Trial Outcomes & Findings for A Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Vaccine Boosters (NCT NCT05137236)
NCT ID: NCT05137236
Last Updated: 2025-07-17
Results Overview
An AR is any adverse event (AE) related to the IP injection. Solicited local ARs included pain at injection site, erythema (redness) at injection site, swelling (hardness) at injection site, localized axillary swelling or tenderness ipsilateral to the injection arm, and groin or underarm swelling or tenderness ipsilateral to the side of injection. Solicited systemic ARs included headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, fever, chills, irritability/crying, sleepiness, and loss of appetite. Note, not all solicited ARs were considered AEs. The Investigator determined if solicited AR was also to be recorded as an AE. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
540 participants
Primary outcome timeframe
Up to Day 7
Results posted on
2025-07-17
Participant Flow
Participant flow data are reported per initial randomized treatment.
Participant milestones
| Measure |
Part A: mRNA-1283 Low Dose
Participants received a single intramuscular (IM) injection of mRNA-1283 at low dose on Day 1.
|
Part A: mRNA-1283 Medium Dose
Participants received a single IM injection of mRNA-1283 at medium dose on Day 1.
|
Part A: mRNA-1283 High Dose
Participants received a single IM injection of mRNA-1283 at high dose on Day 1.
|
Part A: mRNA-1283.211 Low Dose
Participants received a single IM injection of mRNA-1283.211 at low dose on Day 1.
|
Part A: mRNA-1283.211 High Dose
Participants received a single IM injection of mRNA-1283.211 at high dose on Day 1.
|
Part A: mRNA-1273
Participants received a single IM injection of mRNA-1273 on Day 1.
|
Part B: mRNA-1283.529 Low Dose
Participants received a single IM injection of mRNA-1283.529 as a second booster at low dose on Day 1.
|
Part B: mRNA-1283.529 High Dose
Participants received a single IM injection of mRNA-1283.529 as a second booster at high dose on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Part A
STARTED
|
57
|
63
|
56
|
53
|
54
|
57
|
0
|
0
|
|
Part A
Received at Least 1 Dose of Study Drug
|
57
|
63
|
56
|
53
|
54
|
57
|
0
|
0
|
|
Part A
COMPLETED
|
51
|
52
|
54
|
49
|
48
|
47
|
0
|
0
|
|
Part A
NOT COMPLETED
|
6
|
11
|
2
|
4
|
6
|
10
|
0
|
0
|
|
Part B
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
103
|
97
|
|
Part B
Received at Least 1 Dose of Study Drug
|
0
|
0
|
0
|
0
|
0
|
0
|
103
|
97
|
|
Part B
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
98
|
88
|
|
Part B
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
9
|
Reasons for withdrawal
| Measure |
Part A: mRNA-1283 Low Dose
Participants received a single intramuscular (IM) injection of mRNA-1283 at low dose on Day 1.
|
Part A: mRNA-1283 Medium Dose
Participants received a single IM injection of mRNA-1283 at medium dose on Day 1.
|
Part A: mRNA-1283 High Dose
Participants received a single IM injection of mRNA-1283 at high dose on Day 1.
|
Part A: mRNA-1283.211 Low Dose
Participants received a single IM injection of mRNA-1283.211 at low dose on Day 1.
|
Part A: mRNA-1283.211 High Dose
Participants received a single IM injection of mRNA-1283.211 at high dose on Day 1.
|
Part A: mRNA-1273
Participants received a single IM injection of mRNA-1273 on Day 1.
|
Part B: mRNA-1283.529 Low Dose
Participants received a single IM injection of mRNA-1283.529 as a second booster at low dose on Day 1.
|
Part B: mRNA-1283.529 High Dose
Participants received a single IM injection of mRNA-1283.529 as a second booster at high dose on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Part A
Other than Specified
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A
Withdrawal by Subject
|
0
|
4
|
1
|
1
|
3
|
2
|
0
|
0
|
|
Part A
Lost to Follow-up
|
5
|
7
|
1
|
3
|
3
|
8
|
0
|
0
|
|
Part B
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Part B
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
5
|
|
Part B
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
Baseline Characteristics
A Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Vaccine Boosters
Baseline characteristics by cohort
| Measure |
Part A: mRNA-1283 Low Dose
n=57 Participants
Participants received a single IM injection of mRNA-1283 at low dose on Day 1.
|
Part A: mRNA-1283 Medium Dose
n=64 Participants
Participants received a single IM injection of mRNA-1283 at medium dose on Day 1.
|
Part A: mRNA-1283 High Dose
n=56 Participants
Participants received a single IM injection of mRNA-1283 at high dose on Day 1.
|
Part A: mRNA-1283.211 Low Dose
n=52 Participants
Participants received a single IM injection of mRNA-1283.211 at low dose on Day 1.
|
Part A: mRNA-1283.211 High Dose
n=54 Participants
Participants received a single IM injection of mRNA-1283.211 at high dose on Day 1.
|
Part A: mRNA-1273
n=57 Participants
Participants received a single IM injection of mRNA-1273 on Day 1.
|
Part B: mRNA-1283.529 Low Dose
n=103 Participants
Participants received a single IM injection of mRNA-1283.529 as a second booster at low dose on Day 1.
|
Part B: mRNA-1283.529 High Dose
n=97 Participants
Participants received a single IM injection of mRNA-1283.529 as a second booster at high dose on Day 1.
|
Total
n=540 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
>=18 and <56 Years
|
40 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
42 Participants
n=8 Participants
|
44 Participants
n=8 Participants
|
59 Participants
n=24 Participants
|
350 Participants
n=42 Participants
|
|
Age, Customized
>=56 Years
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
59 Participants
n=8 Participants
|
38 Participants
n=24 Participants
|
190 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
32 Participants
n=8 Participants
|
70 Participants
n=8 Participants
|
62 Participants
n=24 Participants
|
343 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
25 Participants
n=8 Participants
|
33 Participants
n=8 Participants
|
35 Participants
n=24 Participants
|
197 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
66 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
45 Participants
n=8 Participants
|
100 Participants
n=8 Participants
|
93 Participants
n=24 Participants
|
468 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
20 Participants
n=42 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
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
70 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
47 Participants
n=8 Participants
|
94 Participants
n=8 Participants
|
88 Participants
n=24 Participants
|
434 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Up to Day 7Population: Measured in the Solicited Safety Set, which consisted of all participants in the Safety Set who contributed any solicited AR data.
An AR is any adverse event (AE) related to the IP injection. Solicited local ARs included pain at injection site, erythema (redness) at injection site, swelling (hardness) at injection site, localized axillary swelling or tenderness ipsilateral to the injection arm, and groin or underarm swelling or tenderness ipsilateral to the side of injection. Solicited systemic ARs included headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, fever, chills, irritability/crying, sleepiness, and loss of appetite. Note, not all solicited ARs were considered AEs. The Investigator determined if solicited AR was also to be recorded as an AE. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Outcome measures
| Measure |
Part A: mRNA-1283 Low Dose
n=54 Participants
Participants received a single IM injection of mRNA-1283 at low dose on Day 1.
|
Part A: mRNA-1283 Medium Dose
n=60 Participants
Participants received a single IM injection of mRNA-1283 at medium dose on Day 1.
|
Part A: mRNA-1283 High Dose
n=52 Participants
Participants received a single IM injection of mRNA-1283 at high dose on Day 1.
|
Part A: mRNA-1283.211 Low Dose
n=48 Participants
Participants received a single IM injection of mRNA-1283.211 at low dose on Day 1.
|
Part A: mRNA-1283.211 High Dose
n=46 Participants
Participants received a single IM injection of mRNA-1283.211 at high dose on Day 1.
|
Part A: mRNA-1273
n=54 Participants
Participants received a single IM injection of mRNA-1273 on Day 1.
|
Part B: mRNA-1283.529 Low Dose
n=103 Participants
Participants received a single IM injection of mRNA-1283.529 as a second booster at low dose on Day 1.
|
Part B: mRNA-1283.529 High Dose
n=96 Participants
Participants received a single IM injection of mRNA-1283.529 as a second booster at high dose on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Parts A and B: Number of Participants With Solicited Local and Solicited Systemic Reactogenicity Adverse Reactions (ARs)
Solicited Local ARs
|
30 Participants
|
40 Participants
|
37 Participants
|
28 Participants
|
29 Participants
|
46 Participants
|
46 Participants
|
69 Participants
|
|
Parts A and B: Number of Participants With Solicited Local and Solicited Systemic Reactogenicity Adverse Reactions (ARs)
Solicited Systemic ARs
|
32 Participants
|
39 Participants
|
35 Participants
|
39 Participants
|
27 Participants
|
41 Participants
|
51 Participants
|
60 Participants
|
PRIMARY outcome
Timeframe: Up to Day 28Population: Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
An unsolicited AE was defined as any AE reported by the participant that was not specified as a solicited AR in the protocol or was specified as a solicited AR but started outside the protocol-defined period for reporting solicited ARs. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Outcome measures
| Measure |
Part A: mRNA-1283 Low Dose
n=57 Participants
Participants received a single IM injection of mRNA-1283 at low dose on Day 1.
|
Part A: mRNA-1283 Medium Dose
n=64 Participants
Participants received a single IM injection of mRNA-1283 at medium dose on Day 1.
|
Part A: mRNA-1283 High Dose
n=56 Participants
Participants received a single IM injection of mRNA-1283 at high dose on Day 1.
|
Part A: mRNA-1283.211 Low Dose
n=52 Participants
Participants received a single IM injection of mRNA-1283.211 at low dose on Day 1.
|
Part A: mRNA-1283.211 High Dose
n=54 Participants
Participants received a single IM injection of mRNA-1283.211 at high dose on Day 1.
|
Part A: mRNA-1273
n=57 Participants
Participants received a single IM injection of mRNA-1273 on Day 1.
|
Part B: mRNA-1283.529 Low Dose
n=103 Participants
Participants received a single IM injection of mRNA-1283.529 as a second booster at low dose on Day 1.
