Trial Outcomes & Findings for A Safety, Reactogenicity, and Immunogenicity Study of mRNA-1073 (COVID-19/Influenza) Vaccine in Adults 18 to 75 Years Old (NCT NCT05375838)
NCT ID: NCT05375838
Last Updated: 2024-02-28
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, that 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 all serious AEs (SAEs) and all nonserious AEs ("Other"), regardless of causality, is in Reported "Adverse Events" section.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
550 participants
Primary outcome timeframe
Up to Day 8 (7 days post vaccination)
Results posted on
2024-02-28
Participant Flow
Participant milestones
| Measure |
mRNA-1273 + Placebo
On Day 1, participants received 2 co-administered intramuscular (IM) injections, mRNA-1273 administered in one arm and placebo matched to mRNA-1273 in the other arm.
|
mRNA-1010 + Placebo
On Day 1, participants received 2 co-administered IM injections, mRNA-1010 administered in one arm and placebo matched to mRNA-1010 in the other arm.
|
mRNA-1010 + mRNA-1273
On Day 1, participants received 2 co-administered IM injections, mRNA-1010 administered in one arm and mRNA-1273 in the other arm.
|
Dose A: mRNA-1073 Low Dose + Placebo
On Day 1, participants received 2 co-administered IM injections, mRNA-1073 low dose administered in one arm and placebo matched to mRNA-1073 in the other arm.
|
Dose B: mRNA-1073 Medium Dose + Placebo
On Day 1, participants received 2 co-administered IM injections, mRNA-1073 medium dose administered in one arm and placebo matched to mRNA-1073 in the other arm.
|
Dose C: mRNA-1073 High Dose + Placebo
On Day 1, participants received 2 co-administered IM injections, mRNA-1073 high dose administered in one arm and placebo matched to mRNA-1073 in the other arm.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
50
|
99
|
101
|
100
|
100
|
100
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
49
|
99
|
101
|
100
|
98
|
100
|
|
Overall Study
COMPLETED
|
46
|
90
|
98
|
93
|
94
|
96
|
|
Overall Study
NOT COMPLETED
|
4
|
9
|
3
|
7
|
6
|
4
|
Reasons for withdrawal
| Measure |
mRNA-1273 + Placebo
On Day 1, participants received 2 co-administered intramuscular (IM) injections, mRNA-1273 administered in one arm and placebo matched to mRNA-1273 in the other arm.
|
mRNA-1010 + Placebo
On Day 1, participants received 2 co-administered IM injections, mRNA-1010 administered in one arm and placebo matched to mRNA-1010 in the other arm.
|
mRNA-1010 + mRNA-1273
On Day 1, participants received 2 co-administered IM injections, mRNA-1010 administered in one arm and mRNA-1273 in the other arm.
|
Dose A: mRNA-1073 Low Dose + Placebo
On Day 1, participants received 2 co-administered IM injections, mRNA-1073 low dose administered in one arm and placebo matched to mRNA-1073 in the other arm.
|
Dose B: mRNA-1073 Medium Dose + Placebo
On Day 1, participants received 2 co-administered IM injections, mRNA-1073 medium dose administered in one arm and placebo matched to mRNA-1073 in the other arm.
|
Dose C: mRNA-1073 High Dose + Placebo
On Day 1, participants received 2 co-administered IM injections, mRNA-1073 high dose administered in one arm and placebo matched to mRNA-1073 in the other arm.
|
|---|---|---|---|---|---|---|
|
Overall Study
Other
|
0
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
3
|
2
|
2
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
7
|
0
|
4
|
2
|
3
|
Baseline Characteristics
A Safety, Reactogenicity, and Immunogenicity Study of mRNA-1073 (COVID-19/Influenza) Vaccine in Adults 18 to 75 Years Old
Baseline characteristics by cohort
| Measure |
mRNA-1273 + Placebo
n=49 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1273 administered in one arm and placebo matched to mRNA-1273 in the other arm.
