Trial Outcomes & Findings for A Study of mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1 Candidate Seasonal Influenza Vaccines in Healthy Adults (NCT NCT05827068)
NCT ID: NCT05827068
Last Updated: 2025-02-03
Results Overview
Solicited ARs (local and systemic) were collected in an electronic diary (eDiary). Local ARs included: injection site pain, injection site erythema (redness), injection site swelling/induration (hardness), and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs included: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. All solicited ARs considered causally related to injection were graded 0-4 (per Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials); lower score indicates lower severity, and a higher score indicates greater severity.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
698 participants
Primary outcome timeframe
7 days post-vaccination
Results posted on
2025-02-03
Participant Flow
Participant milestones
| Measure |
mRNA-1010 50 μg
Participants received a single intramuscular (IM) injection of mRNA-1010 50 micrograms (μg) on Day 1.
|
mRNA-1010.2 50 μg
Participants received a single IM injection of mRNA-1010.2 50 μg on Day 1.
|
mRNA-1010.3 50 μg
Participants received a single IM injection of mRNA-1010.3 50 μg on Day 1.
|
mRNA-1011.1 50 μg
Participants received a single IM injection of mRNA-1011.1 50 μg on Day 1.
|
mRNA-1011.2 40 μg
Participants received a single IM injection of mRNA-1011.2 40 μg on Day 1.
|
mRNA-1012.1 50 μg
Participants received a single IM injection of mRNA-1012.1 50 μg on Day 1.
|
mRNA-1012.1 62.5 μg
Participants received a single IM injection of mRNA-1012.1 62.5 μg on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
99
|
101
|
98
|
99
|
100
|
100
|
101
|
|
Overall Study
Received Injection
|
99
|
100
|
97
|
99
|
100
|
100
|
100
|
|
Overall Study
Safety Set
|
99
|
100
|
97
|
99
|
100
|
100
|
98
|
|
Overall Study
Solicited Safety Set
|
99
|
100
|
97
|
98
|
100
|
100
|
97
|
|
Overall Study
Participants Were Randomized to mRNA-1012.1 62.5 μg But Received mRNA-1012.1 50 μg Instead
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Overall Study
COMPLETED
|
94
|
96
|
96
|
96
|
94
|
96
|
98
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
2
|
3
|
6
|
4
|
3
|
Reasons for withdrawal
| Measure |
mRNA-1010 50 μg
Participants received a single intramuscular (IM) injection of mRNA-1010 50 micrograms (μg) on Day 1.
|
mRNA-1010.2 50 μg
Participants received a single IM injection of mRNA-1010.2 50 μg on Day 1.
|
mRNA-1010.3 50 μg
Participants received a single IM injection of mRNA-1010.3 50 μg on Day 1.
|
mRNA-1011.1 50 μg
Participants received a single IM injection of mRNA-1011.1 50 μg on Day 1.
|
mRNA-1011.2 40 μg
Participants received a single IM injection of mRNA-1011.2 40 μg on Day 1.
|
mRNA-1012.1 50 μg
Participants received a single IM injection of mRNA-1012.1 50 μg on Day 1.
|
mRNA-1012.1 62.5 μg
Participants received a single IM injection of mRNA-1012.1 62.5 μg on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
4
|
1
|
1
|
2
|
4
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
1
|
2
|
3
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
|
Overall Study
Other Than Specified
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study of mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1 Candidate Seasonal Influenza Vaccines in Healthy Adults
Baseline characteristics by cohort
| Measure |
mRNA-1010 50 μg
n=99 Participants
Participants received a single IM injection of mRNA-1010 50 μg on Day 1.
|
mRNA-1010.2 50 μg
n=100 Participants
Participants received a single IM injection of mRNA-1010.2 50 μg on Day 1.
|
mRNA-1010.3 50 μg
n=97 Participants
Participants received a single IM injection of mRNA-1010.3 50 μg on Day 1.
|
mRNA-1011.1 50 μg
n=99 Participants
Participants received a single IM injection of mRNA-1011.1 50 μg on Day 1.
|
mRNA-1011.2 40 μg
n=100 Participants
Participants received a single IM injection of mRNA-1011.2 40 μg on Day 1.