|
Part B: mRNA-1283.529 High Dose
n=97 Participants
Participants received a single IM injection of mRNA-1283.529 as a second booster at high dose on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Parts A and B: Number of Participants With Unsolicited AEs
|
13 Participants
|
9 Participants
|
11 Participants
|
12 Participants
|
7 Participants
|
8 Participants
|
13 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 366Population: Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
SAEs were AEs that resulted in death, were life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly or birth defect, or was a medically important event. MAAEs were AEs that lead to an unscheduled visit to a healthcare provider. AESIs were AEs (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program for which ongoing monitoring and immediate notification by the investigator to the Sponsor was required. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Outcome measures
| Measure |
Part A: mRNA-1283 Low Dose
n=57 Participants
Participants received a single IM injection of mRNA-1283 at low dose on Day 1.
|
Part A: mRNA-1283 Medium Dose
n=64 Participants
Participants received a single IM injection of mRNA-1283 at medium dose on Day 1.
|
Part A: mRNA-1283 High Dose
n=56 Participants
Participants received a single IM injection of mRNA-1283 at high dose on Day 1.
|
Part A: mRNA-1283.211 Low Dose
n=52 Participants
Participants received a single IM injection of mRNA-1283.211 at low dose on Day 1.
|
Part A: mRNA-1283.211 High Dose
n=54 Participants
Participants received a single IM injection of mRNA-1283.211 at high dose on Day 1.
|
Part A: mRNA-1273
n=57 Participants
Participants received a single IM injection of mRNA-1273 on Day 1.
|
Part B: mRNA-1283.529 Low Dose
n=103 Participants
Participants received a single IM injection of mRNA-1283.529 as a second booster at low dose on Day 1.
|
Part B: mRNA-1283.529 High Dose
n=97 Participants
Participants received a single IM injection of mRNA-1283.529 as a second booster at high dose on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Parts A and B: Number of Participants With Serious Adverse Events (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal From Study Participation and AEs of Special Interest (AESIs)
SAEs
|
2 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
6 Participants
|
|
Parts A and B: Number of Participants With Serious Adverse Events (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal From Study Participation and AEs of Special Interest (AESIs)
MAAEs
|
25 Participants
|
23 Participants
|
27 Participants
|
24 Participants
|
18 Participants
|
23 Participants
|
51 Participants
|
42 Participants
|
|
Parts A and B: Number of Participants With Serious Adverse Events (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal From Study Participation and AEs of Special Interest (AESIs)
AEs Leading to Withdrawal from Study Participation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Parts A and B: Number of Participants With Serious Adverse Events (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal From Study Participation and AEs of Special Interest (AESIs)
AESIs
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Day 29Population: Measured in the Per-Protocol Set for Immunogenicity - Pre-booster SARS-CoV-2 Negative, which consisted of all participants in the full analysis set (FAS) who received the planned dose of IP and who had no major protocol deviations that impact key or critical data who were pre-booster SARS-CoV-2 negative and had evaluable data for the endpoint. Here, number analyzed signifies those participants who were evaluable for specified categories only.
The GMT (50% inhibitory dose \[ID50\]) of nAb against ancestral SARS-CoV-2 and against SARS-CoV-2 variant B.1.351 are reported.
Outcome measures
| Measure |
Part A: mRNA-1283 Low Dose
n=31 Participants
Participants received a single IM injection of mRNA-1283 at low dose on Day 1.
|
Part A: mRNA-1283 Medium Dose
n=38 Participants
Participants received a single IM injection of mRNA-1283 at medium dose on Day 1.
|
Part A: mRNA-1283 High Dose
n=32 Participants
Participants received a single IM injection of mRNA-1283 at high dose on Day 1.
|
Part A: mRNA-1283.211 Low Dose
n=24 Participants
Participants received a single IM injection of mRNA-1283.211 at low dose on Day 1.
|
Part A: mRNA-1283.211 High Dose
n=22 Participants
Participants received a single IM injection of mRNA-1283.211 at high dose on Day 1.
|
Part A: mRNA-1273
n=28 Participants
Participants received a single IM injection of mRNA-1273 on Day 1.
|
Part B: mRNA-1283.529 Low Dose
Participants received a single IM injection of mRNA-1283.529 as a second booster at low dose on Day 1.
|
Part B: mRNA-1283.529 High Dose
Participants received a single IM injection of mRNA-1283.529 as a second booster at high dose on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Geometric Mean Titer (GMT) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Specific Neutralizing Antibody (nAb) Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351
Ancestral SARS-CoV-2 ID50
|
4751.7 Titer
Interval 3207.0 to 7040.5
|
5666.5 Titer
Interval 4149.3 to 7738.4
|
7723.0 Titer
Interval 5621.7 to 10609.7
|
5105.5 Titer
Interval 3083.3 to 8453.9
|
4729.8 Titer
Interval 2572.4 to 8696.3
|
3562.9 Titer
Interval 2550.1 to 4977.9
|
—
|
—
|
|
Part A: Geometric Mean Titer (GMT) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Specific Neutralizing Antibody (nAb) Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351
SARS-CoV-2 Variant B.1.351 ID50
|
946.7 Titer
Interval 611.4 to 1465.7
|
1216.2 Titer
Interval 838.9 to 1763.3
|
2020.1 Titer
Interval 1350.7 to 3021.1
|
1566.3 Titer
Interval 942.4 to 2603.2
|
1224.8 Titer
Interval 660.6 to 2271.0
|
964.4 Titer
Interval 659.6 to 1410.1
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 29Population: Measured in the Per-Protocol Set for Immunogenicity - Pre-booster SARS-CoV-2 Negative, which consisted of all participants in the FAS who received the planned dose of IP and who had no major protocol deviations that impact key or critical data who were pre-booster SARS-CoV-2 negative and had evaluable data for the endpoint. Here, number analyzed signifies those participants who were evaluable for specified categories only.
The GMFR measures the changes in immunogenicity titers or levels within participants.
Outcome measures
| Measure |
Part A: mRNA-1283 Low Dose
n=31 Participants
Participants received a single IM injection of mRNA-1283 at low dose on Day 1.
|
Part A: mRNA-1283 Medium Dose
n=38 Participants
Participants received a single IM injection of mRNA-1283 at medium dose on Day 1.
|
Part A: mRNA-1283 High Dose
n=32 Participants
Participants received a single IM injection of mRNA-1283 at high dose on Day 1.
|
Part A: mRNA-1283.211 Low Dose
n=24 Participants
Participants received a single IM injection of mRNA-1283.211 at low dose on Day 1.
|
Part A: mRNA-1283.211 High Dose
n=22 Participants
Participants received a single IM injection of mRNA-1283.211 at high dose on Day 1.
|
Part A: mRNA-1273
n=28 Participants
Participants received a single IM injection of mRNA-1273 on Day 1.
|
Part B: mRNA-1283.529 Low Dose
Participants received a single IM injection of mRNA-1283.529 as a second booster at low dose on Day 1.
|
Part B: mRNA-1283.529 High Dose
Participants received a single IM injection of mRNA-1283.529 as a second booster at high dose on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific nAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351
Ancestral SARS-CoV-2 ID50
|
26.8 Ratio
Interval 16.8 to 42.8
|
34.3 Ratio
Interval 20.9 to 56.0
|
45.3 Ratio
Interval 27.0 to 76.0
|
35.5 Ratio
Interval 18.1 to 69.6
|
28.1 Ratio
Interval 13.2 to 59.9
|
24.5 Ratio
Interval 14.7 to 40.7
|
—
|
—
|
|
Part A: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific nAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351
SARS-CoV-2 Variant B.1.351 ID50
|
27.4 Ratio
Interval 16.2 to 46.6
|
33.7 Ratio
Interval 21.1 to 53.9
|
52.1 Ratio
Interval 30.2 to 89.8
|
54.2 Ratio
Interval 27.2 to 107.7
|
41.8 Ratio
Interval 20.8 to 84.0
|
35.8 Ratio
Interval 19.8 to 64.6
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 29Population: Measured in the Per-Protocol Set for Immunogenicity - Pre-booster SARS-CoV-2 Negative, which consisted of all participants in the FAS who received the planned dose of IP and who had no major protocol deviations that impact key or critical data who were pre-booster SARS-CoV-2 negative and had evaluable data for the endpoint. Here, number analyzed signifies those participants who were evaluable for specified categories only.
Seroresponse was defined as an increase of SARS-CoV-2 specific binding antibody (bAb) level or nAb titer to at least 4x lower limit of quantification (LLOQ) if the baseline is below the LLOQ, or a 4-fold or greater rise if pre-booster ≥ LLOQ.
Outcome measures
| Measure |
Part A: mRNA-1283 Low Dose
n=31 Participants
Participants received a single IM injection of mRNA-1283 at low dose on Day 1.
|
Part A: mRNA-1283 Medium Dose
n=38 Participants
Participants received a single IM injection of mRNA-1283 at medium dose on Day 1.
|
Part A: mRNA-1283 High Dose
n=32 Participants
Participants received a single IM injection of mRNA-1283 at high dose on Day 1.
|
Part A: mRNA-1283.211 Low Dose
n=24 Participants
Participants received a single IM injection of mRNA-1283.211 at low dose on Day 1.
|
Part A: mRNA-1283.211 High Dose
n=22 Participants
Participants received a single IM injection of mRNA-1283.211 at high dose on Day 1.
|
Part A: mRNA-1273
n=28 Participants
Participants received a single IM injection of mRNA-1273 on Day 1.
|
Part B: mRNA-1283.529 Low Dose
Participants received a single IM injection of mRNA-1283.529 as a second booster at low dose on Day 1.
|
Part B: mRNA-1283.529 High Dose
Participants received a single IM injection of mRNA-1283.529 as a second booster at high dose on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With Seroresponse Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351
Ancestral SARS-CoV-2 ID50
|
28 Participants
|
35 Participants
|
30 Participants
|
22 Participants
|
19 Participants
|
26 Participants
|
—
|
—
|
|
Part A: Number of Participants With Seroresponse Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351
SARS-CoV-2 Variant B.1.351 ID50
|
26 Participants
|
35 Participants
|
31 Participants
|
22 Participants
|
19 Participants
|
25 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 29Population: Measured in the Per-Protocol Set for Immunogenicity - Pre-booster SARS-CoV-2 Negative, which consisted of all participants in the FAS who received the planned dose of IP and who had no major protocol deviations that impact key or critical data who were pre-booster SARS-CoV-2 negative and had evaluable data for the endpoint. Here, number analyzed signifies those participants who were evaluable for specified categories only.
