Trial Outcomes & Findings for Safety, Tolerability, and Immunogenicity of mRNA-1325 in Healthy Adult Subjects (NCT NCT03014089)
NCT ID: NCT03014089
Last Updated: 2024-08-21
Results Overview
Solicited adverse reactions (ARs) (local and systemic) were collected in the electronic diary (eDiary). Local ARs included: injection site pain, injection site erythema, and injection site induration/swelling. Systemic ARs included: body temperature (oral), generalized myalgia (muscle ache or pain), generalized arthralgia (joint ache or pain), headache, fatigue/malaise (unusual tiredness), nausea/vomiting, chills, and rash. Data for this outcome measure is reported up to 7 days after the first study vaccination only. A summary of all serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is in Reported "Adverse Events" section.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
90 participants
Primary outcome timeframe
Up to 7 days post-vaccination 1 (up to 8 days)
Results posted on
2024-08-21
Participant Flow
This was a 2-part study. Part A was conducted for 28 days following the second vaccination. Once the participants completed the final visit in Part A, they were entered into Part B. Part B was conducted for 12 months following the second vaccination in Part A.
Participant milestones
| Measure |
mRNA-1325 10 mcg
Participants received mRNA-1325 10 micrograms (mcg) intramuscular (IM) injection on Days 1 and 29.
|
mRNA-1325 25 mcg
Participants received mRNA-1325 25 mcg as an IM injection on Days 1 and 29.
|
mRNA-1325 100 mcg
Participants received mRNA-1325 100 mcg as an IM injection on Days 1 and 29.
|
Placebo
Participants received placebo matched to mRNA-1325 as an IM injection on Days 1 and 29.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
25
|
24
|
25
|
16
|
|
Overall Study
Received Injection 1
|
25
|
24
|
25
|
16
|
|
Overall Study
Received Injection 2
|
25
|
24
|
24
|
16
|
|
Overall Study
COMPLETED
|
23
|
23
|
23
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
2
|
1
|
Reasons for withdrawal
| Measure |
mRNA-1325 10 mcg
Participants received mRNA-1325 10 micrograms (mcg) intramuscular (IM) injection on Days 1 and 29.
|
mRNA-1325 25 mcg
Participants received mRNA-1325 25 mcg as an IM injection on Days 1 and 29.
|
mRNA-1325 100 mcg
Participants received mRNA-1325 100 mcg as an IM injection on Days 1 and 29.
|
Placebo
Participants received placebo matched to mRNA-1325 as an IM injection on Days 1 and 29.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
1
|
0
|
Baseline Characteristics
Safety, Tolerability, and Immunogenicity of mRNA-1325 in Healthy Adult Subjects
Baseline characteristics by cohort
| Measure |
mRNA-1325 10 mcg
n=25 Participants
Participants received mRNA-1325 10 mcg IM injection on Days 1 and 29.
|
mRNA-1325 25 mcg
n=24 Participants
Participants received mRNA-1325 25 mcg as an IM injection on Days 1 and 29.
|
mRNA-1325 100 mcg
n=25 Participants
Participants received mRNA-1325 100 mcg as an IM injection on Days 1 and 29.
|
Placebo
n=16 Participants
Participants received placebo matched to mRNA-1325 as an IM injection on Days 1 and 29.
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
33.9 years
STANDARD_DEVIATION 8.57 • n=5 Participants
|
34.4 years
STANDARD_DEVIATION 9.42 • n=7 Participants
|
35.3 years
STANDARD_DEVIATION 8.59 • n=5 Participants
|
38.9 years
STANDARD_DEVIATION 8.69 • n=4 Participants
|
35.3 years
STANDARD_DEVIATION 8.86 • n=21 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
74 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 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
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
84 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
PRIMARY outcome
Timeframe: Up to 7 days post-vaccination 1 (up to 8 days)Population: The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo) and provided vaccination 1 safety data.
Solicited adverse reactions (ARs) (local and systemic) were collected in the electronic diary (eDiary). Local ARs included: injection site pain, injection site erythema, and injection site induration/swelling. Systemic ARs included: body temperature (oral), generalized myalgia (muscle ache or pain), generalized arthralgia (joint ache or pain), headache, fatigue/malaise (unusual tiredness), nausea/vomiting, chills, and rash. Data for this outcome measure is reported up to 7 days after the first study vaccination only. A summary of all serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is in Reported "Adverse Events" section.