|
mRNA-1012.1 50 μg
n=100 Participants
Participants received a single IM injection of mRNA-1012.1 50 μg on Day 1.
|
mRNA-1012.1 62.5 μg
n=100 Participants
Participants received a single IM injection of mRNA-1012.1 62.5 μg on Day 1.
|
Total
n=695 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
60.9 years
STANDARD_DEVIATION 7.17 • n=5 Participants
|
62.2 years
STANDARD_DEVIATION 6.95 • n=7 Participants
|
60.8 years
STANDARD_DEVIATION 7.47 • n=5 Participants
|
61.4 years
STANDARD_DEVIATION 6.17 • n=4 Participants
|
61.6 years
STANDARD_DEVIATION 7.18 • n=21 Participants
|
60.7 years
STANDARD_DEVIATION 7.79 • n=8 Participants
|
61.1 years
STANDARD_DEVIATION 6.70 • n=8 Participants
|
61.2 years
STANDARD_DEVIATION 7.07 • n=24 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
61 Participants
n=21 Participants
|
48 Participants
n=8 Participants
|
53 Participants
n=8 Participants
|
381 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
52 Participants
n=8 Participants
|
47 Participants
n=8 Participants
|
314 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
19 Participants
n=8 Participants
|
138 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
77 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
72 Participants
n=21 Participants
|
77 Participants
n=8 Participants
|
81 Participants
n=8 Participants
|
542 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
15 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
9 Participants
n=24 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
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
21 Participants
n=8 Participants
|
122 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
86 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
84 Participants
n=21 Participants
|
86 Participants
n=8 Participants
|
75 Participants
n=8 Participants
|
552 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: 7 days post-vaccinationPopulation: The Solicited Safety Set included all randomly assigned participants who received the study vaccination and contributed any solicited AR data. Participants were included in the vaccination group corresponding to what they actually received.
Solicited ARs (local and systemic) were collected in an electronic diary (eDiary). Local ARs included: injection site pain, injection site erythema (redness), injection site swelling/induration (hardness), and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs included: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. All solicited ARs considered causally related to injection were graded 0-4 (per Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials); lower score indicates lower severity, and a higher score indicates greater severity.
Outcome measures
| Measure |
mRNA-1010 50 μg
n=99 Participants
Participants received a single IM injection of mRNA-1010 50 μg on Day 1.
|
mRNA-1010.2 50 μg
n=100 Participants
Participants received a single IM injection of mRNA-1010.2 50 μg on Day 1.
|
mRNA-1010.3 50 μg
n=97 Participants
Participants received a single IM injection of mRNA-1010.3 50 μg on Day 1.
|
mRNA-1011.1 50 μg
n=98 Participants
Participants received a single IM injection of mRNA-1011.1 50 μg on Day 1.
|
mRNA-1011.2 40 μg
n=100 Participants
Participants received a single IM injection of mRNA-1011.2 40 μg on Day 1.
|
mRNA-1012.1 50 μg
n=102 Participants
Participants received a single IM injection of mRNA-1012.1 50 μg on Day 1.
|
mRNA-1012.1 62.5 μg
n=97 Participants
Participants received a single IM injection of mRNA-1012.1 62.5 μg on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Any
|
77 Participants
|
86 Participants
|
81 Participants
|
72 Participants
|
75 Participants
|
85 Participants
|
74 Participants
|
|
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Grade 1
|
42 Participants
|
45 Participants
|
31 Participants
|
29 Participants
|
41 Participants
|
40 Participants
|
33 Participants
|
|
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Grade 2
|
30 Participants
|
38 Participants
|
43 Participants
|
37 Participants
|
30 Participants
|
37 Participants
|
38 Participants
|
|
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Grade 3
|
5 Participants
|
3 Participants
|
7 Participants
|
6 Participants
|
4 Participants
|
8 Participants
|
3 Participants
|
|
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 28 days post-vaccinationPopulation: The Safety Set included all randomly assigned participants who received the study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time \[PT\]/partial thromboplastin time \[PTT\]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE. Number of participants with unsolicited AEs (SAEs and non-serious AEs) up to 28 days post-vaccination are reported in this outcome measure.