The GMT (ID50) of nAb against SARS-CoV-2 omicron variant (B.1.1.529) are reported.
Outcome measures
| Measure |
Part A: mRNA-1283 Low Dose
n=75 Participants
Participants received a single IM injection of mRNA-1283 at low dose on Day 1.
|
Part A: mRNA-1283 Medium Dose
n=69 Participants
Participants received a single IM injection of mRNA-1283 at medium dose on Day 1.
|
Part A: mRNA-1283 High Dose
Participants received a single IM injection of mRNA-1283 at high dose on Day 1.
|
Part A: mRNA-1283.211 Low Dose
Participants received a single IM injection of mRNA-1283.211 at low dose on Day 1.
|
Part A: mRNA-1283.211 High Dose
Participants received a single IM injection of mRNA-1283.211 at high dose on Day 1.
|
Part A: mRNA-1273
Participants received a single IM injection of mRNA-1273 on Day 1.
|
Part B: mRNA-1283.529 Low Dose
Participants received a single IM injection of mRNA-1283.529 as a second booster at low dose on Day 1.
|
Part B: mRNA-1283.529 High Dose
Participants received a single IM injection of mRNA-1283.529 as a second booster at high dose on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: GMT of SARS-CoV-2 Specific nAb Against SARS-CoV-2 Omicron Variant (B.1.1.529)
|
1562.9 Titer
Interval 1113.4 to 2194.0
|
2723.0 Titer
Interval 1938.3 to 3825.4
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 29Population: Measured in the Per-Protocol Set for Immunogenicity - Pre-booster SARS-CoV-2 Negative, which consisted of all participants in the FAS who received the planned dose of IP and who had no major protocol deviations that impact key or critical data who were pre-booster SARS-CoV-2 negative and had evaluable data for the endpoint. Here, number analyzed signifies those participants who were evaluable for specified categories only.
The GMFR measures the changes in immunogenicity titers or levels within participants.
Outcome measures
| Measure |
Part A: mRNA-1283 Low Dose
n=75 Participants
Participants received a single IM injection of mRNA-1283 at low dose on Day 1.
|
Part A: mRNA-1283 Medium Dose
n=69 Participants
Participants received a single IM injection of mRNA-1283 at medium dose on Day 1.
|
Part A: mRNA-1283 High Dose
Participants received a single IM injection of mRNA-1283 at high dose on Day 1.
|
Part A: mRNA-1283.211 Low Dose
Participants received a single IM injection of mRNA-1283.211 at low dose on Day 1.
|
Part A: mRNA-1283.211 High Dose
Participants received a single IM injection of mRNA-1283.211 at high dose on Day 1.
|
Part A: mRNA-1273
Participants received a single IM injection of mRNA-1273 on Day 1.
|
Part B: mRNA-1283.529 Low Dose
Participants received a single IM injection of mRNA-1283.529 as a second booster at low dose on Day 1.
|
Part B: mRNA-1283.529 High Dose
Participants received a single IM injection of mRNA-1283.529 as a second booster at high dose on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: GMFR of SARS-CoV-2 Specific nAb Against SARS-CoV-2 Omicron Variant (B.1.1.529)
|
7.2 Ratio
Interval 5.7 to 9.0
|
7.8 Ratio
Interval 5.9 to 10.4
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 29Population: Measured in the Per-Protocol Set for Immunogenicity - Pre-booster SARS-CoV-2 Negative, which consisted of all participants in the FAS who received the planned dose of IP and who had no major protocol deviations that impact key or critical data who were pre-booster SARS-CoV-2 negative and had evaluable data for the endpoint. Here, number analyzed signifies those participants who were evaluable for specified categories only.
Seroresponse was defined as an increase of SARS-CoV-2 specific bAb level or nAb titer to at least 4x LLOQ if the baseline is below the LLOQ, or a 4-fold or greater rise if pre-booster ≥ LLOQ.
Outcome measures
| Measure |
Part A: mRNA-1283 Low Dose
n=75 Participants
Participants received a single IM injection of mRNA-1283 at low dose on Day 1.
|
Part A: mRNA-1283 Medium Dose
n=69 Participants
Participants received a single IM injection of mRNA-1283 at medium dose on Day 1.
|
Part A: mRNA-1283 High Dose
Participants received a single IM injection of mRNA-1283 at high dose on Day 1.
|
Part A: mRNA-1283.211 Low Dose
Participants received a single IM injection of mRNA-1283.211 at low dose on Day 1.
|
Part A: mRNA-1283.211 High Dose
Participants received a single IM injection of mRNA-1283.211 at high dose on Day 1.
|
Part A: mRNA-1273
Participants received a single IM injection of mRNA-1273 on Day 1.
|
Part B: mRNA-1283.529 Low Dose
Participants received a single IM injection of mRNA-1283.529 as a second booster at low dose on Day 1.
|
Part B: mRNA-1283.529 High Dose
Participants received a single IM injection of mRNA-1283.529 as a second booster at high dose on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Number of Participants With Seroresponse Against SARS-CoV-2 Omicron Variant (B.1.1.529)
|
55 Participants
|
48 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 29, 91, 181, and 366Population: Measured in the Per-Protocol Set for Immunogenicity - Pre-booster SARS-CoV-2 Negative, which consisted of all participants in the FAS who received the planned dose of IP and who had no major protocol deviations that impact key or critical data who were pre-booster SARS-CoV-2 negative and had evaluable data for the endpoint. Here, number analyzed signifies those participants who were evaluable for specified categories only.
The GMT (ID50) of nAb against ancestral SARS-CoV-2 and against SARS-CoV-2 Variant B.1.351 are reported.
Outcome measures
| Measure |
Part A: mRNA-1283 Low Dose
n=31 Participants
Participants received a single IM injection of mRNA-1283 at low dose on Day 1.
|
Part A: mRNA-1283 Medium Dose
n=38 Participants
Participants received a single IM injection of mRNA-1283 at medium dose on Day 1.
|
Part A: mRNA-1283 High Dose
n=32 Participants
Participants received a single IM injection of mRNA-1283 at high dose on Day 1.
|
Part A: mRNA-1283.211 Low Dose
n=24 Participants
Participants received a single IM injection of mRNA-1283.211 at low dose on Day 1.
|
Part A: mRNA-1283.211 High Dose
n=22 Participants
Participants received a single IM injection of mRNA-1283.211 at high dose on Day 1.
|
Part A: mRNA-1273
n=28 Participants
Participants received a single IM injection of mRNA-1273 on Day 1.
|
Part B: mRNA-1283.529 Low Dose
Participants received a single IM injection of mRNA-1283.529 as a second booster at low dose on Day 1.
|
Part B: mRNA-1283.529 High Dose
Participants received a single IM injection of mRNA-1283.529 as a second booster at high dose on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: GMT of SARS-CoV-2 Specific nAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351
Day 1 Ancestral SARS-CoV-2 ID50
|
177.4 Titer
Interval 108.5 to 290.0
|
165.4 Titer
Interval 114.4 to 239.2
|
170.4 Titer
Interval 104.4 to 278.0
|
143.7 Titer
Interval 97.0 to 213.1
|
168.6 Titer
Interval 74.5 to 381.3
|
145.6 Titer
Interval 91.9 to 230.7
|
—
|
—
|
|
Part A: GMT of SARS-CoV-2 Specific nAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351
Day 29 Ancestral SARS-CoV-2 ID50
|
4751.7 Titer
Interval 3207.0 to 7040.5
|
5666.5 Titer
Interval 4149.3 to 7738.4
|
7723.0 Titer
Interval 5621.7 to 10609.7
|
5105.5 Titer
Interval 3083.3 to 8453.9
|
4729.8 Titer
Interval 2572.4 to 8696.3
|
3562.9 Titer
Interval 2550.1 to 4977.9
|
—
|
—
|
|
Part A: GMT of SARS-CoV-2 Specific nAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351
Day 91 Ancestral SARS-CoV-2 ID50
|
3980.4 Titer
Interval 2459.2 to 6442.6
|
4589.2 Titer
Interval 3285.9 to 6409.4
|
6754.5 Titer
Interval 4604.3 to 9909.0
|
4943.1 Titer
Interval 3029.0 to 8066.9
|
4319.8 Titer
Interval 2758.9 to 6763.7
|
3155.1 Titer
Interval 1980.2 to 5027.0
|
—
|
—
|
|
Part A: GMT of SARS-CoV-2 Specific nAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351
Day 181 Ancestral SARS-CoV-2 ID50
|
2476.4 Titer
Interval 1400.5 to 4378.8
|
2861.4 Titer
Interval 1879.2 to 4357.1
|
3834.7 Titer
Interval 2606.2 to 5642.2
|
2960.3 Titer
Interval 1805.5 to 4853.6
|
2767.2 Titer
Interval 1588.2 to 4821.6
|
1269.4 Titer
Interval 809.8 to 1990.0
|
—
|
—
|
|
Part A: GMT of SARS-CoV-2 Specific nAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351
Day 366 Ancestral SARS-CoV-2 ID50
|
1497.4 Titer
Interval 723.2 to 3100.5
|
3097.6 Titer
Interval 2003.1 to 4790.2
|
2921.1 Titer
Interval 2062.2 to 4137.8
|
2013.3 Titer
Interval 1225.1 to 3308.5
|
1539.6 Titer
Interval 772.8 to 3067.3
|
1336.1 Titer
Interval 739.4 to 2414.2
|
—
|
—
|
|
Part A: GMT of SARS-CoV-2 Specific nAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351
Day 1 SARS-CoV-2 Variant B.1.351 ID50
|
34.5 Titer
Interval 21.0 to 56.5
|
36.1 Titer
Interval 25.9 to 50.3
|
38.8 Titer
Interval 24.0 to 62.6
|
28.9 Titer
Interval 19.0 to 44.0
|
29.3 Titer
Interval 14.2 to 60.4
|
27.9 Titer
Interval 17.5 to 44.6
|
—
|
—
|
|
Part A: GMT of SARS-CoV-2 Specific nAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351
Day 29 SARS-CoV-2 Variant B.1.351 ID50
|
946.7 Titer
Interval 611.4 to 1465.7
|
1216.2 Titer
Interval 838.9 to 1763.3
|
2020.1 Titer
Interval 1350.7 to 3021.1
|
1566.3 Titer
Interval 942.4 to 2603.2
|
1224.8 Titer
Interval 660.6 to 2271.0
|
964.4 Titer
Interval 659.6 to 1410.1
|
—
|
—
|
|
Part A: GMT of SARS-CoV-2 Specific nAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351
Day 91 SARS-CoV-2 Variant B.1.351 ID50
|
794.8 Titer
Interval 461.9 to 1367.5
|
965.6 Titer
Interval 631.0 to 1477.7
|
1520.8 Titer
Interval 1025.7 to 2254.8
|
1105.8 Titer
Interval 579.9 to 2108.6
|
990.5 Titer
Interval 591.0 to 1660.0
|
640.2 Titer
Interval 384.2 to 1066.7
|
—
|
—
|
|
Part A: GMT of SARS-CoV-2 Specific nAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351
Day 181 SARS-CoV-2 Variant B.1.351 ID50
|
786.3 Titer
Interval 403.1 to 1533.7
|
760.2 Titer
Interval 438.7 to 1317.2
|
1458.4 Titer
Interval 916.6 to 2320.5
|
967.2 Titer
Interval 531.3 to 1760.7
|
769.6 Titer
Interval 429.6 to 1378.9
|
460.5 Titer
Interval 266.1 to 796.9
|
—
|
—
|
|
Part A: GMT of SARS-CoV-2 Specific nAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351
Day 366 SARS-CoV-2 Variant B.1.351 ID50
|
581.2 Titer
Interval 279.7 to 1207.6
|
1461.8 Titer
Interval 855.0 to 2499.1
|
1259.6 Titer
Interval 789.7 to 2009.1
|
790.3 Titer
Interval 397.0 to 1573.3
|
530.3 Titer
Interval 223.4 to 1258.4
|
534.2 Titer
Interval 252.1 to 1132.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 29, 91, 181, and 366Population: Measured in the Per-Protocol Set for Immunogenicity - Pre-booster SARS-CoV-2 Negative, which consisted of all participants in the FAS who received the planned dose of IP and who had no major protocol deviations that impact key or critical data who were pre-booster SARS-CoV-2 negative and had evaluable data for the endpoint. Here, number analyzed signifies those participants who were evaluable for specified categories only.