|
mRNA-1010 + Placebo
n=99 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1010 administered in one arm and placebo matched to mRNA-1010 in the other arm.
|
mRNA-1010 + mRNA-1273
n=101 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1010 administered in one arm and mRNA-1273 in the other arm.
|
Dose A: mRNA-1073 Low Dose + Placebo
n=100 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1073 low dose administered in one arm and placebo matched to mRNA-1073 in the other arm.
|
Dose B: mRNA-1073 Medium Dose + Placebo
n=98 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1073 medium dose administered in one arm and placebo matched to mRNA-1073 in the other arm.
|
Dose C: mRNA-1073 High Dose + Placebo
n=100 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1073 high dose administered in one arm and placebo matched to mRNA-1073 in the other arm.
|
Total
n=547 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
47.8 years
STANDARD_DEVIATION 15.37 • n=5 Participants
|
47.4 years
STANDARD_DEVIATION 14.49 • n=7 Participants
|
48.5 years
STANDARD_DEVIATION 14.55 • n=5 Participants
|
49.3 years
STANDARD_DEVIATION 15.10 • n=4 Participants
|
49.0 years
STANDARD_DEVIATION 13.93 • n=21 Participants
|
48.2 years
STANDARD_DEVIATION 14.54 • n=10 Participants
|
48.4 years
STANDARD_DEVIATION 14.55 • n=115 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
64 Participants
n=10 Participants
|
323 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
36 Participants
n=10 Participants
|
224 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
54 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
88 Participants
n=4 Participants
|
88 Participants
n=21 Participants
|
92 Participants
n=10 Participants
|
483 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
17 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
13 Participants
n=10 Participants
|
78 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
76 Participants
n=21 Participants
|
83 Participants
n=10 Participants
|
443 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 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
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Up to Day 8 (7 days post 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, that 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 all serious AEs (SAEs) and all nonserious AEs ("Other"), regardless of causality, is in Reported "Adverse Events" section.
Outcome measures
| Measure |
mRNA-1273 + Placebo
n=49 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1273 administered in one arm and placebo matched to mRNA-1273 in the other arm.
|
mRNA-1010 + Placebo
n=98 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1010 administered in one arm and placebo matched to mRNA-1010 in the other arm.
|
mRNA-1010 + mRNA-1273
n=101 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1010 administered in one arm and mRNA-1273 in the other arm.
|
Dose A: mRNA-1073 Low Dose + Placebo
n=100 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1073 low dose administered in one arm and placebo matched to mRNA-1073 in the other arm.
|
Dose B: mRNA-1073 Medium Dose + Placebo
n=98 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1073 medium dose administered in one arm and placebo matched to mRNA-1073 in the other arm.
|
Dose C: mRNA-1073 High Dose + Placebo
n=100 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1073 high dose administered in one arm and placebo matched to mRNA-1073 in the other arm.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Local and Systemic Adverse Reaction (ARs)
Solicited Local ARs
|
38 Participants
|
80 Participants
|
90 Participants
|
92 Participants
|
76 Participants
|
78 Participants
|
|
Number of Participants With Solicited Local and Systemic Adverse Reaction (ARs)
Solicited Systemic ARs
|
31 Participants
|
70 Participants
|
87 Participants
|
80 Participants
|
63 Participants
|
67 Participants
|
PRIMARY outcome
Timeframe: Up to Day 29 (28 days post vaccination)Population: The safety set consisted of all randomly assigned participants who received the IP.
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.
