Trial Outcomes & Findings for Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA Vaccine Candidate Variations in Healthy Adults (NCT NCT05868382)
NCT ID: NCT05868382
Last Updated: 2024-12-20
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. Note, not all solicited ARs were considered adverse events (AEs). The Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
270 participants
Primary outcome timeframe
7 days post-vaccination
Results posted on
2024-12-20
Participant Flow
Participant milestones
| Measure |
mRNA-1010
Participants received a single dose of mRNA-1010 by intramuscular (IM) injection on Day 1.
|
mRNA-1010.4 Low Dose
Participants received mRNA-1010.4 at a low dose level by IM injection on Day 1.
|
mRNA-1010.4 High Dose
Participants received mRNA-1010.4 at a high dose level by IM injection on Day 1.
|
mRNA-1010.6 Low Dose
Participants received mRNA-1010.6 at a low dose level by IM injection on Day 1.
|
mRNA-1010.6 Medium Dose
Participants received mRNA-1010.6 at a medium dose level by IM injection on Day 1.
|
mRNA-1010.6 High Dose
Participants received mRNA-1010.6 at a high dose level by IM injection on Day 1.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
60
|
30
|
60
|
30
|
30
|
60
|
|
Overall Study
Received Injection
|
60
|
30
|
60
|
30
|
30
|
60
|
|
Overall Study
Safety Set
|
60
|
30
|
60
|
30
|
31
|
59
|
|
Overall Study
Solicited Safety Set
|
60
|
30
|
60
|
30
|
31
|
59
|
|
Overall Study
Per-Protocol Set
|
55
|
28
|
56
|
29
|
28
|
52
|
|
Overall Study
COMPLETED
|
54
|
30
|
54
|
26
|
27
|
54
|
|
Overall Study
NOT COMPLETED
|
6
|
0
|
6
|
4
|
3
|
6
|
Reasons for withdrawal
| Measure |
mRNA-1010
Participants received a single dose of mRNA-1010 by intramuscular (IM) injection on Day 1.
|
mRNA-1010.4 Low Dose
Participants received mRNA-1010.4 at a low dose level by IM injection on Day 1.
|
mRNA-1010.4 High Dose
Participants received mRNA-1010.4 at a high dose level by IM injection on Day 1.
|
mRNA-1010.6 Low Dose
Participants received mRNA-1010.6 at a low dose level by IM injection on Day 1.
|
mRNA-1010.6 Medium Dose
Participants received mRNA-1010.6 at a medium dose level by IM injection on Day 1.
|
mRNA-1010.6 High Dose
Participants received mRNA-1010.6 at a high dose level by IM injection on Day 1.
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
0
|
6
|
4
|
2
|
6
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA Vaccine Candidate Variations in Healthy Adults
Baseline characteristics by cohort
| Measure |
mRNA-1010
n=60 Participants
Participants received a single dose of mRNA-1010 by IM injection on Day 1.
|
mRNA-1010.4 Low Dose
n=30 Participants
Participants received mRNA-1010.4 at a low dose level by IM injection on Day 1.
|
mRNA-1010.4 High Dose
n=60 Participants
Participants received mRNA-1010.4 at a high dose level by IM injection on Day 1.
|
mRNA-1010.6 Low Dose
n=30 Participants
Participants received mRNA-1010.6 at a low dose level by IM injection on Day 1.
|
mRNA-1010.6 Medium Dose
n=30 Participants
Participants received mRNA-1010.6 at a medium dose level by IM injection on Day 1.
|
mRNA-1010.6 High Dose
n=60 Participants
Participants received mRNA-1010.6 at a high dose level by IM injection on Day 1.
|
Total
n=270 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
34.5 years
STANDARD_DEVIATION 9.08 • n=5 Participants
|
36.7 years
STANDARD_DEVIATION 8.06 • n=7 Participants
|
34.6 years
STANDARD_DEVIATION 7.87 • n=5 Participants
|
36.7 years
STANDARD_DEVIATION 9.05 • n=4 Participants
|
35.9 years
STANDARD_DEVIATION 7.56 • n=21 Participants
|
33.8 years
STANDARD_DEVIATION 7.54 • n=8 Participants
|
35.0 years
STANDARD_DEVIATION 8.20 • n=8 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
31 Participants
n=8 Participants
|
152 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
29 Participants
n=8 Participants
|
118 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
87 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
40 Participants
n=8 Participants
|
175 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
10 Participants
n=8 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
24 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
94 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
37 Participants
n=8 Participants
|
147 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 7 days post-vaccinationPopulation: Solicited Safety Set included all participants who received 1 dose of study intervention and contributed any solicited AR data (that is, had at least 1 post baseline solicited safety \[eDiary\] assessment). Participants were included in the study intervention group corresponding to the study intervention that they 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. Note, not all solicited ARs were considered adverse events (AEs). The Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Outcome measures
| Measure |
mRNA-1010
n=60 Participants
Participants received a single dose of mRNA-1010 by IM injection on Day 1.
|
mRNA-1010.4 Low Dose
n=30 Participants
Participants received mRNA-1010.4 at a low dose level by IM injection on Day 1.
|
mRNA-1010.4 High Dose
n=60 Participants
Participants received mRNA-1010.4 at a high dose level by IM injection on Day 1
|
mRNA-1010.6 Low Dose
n=30 Participants
Participants received mRNA-1010.6 at a low dose level by IM injection on Day 1.
|
mRNA-1010.6 Medium Dose
n=31 Participants
Participants received mRNA-1010.6 at a medium dose level by IM injection on Day 1.
|
mRNA-1010.6 High Dose
n=59 Participants
Participants received mRNA-1010.6 at a high dose level by IM injection on Day 1.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Grade 1
|
22 Participants
|
11 Participants
|
11 Participants
|
11 Participants
|
12 Participants
|
15 Participants
|
|
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Grade 2
|
24 Participants
|
11 Participants
|
32 Participants
|
5 Participants
|
12 Participants
|
34 Participants
|
|
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Grade 3
|
4 Participants
|
5 Participants
|
10 Participants
|
2 Participants
|
1 Participants
|
6 Participants
|
|
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Any
|
50 Participants
|
27 Participants
|
53 Participants
|
18 Participants
|
25 Participants
|
55 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
|
PRIMARY outcome
Timeframe: Up to 28 days post-vaccinationPopulation: Safety Set included all participants who received 1 dose of study intervention. Participants were included in the study arm corresponding to the study intervention that they received.