The GMT of bAb against ancestral SARS-CoV-2 and against SARS-CoV-2 Variant B.1.351 are reported.
Outcome measures
| Measure |
Part A: mRNA-1283 Low Dose
n=31 Participants
Participants received a single IM injection of mRNA-1283 at low dose on Day 1.
|
Part A: mRNA-1283 Medium Dose
n=38 Participants
Participants received a single IM injection of mRNA-1283 at medium dose on Day 1.
|
Part A: mRNA-1283 High Dose
n=32 Participants
Participants received a single IM injection of mRNA-1283 at high dose on Day 1.
|
Part A: mRNA-1283.211 Low Dose
n=24 Participants
Participants received a single IM injection of mRNA-1283.211 at low dose on Day 1.
|
Part A: mRNA-1283.211 High Dose
n=22 Participants
Participants received a single IM injection of mRNA-1283.211 at high dose on Day 1.
|
Part A: mRNA-1273
n=28 Participants
Participants received a single IM injection of mRNA-1273 on Day 1.
|
Part B: mRNA-1283.529 Low Dose
Participants received a single IM injection of mRNA-1283.529 as a second booster at low dose on Day 1.
|
Part B: mRNA-1283.529 High Dose
Participants received a single IM injection of mRNA-1283.529 as a second booster at high dose on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: GMT of SARS-CoV-2 Specific bAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351
Day 1 Ancestral SARS-CoV-2
|
29458.4 Titer
Interval 18988.8 to 45700.5
|
29839.6 Titer
Interval 21775.9 to 40889.2
|
32632.4 Titer
Interval 22347.8 to 47650.0
|
28886.5 Titer
Interval 21389.0 to 39012.1
|
30803.7 Titer
Interval 17375.8 to 54608.8
|
30644.3 Titer
Interval 21431.7 to 43817.0
|
—
|
—
|
|
Part A: GMT of SARS-CoV-2 Specific bAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351
Day 29 Ancestral SARS-CoV-2
|
717040.9 Titer
Interval 545647.9 to 942269.9
|
737925.6 Titer
Interval 580477.3 to 938080.1
|
1070144.5 Titer
Interval 823120.1 to 1391302.9
|
835783.7 Titer
Interval 570117.5 to 1225246.2
|
688909.2 Titer
Interval 429957.5 to 1103820.5
|
594926.9 Titer
Interval 462362.9 to 765498.3
|
—
|
—
|
|
Part A: GMT of SARS-CoV-2 Specific bAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351
Day 91 Ancestral SARS-CoV-2
|
538518.6 Titer
Interval 370446.8 to 782844.8
|
575062.5 Titer
Interval 432778.8 to 764124.4
|
785822.0 Titer
Interval 601645.3 to 1026379.3
|
613915.9 Titer
Interval 398665.6 to 945385.7
|
629867.6 Titer
Interval 446549.5 to 888441.8
|
390985.5 Titer
Interval 289339.3 to 528340.5
|
—
|
—
|
|
Part A: GMT of SARS-CoV-2 Specific bAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351
Day 181 Ancestral SARS-CoV-2
|
349027.0 Titer
Interval 227163.4 to 536265.3
|
338163.9 Titer
Interval 239965.4 to 476547.2
|
447634.3 Titer
Interval 336503.1 to 595467.0
|
370694.6 Titer
Interval 257195.7 to 534280.0
|
358399.9 Titer
Interval 238972.0 to 537512.6
|
198042.8 Titer
Interval 141579.1 to 277025.1
|
—
|
—
|
|
Part A: GMT of SARS-CoV-2 Specific bAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351
Day 366 Ancestral SARS-CoV-2
|
220315.4 Titer
Interval 125437.1 to 386957.9
|
390137.4 Titer
Interval 266323.9 to 571511.7
|
370475.8 Titer
Interval 277402.5 to 494776.9
|
260942.1 Titer
Interval 185711.7 to 366647.8
|
246749.8 Titer
Interval 150746.4 to 403893.4
|
163960.1 Titer
Interval 107650.0 to 249725.1
|
—
|
—
|
|
Part A: GMT of SARS-CoV-2 Specific bAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351
Day 1 SARS-CoV-2 Variant B.1.351
|
12499.8 Titer
Interval 8275.5 to 18880.3
|
13289.6 Titer
Interval 9765.0 to 18086.4
|
15875.3 Titer
Interval 10891.6 to 23139.3
|
15255.0 Titer
Interval 10255.8 to 22691.2
|
12664.6 Titer
Interval 7792.9 to 20581.8
|
17401.8 Titer
Interval 11236.5 to 26950.0
|
—
|
—
|
|
Part A: GMT of SARS-CoV-2 Specific bAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351
Day 29 SARS-CoV-2 Variant B.1.351
|
359208.1 Titer
Interval 259502.7 to 497221.9
|
369055.6 Titer
Interval 277237.5 to 491282.7
|
504673.7 Titer
Interval 387088.6 to 657977.5
|
399270.2 Titer
Interval 261474.1 to 609684.5
|
352867.0 Titer
Interval 193718.3 to 642763.9
|
333866.2 Titer
Interval 264529.3 to 421377.3
|
—
|
—
|
|
Part A: GMT of SARS-CoV-2 Specific bAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351
Day 91 SARS-CoV-2 Variant B.1.351
|
237940.9 Titer
Interval 154308.2 to 366901.3
|
271701.9 Titer
Interval 194943.5 to 378683.7
|
362689.3 Titer
Interval 275141.6 to 478093.9
|
245501.5 Titer
Interval 154897.5 to 389102.6
|
330103.6 Titer
Interval 246861.3 to 441415.5
|
202152.0 Titer
Interval 158047.0 to 258564.9
|
—
|
—
|
|
Part A: GMT of SARS-CoV-2 Specific bAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351
Day 181 SARS-CoV-2 Variant B.1.351
|
151202.9 Titer
Interval 90854.0 to 251638.2
|
143620.7 Titer
Interval 94068.8 to 219274.8
|
184376.3 Titer
Interval 134452.0 to 252838.3
|
142996.2 Titer
Interval 92494.0 to 221072.9
|
183952.8 Titer
Interval 130226.4 to 259844.8
|
95496.2 Titer
Interval 70938.4 to 128555.5
|
—
|
—
|
|
Part A: GMT of SARS-CoV-2 Specific bAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351
Day 366 SARS-CoV-2 Variant B.1.351
|
105204.5 Titer
Interval 53545.8 to 206701.3
|
218574.3 Titer
Interval 128094.7 to 372964.0
|
203600.7 Titer
Interval 133854.9 to 309687.7
|
121911.8 Titer
Interval 68950.3 to 215553.6
|
134120.4 Titer
Interval 70688.7 to 254471.9
|
89012.3 Titer
Interval 53840.6 to 147160.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 29, 91, 181, and 366Population: Measured in the Per-Protocol Set for Immunogenicity - Pre-booster SARS-CoV-2 Negative, which consisted of all participants in the FAS who received the planned dose of IP and who had no major protocol deviations that impact key or critical data who were pre-booster SARS-CoV-2 negative and had evaluable data for the endpoint. Here, number analyzed signifies those participants who were evaluable for specified categories only.
The GMT (ID50) of nAb against SARS-CoV-2 omicron variant (B.1.1.529) are reported.