Outcome measures
| Measure |
mRNA-1273 + Placebo
n=49 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1273 administered in one arm and placebo matched to mRNA-1273 in the other arm.
|
mRNA-1010 + Placebo
n=99 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1010 administered in one arm and placebo matched to mRNA-1010 in the other arm.
|
mRNA-1010 + mRNA-1273
n=101 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1010 administered in one arm and mRNA-1273 in the other arm.
|
Dose A: mRNA-1073 Low Dose + Placebo
n=100 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1073 low dose administered in one arm and placebo matched to mRNA-1073 in the other arm.
|
Dose B: mRNA-1073 Medium Dose + Placebo
n=98 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1073 medium dose administered in one arm and placebo matched to mRNA-1073 in the other arm.
|
Dose C: mRNA-1073 High Dose + Placebo
n=100 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1073 high dose administered in one arm and placebo matched to mRNA-1073 in the other arm.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Unsolicited Adverse Events (AEs)
|
7 Participants
|
21 Participants
|
14 Participants
|
19 Participants
|
11 Participants
|
22 Participants
|
PRIMARY outcome
Timeframe: Up to Day 181Population: The safety set consisted of all randomly assigned participants who received the IP.
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 a 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.
Outcome measures
| Measure |
mRNA-1273 + Placebo
n=49 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1273 administered in one arm and placebo matched to mRNA-1273 in the other arm.
|
mRNA-1010 + Placebo
n=99 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1010 administered in one arm and placebo matched to mRNA-1010 in the other arm.
|
mRNA-1010 + mRNA-1273
n=101 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1010 administered in one arm and mRNA-1273 in the other arm.
|
Dose A: mRNA-1073 Low Dose + Placebo
n=100 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1073 low dose administered in one arm and placebo matched to mRNA-1073 in the other arm.
|
Dose B: mRNA-1073 Medium Dose + Placebo
n=98 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1073 medium dose administered in one arm and placebo matched to mRNA-1073 in the other arm.
|
Dose C: mRNA-1073 High Dose + Placebo
n=100 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1073 high dose administered in one arm and placebo matched to mRNA-1073 in the other arm.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically-Attended AEs (MAAEs) and AEs Leading to Discontinuation
SAEs
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically-Attended AEs (MAAEs) and AEs Leading to Discontinuation
AESIs
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically-Attended AEs (MAAEs) and AEs Leading to Discontinuation
MAAEs
|
13 Participants
|
38 Participants
|
32 Participants
|
34 Participants
|
34 Participants
|
44 Participants
|
|
Number of Participants With Serious Adverse Events (SAEs), Adverse Events 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
|
SECONDARY outcome
Timeframe: Day 29Population: Per protocol 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 and a Day 29 assessment, do not have influenza or SARS-CoV-2 infection at baseline and post-baseline up to Day 29 and have no major protocol deviations and/or prohibited concomitant medication use that are prespecified with impacts on immune response. N=number evaluable for this endpoint.
Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included BV and BY.
Outcome measures
| Measure |
mRNA-1273 + Placebo
n=87 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1273 administered in one arm and placebo matched to mRNA-1273 in the other arm.
|
mRNA-1010 + Placebo
n=94 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1010 administered in one arm and placebo matched to mRNA-1010 in the other arm.
|
mRNA-1010 + mRNA-1273
n=91 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1010 administered in one arm and mRNA-1273 in the other arm.
|
Dose A: mRNA-1073 Low Dose + Placebo
n=86 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1073 low dose administered in one arm and placebo matched to mRNA-1073 in the other arm.
|
Dose B: mRNA-1073 Medium Dose + Placebo
n=95 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1073 medium dose administered in one arm and placebo matched to mRNA-1073 in the other arm.