An unsolicited AE was an AE that was not solicited using a participant diary and that was communicated by a participant who has signed the informed consent. 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
n=60 Participants
Participants received a single dose of mRNA-1010 by IM injection on Day 1.
|
mRNA-1010.4 Low Dose
n=30 Participants
Participants received mRNA-1010.4 at a low dose level by IM injection on Day 1.
|
mRNA-1010.4 High Dose
n=60 Participants
Participants received mRNA-1010.4 at a high dose level by IM injection on Day 1
|
mRNA-1010.6 Low Dose
n=30 Participants
Participants received mRNA-1010.6 at a low dose level by IM injection on Day 1.
|
mRNA-1010.6 Medium Dose
n=31 Participants
Participants received mRNA-1010.6 at a medium dose level by IM injection on Day 1.
|
mRNA-1010.6 High Dose
n=59 Participants
Participants received mRNA-1010.6 at a high dose level by IM injection on Day 1.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Unsolicited Adverse Events (AEs)
|
11 Participants
|
4 Participants
|
9 Participants
|
0 Participants
|
4 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 181 (end of study [EOS])Population: Safety Set included all participants who received 1 dose of study intervention. Participants were included in the study arm corresponding to the study intervention that they 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/or coronavirus disease 2019 \[COVID-19\] 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
n=60 Participants
Participants received a single dose of mRNA-1010 by IM injection on Day 1.
|
mRNA-1010.4 Low Dose
n=30 Participants
Participants received mRNA-1010.4 at a low dose level by IM injection on Day 1.
|
mRNA-1010.4 High Dose
n=60 Participants
Participants received mRNA-1010.4 at a high dose level by IM injection on Day 1
|
mRNA-1010.6 Low Dose
n=30 Participants
Participants received mRNA-1010.6 at a low dose level by IM injection on Day 1.
|
mRNA-1010.6 Medium Dose
n=31 Participants
Participants received mRNA-1010.6 at a medium dose level by IM injection on Day 1.
|
mRNA-1010.6 High Dose
n=59 Participants
Participants received mRNA-1010.6 at a high dose level by IM injection on Day 1.
|
|---|---|---|---|---|---|---|
|
Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Study or Treatment Discontinuation
MAAEs
|
14 Participants
|
5 Participants
|
12 Participants
|
2 Participants
|
3 Participants
|
8 Participants
|
|
Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Study or Treatment Discontinuation
AEs Leading to Study or Treatment Discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Study or Treatment Discontinuation
SAEs
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Study or Treatment Discontinuation
AESIs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days 1 (Baseline), 8, 29, 91, and 181Population: Per-Protocol Set: all randomized participants who received study drug, complied with injection schedule, timing of immunogenicity blood sampling to have a baseline (Day 1), had at least 1 post injection assessment, had a Day 29 assessment that was within 22 days to 43 days after injection, had no important protocol deviations which impacted immune response, and did not use prohibited medication/nonstudy vaccines against influenza. 'Number analyzed'= participants evaluable for specified category.
Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. 95% CI was calculated based on the t-distribution of log-transformed values for GM titer, then back transformed to original scale for presentation.
Outcome measures
| Measure |
mRNA-1010
n=55 Participants
Participants received a single dose of mRNA-1010 by IM injection on Day 1.
|
mRNA-1010.4 Low Dose
n=28 Participants
Participants received mRNA-1010.4 at a low dose level by IM injection on Day 1.
|
mRNA-1010.4 High Dose
n=56 Participants
Participants received mRNA-1010.4 at a high dose level by IM injection on Day 1
|
mRNA-1010.6 Low Dose
n=29 Participants
Participants received mRNA-1010.6 at a low dose level by IM injection on Day 1.
|
mRNA-1010.6 Medium Dose
n=28 Participants
Participants received mRNA-1010.6 at a medium dose level by IM injection on Day 1.