Outcome measures
| Measure |
Part A: mRNA-1283 Low Dose
n=75 Participants
Participants received a single IM injection of mRNA-1283 at low dose on Day 1.
|
Part A: mRNA-1283 Medium Dose
n=69 Participants
Participants received a single IM injection of mRNA-1283 at medium dose on Day 1.
|
Part A: mRNA-1283 High Dose
Participants received a single IM injection of mRNA-1283 at high dose on Day 1.
|
Part A: mRNA-1283.211 Low Dose
Participants received a single IM injection of mRNA-1283.211 at low dose on Day 1.
|
Part A: mRNA-1283.211 High Dose
Participants received a single IM injection of mRNA-1283.211 at high dose on Day 1.
|
Part A: mRNA-1273
Participants received a single IM injection of mRNA-1273 on Day 1.
|
Part B: mRNA-1283.529 Low Dose
Participants received a single IM injection of mRNA-1283.529 as a second booster at low dose on Day 1.
|
Part B: mRNA-1283.529 High Dose
Participants received a single IM injection of mRNA-1283.529 as a second booster at high dose on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: GMT of SARS-CoV-2 Specific nAb Against SARS-CoV-2 Omicron Variant (B.1.1.529)
Day 1 SARS-CoV-2 Variant B.1.1.529 ID50
|
217.6 Titer
Interval 162.0 to 292.4
|
349.2 Titer
Interval 239.7 to 508.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: GMT of SARS-CoV-2 Specific nAb Against SARS-CoV-2 Omicron Variant (B.1.1.529)
Day 29 SARS-CoV-2 Variant B.1.1.529 ID50
|
1562.9 Titer
Interval 1113.4 to 2194.0
|
2723.0 Titer
Interval 1938.3 to 3825.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: GMT of SARS-CoV-2 Specific nAb Against SARS-CoV-2 Omicron Variant (B.1.1.529)
Day 91 SARS-CoV-2 Variant B.1.1.529 ID50
|
978.5 Titer
Interval 667.7 to 1434.0
|
1713.5 Titer
Interval 1238.2 to 2371.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: GMT of SARS-CoV-2 Specific nAb Against SARS-CoV-2 Omicron Variant (B.1.1.529)
Day 181 SARS-CoV-2 Variant B.1.1.529 ID50
|
724.0 Titer
Interval 500.9 to 1046.5
|
1608.7 Titer
Interval 1053.9 to 2455.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: GMT of SARS-CoV-2 Specific nAb Against SARS-CoV-2 Omicron Variant (B.1.1.529)
Day 366 SARS-CoV-2 Variant B.1.1.529 ID50
|
666.0 Titer
Interval 395.5 to 1121.8
|
1873.7 Titer
Interval 1156.9 to 3034.9
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 29, 91, 181, and 366Population: Measured in the Per-Protocol Set for Immunogenicity - Pre-booster SARS-CoV-2 Negative, which consisted of all participants in the FAS who received the planned dose of IP and who had no major protocol deviations that impact key or critical data who were pre-booster SARS-CoV-2 negative and had evaluable data for the endpoint. Here, number analyzed signifies those participants who were evaluable for specified categories only.
The GMT of bAb against SARS-CoV-2 omicron variant (B.1.1.529) are reported.
Outcome measures
| Measure |
Part A: mRNA-1283 Low Dose
n=74 Participants
Participants received a single IM injection of mRNA-1283 at low dose on Day 1.
|
Part A: mRNA-1283 Medium Dose
n=67 Participants
Participants received a single IM injection of mRNA-1283 at medium dose on Day 1.
|
Part A: mRNA-1283 High Dose
Participants received a single IM injection of mRNA-1283 at high dose on Day 1.
|
Part A: mRNA-1283.211 Low Dose
Participants received a single IM injection of mRNA-1283.211 at low dose on Day 1.
|
Part A: mRNA-1283.211 High Dose
Participants received a single IM injection of mRNA-1283.211 at high dose on Day 1.
|
Part A: mRNA-1273
Participants received a single IM injection of mRNA-1273 on Day 1.
|
Part B: mRNA-1283.529 Low Dose
Participants received a single IM injection of mRNA-1283.529 as a second booster at low dose on Day 1.
|
Part B: mRNA-1283.529 High Dose
Participants received a single IM injection of mRNA-1283.529 as a second booster at high dose on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: GMT of SARS-CoV-2 Specific bAb Against SARS-CoV-2 Omicron Variant (B.1.1.529)
Day 1 SARS-CoV-2 Variant B.1.1.529
|
50830.3 Titer
Interval 41890.8 to 61677.5
|
61419.3 Titer
Interval 49407.6 to 76351.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: GMT of SARS-CoV-2 Specific bAb Against SARS-CoV-2 Omicron Variant (B.1.1.529)
Day 29 SARS-CoV-2 Variant B.1.1.529
|
182046.9 Titer
Interval 153016.2 to 216585.4
|
233677.5 Titer
Interval 189382.6 to 288332.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: GMT of SARS-CoV-2 Specific bAb Against SARS-CoV-2 Omicron Variant (B.1.1.529)
Day 91 SARS-CoV-2 Variant B.1.1.529
|
118658.1 Titer
Interval 97721.5 to 144080.3
|
157262.3 Titer
Interval 126717.0 to 195170.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: GMT of SARS-CoV-2 Specific bAb Against SARS-CoV-2 Omicron Variant (B.1.1.529)
Day 181 SARS-CoV-2 Variant B.1.1.529
|
73469.5 Titer
Interval 58947.0 to 91569.8
|
103322.9 Titer
Interval 81221.9 to 131437.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: GMT of SARS-CoV-2 Specific bAb Against SARS-CoV-2 Omicron Variant (B.1.1.529)
Day 366 SARS-CoV-2 Variant B.1.1.529
|
46721.5 Titer
Interval 32757.5 to 66638.1
|
98989.7 Titer
Interval 67965.4 to 144175.8
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 29, 91, 181, and 366Population: Measured in the Per-Protocol Set for Immunogenicity - Pre-booster SARS-CoV-2 Negative, which consisted of all participants in the FAS who received the planned dose of IP and who had no major protocol deviations that impact key or critical data who were pre-booster SARS-CoV-2 negative and had evaluable data for the endpoint. Here, number analyzed signifies those participants who were evaluable for specified categories only.
The GMFR measures the changes in immunogenicity titers or levels within participants.
Outcome measures
| Measure |
Part A: mRNA-1283 Low Dose
n=31 Participants
Participants received a single IM injection of mRNA-1283 at low dose on Day 1.
|
Part A: mRNA-1283 Medium Dose
n=38 Participants
Participants received a single IM injection of mRNA-1283 at medium dose on Day 1.
|
Part A: mRNA-1283 High Dose
n=32 Participants
Participants received a single IM injection of mRNA-1283 at high dose on Day 1.
|
Part A: mRNA-1283.211 Low Dose
n=24 Participants
Participants received a single IM injection of mRNA-1283.211 at low dose on Day 1.
|
Part A: mRNA-1283.211 High Dose
n=22 Participants
Participants received a single IM injection of mRNA-1283.211 at high dose on Day 1.
|
Part A: mRNA-1273
n=28 Participants
Participants received a single IM injection of mRNA-1273 on Day 1.
|
Part B: mRNA-1283.529 Low Dose
Participants received a single IM injection of mRNA-1283.529 as a second booster at low dose on Day 1.
|
Part B: mRNA-1283.529 High Dose
Participants received a single IM injection of mRNA-1283.529 as a second booster at high dose on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: GMFR of SARS-CoV-2 Specific nAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351
Day 29 Ancestral SARS-CoV-2 ID50
|
26.8 Ratio
Interval 16.8 to 42.8
|
34.3 Ratio
Interval 20.9 to 56.0
|
45.3 Ratio
Interval 27.0 to 76.0
|
35.5 Ratio
Interval 18.1 to 69.6
|
28.1 Ratio
Interval 13.2 to 59.9
|
24.5 Ratio
Interval 14.7 to 40.7
|
—
|
—
|
|
Part A: GMFR of SARS-CoV-2 Specific nAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351
Day 91 Ancestral SARS-CoV-2 ID50
|
22.4 Ratio
Interval 13.5 to 37.4
|
27.1 Ratio
Interval 16.5 to 44.6
|
39.6 Ratio
Interval 23.0 to 68.3
|
34.0 Ratio
Interval 17.2 to 67.1
|
25.6 Ratio
Interval 12.2 to 53.9
|
21.7 Ratio
Interval 12.4 to 38.0
|
—
|
—
|
|
Part A: GMFR of SARS-CoV-2 Specific nAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351
Day 181 Ancestral SARS-CoV-2 ID50
|
13.9 Ratio
Interval 7.4 to 26.0
|
17.1 Ratio
Interval 9.9 to 29.7
|
23.6 Ratio
Interval 13.2 to 42.1
|
20.6 Ratio
Interval 11.1 to 38.2
|
15.3 Ratio
Interval 7.6 to 30.7
|
8.2 Ratio
Interval 4.6 to 14.6
|
—
|
—
|
|
Part A: GMFR of SARS-CoV-2 Specific nAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351
Day 366 Ancestral SARS-CoV-2 ID50
|
9.1 Ratio
Interval 4.3 to 19.2
|
18.0 Ratio
Interval 9.5 to 33.9
|
17.8 Ratio
Interval 10.3 to 30.6
|
13.7 Ratio
Interval 7.1 to 26.4
|
9.8 Ratio
Interval 4.1 to 23.3
|
8.7 Ratio
Interval 4.3 to 17.6
|
—
|
—
|
|
Part A: GMFR of SARS-CoV-2 Specific nAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351
Day 29 SARS-CoV-2 Variant B.1.351 ID50
|
27.4 Ratio
Interval 16.2 to 46.6
|
33.7 Ratio
Interval 21.1 to 53.9
|
52.1 Ratio
Interval 30.2 to 89.8
|
54.2 Ratio
Interval 27.2 to 107.7
|
41.8 Ratio
Interval 20.8 to 84.0
|
35.8 Ratio
Interval 19.8 to 64.6
|
—
|
—
|
|
Part A: GMFR of SARS-CoV-2 Specific nAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351
Day 91 SARS-CoV-2 Variant B.1.351 ID50
|
23.0 Ratio
Interval 12.8 to 41.6
|
27.0 Ratio
Interval 16.5 to 44.4
|
39.2 Ratio
Interval 21.9 to 70.3
|
38.1 Ratio
Interval 16.9 to 85.9
|
33.8 Ratio
Interval 17.7 to 64.6
|
23.9 Ratio
Interval 12.7 to 45.3
|
—
|
—
|
|
Part A: GMFR of SARS-CoV-2 Specific nAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351
Day 181 SARS-CoV-2 Variant B.1.351 ID50
|
21.4 Ratio
Interval 10.1 to 45.1
|
21.4 Ratio
Interval 12.3 to 37.2
|
39.3 Ratio
Interval 21.0 to 73.4
|
33.4 Ratio
Interval 15.8 to 70.6
|
24.9 Ratio
Interval 12.6 to 49.4
|
16.5 Ratio
Interval 8.3 to 32.8
|
—
|
—
|
|
Part A: GMFR of SARS-CoV-2 Specific nAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351
Day 366 SARS-CoV-2 Variant B.1.351 ID50
|
17.6 Ratio
Interval 8.0 to 38.7
|
38.2 Ratio
Interval 20.0 to 73.2
|
32.5 Ratio
Interval 17.6 to 59.7
|
27.4 Ratio
Interval 12.3 to 61.0
|
20.0 Ratio
Interval 7.9 to 50.4
|
18.9 Ratio
Interval 8.0 to 44.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 29, 91, 181, and 366Population: Measured in the Per-Protocol Set for Immunogenicity - Pre-booster SARS-CoV-2 Negative, which consisted of all participants in the FAS who received the planned dose of IP and who had no major protocol deviations that impact key or critical data who were pre-booster SARS-CoV-2 negative and had evaluable data for the endpoint. Here, number analyzed signifies those participants who were evaluable for specified categories only.