Outcome measures
| Measure |
mRNA-1010 50 μg
n=99 Participants
Participants received a single IM injection of mRNA-1010 50 μg on Day 1.
|
mRNA-1010.2 50 μg
n=100 Participants
Participants received a single IM injection of mRNA-1010.2 50 μg on Day 1.
|
mRNA-1010.3 50 μg
n=97 Participants
Participants received a single IM injection of mRNA-1010.3 50 μg on Day 1.
|
mRNA-1011.1 50 μg
n=99 Participants
Participants received a single IM injection of mRNA-1011.1 50 μg on Day 1.
|
mRNA-1011.2 40 μg
n=100 Participants
Participants received a single IM injection of mRNA-1011.2 40 μg on Day 1.
|
mRNA-1012.1 50 μg
n=102 Participants
Participants received a single IM injection of mRNA-1012.1 50 μg on Day 1.
|
mRNA-1012.1 62.5 μg
n=98 Participants
Participants received a single IM injection of mRNA-1012.1 62.5 μg on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Unsolicited AEs
|
11 Participants
|
17 Participants
|
15 Participants
|
6 Participants
|
7 Participants
|
10 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 181 (end of study [EOS])Population: The Safety Set included all randomly assigned participants who received the study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/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 lead to an unscheduled visit to an healthcare practitioner. This included visits to a study site for unscheduled assessments (for example, abnormal laboratory follow-up) and visits to healthcare practitioners external to the study site (for example, urgent care, primary care physician). Number of participants with SAEs, AESIs, MAAEs, and AEs leading to discontinuation up to the end of study (Day 181) are reported in this outcome measure.
Outcome measures
| Measure |
mRNA-1010 50 μg
n=99 Participants
Participants received a single IM injection of mRNA-1010 50 μg on Day 1.
|
mRNA-1010.2 50 μg
n=100 Participants
Participants received a single IM injection of mRNA-1010.2 50 μg on Day 1.
|
mRNA-1010.3 50 μg
n=97 Participants
Participants received a single IM injection of mRNA-1010.3 50 μg on Day 1.
|
mRNA-1011.1 50 μg
n=99 Participants
Participants received a single IM injection of mRNA-1011.1 50 μg on Day 1.
|
mRNA-1011.2 40 μg
n=100 Participants
Participants received a single IM injection of mRNA-1011.2 40 μg on Day 1.
|
mRNA-1012.1 50 μg
n=102 Participants
Participants received a single IM injection of mRNA-1012.1 50 μg on Day 1.
|
mRNA-1012.1 62.5 μg
n=98 Participants
Participants received a single IM injection of mRNA-1012.1 62.5 μg on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation
SAEs
|
2 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation
AESIs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation
MAAEs
|
10 Participants
|
21 Participants
|
18 Participants
|
12 Participants
|
24 Participants
|
23 Participants
|
16 Participants
|
|
Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation
AEs Leading to Discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 29Population: Per-Protocol (PP) Set included all randomly assigned participants who received study vaccination, complied with the injection schedule, complied with the timings of immunogenicity blood sampling to have a baseline and at least the Day 29 post-injection assessment, had no RT-PCR-confirmed influenza infection prior to Day 29 visit and had no major protocol deviations that impacted the immune response. Participants were analyzed according to the group to which they were randomized.
Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage.
Outcome measures
| Measure |
mRNA-1010 50 μg
n=93 Participants
Participants received a single IM injection of mRNA-1010 50 μg on Day 1.
|
mRNA-1010.2 50 μg
n=89 Participants
Participants received a single IM injection of mRNA-1010.2 50 μg on Day 1.
|
mRNA-1010.3 50 μg
n=95 Participants
Participants received a single IM injection of mRNA-1010.3 50 μg on Day 1.
|
mRNA-1011.1 50 μg
n=87 Participants
Participants received a single IM injection of mRNA-1011.1 50 μg on Day 1.
|
mRNA-1011.2 40 μg
n=90 Participants
Participants received a single IM injection of mRNA-1011.2 40 μg on Day 1.
|
mRNA-1012.1 50 μg
n=92 Participants
Participants received a single IM injection of mRNA-1012.1 50 μg on Day 1.