|
Dose C: mRNA-1073 High Dose + Placebo
On Day 1, participants received 2 co-administered IM injections, mRNA-1073 high dose administered in one arm and placebo matched to mRNA-1073 in the other arm.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titer of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains
Influenza A H1N1 Antibody
|
175.41 titer
Interval 139.67 to 220.3
|
134.04 titer
Interval 110.72 to 162.26
|
104.78 titer
Interval 82.94 to 132.39
|
111.33 titer
Interval 90.94 to 136.29
|
108.68 titer
Interval 88.64 to 133.26
|
—
|
|
Geometric Mean Titer of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains
Influenza A H3N2 Antibody
|
189.9 titer
Interval 145.67 to 247.54
|
214.12 titer
Interval 171.36 to 267.56
|
144.36 titer
Interval 111.87 to 186.29
|
141.15 titer
Interval 112.68 to 176.8
|
129.94 titer
Interval 103.77 to 162.715
|
—
|
|
Geometric Mean Titer of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains
Influenza B BV Antibody
|
106.22 titer
Interval 89.66 to 125.83
|
107.91 titer
Interval 92.79 to 125.5
|
91.78 titer
Interval 77.16 to 109.16
|
89.27 titer
Interval 75.92 to 104.98
|
84.82 titer
Interval 72.56 to 99.15
|
—
|
|
Geometric Mean Titer of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains
Influenza B BY Antibody
|
194.51 titer
Interval 163.21 to 231.81
|
182.01 titer
Interval 152.26 to 217.58
|
139.48 titer
Interval 112.7 to 172.61
|
130.27 titer
Interval 107.67 to 157.61
|
121.29 titer
Interval 99.73 to 147.52
|
—
|
SECONDARY outcome
Timeframe: Day 29Population: Per protocol 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 and a Day 29 assessment, do not have influenza or SARS-CoV-2 infection at baseline and post-baseline up to Day 29 and have no major protocol deviations and/or prohibited concomitant medication use that are prespecified with impacts on immune response. N=number evaluable for this endpoint.
Outcome measures
| Measure |
mRNA-1273 + Placebo
n=43 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1273 administered in one arm and placebo matched to mRNA-1273 in the other arm.
|
mRNA-1010 + Placebo
n=93 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1010 administered in one arm and placebo matched to mRNA-1010 in the other arm.
|
mRNA-1010 + mRNA-1273
n=88 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1010 administered in one arm and mRNA-1273 in the other arm.
|
Dose A: mRNA-1073 Low Dose + Placebo
n=85 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1073 low dose administered in one arm and placebo matched to mRNA-1073 in the other arm.
|
Dose B: mRNA-1073 Medium Dose + Placebo
n=92 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1073 medium dose administered in one arm and placebo matched to mRNA-1073 in the other arm.
|
Dose C: mRNA-1073 High Dose + Placebo
On Day 1, participants received 2 co-administered IM injections, mRNA-1073 high dose administered in one arm and placebo matched to mRNA-1073 in the other arm.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titer of VAC62 Neutralizing Antibody at Day 29, as Measured by Pseudovirus Neutralization Assay (or Binding Antibody Assay) For Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
|
8477.30 titer
Interval 6424.05 to 11186.62
|
6075.76 titer
Interval 5119.62 to 7210.47
|
7573.97 titer
Interval 6475.43 to 8858.86
|
5678.54 titer
Interval 4671.74 to 6902.32
|
4410.29 titer
Interval 3762.65 to 5169.41
|
—
|
SECONDARY outcome
Timeframe: Day 29Population: Per protocol 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 and a Day 29 assessment, do not have influenza or SARS-CoV-2 infection at baseline and post-baseline up to Day 29 and have no major protocol deviations and/or prohibited concomitant medication use that are prespecified with impacts on immune response. N=number evaluable for this endpoint.
Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included BV and BY.
Outcome measures
| Measure |
mRNA-1273 + Placebo
n=87 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1273 administered in one arm and placebo matched to mRNA-1273 in the other arm.
|
mRNA-1010 + Placebo
n=94 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1010 administered in one arm and placebo matched to mRNA-1010 in the other arm.
|
mRNA-1010 + mRNA-1273
n=91 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1010 administered in one arm and mRNA-1273 in the other arm.
|
Dose A: mRNA-1073 Low Dose + Placebo
n=86 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1073 low dose administered in one arm and placebo matched to mRNA-1073 in the other arm.
|
Dose B: mRNA-1073 Medium Dose + Placebo
n=95 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1073 medium dose administered in one arm and placebo matched to mRNA-1073 in the other arm.