The GMFR measures the changes in immunogenicity titers or levels within participants.
Outcome measures
| Measure |
Part A: mRNA-1283 Low Dose
n=31 Participants
Participants received a single IM injection of mRNA-1283 at low dose on Day 1.
|
Part A: mRNA-1283 Medium Dose
n=38 Participants
Participants received a single IM injection of mRNA-1283 at medium dose on Day 1.
|
Part A: mRNA-1283 High Dose
n=32 Participants
Participants received a single IM injection of mRNA-1283 at high dose on Day 1.
|
Part A: mRNA-1283.211 Low Dose
n=24 Participants
Participants received a single IM injection of mRNA-1283.211 at low dose on Day 1.
|
Part A: mRNA-1283.211 High Dose
n=22 Participants
Participants received a single IM injection of mRNA-1283.211 at high dose on Day 1.
|
Part A: mRNA-1273
n=28 Participants
Participants received a single IM injection of mRNA-1273 on Day 1.
|
Part B: mRNA-1283.529 Low Dose
Participants received a single IM injection of mRNA-1283.529 as a second booster at low dose on Day 1.
|
Part B: mRNA-1283.529 High Dose
Participants received a single IM injection of mRNA-1283.529 as a second booster at high dose on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: GMFR of SARS-CoV-2 Specific bAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351
Day 29 Ancestral SARS-CoV-2
|
24.3 Ratio
Interval 16.1 to 36.9
|
24.7 Ratio
Interval 16.2 to 37.7
|
32.8 Ratio
Interval 21.4 to 50.2
|
28.9 Ratio
Interval 16.2 to 51.6
|
22.4 Ratio
Interval 12.1 to 41.4
|
19.8 Ratio
Interval 12.4 to 31.4
|
—
|
—
|
|
Part A: GMFR of SARS-CoV-2 Specific bAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351
Day 91 Ancestral SARS-CoV-2
|
17.5 Ratio
Interval 11.3 to 27.2
|
19.0 Ratio
Interval 12.1 to 29.8
|
24.1 Ratio
Interval 15.6 to 37.3
|
20.9 Ratio
Interval 11.3 to 38.5
|
20.4 Ratio
Interval 12.2 to 34.3
|
12.8 Ratio
Interval 8.2 to 20.0
|
—
|
—
|
|
Part A: GMFR of SARS-CoV-2 Specific bAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351
Day 181 Ancestral SARS-CoV-2
|
11.5 Ratio
Interval 7.1 to 18.7
|
11.2 Ratio
Interval 6.9 to 18.2
|
14.0 Ratio
Interval 8.8 to 22.3
|
12.8 Ratio
Interval 7.6 to 21.8
|
11.6 Ratio
Interval 6.8 to 20.0
|
6.2 Ratio
Interval 3.9 to 9.9
|
—
|
—
|
|
Part A: GMFR of SARS-CoV-2 Specific bAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351
Day 366 Ancestral SARS-CoV-2
|
8.5 Ratio
Interval 4.8 to 15.0
|
12.9 Ratio
Interval 7.5 to 22.1
|
11.4 Ratio
Interval 7.4 to 17.5
|
8.8 Ratio
Interval 5.3 to 14.8
|
8.5 Ratio
Interval 4.5 to 16.1
|
5.3 Ratio
Interval 3.0 to 9.4
|
—
|
—
|
|
Part A: GMFR of SARS-CoV-2 Specific bAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351
Day 29 SARS-CoV-2 Variant B.1.351
|
28.7 Ratio
Interval 18.9 to 43.8
|
27.8 Ratio
Interval 17.6 to 43.8
|
31.8 Ratio
Interval 20.3 to 49.8
|
26.2 Ratio
Interval 14.1 to 48.7
|
27.9 Ratio
Interval 13.1 to 59.4
|
19.8 Ratio
Interval 12.0 to 32.7
|
—
|
—
|
|
Part A: GMFR of SARS-CoV-2 Specific bAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351
Day 91 SARS-CoV-2 Variant B.1.351
|
18.1 Ratio
Interval 11.4 to 28.7
|
20.5 Ratio
Interval 12.7 to 33.1
|
22.8 Ratio
Interval 14.0 to 37.4
|
15.9 Ratio
Interval 8.1 to 31.0
|
26.1 Ratio
Interval 15.1 to 45.0
|
11.7 Ratio
Interval 7.5 to 18.3
|
—
|
—
|
|
Part A: GMFR of SARS-CoV-2 Specific bAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351
Day 181 SARS-CoV-2 Variant B.1.351
|
11.5 Ratio
Interval 6.8 to 19.6
|
10.8 Ratio
Interval 6.3 to 18.4
|
11.9 Ratio
Interval 7.1 to 20.0
|
9.4 Ratio
Interval 5.2 to 17.0
|
15.0 Ratio
Interval 8.5 to 26.6
|
5.1 Ratio
Interval 3.2 to 8.2
|
—
|
—
|
|
Part A: GMFR of SARS-CoV-2 Specific bAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351
Day 366 SARS-CoV-2 Variant B.1.351
|
8.3 Ratio
Interval 4.4 to 16.0
|
17.1 Ratio
Interval 9.4 to 31.1
|
12.9 Ratio
Interval 7.6 to 21.7
|
7.7 Ratio
Interval 3.4 to 17.5
|
12.4 Ratio
Interval 6.0 to 25.5
|
5.2 Ratio
Interval 2.7 to 9.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 29, 91, 181, and 366Population: Measured in the Per-Protocol Set for Immunogenicity - Pre-booster SARS-CoV-2 Negative, which consisted of all participants in the FAS who received the planned dose of IP and who had no major protocol deviations that impact key or critical data who were pre-booster SARS-CoV-2 negative and had evaluable data for the endpoint. Here, number analyzed signifies those participants who were evaluable for specified categories only.
The GMFR measures the changes in immunogenicity titers or levels within participants.
Outcome measures
| Measure |
Part A: mRNA-1283 Low Dose
n=75 Participants
Participants received a single IM injection of mRNA-1283 at low dose on Day 1.
|
Part A: mRNA-1283 Medium Dose
n=69 Participants
Participants received a single IM injection of mRNA-1283 at medium dose on Day 1.
|
Part A: mRNA-1283 High Dose
Participants received a single IM injection of mRNA-1283 at high dose on Day 1.
|
Part A: mRNA-1283.211 Low Dose
Participants received a single IM injection of mRNA-1283.211 at low dose on Day 1.
|
Part A: mRNA-1283.211 High Dose
Participants received a single IM injection of mRNA-1283.211 at high dose on Day 1.
|
Part A: mRNA-1273
Participants received a single IM injection of mRNA-1273 on Day 1.
|
Part B: mRNA-1283.529 Low Dose
Participants received a single IM injection of mRNA-1283.529 as a second booster at low dose on Day 1.
|
Part B: mRNA-1283.529 High Dose
Participants received a single IM injection of mRNA-1283.529 as a second booster at high dose on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: GMFR of SARS-CoV-2 Specific nAb Against SARS-CoV-2 Omicron Variant (B.1.1.529)
Day 29 SARS-CoV-2 Variant B.1.1.529 ID50
|
7.2 Ratio
Interval 5.7 to 9.0
|
7.8 Ratio
Interval 5.9 to 10.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: GMFR of SARS-CoV-2 Specific nAb Against SARS-CoV-2 Omicron Variant (B.1.1.529)
Day 91 SARS-CoV-2 Variant B.1.1.529 ID50
|
4.6 Ratio
Interval 3.3 to 6.3
|
5.0 Ratio
Interval 3.6 to 6.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: GMFR of SARS-CoV-2 Specific nAb Against SARS-CoV-2 Omicron Variant (B.1.1.529)
Day 181 SARS-CoV-2 Variant B.1.1.529 ID50
|
3.4 Ratio
Interval 2.3 to 5.0
|
4.5 Ratio
Interval 2.8 to 7.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: GMFR of SARS-CoV-2 Specific nAb Against SARS-CoV-2 Omicron Variant (B.1.1.529)
Day 366 SARS-CoV-2 Variant B.1.1.529 ID50
|
2.5 Ratio
Interval 1.5 to 4.3
|
6.4 Ratio
Interval 3.3 to 12.6
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 29, 91, 181, and 366Population: Measured in the Per-Protocol Set for Immunogenicity - Pre-booster SARS-CoV-2 Negative, which consisted of all participants in the FAS who received the planned dose of IP and who had no major protocol deviations that impact key or critical data who were pre-booster SARS-CoV-2 negative and had evaluable data for the endpoint. Here, number analyzed signifies those participants who were evaluable for specified categories only.
The GMFR measures the changes in immunogenicity titers or levels within participants.