Outcome measures
| Measure |
mRNA-1325 10 mcg
n=25 Participants
Participants received mRNA-1325 10 mcg IM injection on Days 1 and 29.
|
mRNA-1325 25 mcg
n=24 Participants
Participants received mRNA-1325 25 mcg as an IM injection on Days 1 and 29.
|
mRNA-1325 100 mcg
n=25 Participants
Participants received mRNA-1325 100 mcg as an IM injection on Days 1 and 29.
|
Placebo
n=16 Participants
Participants received placebo matched to mRNA-1325 as an IM injection on Days 1 and 29.
|
|---|---|---|---|---|
|
Part A: Number of Participants With Solicited Adverse Events- Vaccination 1
Local Event- Pain
|
17 Participants
|
20 Participants
|
24 Participants
|
0 Participants
|
|
Part A: Number of Participants With Solicited Adverse Events- Vaccination 1
Local Event- Tenderness
|
21 Participants
|
20 Participants
|
23 Participants
|
3 Participants
|
|
Part A: Number of Participants With Solicited Adverse Events- Vaccination 1
Local Event- Swelling
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Part A: Number of Participants With Solicited Adverse Events- Vaccination 1
Local Event- Redness
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part A: Number of Participants With Solicited Adverse Events- Vaccination 1
Systemic Event- Fever
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Part A: Number of Participants With Solicited Adverse Events- Vaccination 1
Systemic Event- Vomiting
|
3 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Part A: Number of Participants With Solicited Adverse Events- Vaccination 1
Systemic Event- Diarrhea
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Solicited Adverse Events- Vaccination 1
Systemic Event- Headache
|
11 Participants
|
4 Participants
|
10 Participants
|
3 Participants
|
|
Part A: Number of Participants With Solicited Adverse Events- Vaccination 1
Systemic Event- Fatigue
|
7 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
|
Part A: Number of Participants With Solicited Adverse Events- Vaccination 1
Systemic Event- Generalized Myalgia
|
8 Participants
|
9 Participants
|
11 Participants
|
0 Participants
|
|
Part A: Number of Participants With Solicited Adverse Events- Vaccination 1
Systemic Event- Generalized Arthralgia
|
3 Participants
|
3 Participants
|
5 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 7 days post-vaccination 2 (Day 29 to Day 36)Population: The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo) and provided post vaccination 2 safety data.
Solicited adverse reactions (ARs) (local and systemic) were collected in the electronic diary (eDiary). Local ARs included: injection site pain, injection site erythema, and injection site induration/swelling. Systemic ARs included: body temperature (oral), generalized myalgia (muscle ache or pain), generalized arthralgia (joint ache or pain), headache, fatigue/malaise (unusual tiredness), nausea/vomiting, chills, and rash. Data for this outcome measure is reported up to 7 days after the second study vaccination only. A summary of all serious AEs (SAEs) and all nonserious AEs ("Other"), regardless of causality, is in Reported "Adverse Events" section.
Outcome measures
| Measure |
mRNA-1325 10 mcg
n=25 Participants
Participants received mRNA-1325 10 mcg IM injection on Days 1 and 29.
|
mRNA-1325 25 mcg
n=24 Participants
Participants received mRNA-1325 25 mcg as an IM injection on Days 1 and 29.
|
mRNA-1325 100 mcg
n=24 Participants
Participants received mRNA-1325 100 mcg as an IM injection on Days 1 and 29.
|
Placebo
n=16 Participants
Participants received placebo matched to mRNA-1325 as an IM injection on Days 1 and 29.