|
mRNA-1010.6 High Dose
n=52 Participants
Participants received mRNA-1010.6 at a high dose level by IM injection on Day 1.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains
Influenza B/ Victoria Lineage: Day 1
|
63.4 titer
Interval 55.1 to 72.9
|
78.1 titer
Interval 60.5 to 100.9
|
82.5 titer
Interval 66.9 to 101.8
|
74.5 titer
Interval 59.4 to 93.4
|
64.0 titer
Interval 49.8 to 82.3
|
67.8 titer
Interval 58.2 to 78.9
|
|
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains
Influenza B/ Victoria Lineage: Day 8
|
88.9 titer
Interval 72.2 to 109.3
|
164.0 titer
Interval 119.5 to 225.1
|
194.7 titer
Interval 145.8 to 260.0
|
150.7 titer
Interval 112.2 to 202.4
|
129.6 titer
Interval 91.9 to 182.8
|
126.4 titer
Interval 100.7 to 158.7
|
|
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains
Influenza B/ Victoria Lineage: Day 29
|
94.3 titer
Interval 75.4 to 117.8
|
174.5 titer
Interval 124.2 to 245.3
|
218.0 titer
Interval 160.3 to 296.5
|
132.2 titer
Interval 99.2 to 176.2
|
120.4 titer
Interval 90.3 to 160.6
|
132.8 titer
Interval 104.2 to 169.3
|
|
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains
Influenza A H1N1 Antibody: Day 8
|
226.2 titer
Interval 164.8 to 310.6
|
272.4 titer
Interval 196.2 to 378.3
|
337.2 titer
Interval 244.9 to 464.3
|
240.2 titer
Interval 163.8 to 352.2
|
259.3 titer
Interval 166.9 to 403.0
|
331.3 titer
Interval 247.0 to 444.5
|
|
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains
Influenza A H1N1 Antibody: Day 29
|
334.4 titer
Interval 247.8 to 451.2
|
316.1 titer
Interval 214.5 to 465.8
|
394.9 titer
Interval 299.1 to 521.5
|
255.0 titer
Interval 177.7 to 366.1
|
269.1 titer
Interval 184.5 to 392.5
|
349.0 titer
Interval 266.9 to 456.3
|
|
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains
Influenza A H1N1 Antibody: Day 91
|
168.9 titer
Interval 125.2 to 227.8
|
202.4 titer
Interval 144.2 to 284.2
|
229.3 titer
Interval 174.4 to 301.4
|
160.0 titer
Interval 108.8 to 235.4
|
174.5 titer
Interval 117.0 to 260.3
|
179.6 titer
Interval 137.8 to 234.1
|
|
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains
Influenza A H3N2 Antibody: Day 91
|
105.1 titer
Interval 77.3 to 142.7
|
146.8 titer
Interval 101.4 to 212.6
|
154.8 titer
Interval 116.6 to 205.5
|
99.5 titer
Interval 69.8 to 141.9
|
94.0 titer
Interval 66.9 to 132.0
|
103.6 titer
Interval 80.0 to 134.0
|
|
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains
Influenza B/ Yamagata Lineage: Day 29
|
181.5 titer
Interval 146.6 to 224.7
|
275.8 titer
Interval 187.5 to 405.8
|
336.2 titer
Interval 270.4 to 418.1
|
205.7 titer
Interval 142.4 to 297.0
|
187.9 titer
Interval 136.8 to 258.2
|
309.5 titer
Interval 246.8 to 388.1
|
|
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains
Influenza B/ Yamagata Lineage: Day 181
|
109.4 titer
Interval 91.3 to 131.2
|
137.9 titer
Interval 101.0 to 188.3
|
140.6 titer
Interval 113.6 to 174.1
|
111.6 titer
Interval 79.5 to 156.4
|
125.4 titer
Interval 98.6 to 159.4
|
138.3 titer
Interval 114.3 to 167.4
|
|
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains
Influenza A H1N1 Antibody: Day 1
|
52.4 titer
Interval 41.5 to 66.2
|
60.9 titer
Interval 41.9 to 88.7
|
72.9 titer
Interval 53.9 to 98.5
|
78.2 titer
Interval 54.5 to 112.1
|
50.5 titer
Interval 34.2 to 74.6
|
48.2 titer
Interval 36.7 to 63.3
|
|
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains
Influenza A H1N1 Antibody: Day 181
|
127.6 titer
Interval 95.9 to 169.7
|
164.1 titer
Interval 119.9 to 224.7
|
167.8 titer
Interval 122.4 to 230.0
|
119.9 titer
Interval 82.4 to 174.5
|
123.8 titer
Interval 88.2 to 173.8
|
137.4 titer
Interval 106.1 to 177.9
|
|
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains
Influenza A H3N2 Antibody: Day 1
|
33.3 titer
Interval 26.3 to 42.3
|
46.4 titer
Interval 31.6 to 68.1
|
41.2 titer
Interval 32.8 to 51.9
|
37.2 titer
Interval 26.7 to 51.9
|
29.7 titer
Interval 21.5 to 40.9
|
27.4 titer
Interval 21.8 to 34.4
|
|
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains
Influenza A H3N2 Antibody: Day 8
|
125.6 titer
Interval 88.7 to 178.1
|
187.9 titer
Interval 128.2 to 275.5
|
188.4 titer
Interval 147.5 to 240.6
|
109.1 titer
Interval 71.4 to 166.6
|
125.0 titer
Interval 80.0 to 195.2
|
162.3 titer
Interval 118.2 to 222.8
|
|
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains
Influenza A H3N2 Antibody: Day 29
|
159.0 titer
Interval 115.8 to 218.4
|
262.7 titer
Interval 170.9 to 403.8
|
248.2 titer
Interval 192.2 to 320.6
|
124.4 titer
Interval 78.2 to 198.1
|
136.2 titer
Interval 89.7 to 206.9
|
160.0 titer
Interval 118.7 to 215.7
|
|
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains
Influenza A H3N2 Antibody: Day 181
|
87.8 titer
Interval 66.0 to 116.8
|
124.9 titer
Interval 84.6 to 184.2
|
107.9 titer
Interval 81.7 to 142.3
|
68.2 titer
Interval 46.4 to 100.4
|
67.7 titer
Interval 48.3 to 94.8
|
87.0 titer
Interval 65.2 to 116.2
|
|
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains
Influenza B/ Victoria Lineage: Day 91
|
89.2 titer
Interval 77.2 to 103.2
|
126.5 titer
Interval 100.9 to 158.5
|
138.2 titer
Interval 109.6 to 174.2
|
100.9 titer
Interval 78.2 to 130.1
|
84.1 titer
Interval 66.4 to 106.5
|
94.2 titer
Interval 80.8 to 109.7
|
|
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains
Influenza B/ Victoria Lineage: Day 181
|
62.9 titer
Interval 53.7 to 73.7
|
75.2 titer
Interval 56.2 to 100.5
|
83.9 titer
Interval 68.5 to 102.7
|
59.9 titer
Interval 47.2 to 76.1
|
60.3 titer
Interval 49.7 to 73.2
|
60.2 titer
Interval 51.8 to 69.9
|
|
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains
Influenza B/ Yamagata Lineage: Day 1
|
71.9 titer
Interval 57.6 to 89.7
|
107.7 titer
Interval 72.3 to 160.4
|
96.3 titer
Interval 75.6 to 122.8
|
99.2 titer
Interval 70.0 to 140.5
|
77.1 titer
Interval 57.3 to 103.6
|
84.9 titer
Interval 67.4 to 106.9
|
|
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains
Influenza B/ Yamagata Lineage: Day 8
|
181.2 titer
Interval 142.0 to 231.1
|
293.5 titer
Interval 195.8 to 440.0
|
305.7 titer
Interval 233.2 to 400.8
|
198.3 titer
Interval 141.9 to 277.3
|
215.5 titer
Interval 155.2 to 299.2
|
367.6 titer
Interval 280.4 to 481.8
|
|
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains
Influenza B/ Yamagata Lineage: Day 91
|
134.1 titer
Interval 112.7 to 159.5
|
190.3 titer
Interval 140.0 to 258.7
|
218.9 titer
Interval 173.4 to 276.2
|
160.0 titer
Interval 120.1 to 213.2
|
141.4 titer
Interval 107.8 to 185.5
|
194.8 titer
Interval 161.7 to 234.7
|
SECONDARY outcome
Timeframe: Baseline, Days 8, 29, 91, and 181Population: Per-Protocol Set: all randomized participants who received study drug, complied with injection schedule, timing of immunogenicity blood sampling to have a baseline (Day 1), had at least 1 post injection assessment, had a Day 29 assessment that was within 22 days to 43 days after injection, had no important protocol deviations which impacted immune response, and did not use prohibited medication/nonstudy vaccines against influenza. 'Number analyzed'= participants evaluable for specified category.