Outcome measures
| Measure |
Part A: mRNA-1283 Low Dose
n=74 Participants
Participants received a single IM injection of mRNA-1283 at low dose on Day 1.
|
Part A: mRNA-1283 Medium Dose
n=67 Participants
Participants received a single IM injection of mRNA-1283 at medium dose on Day 1.
|
Part A: mRNA-1283 High Dose
Participants received a single IM injection of mRNA-1283 at high dose on Day 1.
|
Part A: mRNA-1283.211 Low Dose
Participants received a single IM injection of mRNA-1283.211 at low dose on Day 1.
|
Part A: mRNA-1283.211 High Dose
Participants received a single IM injection of mRNA-1283.211 at high dose on Day 1.
|
Part A: mRNA-1273
Participants received a single IM injection of mRNA-1273 on Day 1.
|
Part B: mRNA-1283.529 Low Dose
Participants received a single IM injection of mRNA-1283.529 as a second booster at low dose on Day 1.
|
Part B: mRNA-1283.529 High Dose
Participants received a single IM injection of mRNA-1283.529 as a second booster at high dose on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: GMFR of SARS-CoV-2 Specific bAb Against SARS-CoV-2 Omicron Variant (B.1.1.529)
Day 29
|
3.6 Ratio
Interval 3.0 to 4.3
|
3.8 Ratio
Interval 3.2 to 4.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: GMFR of SARS-CoV-2 Specific bAb Against SARS-CoV-2 Omicron Variant (B.1.1.529)
Day 91
|
2.3 Ratio
Interval 1.9 to 2.8
|
2.5 Ratio
Interval 2.0 to 3.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: GMFR of SARS-CoV-2 Specific bAb Against SARS-CoV-2 Omicron Variant (B.1.1.529)
Day 181
|
1.5 Ratio
Interval 1.2 to 1.8
|
1.6 Ratio
Interval 1.3 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: GMFR of SARS-CoV-2 Specific bAb Against SARS-CoV-2 Omicron Variant (B.1.1.529)
Day 366
|
0.9 Ratio
Interval 0.6 to 1.2
|
1.7 Ratio
Interval 1.1 to 2.6
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 29, 91, 181, and 366Population: Measured in the Per-Protocol Set for Immunogenicity - Pre-booster SARS-CoV-2 Negative, which consisted of all participants in the FAS who received the planned dose of IP and who had no major protocol deviations that impact key or critical data who were pre-booster SARS-CoV-2 negative and had evaluable data for the endpoint. Here, number analyzed signifies those participants who were evaluable for specified categories only.
Seroresponse was defined as an increase of SARS-CoV-2 specific bAb level or nAb titer to at least 4x LLOQ if the baseline is below the LLOQ, or a 4-fold or greater rise if pre-booster ≥ LLOQ.
Outcome measures
| Measure |
Part A: mRNA-1283 Low Dose
n=31 Participants
Participants received a single IM injection of mRNA-1283 at low dose on Day 1.
|
Part A: mRNA-1283 Medium Dose
n=38 Participants
Participants received a single IM injection of mRNA-1283 at medium dose on Day 1.
|
Part A: mRNA-1283 High Dose
n=32 Participants
Participants received a single IM injection of mRNA-1283 at high dose on Day 1.
|
Part A: mRNA-1283.211 Low Dose
n=24 Participants
Participants received a single IM injection of mRNA-1283.211 at low dose on Day 1.
|
Part A: mRNA-1283.211 High Dose
n=22 Participants
Participants received a single IM injection of mRNA-1283.211 at high dose on Day 1.
|
Part A: mRNA-1273
n=28 Participants
Participants received a single IM injection of mRNA-1273 on Day 1.
|
Part B: mRNA-1283.529 Low Dose
Participants received a single IM injection of mRNA-1283.529 as a second booster at low dose on Day 1.
|
Part B: mRNA-1283.529 High Dose
Participants received a single IM injection of mRNA-1283.529 as a second booster at high dose on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With Seroresponse Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351
Day 29 Ancestral SARS-CoV-2 ID50
|
28 Participants
|
35 Participants
|
30 Participants
|
22 Participants
|
19 Participants
|
26 Participants
|
—
|
—
|
|
Part A: Number of Participants With Seroresponse Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351
Day 91 Ancestral SARS-CoV-2 ID50
|
27 Participants
|
32 Participants
|
29 Participants
|
20 Participants
|
19 Participants
|
26 Participants
|
—
|
—
|
|
Part A: Number of Participants With Seroresponse Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351
Day 181 Ancestral SARS-CoV-2 ID50
|
24 Participants
|
29 Participants
|
27 Participants
|
19 Participants
|
17 Participants
|
17 Participants
|
—
|
—
|
|
Part A: Number of Participants With Seroresponse Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351
Day 366 Ancestral SARS-CoV-2 ID50
|
18 Participants
|
25 Participants
|
27 Participants
|
18 Participants
|
12 Participants
|
14 Participants
|
—
|
—
|
|
Part A: Number of Participants With Seroresponse Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351
Day 29 SARS-CoV-2 Variant B.1.351 ID50
|
26 Participants
|
35 Participants
|
31 Participants
|
22 Participants
|
19 Participants
|
25 Participants
|
—
|
—
|
|
Part A: Number of Participants With Seroresponse Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351
Day 91 SARS-CoV-2 Variant B.1.351 ID50
|
26 Participants
|
33 Participants
|
29 Participants
|
20 Participants
|
20 Participants
|
24 Participants
|
—
|
—
|
|
Part A: Number of Participants With Seroresponse Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351
Day 181 SARS-CoV-2 Variant B.1.351 ID50
|
23 Participants
|
30 Participants
|
28 Participants
|
22 Participants
|
17 Participants
|
20 Participants
|
—
|
—
|
|
Part A: Number of Participants With Seroresponse Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351
Day 366 SARS-CoV-2 Variant B.1.351 ID50
|
17 Participants
|
27 Participants
|
28 Participants
|
17 Participants
|
14 Participants
|
16 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 29, 91, 181, and 366Population: Measured in the Per-Protocol Set for Immunogenicity - Pre-booster SARS-CoV-2 Negative, which consisted of all participants in the FAS who received the planned dose of IP and who had no major protocol deviations that impact key or critical data who were pre-booster SARS-CoV-2 negative and had evaluable data for the endpoint. Here, number analyzed signifies those participants who were evaluable for specified categories only.
Seroresponse was defined as an increase of SARS-CoV-2 specific bAb level or nAb titer to at least 4x LLOQ if the baseline is below the LLOQ, or a 4-fold or greater rise if pre-booster ≥ LLOQ.
Outcome measures
| Measure |
Part A: mRNA-1283 Low Dose
n=75 Participants
Participants received a single IM injection of mRNA-1283 at low dose on Day 1.
|
Part A: mRNA-1283 Medium Dose
n=69 Participants
Participants received a single IM injection of mRNA-1283 at medium dose on Day 1.
|
Part A: mRNA-1283 High Dose
Participants received a single IM injection of mRNA-1283 at high dose on Day 1.
|
Part A: mRNA-1283.211 Low Dose
Participants received a single IM injection of mRNA-1283.211 at low dose on Day 1.
|
Part A: mRNA-1283.211 High Dose
Participants received a single IM injection of mRNA-1283.211 at high dose on Day 1.
|
Part A: mRNA-1273
Participants received a single IM injection of mRNA-1273 on Day 1.
|
Part B: mRNA-1283.529 Low Dose
Participants received a single IM injection of mRNA-1283.529 as a second booster at low dose on Day 1.
|
Part B: mRNA-1283.529 High Dose
Participants received a single IM injection of mRNA-1283.529 as a second booster at high dose on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Number of Participants With Seroresponse Against SARS-CoV-2 Omicron Variant (B.1.1.529)
Day 29 ID50
|
55 Participants
|
48 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Seroresponse Against SARS-CoV-2 Omicron Variant (B.1.1.529)
Day 91 ID50
|
32 Participants
|
35 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Seroresponse Against SARS-CoV-2 Omicron Variant (B.1.1.529)
Day 181 ID50
|
26 Participants
|
28 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Seroresponse Against SARS-CoV-2 Omicron Variant (B.1.1.529)
Day 366 ID50
|
20 Participants
|
24 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 to Day 366Population: Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
A death that occurred during the study or that came to the attention of the investigator during the study was reported to the Sponsor, whether or not it was considered related to study drug. The investigator assessed causality (that is, whether there is a reasonable possibility that the study drug caused the death). The relationship was characterized using the following classifications: Not related: There was not a reasonable possibility of a relationship to the study drug. The temporal sequence of the death relative to administration of the study drug was not reasonable AND/OR the death was more likely explained by a cause other than the study drug. Related: There was a reasonable possibility of a relationship to the study drug. There was evidence of exposure to the study drug. The temporal sequence of the death relative to the administration of the study drug was reasonable. The death was more likely explained by the study drug than by another cause.
