4%
1/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
2.9%
2/70 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
|
Infections and infestations
Rhinovirus infection
|
4.2%
3/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
1.4%
1/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
1.4%
1/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
1.4%
1/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
3.0%
2/67 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
4.3%
3/70 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
1.4%
1/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
2.8%
2/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/67 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
1.4%
1/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
1.4%
1/70 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
|
Infections and infestations
Sinusitis
|
1.4%
1/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
3.0%
2/67 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
1.4%
1/70 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
2.8%
2/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/67 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
1.4%
1/70 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
1.4%
1/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/67 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
2.8%
2/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/70 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
|
Nervous system disorders
Headache
|
22.5%
16/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
64.8%
46/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
42.3%
30/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
59.2%
42/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
47.2%
34/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
71.6%
48/67 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
68.1%
49/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
71.4%
50/70 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.8%
2/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
1.5%
1/67 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
2.8%
2/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/70 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.4%
1/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
2.8%
2/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
1.4%
1/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/67 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/70 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
19.7%
14/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
32.4%
23/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
18.3%
13/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
43.7%
31/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
47.2%
34/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
55.2%
37/67 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
55.6%
40/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
62.9%
44/70 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
2.8%
2/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/67 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/70 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
|
General disorders
Fatigue
|
25.4%
18/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
62.0%
44/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
46.5%
33/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
64.8%
46/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
63.9%
46/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
73.1%
49/67 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
75.0%
54/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
80.0%
56/70 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
|
General disorders
Injection site pain
|
49.3%
35/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
85.9%
61/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
83.1%
59/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
83.1%
59/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
76.4%
55/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
85.1%
57/67 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
93.1%
67/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
95.7%
67/70 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
|
General disorders
Injection site lymphadenopathy
|
14.1%
10/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
35.2%
25/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
25.4%
18/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
22.5%
16/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
27.8%
20/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
29.9%
20/67 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
38.9%
28/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
38.6%
27/70 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
|
General disorders
Injection site erythema
|
2.8%
2/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
4.2%
3/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
1.4%
1/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
4.2%
3/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
2.8%
2/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
7.5%
5/67 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
8.3%
6/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
17.1%
12/70 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
|
General disorders
Injection site induration
|
2.8%
2/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
7.0%
5/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
5.6%
4/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
5.6%
4/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
6.9%
5/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
14.9%
10/67 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
11.1%
8/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
21.4%
15/70 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
|
Investigations
Haemoglobin decreased
|
1.4%
1/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
1.4%
1/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
2.8%
2/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
2.8%
2/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
1.4%
1/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
1.5%
1/67 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
1.4%
1/70 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
1.4%
1/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/67 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
2.8%
2/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/70 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
|
Gastrointestinal disorders
Vomiting
|
9.9%
7/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
16.9%
12/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
12.7%
9/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
14.1%
10/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
20.8%
15/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
14.9%
10/67 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
22.2%
16/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
18.6%
13/70 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
|
General disorders
Chills
|
11.3%
8/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
42.3%
30/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
21.1%
15/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
32.4%
23/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
41.7%
30/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
52.2%
35/67 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
56.9%
41/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
55.7%
39/70 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
|
General disorders
Pyrexia
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
14.1%
10/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
2.8%
2/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
4.2%
3/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
11.1%
8/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
14.9%
10/67 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
13.9%
10/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
17.1%
12/70 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
2.8%
2/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/67 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/70 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/67 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
0.00%
0/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
2.9%
2/70 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.5%
11/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
53.5%
38/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
28.2%
20/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
56.3%
40/71 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
58.3%
42/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
68.7%
46/67 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
70.8%
51/72 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
71.4%
50/70 • Day 1 through Day 181
Safety Analysis Set consisted of all randomly assigned participants who received the investigational product. Participants were included in the vaccination group corresponding to the study injection they actually received. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. All cause mortality was based on the randomized set.
|
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