|
mRNA-1012.1 62.5 μg
n=88 Participants
Participants received a single IM injection of mRNA-1012.1 62.5 μg on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains
Influenza B/ Yamagata Lineage
|
111.1 titer
Interval 98.52 to 125.25
|
125.2 titer
Interval 106.42 to 147.3
|
118.7 titer
Interval 103.2 to 136.49
|
113.2 titer
Interval 97.59 to 131.32
|
81.6 titer
Interval 71.33 to 93.38
|
77.1 titer
Interval 67.58 to 87.88
|
71.7 titer
Interval 64.2 to 80.0
|
|
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains
Influenza A H1N1 Antibody
|
197.9 titer
Interval 156.37 to 250.35
|
214.3 titer
Interval 174.66 to 262.85
|
204.3 titer
Interval 163.67 to 255.05
|
189.1 titer
Interval 149.05 to 239.98
|
207.2 titer
Interval 165.1 to 259.97
|
188.9 titer
Interval 154.11 to 231.47
|
216.7 titer
Interval 174.91 to 268.52
|
|
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains
Influenza A H3N2 (Darwin) Antibody
|
122.3 titer
Interval 99.84 to 149.93
|
79.4 titer
Interval 63.87 to 98.62
|
83.3 titer
Interval 69.5 to 99.76
|
117.8 titer
Interval 95.33 to 145.44
|
138.2 titer
Interval 108.34 to 176.27
|
115.7 titer
Interval 94.61 to 141.59
|
122.0 titer
Interval 98.63 to 150.86
|
|
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains
Influenza A H3N2 (Newcastle) Antibody
|
130.8 titer
Interval 104.44 to 163.9
|
205.3 titer
Interval 168.2 to 250.58
|
127.2 titer
Interval 106.29 to 152.1
|
178.2 titer
Interval 142.2 to 223.29
|
232.2 titer
Interval 188.1 to 286.53
|
187.4 titer
Interval 151.33 to 232.06
|
224.5 titer
Interval 179.54 to 280.6
|
|
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains
Influenza A H3N2 (Hong Kong) Antibody
|
73.4 titer
Interval 59.36 to 90.8
|
82.2 titer
Interval 67.36 to 100.33
|
97.1 titer
Interval 82.28 to 114.53
|
86.9 titer
Interval 68.07 to 111.03
|
111.8 titer
Interval 90.22 to 138.5
|
105.0 titer
Interval 85.77 to 128.43
|
122.9 titer
Interval 99.89 to 151.25
|
|
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains
Influenza B/ Victoria Lineage
|
207.7 titer
Interval 179.36 to 240.54
|
234.4 titer
Interval 198.48 to 276.72
|
192.0 titer
Interval 162.22 to 227.25
|
197.7 titer
Interval 167.69 to 232.97
|
209.5 titer
Interval 174.89 to 250.88
|
204.4 titer
Interval 172.26 to 242.52
|
211.6 titer
Interval 182.9 to 244.86
|
SECONDARY outcome
Timeframe: Baseline, Day 29Population: The PP Set included all randomly assigned participants who received study vaccination, complied with the injection schedule, complied with the timings of immunogenicity blood sampling to have a baseline and at least the Day 29 post-injection assessment, had no RT-PCR-confirmed influenza infection prior to Day 29 visit and had no major protocol deviations that impacted the immune response. Participants were analyzed according to the group to which they were randomized.
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% confidence interval (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 |
mRNA-1010 50 μg
n=93 Participants
Participants received a single IM injection of mRNA-1010 50 μg on Day 1.
|
mRNA-1010.2 50 μg
n=89 Participants
Participants received a single IM injection of mRNA-1010.2 50 μg on Day 1.
|
mRNA-1010.3 50 μg
n=95 Participants
Participants received a single IM injection of mRNA-1010.3 50 μg on Day 1.
|
mRNA-1011.1 50 μg
n=87 Participants
Participants received a single IM injection of mRNA-1011.1 50 μg on Day 1.
|
mRNA-1011.2 40 μg
n=90 Participants
Participants received a single IM injection of mRNA-1011.2 40 μg on Day 1.
|
mRNA-1012.1 50 μg
n=92 Participants
Participants received a single IM injection of mRNA-1012.1 50 μg on Day 1.