Outcome measures
| Measure |
Part A: mRNA-1283 Low Dose
n=57 Participants
Participants received a single IM injection of mRNA-1283 at low dose on Day 1.
|
Part A: mRNA-1283 Medium Dose
n=64 Participants
Participants received a single IM injection of mRNA-1283 at medium dose on Day 1.
|
Part A: mRNA-1283 High Dose
n=56 Participants
Participants received a single IM injection of mRNA-1283 at high dose on Day 1.
|
Part A: mRNA-1283.211 Low Dose
n=52 Participants
Participants received a single IM injection of mRNA-1283.211 at low dose on Day 1.
|
Part A: mRNA-1283.211 High Dose
n=54 Participants
Participants received a single IM injection of mRNA-1283.211 at high dose on Day 1.
|
Part A: mRNA-1273
n=57 Participants
Participants received a single IM injection of mRNA-1273 on Day 1.
|
Part B: mRNA-1283.529 Low Dose
n=103 Participants
Participants received a single IM injection of mRNA-1283.529 as a second booster at low dose on Day 1.
|
Part B: mRNA-1283.529 High Dose
n=97 Participants
Participants received a single IM injection of mRNA-1283.529 as a second booster at high dose on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Deaths Related to Study Drug
Deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Deaths Related to Study Drug
Deaths related to study drug
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Part A: mRNA-1283 2.5ug Booster
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Part A: mRNA-1283 5ug Booster
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Part A: mRNA-1283 10ug Booster
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Part A: mRNA-1283.211 5ug Booster
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
Part A: mRNA-1283.211 10ug Booster
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Part A: mRNA-1273 50ug Booster
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Part B: mRNA-1283.529 5ug Booster
Serious events: 2 serious events
Other events: 24 other events
Deaths: 0 deaths
Part B: mRNA-1283.529 10ug Booster
Serious events: 6 serious events
Other events: 24 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Part A: mRNA-1283 2.5ug Booster
n=57 participants at risk
Participants received a single booster dose of mRNA-1283 2.5 ug by intramuscular (IM) injection on day 1
|
Part A: mRNA-1283 5ug Booster
n=64 participants at risk
Participants received a single booster dose of mRNA-1283 5 ug by intramuscular (IM) injection on day 1
|
Part A: mRNA-1283 10ug Booster
n=56 participants at risk
Participants received a single booster dose of mRNA-1283 10 ug by intramuscular (IM) injection on day 1
|
Part A: mRNA-1283.211 5ug Booster
n=52 participants at risk
Participants received a single booster dose of mRNA-1283.211 5 ug by intramuscular (IM) injection on day 1
|
Part A: mRNA-1283.211 10ug Booster
n=54 participants at risk
Participants received a single booster dose of mRNA-1283.211 10 ug by intramuscular (IM) injection on day 1
|
Part A: mRNA-1273 50ug Booster
n=57 participants at risk
Participants received a single booster dose of mRNA-1273 50 ug by intramuscular (IM) injection on day 1
|
Part B: mRNA-1283.529 5ug Booster
n=103 participants at risk
Participants received a single booster dose of mRNA-1283.529 5 ug by intramuscular (IM) injection on day 1
|
Part B: mRNA-1283.529 10ug Booster
n=97 participants at risk
Participants received a single booster dose of mRNA-1283.529 10 ug by intramuscular (IM) injection on day 1
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
1.8%
1/57 • Number of events 1 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/64 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/56 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/52 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/54 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/57 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/103 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
1.0%
1/97 • Number of events 1 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/57 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/64 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/56 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
1.9%
1/52 • Number of events 1 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
1.9%
1/54 • Number of events 1 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/57 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/103 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/97 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/57 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/64 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/56 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/52 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/54 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/57 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/103 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
1.0%
1/97 • Number of events 1 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/57 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/64 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/56 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/52 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
1.9%
1/54 • Number of events 1 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/57 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/103 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/97 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/57 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/64 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
1.8%
1/56 • Number of events 1 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/52 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/54 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/57 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/103 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/97 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage I
|
0.00%
0/57 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/64 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/56 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
1.9%
1/52 • Number of events 1 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/54 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/57 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/103 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/97 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine carcinoma
|
0.00%
0/57 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/64 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/56 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/52 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
1.9%
1/54 • Number of events 1 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/57 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/103 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/97 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/57 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/64 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/56 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/52 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/54 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/57 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/103 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
1.0%
1/97 • Number of events 1 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/57 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
1.6%
1/64 • Number of events 1 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/56 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/52 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/54 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/57 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/103 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/97 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/57 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/64 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/56 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
1.9%
1/52 • Number of events 1 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/54 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/57 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/103 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/97 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.00%
0/57 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/64 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/56 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
1.9%
1/52 • Number of events 1 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/54 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/57 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/103 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/97 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
|
Nervous system disorders
Transient ischaemic attack
|
1.8%
1/57 • Number of events 1 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/64 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/56 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/52 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/54 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/57 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/103 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/97 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/57 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/64 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/56 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/52 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/54 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/57 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/103 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
1.0%
1/97 • Number of events 1 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
|
Vascular disorders
Circulatory collapse
|
1.8%
1/57 • Number of events 1 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/64 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/56 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/52 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/54 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/57 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/103 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/97 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/57 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/64 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/56 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/52 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/54 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/57 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/103 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
1.0%
1/97 • Number of events 1 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/57 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/64 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/56 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/52 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/54 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/57 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/103 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
1.0%
1/97 • Number of events 1 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/57 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/64 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/56 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/52 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/54 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
1.8%
1/57 • Number of events 1 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/103 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/97 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/57 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/64 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
1.8%
1/56 • Number of events 1 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/52 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/54 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/57 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/103 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/97 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/57 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/64 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/56 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
1.9%
1/52 • Number of events 1 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/54 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/57 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/103 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/97 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/57 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/64 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/56 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/52 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/54 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/57 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.97%
1/103 • Number of events 1 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/97 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.00%
0/57 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/64 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/56 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/52 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/54 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
1.8%
1/57 • Number of events 1 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/103 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/97 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
|
General disorders
Death
|
0.00%
0/57 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/64 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/56 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/52 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/54 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/57 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/103 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
1.0%
1/97 • Number of events 1 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
|
General disorders
Non-cardiac chest pain
|
1.8%
1/57 • Number of events 1 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/64 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/56 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/52 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/54 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/57 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/103 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/97 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/57 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/64 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/56 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/52 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/54 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/57 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.97%
1/103 • Number of events 1 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/97 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
Other adverse events
| Measure |
Part A: mRNA-1283 2.5ug Booster
n=57 participants at risk
Participants received a single booster dose of mRNA-1283 2.5 ug by intramuscular (IM) injection on day 1
|
Part A: mRNA-1283 5ug Booster
n=64 participants at risk
Participants received a single booster dose of mRNA-1283 5 ug by intramuscular (IM) injection on day 1
|
Part A: mRNA-1283 10ug Booster
n=56 participants at risk
Participants received a single booster dose of mRNA-1283 10 ug by intramuscular (IM) injection on day 1
|
Part A: mRNA-1283.211 5ug Booster
n=52 participants at risk
Participants received a single booster dose of mRNA-1283.211 5 ug by intramuscular (IM) injection on day 1
|
Part A: mRNA-1283.211 10ug Booster
n=54 participants at risk
Participants received a single booster dose of mRNA-1283.211 10 ug by intramuscular (IM) injection on day 1
|
Part A: mRNA-1273 50ug Booster
n=57 participants at risk
Participants received a single booster dose of mRNA-1273 50 ug by intramuscular (IM) injection on day 1
|
Part B: mRNA-1283.529 5ug Booster
n=103 participants at risk
Participants received a single booster dose of mRNA-1283.529 5 ug by intramuscular (IM) injection on day 1
|
Part B: mRNA-1283.529 10ug Booster
n=97 participants at risk
Participants received a single booster dose of mRNA-1283.529 10 ug by intramuscular (IM) injection on day 1
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Influenza
|
5.3%
3/57 • Number of events 3 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
1.6%
1/64 • Number of events 1 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
1.8%
1/56 • Number of events 1 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
1.9%
1/52 • Number of events 1 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
1.9%
1/54 • Number of events 1 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
1.8%
1/57 • Number of events 1 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/103 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
4.1%
4/97 • Number of events 4 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
|
Infections and infestations
Nasopharyngitis
|
1.8%
1/57 • Number of events 1 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
1.6%
1/64 • Number of events 1 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
3.6%
2/56 • Number of events 2 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
5.8%
3/52 • Number of events 3 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
3.7%
2/54 • Number of events 2 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
1.8%
1/57 • Number of events 1 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/103 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
3.1%
3/97 • Number of events 3 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
|
Infections and infestations
Respiratory tract infection viral
|
1.8%
1/57 • Number of events 1 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/64 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
1.8%
1/56 • Number of events 1 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
1.9%
1/52 • Number of events 1 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/54 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
5.3%
3/57 • Number of events 4 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.97%
1/103 • Number of events 1 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
2.1%
2/97 • Number of events 3 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
|
Infections and infestations
Upper respiratory tract infection
|
12.3%
7/57 • Number of events 8 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
12.5%
8/64 • Number of events 9 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
14.3%
8/56 • Number of events 11 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
9.6%
5/52 • Number of events 5 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
11.1%
6/54 • Number of events 9 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
10.5%
6/57 • Number of events 8 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
13.6%
14/103 • Number of events 15 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
17.5%
17/97 • Number of events 22 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/57 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
3.1%
2/64 • Number of events 2 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
1.8%
1/56 • Number of events 1 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
1.9%
1/52 • Number of events 1 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/54 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
5.3%
3/57 • Number of events 3 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
2.9%
3/103 • Number of events 3 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
2.1%
2/97 • Number of events 2 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
|
Vascular disorders
Hypertension
|
7.0%
4/57 • Number of events 4 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
1.6%
1/64 • Number of events 1 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
3.6%
2/56 • Number of events 2 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
1.9%
1/52 • Number of events 1 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/54 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/57 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
4.9%
5/103 • Number of events 5 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
4.1%
4/97 • Number of events 4 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/57 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/64 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/56 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/52 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/54 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
5.3%
3/57 • Number of events 3 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/103 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/97 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.5%
2/57 • Number of events 3 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/64 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
1.8%
1/56 • Number of events 1 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
5.8%
3/52 • Number of events 3 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
1.9%
1/54 • Number of events 1 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
1.8%
1/57 • Number of events 1 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
1.9%
2/103 • Number of events 2 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
2.1%
2/97 • Number of events 2 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/57 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/64 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/56 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
5.8%
3/52 • Number of events 3 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
1.9%
1/54 • Number of events 1 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
3.5%
2/57 • Number of events 2 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
1.9%
2/103 • Number of events 2 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
2.1%
2/97 • Number of events 2 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
|
General disorders
Influenza like illness
|
0.00%
0/57 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
1.6%
1/64 • Number of events 1 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
1.8%
1/56 • Number of events 1 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
5.8%
3/52 • Number of events 3 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
1.9%
1/54 • Number of events 1 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/57 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/103 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
0.00%
0/97 • Day 1 to Day 366
Measured in the Safety Set, which consisted of all randomized/enrolled (Part A: randomized, Part B: enrolled) participants who received one dose of IP. Data in the Safety Set is presented per actual dose received. There was 1 participant in the mRNA-1283.211 low dose group who had a dosing error and received mRNA-1283 at medium dose.
|
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