The GMFR measures the changes in immunogenicity titers or levels from Baseline within participants. Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. Fold-rise was calculated by dividing post-vaccination results by the baseline value. 95% 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
n=55 Participants
Participants received a single dose of mRNA-1010 by IM injection on Day 1.
|
mRNA-1010.4 Low Dose
n=28 Participants
Participants received mRNA-1010.4 at a low dose level by IM injection on Day 1.
|
mRNA-1010.4 High Dose
n=56 Participants
Participants received mRNA-1010.4 at a high dose level by IM injection on Day 1
|
mRNA-1010.6 Low Dose
n=29 Participants
Participants received mRNA-1010.6 at a low dose level by IM injection on Day 1.
|
mRNA-1010.6 Medium Dose
n=28 Participants
Participants received mRNA-1010.6 at a medium dose level by IM injection on Day 1.
|
mRNA-1010.6 High Dose
n=52 Participants
Participants received mRNA-1010.6 at a high dose level by IM injection on Day 1.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
Influenza A H1N1 Antibody: Day 29
|
6.38 ratio
Interval 4.58 to 8.89
|
5.19 ratio
Interval 3.37 to 7.99
|
5.42 ratio
Interval 3.94 to 7.44
|
3.26 ratio
Interval 2.15 to 4.95
|
5.32 ratio
Interval 3.31 to 8.57
|
7.24 ratio
Interval 5.16 to 10.17
|
|
Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
Influenza A H3N2 Antibody: Day 181
|
2.59 ratio
Interval 2.06 to 3.26
|
2.69 ratio
Interval 2.01 to 3.61
|
2.66 ratio
Interval 1.99 to 3.55
|
2.06 ratio
Interval 1.43 to 2.97
|
2.25 ratio
Interval 1.6 to 3.16
|
3.14 ratio
Interval 2.47 to 4.0
|
|
Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
Influenza B/Victoria Lineage: Day 8
|
1.41 ratio
Interval 1.2 to 1.65
|
2.10 ratio
Interval 1.53 to 2.88
|
2.39 ratio
Interval 1.93 to 3.0
|
2.02 ratio
Interval 1.59 to 2.58
|
2.03 ratio
Interval 1.62 to 2.52
|
1.90 ratio
Interval 1.58 to 2.3
|
|
Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
Influenza B/Victoria Lineage: Day 181
|
0.95 ratio
Interval 0.79 to 1.15
|
0.96 ratio
Interval 0.75 to 1.24
|
0.98 ratio
Interval 0.81 to 1.19
|
0.74 ratio
Interval 0.55 to 0.99
|
0.93 ratio
Interval 0.74 to 1.15
|
0.89 ratio
Interval 0.73 to 1.09
|
|
Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
Influenza A H1N1 Antibody: Day 8
|
4.27 ratio
Interval 3.13 to 5.783
|
4.47 ratio
Interval 2.95 to 6.78
|
4.38 ratio
Interval 3.18 to 6.04
|
3.07 ratio
Interval 2.04 to 4.64
|
5.13 ratio
Interval 3.4 to 7.75
|
6.87 ratio
Interval 4.79 to 9.86
|
|
Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
Influenza A H1N1 Antibody: Day 91
|
3.13 ratio
Interval 2.36 to 4.17
|
3.32 ratio
Interval 2.34 to 4.71
|
3.08 ratio
Interval 2.24 to 4.25
|
2.05 ratio
Interval 1.5 to 2.81
|
3.45 ratio
Interval 1.94 to 6.13
|
3.71 ratio
Interval 2.69 to 5.13
|
|
Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
Influenza A H1N1 Antibody: Day 181
|
2.36 ratio
Interval 1.8 to 3.1
|
2.69 ratio
Interval 1.88 to 3.86
|
2.23 ratio
Interval 1.61 to 3.08
|
1.59 ratio
Interval 1.14 to 2.21
|
2.43 ratio
Interval 1.43 to 4.12
|
2.87 ratio
Interval 2.12 to 3.88
|
|
Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
Influenza A H3N2 Antibody: Day 8
|
3.82 ratio
Interval 2.87 to 5.08
|
4.05 ratio
Interval 3.03 to 5.42
|
4.44 ratio
Interval 3.46 to 5.71
|
2.93 ratio
Interval 2.05 to 4.19
|
4.21 ratio
Interval 2.82 to 6.29
|
6.11 ratio
Interval 4.65 to 8.02
|
|
Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
Influenza A H3N2 Antibody: Day 29
|
4.77 ratio
Interval 3.74 to 6.09
|
5.66 ratio
Interval 3.98 to 8.06
|
6.02 ratio
Interval 4.68 to 7.75
|
3.34 ratio
Interval 2.27 to 4.91
|
4.59 ratio
Interval 3.08 to 6.83