|
|---|---|---|---|---|
|
Part A: Number of Participants With Solicited Adverse Events: Vaccination 2
Local Event- Redness
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Part A: Number of Participants With Solicited Adverse Events: Vaccination 2
Systemic Event- Fever
|
1 Participants
|
2 Participants
|
7 Participants
|
0 Participants
|
|
Part A: Number of Participants With Solicited Adverse Events: Vaccination 2
Systemic Event- Diarrhea
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part A: Number of Participants With Solicited Adverse Events: Vaccination 2
Systemic Event- Fatigue
|
11 Participants
|
12 Participants
|
11 Participants
|
0 Participants
|
|
Part A: Number of Participants With Solicited Adverse Events: Vaccination 2
Systemic Event- Generalized Myalgia
|
13 Participants
|
10 Participants
|
12 Participants
|
0 Participants
|
|
Part A: Number of Participants With Solicited Adverse Events: Vaccination 2
Systemic Event- Generalized Arthralgia
|
6 Participants
|
7 Participants
|
6 Participants
|
0 Participants
|
|
Part A: Number of Participants With Solicited Adverse Events: Vaccination 2
Local Event- Pain
|
19 Participants
|
19 Participants
|
19 Participants
|
1 Participants
|
|
Part A: Number of Participants With Solicited Adverse Events: Vaccination 2
Local Event- Tenderness
|
22 Participants
|
19 Participants
|
20 Participants
|
0 Participants
|
|
Part A: Number of Participants With Solicited Adverse Events: Vaccination 2
Local Event- Swelling
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part A: Number of Participants With Solicited Adverse Events: Vaccination 2
Systemic Event- Vomiting
|
4 Participants
|
4 Participants
|
7 Participants
|
0 Participants
|
|
Part A: Number of Participants With Solicited Adverse Events: Vaccination 2
Systemic Event- Headache
|
9 Participants
|
11 Participants
|
10 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to Day 392 (all AEs considered an SAE were collected till end of study [Day 392]; the Other AEs [non-SAE] were collected up to Day 57)Population: The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo).
An unsolicited AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. The treatment-emergent AEs are defined as any event not present before exposure to study drug or any event already present that worsened in intensity or frequency after exposure. A summary of all SAEs and all nonserious AEs ("Other") reported up to the end of the study, regardless of causality, is located in the Reported "Adverse Events" section.
Outcome measures
| Measure |
mRNA-1325 10 mcg
n=25 Participants
Participants received mRNA-1325 10 mcg IM injection on Days 1 and 29.
|
mRNA-1325 25 mcg
n=24 Participants
Participants received mRNA-1325 25 mcg as an IM injection on Days 1 and 29.
|
mRNA-1325 100 mcg
n=25 Participants
Participants received mRNA-1325 100 mcg as an IM injection on Days 1 and 29.
|
Placebo
n=16 Participants
Participants received placebo matched to mRNA-1325 as an IM injection on Days 1 and 29.
|
|---|---|---|---|---|
|
Part A: Number of Participants With Unsolicited Adverse Events
|
14 Participants
|
9 Participants
|
14 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Up to 1 year post-vaccination (Day 392)Population: The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo).
An MAAE is an AE that leads to an unscheduled visit to an healthcare practitioner. A summary of all SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Outcome measures
| Measure |
mRNA-1325 10 mcg
n=25 Participants
Participants received mRNA-1325 10 mcg IM injection on Days 1 and 29.
|
mRNA-1325 25 mcg
n=24 Participants
Participants received mRNA-1325 25 mcg as an IM injection on Days 1 and 29.
|
mRNA-1325 100 mcg
n=25 Participants
Participants received mRNA-1325 100 mcg as an IM injection on Days 1 and 29.
|
Placebo
n=16 Participants
Participants received placebo matched to mRNA-1325 as an IM injection on Days 1 and 29.
|
|---|---|---|---|---|
|
Part A: Number of Participants With Medically-Attended Adverse Events (MAAEs)
|
5 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 1 year post-vaccination (Day 392)Population: The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo).
An SAE was defined as any AE that resulted in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions was a congenital anomaly/birth defect, or was an important medical event. AESIs included potentially immune-mediated medical conditions (autoimmune or autoinflammatory diseases) that may have the theoretical potential for association with novel vaccines. A summary of all SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Outcome measures
| Measure |
mRNA-1325 10 mcg
n=25 Participants
Participants received mRNA-1325 10 mcg IM injection on Days 1 and 29.
|
mRNA-1325 25 mcg
n=24 Participants
Participants received mRNA-1325 25 mcg as an IM injection on Days 1 and 29.