|
mRNA-1012.1 62.5 μg
n=88 Participants
Participants received a single IM injection of mRNA-1012.1 62.5 μg on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
Influenza B/Yamagata Lineage
|
1.6 ratio
Interval 1.41 to 1.8
|
1.9 ratio
Interval 1.62 to 2.15
|
1.7 ratio
Interval 1.52 to 1.81
|
1.7 ratio
Interval 1.5 to 1.86
|
1.2 ratio
Interval 1.07 to 1.28
|
1.1 ratio
Interval 1.04 to 1.21
|
1.1 ratio
Interval 0.99 to 1.13
|
|
Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
Influenza A H1N1 Antibody
|
3.0 ratio
Interval 2.44 to 3.67
|
3.7 ratio
Interval 2.93 to 4.68
|
3.4 ratio
Interval 2.86 to 4.16
|
2.7 ratio
Interval 2.26 to 3.19
|
3.2 ratio
Interval 2.55 to 3.96
|
3.1 ratio
Interval 2.59 to 3.82
|
2.9 ratio
Interval 2.37 to 3.44
|
|
Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
Influenza A H3N2 (Darwin) Antibody
|
2.8 ratio
Interval 2.32 to 3.46
|
2.0 ratio
Interval 1.76 to 2.35
|
2.0 ratio
Interval 1.77 to 2.31
|
3.1 ratio
Interval 2.64 to 3.71
|
3.4 ratio
Interval 2.74 to 4.13
|
3.4 ratio
Interval 2.88 to 4.08
|
2.6 ratio
Interval 2.23 to 3.14
|
|
Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
Influenza A H3N2 (Newcastle) Antibody
|
2.2 ratio
Interval 1.79 to 2.78
|
4.0 ratio
Interval 3.24 to 4.87
|
2.4 ratio
Interval 2.05 to 2.92
|
3.2 ratio
Interval 2.66 to 3.86
|
4.2 ratio
Interval 3.35 to 5.24
|
4.4 ratio
Interval 3.58 to 5.53
|
3.7 ratio
Interval 3.0 to 4.59
|
|
Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
Influenza A H3N2 (Hong Kong) Antibody
|
2.7 ratio
Interval 2.13 to 3.31
|
3.0 ratio
Interval 2.5 to 3.54
|
3.4 ratio
Interval 2.87 to 4.08
|
3.1 ratio
Interval 2.56 to 3.72
|
4.0 ratio
Interval 3.23 to 4.84
|
5.0 ratio
Interval 4.1 to 6.14
|
4.1 ratio
Interval 3.26 to 5.07
|
|
Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
Influenza B/Victoria Lineage
|
1.6 ratio
Interval 1.36 to 1.81
|
1.8 ratio
Interval 1.55 to 2.06
|
1.4 ratio
Interval 1.3 to 1.59
|
1.6 ratio
Interval 1.44 to 1.78
|
1.8 ratio
Interval 1.56 to 2.13
|
1.7 ratio
Interval 1.45 to 1.88
|
1.5 ratio
Interval 1.34 to 1.72
|
SECONDARY outcome
Timeframe: Day 29Population: The PP Set included all randomly assigned participants who received study vaccination, complied with the injection schedule, complied with the timings of immunogenicity blood sampling to have a baseline and at least the Day 29 post-injection assessment, had no RT-PCR-confirmed influenza infection prior to Day 29 visit and had no major protocol deviations that impacted the immune response. Participants were analyzed according to the group to which they were randomized.
Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. Seroconversion was defined as a postbaseline 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.
Outcome measures
| Measure |
mRNA-1010 50 μg
n=93 Participants
Participants received a single IM injection of mRNA-1010 50 μg on Day 1.
|
mRNA-1010.2 50 μg
n=89 Participants
Participants received a single IM injection of mRNA-1010.2 50 μg on Day 1.
|
mRNA-1010.3 50 μg
n=95 Participants
Participants received a single IM injection of mRNA-1010.3 50 μg on Day 1.
|
mRNA-1011.1 50 μg
n=87 Participants
Participants received a single IM injection of mRNA-1011.1 50 μg on Day 1.
|
mRNA-1011.2 40 μg
n=90 Participants
Participants received a single IM injection of mRNA-1011.2 40 μg on Day 1.