|
5.85 ratio
Interval 4.49 to 7.61
|
|
Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
Influenza A H3N2 Antibody: Day 91
|
3.11 ratio
Interval 2.47 to 3.93
|
3.17 ratio
Interval 2.2 to 4.55
|
3.79 ratio
Interval 2.81 to 5.12
|
2.76 ratio
Interval 1.91 to 3.99
|
3.17 ratio
Interval 2.14 to 4.69
|
3.76 ratio
Interval 3.05 to 4.65
|
|
Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
Influenza B/Victoria Lineage: Day 29
|
1.49 ratio
Interval 1.26 to 1.76
|
2.23 ratio
Interval 1.65 to 3.03
|
2.64 ratio
Interval 2.11 to 3.31
|
1.78 ratio
Interval 1.4 to 2.26
|
1.88 ratio
Interval 1.54 to 2.29
|
1.96 ratio
Interval 1.61 to 2.38
|
|
Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
Influenza B/Victoria Lineage: Day 91
|
1.36 ratio
Interval 1.16 to 1.59
|
1.62 ratio
Interval 1.27 to 2.06
|
1.65 ratio
Interval 1.38 to 1.97
|
1.34 ratio
Interval 1.04 to 1.73
|
1.31 ratio
Interval 1.04 to 1.66
|
1.39 ratio
Interval 1.19 to 1.64
|
|
Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
Influenza B/Yamagata Lineage: Day 8
|
2.53 ratio
Interval 2.02 to 3.17
|
2.73 ratio
Interval 2.04 to 3.65
|
3.20 ratio
Interval 2.42 to 4.23
|
2.00 ratio
Interval 1.49 to 2.68
|
2.80 ratio
Interval 2.07 to 3.78
|
4.32 ratio
Interval 3.41 to 5.47
|
|
Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
Influenza B/Yamagata Lineage: Day 29
|
2.53 ratio
Interval 2.04 to 3.12
|
2.56 ratio
Interval 1.99 to 3.29
|
3.49 ratio
Interval 2.72 to 4.48
|
2.07 ratio
Interval 1.75 to 2.74
|
2.44 ratio
Interval 1.75 to 3.39
|
3.65 ratio
Interval 2.9 to 4.59
|
|
Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
Influenza B/Yamagata Lineage: Day 91
|
1.83 ratio
Interval 1.54 to 2.17
|
1.77 ratio
Interval 1.42 to 2.2
|
2.21 ratio
Interval 1.78 to 2.74
|
1.59 ratio
Interval 1.24 to 2.03
|
1.83 ratio
Interval 1.37 to 2.46
|
2.29 ratio
Interval 1.88 to 2.8
|
|
Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
Influenza B/Yamagata Lineage: Day 181
|
1.47 ratio
Interval 1.24 to 1.75
|
1.28 ratio
Interval 0.97 to 1.69
|
1.41 ratio
Interval 1.13 to 1.76
|
1.09 ratio
Interval 0.84 to 1.42
|
1.61 ratio
Interval 1.22 to 2.13
|
1.63 ratio
Interval 1.34 to 1.97
|
SECONDARY outcome
Timeframe: Days 8, 29, 91, and 181Population: Per-Protocol Set: all randomized participants who received study drug, complied with injection schedule, timing of immunogenicity blood sampling to have a baseline (Day 1), had at least 1 post injection assessment, had a Day 29 assessment that was within 22 days to 43 days after injection, had no important protocol deviations which impacted immune response, and did not use prohibited medication/nonstudy vaccines against influenza. 'Number analyzed'= participants evaluable for specified category.
Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. Seroresponse was defined as (a) a post-vaccination antibody titer ≥ 4 \* lower limit of quantification (LLOQ) if baseline (Day 1) antibody titer was \< LLOQ or (b) a post-vaccination antibody titer ≥ 4-fold of baseline antibody titer if baseline antibody titer was ≥ LLOQ.
Outcome measures
| Measure |
mRNA-1010
n=55 Participants
Participants received a single dose of mRNA-1010 by IM injection on Day 1.
|
mRNA-1010.4 Low Dose
n=28 Participants
Participants received mRNA-1010.4 at a low dose level by IM injection on Day 1.
|
mRNA-1010.4 High Dose
n=56 Participants
Participants received mRNA-1010.4 at a high dose level by IM injection on Day 1
|
mRNA-1010.6 Low Dose
n=29 Participants
Participants received mRNA-1010.6 at a low dose level by IM injection on Day 1.
|
mRNA-1010.6 Medium Dose
n=28 Participants
Participants received mRNA-1010.6 at a medium dose level by IM injection on Day 1.