|
Dose C: mRNA-1073 High Dose + Placebo
On Day 1, participants received 2 co-administered IM injections, mRNA-1073 high dose administered in one arm and placebo matched to mRNA-1073 in the other arm.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Fold Rise of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains
Influenza B BV Antibody
|
1.61 ratio
Interval 1.42 to 1.82
|
1.64 ratio
Interval 1.47 to 1.84
|
1.29 ratio
Interval 1.14 to 1.44
|
1.29 ratio
Interval 1.18 to 1.43
|
1.29 ratio
Interval 1.16 to 1.43
|
—
|
|
Geometric Mean Fold Rise of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains
Influenza A H1N1 Antibody
|
3.97 ratio
Interval 3.19 to 4.95
|
3.31 ratio
Interval 2.76 to 3.96
|
2.25 ratio
Interval 1.89 to 2.68
|
2.48 ratio
Interval 2.06 to 2.98
|
2.67 ratio
Interval 2.21 to 3.23
|
—
|
|
Geometric Mean Fold Rise of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains
Influenza A H3N2 Antibody
|
5.82 ratio
Interval 4.56 to 7.43
|
5.07 ratio
Interval 4.19 to 6.14
|
3.84 ratio
Interval 3.22 to 4.58
|
4.15 ratio
Interval 3.33 to 5.18
|
3.41 ratio
Interval 2.8 to 4.14
|
—
|
|
Geometric Mean Fold Rise of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains
Influenza B BY Antibody
|
2.68 ratio
Interval 2.25 to 3.19
|
2.17 ratio
Interval 1.85 to 2.53
|
1.63 ratio
Interval 1.46 to 1.83
|
1.65 ratio
Interval 1.46 to 1.87
|
1.58 ratio
Interval 1.41 to 1.78
|
—
|
SECONDARY outcome
Timeframe: Day 29Population: Per protocol 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 and a Day 29 assessment, do not have influenza or SARS-CoV-2 infection at baseline and post-baseline up to Day 29 and have no major protocol deviations and/or prohibited concomitant medication use that are prespecified with impacts on immune response. N=number evaluable for this endpoint.
The GMFR measures the changes in immunogenicity titers or levels from Baseline within participants. 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 |
mRNA-1273 + Placebo
n=43 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1273 administered in one arm and placebo matched to mRNA-1273 in the other arm.
|
mRNA-1010 + Placebo
n=93 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1010 administered in one arm and placebo matched to mRNA-1010 in the other arm.
|
mRNA-1010 + mRNA-1273
n=88 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1010 administered in one arm and mRNA-1273 in the other arm.
|
Dose A: mRNA-1073 Low Dose + Placebo
n=85 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1073 low dose administered in one arm and placebo matched to mRNA-1073 in the other arm.
|
Dose B: mRNA-1073 Medium Dose + Placebo
n=92 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1073 medium dose administered in one arm and placebo matched to mRNA-1073 in the other arm.
|
Dose C: mRNA-1073 High Dose + Placebo
On Day 1, participants received 2 co-administered IM injections, mRNA-1073 high dose administered in one arm and placebo matched to mRNA-1073 in the other arm.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Fold Rise of VAC62 Neutralizing Antibody at Day 29, as Measured by Pseudovirus Neutralization Assay (or Binding Antibody Assay) For SARS-CoV-2
|
6.14 ratio
Interval 3.98 to 9.48
|
4.07 ratio
Interval 3.26 to 5.07
|
3.50 ratio
Interval 2.76 to 4.44
|
3.45 ratio
Interval 2.82 to 4.22
|
3.18 ratio
Interval 2.73 to 3.69
|
—
|
SECONDARY outcome
Timeframe: Day 29Population: Per protocol 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 and a Day 29 assessment, do not have influenza or SARS-CoV-2 infection at baseline and post-baseline up to Day 29 and have no major protocol deviations and/or prohibited concomitant medication use that are prespecified with impacts on immune response. N=number evaluable for this endpoint.
Seroconversion at a participant level is defined as a pre-vaccination HAI titer \< 1:10 and a post-vaccination HAI titer \>= 1:40 or a pre-vaccination HAI titer \>= 1:10 and a minimum 4-fold rise in post vaccination HAI antibody titer.