|
mRNA-1325 100 mcg
n=25 Participants
Participants received mRNA-1325 100 mcg as an IM injection on Days 1 and 29.
|
Placebo
n=16 Participants
Participants received placebo matched to mRNA-1325 as an IM injection on Days 1 and 29.
|
|---|---|---|---|---|
|
Part B: Number of Participants With Adverse Events of Special Interest (AESIs) and Serious Adverse Events (SAEs)
AESI
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With Adverse Events of Special Interest (AESIs) and Serious Adverse Events (SAEs)
SAE
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, 28 days post each vaccination (Days 29 and 57)Population: The per-protocol set included all participants in the randomized set who did not have a major protocol violation, received the full dose of the assigned investigational product within the acceptable vaccination window, had blood collection within accepted visit windows, and had a pre-vaccination and at least 1 serum sample from the post-vaccination immunogenicity testing period available for testing. Here, number analyzed signifies those participants who were evaluable at specified time points.
GMT 95% CI is calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation.
Outcome measures
| Measure |
mRNA-1325 10 mcg
n=25 Participants
Participants received mRNA-1325 10 mcg IM injection on Days 1 and 29.
|
mRNA-1325 25 mcg
n=24 Participants
Participants received mRNA-1325 25 mcg as an IM injection on Days 1 and 29.
|
mRNA-1325 100 mcg
n=25 Participants
Participants received mRNA-1325 100 mcg as an IM injection on Days 1 and 29.
|
Placebo
n=16 Participants
Participants received placebo matched to mRNA-1325 as an IM injection on Days 1 and 29.
|
|---|---|---|---|---|
|
Part A: Geometric Mean Titer of Neutralizing Serum Antibody (PRNT50) to Zika Virus
Baseline
|
5.4 Titer
Interval 4.6 to 6.4
|
5.0 Titer
All values were equal to 5.0, therefore CI (upper and lower limit) could not be calculated.
|
5.0 Titer
All values were equal to 5.0, therefore CI (upper and lower limit) could not be calculated.
|
5.0 Titer
All values were equal to 5.0, therefore CI (upper and lower limit) could not be calculated.
|
|
Part A: Geometric Mean Titer of Neutralizing Serum Antibody (PRNT50) to Zika Virus
Day 29
|
5.8 Titer
Interval 4.2 to 8.0
|
5.6 Titer
Interval 4.8 to 6.6
|
5.2 Titer
Interval 4.8 to 5.7
|
5.0 Titer
All values were equal to 5.0, therefore CI (upper and lower limit) could not be calculated.
|
|
Part A: Geometric Mean Titer of Neutralizing Serum Antibody (PRNT50) to Zika Virus
Day 57
|
10.3 Titer
Interval 5.9 to 18.2
|
6.6 Titer
Interval 4.8 to 9.0
|
7.7 Titer
Interval 5.2 to 11.4
|
5.0 Titer
All values were equal to 5.0, therefore CI (upper and lower limit) could not be calculated.
|
Adverse Events
mRNA-1325 10 mcg
Serious events: 1 serious events
Other events: 24 other events
Deaths: 1 deaths
mRNA-1325 25 mcg
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
mRNA-1325 100 mcg
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
mRNA-1325 10 mcg
n=25 participants at risk
Participants received mRNA-1325 10 mcg IM injection on Days 1 and 29.
|
mRNA-1325 25 mcg
n=24 participants at risk
Participants received placebo matched to mRNA-1325 as an IM injection on Days 1 and 29.
|
mRNA-1325 100 mcg
n=25 participants at risk
Participants received mRNA-1325 25 mcg as an IM injection on Days 1 and 29.
|
Placebo
n=16 participants at risk
Participants received mRNA-1325 100 mcg as an IM injection on Days 1 and 29.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
4.0%
1/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/24 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/16 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
4.0%
1/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/24 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/16 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
Other adverse events
| Measure |
mRNA-1325 10 mcg
n=25 participants at risk
Participants received mRNA-1325 10 mcg IM injection on Days 1 and 29.
|
mRNA-1325 25 mcg
n=24 participants at risk
Participants received placebo matched to mRNA-1325 as an IM injection on Days 1 and 29.
|
mRNA-1325 100 mcg
n=25 participants at risk
Participants received mRNA-1325 25 mcg as an IM injection on Days 1 and 29.