|
mRNA-1012.1 50 μg
n=92 Participants
Participants received a single IM injection of mRNA-1012.1 50 μg on Day 1.
|
mRNA-1012.1 62.5 μg
n=88 Participants
Participants received a single IM injection of mRNA-1012.1 62.5 μg on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Reaching Seroconversion at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
Influenza A H3N2 (Hong Kong) Antibody
|
34.4 percentage of participants
Interval 24.86 to 44.98
|
39.3 percentage of participants
Interval 29.13 to 50.25
|
47.4 percentage of participants
Interval 37.03 to 57.88
|
44.8 percentage of participants
Interval 34.15 to 55.87
|
53.3 percentage of participants
Interval 42.51 to 63.93
|
57.6 percentage of participants
Interval 46.86 to 67.85
|
52.3 percentage of participants
Interval 41.35 to 63.04
|
|
Percentage of Participants Reaching Seroconversion at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
Influenza B/Yamagata Lineage
|
12.9 percentage of participants
Interval 6.85 to 21.45
|
16.9 percentage of participants
Interval 9.75 to 26.27
|
8.4 percentage of participants
Interval 3.71 to 15.92
|
10.3 percentage of participants
Interval 4.84 to 18.73
|
1.1 percentage of participants
Interval 0.03 to 6.04
|
1.1 percentage of participants
Interval 0.03 to 5.91
|
0 percentage of participants
Interval 0.0 to 4.11
|
|
Percentage of Participants Reaching Seroconversion at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
Influenza A H3N2 (Darwin) Antibody
|
40.9 percentage of participants
Interval 30.77 to 51.54
|
21.3 percentage of participants
Interval 13.37 to 31.31
|
21.1 percentage of participants
Interval 13.36 to 30.62
|
40.2 percentage of participants
Interval 29.85 to 51.29
|
37.8 percentage of participants
Interval 27.77 to 48.62
|
45.7 percentage of participants
Interval 35.22 to 56.37
|
33.0 percentage of participants
Interval 23.3 to 43.79
|
|
Percentage of Participants Reaching Seroconversion at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
Influenza B/ Victoria Lineage
|
10.8 percentage of participants
Interval 5.28 to 18.89
|
22.5 percentage of participants
Interval 14.3 to 32.55
|
6.3 percentage of participants
Interval 2.35 to 13.24
|
9.2 percentage of participants
Interval 4.05 to 17.32
|
14.4 percentage of participants
Interval 7.92 to 23.43
|
14.1 percentage of participants
Interval 7.74 to 22.95
|
11.4 percentage of participants
Interval 5.59 to 19.91
|
|
Percentage of Participants Reaching Seroconversion at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
Influenza A H1N1 Antibody
|
36.6 percentage of participants
Interval 26.81 to 47.19
|
49.4 percentage of participants
Interval 38.67 to 60.25
|
44.2 percentage of participants
Interval 34.02 to 54.77
|
40.2 percentage of participants
Interval 29.85 to 51.29
|
40.0 percentage of participants
Interval 29.81 to 50.87
|
35.9 percentage of participants
Interval 26.13 to 46.54
|
35.2 percentage of participants
Interval 25.34 to 46.14
|
|
Percentage of Participants Reaching Seroconversion at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
Influenza A H3N2 (Newcastle) Antibody
|
24.7 percentage of participants
Interval 16.37 to 34.76
|
53.9 percentage of participants
Interval 43.04 to 64.56
|
32.6 percentage of participants
Interval 23.36 to 43.02
|
47.1 percentage of participants
Interval 36.33 to 58.13
|
52.2 percentage of participants
Interval 41.43 to 62.87
|
55.4 percentage of participants
Interval 44.7 to 65.81
|
48.9 percentage of participants
Interval 38.05 to 59.75
|
Adverse Events
mRNA-1010 50 ug
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
mRNA-1010.2 50 ug
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
mRNA-1010.3 50 ug
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
mRNA-1011.1 50 ug
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
mRNA-1011.2 40 ug
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
mRNA-1012.1 50 ug
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
mRNA-1012.1 62.5 ug
Serious events: 3 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
mRNA-1010 50 ug
n=99 participants at risk
Participants received a single IM injection of mRNA-1010 50 μg on Day 1.