|
mRNA-1010.6 High Dose
n=52 Participants
Participants received mRNA-1010.6 at a high dose level by IM injection on Day 1.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroresponse for mRNA-1010, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
Influenza A H1N1 Antibody: Day 8
|
54.7 percentage of participants
Interval 40.4 to 68.4
|
50.0 percentage of participants
Interval 30.6 to 69.4
|
50.9 percentage of participants
Interval 36.8 to 64.9
|
31.0 percentage of participants
Interval 15.3 to 50.8
|
60.7 percentage of participants
Interval 40.6 to 78.5
|
70.0 percentage of participants
Interval 55.4 to 82.1
|
|
Percentage of Participants With Seroresponse for mRNA-1010, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
Influenza A H1N1 Antibody: Day 91
|
58.8 percentage of participants
Interval 44.2 to 72.4
|
50.0 percentage of participants
Interval 30.6 to 69.4
|
38.5 percentage of participants
Interval 25.3 to 53.0
|
29.6 percentage of participants
Interval 13.8 to 50.2
|
42.9 percentage of participants
Interval 24.5 to 62.8
|
51.0 percentage of participants
Interval 36.6 to 65.2
|
|
Percentage of Participants With Seroresponse for mRNA-1010, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
Influenza A H1N1 Antibody: Day 181
|
36.5 percentage of participants
Interval 23.6 to 51.0
|
39.3 percentage of participants
Interval 21.5 to 59.4
|
31.4 percentage of participants
Interval 19.1 to 45.9
|
16.7 percentage of participants
Interval 4.7 to 37.4
|
37.0 percentage of participants
Interval 19.4 to 57.6
|
42.0 percentage of participants
Interval 28.2 to 56.8
|
|
Percentage of Participants With Seroresponse for mRNA-1010, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
Influenza A H3N2 Antibody: Day 8
|
54.7 percentage of participants
Interval 40.4 to 68.4
|
67.9 percentage of participants
Interval 47.6 to 84.1
|
56.6 percentage of participants
Interval 42.3 to 70.2
|
41.4 percentage of participants
Interval 23.5 to 61.1
|
57.1 percentage of participants
Interval 37.2 to 75.5
|
70.0 percentage of participants
Interval 55.4 to 82.1
|
|
Percentage of Participants With Seroresponse for mRNA-1010, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
Influenza A H3N2 Antibody: Day 29
|
65.5 percentage of participants
Interval 51.4 to 77.8
|
67.9 percentage of participants
Interval 47.6 to 84.1
|
73.2 percentage of participants
Interval 59.7 to 84.2
|
58.6 percentage of participants
Interval 38.9 to 76.5
|
64.3 percentage of participants
Interval 44.1 to 81.4
|
69.2 percentage of participants
Interval 54.9 to 81.3
|
|
Percentage of Participants With Seroresponse for mRNA-1010, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
Influenza A H3N2 Antibody: Day 181
|
42.3 percentage of participants
Interval 28.7 to 56.8
|
35.7 percentage of participants
Interval 18.6 to 55.9
|
45.1 percentage of participants
Interval 31.1 to 59.7
|
25.0 percentage of participants
Interval 9.8 to 46.7
|
37.0 percentage of participants
Interval 19.4 to 57.6
|
48.0 percentage of participants
Interval 33.7 to 62.6
|
|
Percentage of Participants With Seroresponse for mRNA-1010, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
Influenza B/Victoria Lineage: Day 29
|
12.7 percentage of participants
Interval 5.3 to 24.5
|
25.0 percentage of participants
Interval 10.7 to 44.9
|
35.7 percentage of participants
Interval 23.4 to 49.6
|
17.2 percentage of participants
Interval 5.8 to 35.8
|
14.3 percentage of participants
Interval 4.0 to 32.7
|
19.2 percentage of participants
Interval 9.6 to 32.5
|
|
Percentage of Participants With Seroresponse for mRNA-1010, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
Influenza B/Victoria Lineage: Day 181
|
5.8 percentage of participants
Interval 1.2 to 15.9
|
7.1 percentage of participants
Interval 0.9 to 23.5
|
3.9 percentage of participants
Interval 0.5 to 13.5
|
4.2 percentage of participants
Interval 0.1 to 21.1
|
0 percentage of participants
Interval 0.0 to 12.8
|
4.0 percentage of participants
Interval 0.5 to 13.7
|
|
Percentage of Participants With Seroresponse for mRNA-1010, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
Influenza B/Yamagata Lineage: Day 8
|
35.8 percentage of participants
Interval 23.1 to 50.2
|
39.3 percentage of participants
Interval 21.5 to 59.4
|
39.6 percentage of participants
Interval 26.5 to 54.0
|
20.7 percentage of participants
Interval 8.0 to 39.7
|
28.6 percentage of participants
Interval 13.2 to 48.7
|
62.0 percentage of participants
Interval 47.2 to 75.3
|
|
Percentage of Participants With Seroresponse for mRNA-1010, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
Influenza B/Yamagata Lineage: Day 181
|
11.5 percentage of participants
Interval 4.4 to 23.4
|
10.7 percentage of participants
Interval 2.3 to 28.2
|
11.8 percentage of participants
Interval 4.4 to 23.9
|
4.2 percentage of participants
Interval 0.1 to 21.1
|
11.1 percentage of participants
Interval 2.4 to 29.2
|
16.0 percentage of participants
Interval 7.2 to 29.1
|
|
Percentage of Participants With Seroresponse for mRNA-1010, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
Influenza A H1N1 Antibody: Day 29
|
69.1 percentage of participants
Interval 55.2 to 80.9
|
53.6 percentage of participants
Interval 33.9 to 72.5
|
60.7 percentage of participants
Interval 46.8 to 73.5
|
41.4 percentage of participants
Interval 23.5 to 61.1
|
60.7 percentage of participants
Interval 40.6 to 78.5
|
69.2 percentage of participants
Interval 54.9 to 81.3
|
|
Percentage of Participants With Seroresponse for mRNA-1010, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
Influenza A H3N2 Antibody: Day 91
|
54.9 percentage of participants
Interval 40.3 to 68.9
|
50.0 percentage of participants
Interval 30.6 to 69.4
|
57.7 percentage of participants
Interval 43.2 to 71.3
|
40.7 percentage of participants
Interval 22.4 to 61.2
|
60.7 percentage of participants
Interval 40.6 to 78.5
|
56.9 percentage of participants
Interval 42.2 to 70.7
|
|
Percentage of Participants With Seroresponse for mRNA-1010, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
Influenza B/Victoria Lineage: Day 8
|
11.3 percentage of participants
Interval 4.3 to 23.0
|
17.9 percentage of participants
Interval 6.1 to 36.9
|
28.3 percentage of participants
Interval 16.8 to 42.3
|
20.7 percentage of participants
Interval 8.0 to 39.7
|
17.9 percentage of participants
Interval 6.1 to 36.9
|
18.0 percentage of participants
Interval 8.6 to 31.4
|
|
Percentage of Participants With Seroresponse for mRNA-1010, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
Influenza B/Victoria Lineage: Day 91