|
Placebo
n=16 participants at risk
Participants received mRNA-1325 100 mcg as an IM injection on Days 1 and 29.
|
|---|---|---|---|---|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
8.3%
2/24 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
6.2%
1/16 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
|
Infections and infestations
Nasopharyngitis
|
4.0%
1/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/24 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
6.2%
1/16 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
4.2%
1/24 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/16 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
|
Infections and infestations
Bronchitis
|
0.00%
0/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/24 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
4.0%
1/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/16 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
|
Infections and infestations
Ear infection
|
0.00%
0/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/24 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
4.0%
1/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/16 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
8.0%
2/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
4.2%
1/24 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
6.2%
1/16 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
4.0%
1/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
8.3%
2/24 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/16 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
|
Metabolism and nutrition disorders
Dehydration
|
4.0%
1/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/24 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/16 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
|
Psychiatric disorders
Anxiety
|
4.0%
1/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/24 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
6.2%
1/16 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
|
Nervous system disorders
Headache
|
56.0%
14/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
45.8%
11/24 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
56.0%
14/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
37.5%
6/16 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/24 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
4.0%
1/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/16 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/24 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
12.5%
2/16 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
|
Gastrointestinal disorders
Vomiting
|
28.0%
7/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
16.7%
4/24 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
28.0%
7/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/16 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
|
Gastrointestinal disorders
Diarrhoea
|
12.0%
3/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
4.2%
1/24 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
4.0%
1/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/16 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
|
Gastrointestinal disorders
Abdominal discomfort
|
4.0%
1/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/24 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/16 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
|
Gastrointestinal disorders
Gastritis
|
4.0%
1/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/24 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/16 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
4.0%
1/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/24 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/16 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/24 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
4.0%
1/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/16 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/24 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
4.0%
1/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/16 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
4.0%
1/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/24 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/16 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
4.0%
1/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/24 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/16 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
64.0%
16/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
58.3%
14/24 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
60.0%
15/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
6.2%
1/16 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
32.0%
8/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
33.3%
8/24 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
32.0%
8/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/16 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
4.2%
1/24 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/16 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/24 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
4.0%
1/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/16 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
4.2%
1/24 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/16 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/24 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
4.0%
1/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/16 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
|
General disorders
Injection site lymphadenopathy
|
92.0%
23/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
83.3%
20/24 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
100.0%
25/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
18.8%
3/16 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
|
General disorders
Injection site pain
|
84.0%
21/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
91.7%
22/24 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
100.0%
25/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
6.2%
1/16 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
|
General disorders
Fatigue
|
56.0%
14/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
54.2%
13/24 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
52.0%
13/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
12.5%
2/16 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
|
General disorders
Pyrexia
|
4.0%
1/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
8.3%
2/24 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
28.0%
7/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
6.2%
1/16 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
|
General disorders
Injection site erythema
|
4.0%
1/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/24 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
8.0%
2/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/16 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
|
General disorders
Non-cardiac chest pain
|
4.0%
1/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/24 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
4.0%
1/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/16 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
|
General disorders
Injection site induration
|
0.00%
0/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
4.2%
1/24 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
4.0%
1/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/16 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
|
General disorders
Influenza like illness
|
4.0%
1/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/24 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/16 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
|
General disorders
Chills
|
0.00%
0/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/24 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
4.0%
1/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/16 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
|
General disorders
Pain
|
0.00%
0/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/24 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
4.0%
1/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/16 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
|
Investigations
Lipase increased
|
0.00%
0/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
4.2%
1/24 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
16.0%
4/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
6.2%
1/16 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
|
Investigations
Haemoglobin decreased
|
4.0%
1/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/24 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/16 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
|
Investigations
Red blood cells urine positive
|
0.00%
0/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/24 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
6.2%
1/16 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
4.2%
1/24 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
4.0%
1/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/16 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
|
Injury, poisoning and procedural complications
Animal bite
|
4.0%
1/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/24 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/16 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
4.0%
1/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/24 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/16 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
|
Injury, poisoning and procedural complications
Thermal burn
|
4.0%
1/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/24 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/25 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
0.00%
0/16 • Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
|
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