Outcome measures
| Measure |
mRNA-1273 + Placebo
n=87 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1273 administered in one arm and placebo matched to mRNA-1273 in the other arm.
|
mRNA-1010 + Placebo
n=94 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1010 administered in one arm and placebo matched to mRNA-1010 in the other arm.
|
mRNA-1010 + mRNA-1273
n=91 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1010 administered in one arm and mRNA-1273 in the other arm.
|
Dose A: mRNA-1073 Low Dose + Placebo
n=86 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1073 low dose administered in one arm and placebo matched to mRNA-1073 in the other arm.
|
Dose B: mRNA-1073 Medium Dose + Placebo
n=95 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1073 medium dose administered in one arm and placebo matched to mRNA-1073 in the other arm.
|
Dose C: mRNA-1073 High Dose + Placebo
On Day 1, participants received 2 co-administered IM injections, mRNA-1073 high dose administered in one arm and placebo matched to mRNA-1073 in the other arm.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroconversion as Measured by HAI Assay For Vaccine-Matched Seasonal Influenza A and B Strains
Influenza A H1N1 Antibody
|
47.1 percentage of participants
Interval 36.3 to 58.1
|
42.6 percentage of participants
Interval 32.4 to 53.2
|
27.5 percentage of participants
Interval 18.6 to 37.8
|
31.4 percentage of participants
Interval 21.8 to 42.3
|
31.6 percentage of participants
Interval 22.4 to 41.9
|
—
|
|
Percentage of Participants With Seroconversion as Measured by HAI Assay For Vaccine-Matched Seasonal Influenza A and B Strains
Influenza A H3N2 Antibody
|
64.4 percentage of participants
Interval 53.4 to 74.4
|
63.8 percentage of participants
Interval 53.3 to 73.5
|
53.8 percentage of participants
Interval 43.1 to 64.4
|
53.5 percentage of participants
Interval 42.4 to 64.3
|
42.1 percentage of participants
Interval 32.0 to 52.7
|
—
|
|
Percentage of Participants With Seroconversion as Measured by HAI Assay For Vaccine-Matched Seasonal Influenza A and B Strains
Influenza B BV Antibody
|
16.1 percentage of participants
Interval 9.1 to 25.5
|
9.6 percentage of participants
Interval 4.5 to 17.4
|
3.3 percentage of participants
Interval 0.7 to 9.3
|
2.3 percentage of participants
Interval 0.3 to 8.1
|
6.3 percentage of participants
Interval 2.4 to 13.2
|
—
|
|
Percentage of Participants With Seroconversion as Measured by HAI Assay For Vaccine-Matched Seasonal Influenza A and B Strains
Influenza B BY Antibody
|
32.2 percentage of participants
Interval 22.6 to 43.1
|
19.1 percentage of participants
Interval 11.8 to 28.6
|
11.0 percentage of participants
Interval 5.4 to 19.3
|
10.5 percentage of participants
Interval 4.9 to 18.9
|
10.5 percentage of participants
Interval 5.2 to 18.5
|
—
|
SECONDARY outcome
Timeframe: Day 29Population: Per protocol 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 and a Day 29 assessment, do not have influenza or SARS-CoV-2 infection at baseline and post-baseline up to Day 29 and have no major protocol deviations and/or prohibited concomitant medication use that are prespecified with impacts on immune response. N=number evaluable for this endpoint.
Seroresponse at a participant level is defined as an increase from below the lower limit of quantification (LLOQ) to \>= 4 x LLOQ if baseline neutralizing antibody (nAb) level is \< LLOQ, or \>= 4 fold rise if baseline nAb level is \>=LLOQ.