|
3.9 percentage of participants
Interval 0.5 to 13.5
|
14.3 percentage of participants
Interval 4.0 to 32.7
|
17.3 percentage of participants
Interval 8.2 to 30.3
|
11.1 percentage of participants
Interval 2.4 to 29.2
|
3.6 percentage of participants
Interval 0.1 to 18.3
|
3.9 percentage of participants
Interval 0.5 to 13.5
|
|
Percentage of Participants With Seroresponse for mRNA-1010, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
Influenza B/Yamagata Lineage: Day 29
|
29.1 percentage of participants
Interval 17.6 to 42.9
|
32.1 percentage of participants
Interval 15.9 to 52.4
|
50.0 percentage of participants
Interval 36.3 to 63.7
|
27.6 percentage of participants
Interval 12.7 to 47.2
|
25.0 percentage of participants
Interval 10.7 to 44.9
|
53.8 percentage of participants
Interval 39.5 to 67.8
|
|
Percentage of Participants With Seroresponse for mRNA-1010, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
Influenza B/Yamagata Lineage: Day 91
|
17.6 percentage of participants
Interval 8.4 to 30.9
|
14.3 percentage of participants
Interval 4.0 to 32.7
|
26.9 percentage of participants
Interval 15.6 to 41.0
|
14.8 percentage of participants
Interval 4.2 to 33.7
|
21.4 percentage of participants
Interval 8.3 to 41.0
|
31.4 percentage of participants
Interval 19.1 to 45.9
|
Adverse Events
mRNA-1010
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
mRNA-1010.4 Low Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
mRNA-1010.4 High Dose
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
mRNA-1010.6 Low Dose
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
mRNA-1010.6 Medium Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
mRNA-1010.6 High Dose
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
mRNA-1010
n=60 participants at risk
Participants received a single dose of mRNA-1010 by IM injection on Day 1.
|
mRNA-1010.4 Low Dose
n=30 participants at risk
Participants received mRNA-1010.4 at a low dose level by IM injection on Day 1.
|
mRNA-1010.4 High Dose
n=60 participants at risk
Participants received mRNA-1010.4 at a high dose level by IM injection on Day 1.
|
mRNA-1010.6 Low Dose
n=30 participants at risk
Participants received mRNA-1010.6 at a low dose level by IM injection on Day 1.
|
mRNA-1010.6 Medium Dose
n=31 participants at risk
Participants received mRNA-1010.6 at a medium dose level by IM injection on Day 1.
|
mRNA-1010.6 High Dose
n=59 participants at risk
Participants received mRNA-1010.6 at a high dose level by IM injection on Day 1.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Cellulitis
|
0.00%
0/60 • Day 1 up to the end of study (Day 181)
All-cause mortality and AE (Serious and Non-serious) data were collected and reported for all randomized participants. Participants were included in the study arm corresponding to the study intervention that they received.
|
0.00%
0/30 • Day 1 up to the end of study (Day 181)
All-cause mortality and AE (Serious and Non-serious) data were collected and reported for all randomized participants. Participants were included in the study arm corresponding to the study intervention that they received.
|
1.7%
1/60 • Number of events 1 • Day 1 up to the end of study (Day 181)
All-cause mortality and AE (Serious and Non-serious) data were collected and reported for all randomized participants. Participants were included in the study arm corresponding to the study intervention that they received.
|
0.00%
0/30 • Day 1 up to the end of study (Day 181)
All-cause mortality and AE (Serious and Non-serious) data were collected and reported for all randomized participants. Participants were included in the study arm corresponding to the study intervention that they received.
|
0.00%
0/31 • Day 1 up to the end of study (Day 181)
All-cause mortality and AE (Serious and Non-serious) data were collected and reported for all randomized participants. Participants were included in the study arm corresponding to the study intervention that they received.
|
0.00%
0/59 • Day 1 up to the end of study (Day 181)
All-cause mortality and AE (Serious and Non-serious) data were collected and reported for all randomized participants. Participants were included in the study arm corresponding to the study intervention that they received.
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/60 • Day 1 up to the end of study (Day 181)
All-cause mortality and AE (Serious and Non-serious) data were collected and reported for all randomized participants. Participants were included in the study arm corresponding to the study intervention that they received.
|
0.00%
0/30 • Day 1 up to the end of study (Day 181)
All-cause mortality and AE (Serious and Non-serious) data were collected and reported for all randomized participants. Participants were included in the study arm corresponding to the study intervention that they received.
|
1.7%
1/60 • Number of events 1 • Day 1 up to the end of study (Day 181)
All-cause mortality and AE (Serious and Non-serious) data were collected and reported for all randomized participants. Participants were included in the study arm corresponding to the study intervention that they received.
|
0.00%
0/30 • Day 1 up to the end of study (Day 181)
All-cause mortality and AE (Serious and Non-serious) data were collected and reported for all randomized participants. Participants were included in the study arm corresponding to the study intervention that they received.
|
0.00%
0/31 • Day 1 up to the end of study (Day 181)
All-cause mortality and AE (Serious and Non-serious) data were collected and reported for all randomized participants. Participants were included in the study arm corresponding to the study intervention that they received.
|
0.00%
0/59 • Day 1 up to the end of study (Day 181)
All-cause mortality and AE (Serious and Non-serious) data were collected and reported for all randomized participants. Participants were included in the study arm corresponding to the study intervention that they received.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/60 • Day 1 up to the end of study (Day 181)
All-cause mortality and AE (Serious and Non-serious) data were collected and reported for all randomized participants. Participants were included in the study arm corresponding to the study intervention that they received.
|
0.00%
0/30 • Day 1 up to the end of study (Day 181)
All-cause mortality and AE (Serious and Non-serious) data were collected and reported for all randomized participants. Participants were included in the study arm corresponding to the study intervention that they received.