|
mRNA-1010.2 50 ug
n=100 participants at risk
Participants received a single IM injection of mRNA-1010.2 50 μg on Day 1.
|
mRNA-1010.3 50 ug
n=97 participants at risk
Participants received a single IM injection of mRNA-1010.3 50 μg on Day 1.
|
mRNA-1011.1 50 ug
n=99 participants at risk
Participants received a single IM injection of mRNA-1011.1 50 μg on Day 1.
|
mRNA-1011.2 40 ug
n=100 participants at risk
Participants received a single IM injection of mRNA-1011.2 40 μg on Day 1.
|
mRNA-1012.1 50 ug
n=102 participants at risk
Participants received a single IM injection of mRNA-1012.1 50 μg on Day 1.
|
mRNA-1012.1 62.5 ug
n=98 participants at risk
Participants received a single IM injection of mRNA-1012.1 62.5 μg on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Prinzmetal angina
|
0.00%
0/99 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/100 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/97 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/99 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/100 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/102 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
1.0%
1/98 • Number of events 1 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/99 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
1.0%
1/100 • Number of events 1 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/97 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/99 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/100 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/102 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/98 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive lobular breast carcinoma
|
0.00%
0/99 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/100 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/97 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/99 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
1.0%
1/100 • Number of events 1 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/102 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/98 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/99 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/100 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/97 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/99 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/100 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/102 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
1.0%
1/98 • Number of events 1 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/99 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/100 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
1.0%
1/97 • Number of events 1 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/99 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/100 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/102 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/98 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/99 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/100 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/97 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/99 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/100 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.98%
1/102 • Number of events 1 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/98 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
|
Nervous system disorders
Syncope
|
1.0%
1/99 • Number of events 1 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/100 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/97 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/99 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/100 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/102 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/98 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/99 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/100 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/97 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/99 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/100 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.98%
1/102 • Number of events 1 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/98 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
|
Cardiac disorders
Mitral valve prolapse
|
1.0%
1/99 • Number of events 1 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/100 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/97 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/99 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/100 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/102 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/98 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/99 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
1.0%
1/100 • Number of events 1 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/97 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/99 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/100 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/102 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/98 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/99 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/100 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/97 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/99 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
1.0%
1/100 • Number of events 1 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/102 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/98 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/99 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
1.0%
1/100 • Number of events 1 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/97 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/99 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/100 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/102 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/98 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
|
General disorders
Non-cardiac chest pain
|
1.0%
1/99 • Number of events 1 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/100 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/97 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/99 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/100 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/102 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/98 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/99 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/100 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/97 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/99 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/100 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/102 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
1.0%
1/98 • Number of events 1 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/99 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/100 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/97 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/99 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/100 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/102 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
1.0%
1/98 • Number of events 1 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
Other adverse events
| Measure |
mRNA-1010 50 ug
n=99 participants at risk
Participants received a single IM injection of mRNA-1010 50 μg on Day 1.
|
mRNA-1010.2 50 ug
n=100 participants at risk
Participants received a single IM injection of mRNA-1010.2 50 μg on Day 1.
|
mRNA-1010.3 50 ug
n=97 participants at risk
Participants received a single IM injection of mRNA-1010.3 50 μg on Day 1.
|
mRNA-1011.1 50 ug
n=99 participants at risk
Participants received a single IM injection of mRNA-1011.1 50 μg on Day 1.
|
mRNA-1011.2 40 ug
n=100 participants at risk
Participants received a single IM injection of mRNA-1011.2 40 μg on Day 1.
|
mRNA-1012.1 50 ug
n=102 participants at risk
Participants received a single IM injection of mRNA-1012.1 50 μg on Day 1.
|
mRNA-1012.1 62.5 ug
n=98 participants at risk
Participants received a single IM injection of mRNA-1012.1 62.5 μg on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
2.0%
2/99 • Number of events 2 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
6.0%
6/100 • Number of events 6 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
1.0%
1/97 • Number of events 1 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.00%
0/99 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
6.0%
6/100 • Number of events 6 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
0.98%
1/102 • Number of events 1 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
1.0%
1/98 • Number of events 1 • Day 1 up to the end of study (Day 181)
The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.
|
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