Outcome measures
| Measure |
mRNA-1273 + Placebo
n=43 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1273 administered in one arm and placebo matched to mRNA-1273 in the other arm.
|
mRNA-1010 + Placebo
n=93 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1010 administered in one arm and placebo matched to mRNA-1010 in the other arm.
|
mRNA-1010 + mRNA-1273
n=88 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1010 administered in one arm and mRNA-1273 in the other arm.
|
Dose A: mRNA-1073 Low Dose + Placebo
n=85 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1073 low dose administered in one arm and placebo matched to mRNA-1073 in the other arm.
|
Dose B: mRNA-1073 Medium Dose + Placebo
n=92 Participants
On Day 1, participants received 2 co-administered IM injections, mRNA-1073 medium dose administered in one arm and placebo matched to mRNA-1073 in the other arm.
|
Dose C: mRNA-1073 High Dose + Placebo
On Day 1, participants received 2 co-administered IM injections, mRNA-1073 high dose administered in one arm and placebo matched to mRNA-1073 in the other arm.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroresponse as Measured by PsVNA (or Binding Antibody Assay) For SARS-CoV-2
|
52.4 percentage of participants
Interval 36.4 to 68.0
|
44.4 percentage of participants
Interval 34.0 to 55.3
|
37.5 percentage of participants
Interval 27.4 to 48.5
|
36.5 percentage of participants
Interval 26.3 to 47.6
|
35.9 percentage of participants
Interval 26.1 to 46.5
|
—
|
Adverse Events
mRNA-1273 + Placebo
Serious events: 2 serious events
Other events: 42 other events
Deaths: 0 deaths
mRNA-1010 + Placebo
Serious events: 1 serious events
Other events: 86 other events
Deaths: 0 deaths
mRNA-1010 + mRNA-1273
Serious events: 0 serious events
Other events: 93 other events
Deaths: 0 deaths
Dose A: mRNA-1073 Low Dose + Placebo
Serious events: 0 serious events
Other events: 94 other events
Deaths: 0 deaths
Dose B: mRNA-1073 Medium Dose + Placebo
Serious events: 1 serious events
Other events: 81 other events
Deaths: 0 deaths
Dose C: mRNA-1073 High Dose + Placebo
Serious events: 0 serious events
Other events: 89 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
mRNA-1273 + Placebo
n=49 participants at risk
On Day 1, participants received 2 co-administered IM injections, mRNA-1273 administered in one arm and placebo matched to mRNA-1273 in the other arm.
|
mRNA-1010 + Placebo
n=99 participants at risk
On Day 1, participants received 2 co-administered IM injections, mRNA-1010 administered in one arm and placebo matched to mRNA-1010 in the other arm.
|
mRNA-1010 + mRNA-1273
n=101 participants at risk
On Day 1, participants received 2 co-administered IM injections, mRNA-1010 administered in one arm and mRNA-1273 in the other arm.
|
Dose A: mRNA-1073 Low Dose + Placebo
n=100 participants at risk
On Day 1, participants received 2 co-administered IM injections, mRNA-1073 low dose administered in one arm and placebo matched to mRNA-1073 in the other arm.
|
Dose B: mRNA-1073 Medium Dose + Placebo
n=98 participants at risk
On Day 1, participants received 2 co-administered IM injections, mRNA-1073 medium dose administered in one arm and placebo matched to mRNA-1073 in the other arm.
|
Dose C: mRNA-1073 High Dose + Placebo
n=100 participants at risk
On Day 1, participants received 2 co-administered IM injections, mRNA-1073 high dose administered in one arm and placebo matched to mRNA-1073 in the other arm.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Septic shock
|
0.00%
0/49 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/99 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/101 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/100 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.0%
1/98 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/100 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Urinary tract infection
|
2.0%
1/49 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/99 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/101 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/100 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/98 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/100 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Cardiac disorders
Cardiac failure congestive
|
2.0%
1/49 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/99 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/101 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/100 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/98 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/100 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.00%
0/49 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/99 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/101 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/100 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.0%
1/98 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/100 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/49 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
1.0%
1/99 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/101 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/100 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/98 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/100 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
Other adverse events
| Measure |
mRNA-1273 + Placebo
n=49 participants at risk
On Day 1, participants received 2 co-administered IM injections, mRNA-1273 administered in one arm and placebo matched to mRNA-1273 in the other arm.