|
0.00%
0/60 • Day 1 up to the end of study (Day 181)
All-cause mortality and AE (Serious and Non-serious) data were collected and reported for all randomized participants. Participants were included in the study arm corresponding to the study intervention that they received.
|
0.00%
0/30 • Day 1 up to the end of study (Day 181)
All-cause mortality and AE (Serious and Non-serious) data were collected and reported for all randomized participants. Participants were included in the study arm corresponding to the study intervention that they received.
|
0.00%
0/31 • Day 1 up to the end of study (Day 181)
All-cause mortality and AE (Serious and Non-serious) data were collected and reported for all randomized participants. Participants were included in the study arm corresponding to the study intervention that they received.
|
1.7%
1/59 • Number of events 1 • Day 1 up to the end of study (Day 181)
All-cause mortality and AE (Serious and Non-serious) data were collected and reported for all randomized participants. Participants were included in the study arm corresponding to the study intervention that they received.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.7%
1/60 • Number of events 1 • Day 1 up to the end of study (Day 181)
All-cause mortality and AE (Serious and Non-serious) data were collected and reported for all randomized participants. Participants were included in the study arm corresponding to the study intervention that they received.
|
0.00%
0/30 • Day 1 up to the end of study (Day 181)
All-cause mortality and AE (Serious and Non-serious) data were collected and reported for all randomized participants. Participants were included in the study arm corresponding to the study intervention that they received.
|
0.00%
0/60 • Day 1 up to the end of study (Day 181)
All-cause mortality and AE (Serious and Non-serious) data were collected and reported for all randomized participants. Participants were included in the study arm corresponding to the study intervention that they received.
|
0.00%
0/30 • Day 1 up to the end of study (Day 181)
All-cause mortality and AE (Serious and Non-serious) data were collected and reported for all randomized participants. Participants were included in the study arm corresponding to the study intervention that they received.
|
0.00%
0/31 • Day 1 up to the end of study (Day 181)
All-cause mortality and AE (Serious and Non-serious) data were collected and reported for all randomized participants. Participants were included in the study arm corresponding to the study intervention that they received.
|
0.00%
0/59 • Day 1 up to the end of study (Day 181)
All-cause mortality and AE (Serious and Non-serious) data were collected and reported for all randomized participants. Participants were included in the study arm corresponding to the study intervention that they received.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/60 • Day 1 up to the end of study (Day 181)
All-cause mortality and AE (Serious and Non-serious) data were collected and reported for all randomized participants. Participants were included in the study arm corresponding to the study intervention that they received.
|
0.00%
0/30 • Day 1 up to the end of study (Day 181)
All-cause mortality and AE (Serious and Non-serious) data were collected and reported for all randomized participants. Participants were included in the study arm corresponding to the study intervention that they received.
|
0.00%
0/60 • Day 1 up to the end of study (Day 181)
All-cause mortality and AE (Serious and Non-serious) data were collected and reported for all randomized participants. Participants were included in the study arm corresponding to the study intervention that they received.
|
3.3%
1/30 • Number of events 1 • Day 1 up to the end of study (Day 181)
All-cause mortality and AE (Serious and Non-serious) data were collected and reported for all randomized participants. Participants were included in the study arm corresponding to the study intervention that they received.
|
0.00%
0/31 • Day 1 up to the end of study (Day 181)
All-cause mortality and AE (Serious and Non-serious) data were collected and reported for all randomized participants. Participants were included in the study arm corresponding to the study intervention that they received.
|
0.00%
0/59 • Day 1 up to the end of study (Day 181)
All-cause mortality and AE (Serious and Non-serious) data were collected and reported for all randomized participants. Participants were included in the study arm corresponding to the study intervention that they received.
|
Other adverse events
| Measure |
mRNA-1010
n=60 participants at risk
Participants received a single dose of mRNA-1010 by IM injection on Day 1.
|
mRNA-1010.4 Low Dose
n=30 participants at risk
Participants received mRNA-1010.4 at a low dose level by IM injection on Day 1.
|
mRNA-1010.4 High Dose
n=60 participants at risk
Participants received mRNA-1010.4 at a high dose level by IM injection on Day 1.
|
mRNA-1010.6 Low Dose
n=30 participants at risk
Participants received mRNA-1010.6 at a low dose level by IM injection on Day 1.
|
mRNA-1010.6 Medium Dose
n=31 participants at risk
Participants received mRNA-1010.6 at a medium dose level by IM injection on Day 1.
|
mRNA-1010.6 High Dose
n=59 participants at risk
Participants received mRNA-1010.6 at a high dose level by IM injection on Day 1.
|
|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/60 • Day 1 up to the end of study (Day 181)
All-cause mortality and AE (Serious and Non-serious) data were collected and reported for all randomized participants. Participants were included in the study arm corresponding to the study intervention that they received.
|
0.00%
0/30 • Day 1 up to the end of study (Day 181)
All-cause mortality and AE (Serious and Non-serious) data were collected and reported for all randomized participants. Participants were included in the study arm corresponding to the study intervention that they received.
|
0.00%
0/60 • Day 1 up to the end of study (Day 181)
All-cause mortality and AE (Serious and Non-serious) data were collected and reported for all randomized participants. Participants were included in the study arm corresponding to the study intervention that they received.
|
0.00%
0/30 • Day 1 up to the end of study (Day 181)
All-cause mortality and AE (Serious and Non-serious) data were collected and reported for all randomized participants. Participants were included in the study arm corresponding to the study intervention that they received.
|
0.00%
0/31 • Day 1 up to the end of study (Day 181)
All-cause mortality and AE (Serious and Non-serious) data were collected and reported for all randomized participants. Participants were included in the study arm corresponding to the study intervention that they received.
|
5.1%
3/59 • Number of events 5 • Day 1 up to the end of study (Day 181)
All-cause mortality and AE (Serious and Non-serious) data were collected and reported for all randomized participants. Participants were included in the study arm corresponding to the study intervention that they 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