|
mRNA-1010 + Placebo
n=99 participants at risk
On Day 1, participants received 2 co-administered IM injections, mRNA-1010 administered in one arm and placebo matched to mRNA-1010 in the other arm.
|
mRNA-1010 + mRNA-1273
n=101 participants at risk
On Day 1, participants received 2 co-administered IM injections, mRNA-1010 administered in one arm and mRNA-1273 in the other arm.
|
Dose A: mRNA-1073 Low Dose + Placebo
n=100 participants at risk
On Day 1, participants received 2 co-administered IM injections, mRNA-1073 low dose administered in one arm and placebo matched to mRNA-1073 in the other arm.
|
Dose B: mRNA-1073 Medium Dose + Placebo
n=98 participants at risk
On Day 1, participants received 2 co-administered IM injections, mRNA-1073 medium dose administered in one arm and placebo matched to mRNA-1073 in the other arm.
|
Dose C: mRNA-1073 High Dose + Placebo
n=100 participants at risk
On Day 1, participants received 2 co-administered IM injections, mRNA-1073 high dose administered in one arm and placebo matched to mRNA-1073 in the other arm.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
6.1%
3/49 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
14.1%
14/99 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
10.9%
11/101 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
13.0%
13/100 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
13.3%
13/98 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
18.0%
18/100 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.1%
3/49 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
3.0%
3/99 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.99%
1/101 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
3.0%
3/100 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
8.2%
8/98 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
11.0%
11/100 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Infections and infestations
Rhinovirus infection
|
2.0%
1/49 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
4.0%
4/99 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
8.9%
9/101 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
2/100 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
8.2%
8/98 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
4.0%
4/100 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Nervous system disorders
Headache
|
36.7%
18/49 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
41.4%
41/99 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
63.4%
64/101 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
63.0%
63/100 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
42.9%
42/98 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
45.0%
45/100 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
7/49 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
14.1%
14/99 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
22.8%
23/101 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
14.0%
14/100 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
14.3%
14/98 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
6.0%
6/100 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
40.8%
20/49 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
52.5%
52/99 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
72.3%
73/101 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
59.0%
59/100 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
42.9%
42/98 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
41.0%
41/100 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
34.7%
17/49 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
30.3%
30/99 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
48.5%
49/101 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
49.0%
49/100 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
35.7%
35/98 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
31.0%
31/100 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
General disorders
Injection site pain
|
77.6%
38/49 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
80.8%
80/99 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
88.1%
89/101 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
91.0%
91/100 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
77.6%
76/98 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
78.0%
78/100 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
General disorders
Fatigue
|
51.0%
25/49 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
57.6%
57/99 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
78.2%
79/101 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
67.0%
67/100 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
45.9%
45/98 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
51.0%
51/100 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
General disorders
Chills
|
20.4%
10/49 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
31.3%
31/99 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
50.5%
51/101 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
46.0%
46/100 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
30.6%
30/98 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
20.0%
20/100 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
General disorders
Injection site lymphadenopathy
|
30.6%
15/49 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
19.2%
19/99 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
24.8%
25/101 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
26.0%
26/100 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
20.4%
20/98 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
22.0%
22/100 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
General disorders
Pyrexia
|
4.1%
2/49 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
4.0%
4/99 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
19.8%
20/101 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
17.0%
17/100 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
5.1%
5/98 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
2/100 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
General disorders
Injection site induration
|
12.2%
6/49 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
2/99 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
4.0%
4/101 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
10.0%
10/100 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
3.1%
3/98 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
4.0%
4/100 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
|
General disorders
Injection site erythema
|
0.00%
0/49 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/99 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
2.0%
2/101 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
8.0%
8/100 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/98 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
0.00%
0/100 • Day 1 through Day 181
The safety set consisted of all randomly assigned participants who received the IP. Participants will be included in the vaccination group corresponding to what they actually received. Note, that not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE.
|
Additional Information
Moderna Clinical Trials Support Center
ModernaTX, Inc
Phone: 1-877-777-7187
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place