Trial Outcomes & Findings for Safety, Tolerability, and Immunogenicity of Zika Vaccine mRNA-1893 in Healthy Flavivirus Seropositive and Seronegative Adults (NCT NCT04064905)
NCT ID: NCT04064905
Last Updated: 2024-08-21
Results Overview
Solicited ARs (local and systemic) were collected in the daily diary. 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 adverse events (SAEs) and all nonserious AEs ("Other"), regardless of causality, is in Reported "Adverse Events" section.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
120 participants
Primary outcome timeframe
Up to Day 7 after first vaccination (up to 8 days)
Results posted on
2024-08-21
Participant Flow
Participant milestones
| Measure |
Placebo
Participants received placebo matched to mRNA-1893 by IM injection on Days 1 and 29.
|
mRNA-1893 10 mcg
Participants received mRNA-1893 10 mcg by IM injection on Days 1 and 29.
|
mRNA-1893 30 mcg
Participants received mRNA-1893 30 mcg by IM injection on Days 1 and 29.
|
mRNA-1893 100 mcg
Participants received mRNA-1893 100 mcg by IM injection on Days 1 and 29.
|
mRNA-1893 250 mcg
Participants received mRNA-1893 250 mcg by IM injection on Days 1 and 29.
|
|---|---|---|---|---|---|
|
Overall Study
Received First Vaccination
|
24
|
24
|
24
|
24
|
24
|
|
Overall Study
STARTED
|
24
|
24
|
24
|
24
|
24
|
|
Overall Study
Received Second Vaccination
|
24
|
23
|
23
|
24
|
24
|
|
Overall Study
COMPLETED
|
24
|
21
|
23
|
20
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
1
|
4
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo matched to mRNA-1893 by IM injection on Days 1 and 29.
|
mRNA-1893 10 mcg
Participants received mRNA-1893 10 mcg by IM injection on Days 1 and 29.
|
mRNA-1893 30 mcg
Participants received mRNA-1893 30 mcg by IM injection on Days 1 and 29.
|
mRNA-1893 100 mcg
Participants received mRNA-1893 100 mcg by IM injection on Days 1 and 29.
|
mRNA-1893 250 mcg
Participants received mRNA-1893 250 mcg by IM injection on Days 1 and 29.
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
1
|
4
|
2
|
Baseline Characteristics
Safety, Tolerability, and Immunogenicity of Zika Vaccine mRNA-1893 in Healthy Flavivirus Seropositive and Seronegative Adults
Baseline characteristics by cohort
| Measure |
Placebo
n=24 Participants
Participants received placebo matched to mRNA-1893 by IM injection on Days 1 and 29.
|
mRNA-1893 10 mcg
n=24 Participants
Participants received mRNA-1893 10 mcg by IM injection on Days 1 and 29.
|
mRNA-1893 30 mcg
n=24 Participants
Participants received mRNA-1893 30 mcg by IM injection on Days 1 and 29.
|
mRNA-1893 100 mcg
n=24 Participants
Participants received mRNA-1893 100 mcg by IM injection on Days 1 and 29.
|
mRNA-1893 250 mcg
n=24 Participants
Participants received mRNA-1893 250 mcg by IM injection on Days 1 and 29.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
120 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
70 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
50 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
29 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
91 Participants
n=10 Participants
|
|
Ethnicity (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
|
0 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
28 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
89 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Flavivirus Serostatus
Seropositive
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
20 Participants
n=10 Participants
|
|
Flavivirus Serostatus
Seronegative
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
100 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Up to Day 7 after first vaccination (up to 8 days)Population: The First Vaccination Solicited Safety Set consisted of all participants in the Safety Set who had received the first study vaccination and had contributed any solicited AR data (local or systemic reactogenicity events) from the time of first study vaccination through the following 7 days. Here, number analyzed signifies those participants who were evaluable at specified categories.
Solicited ARs (local and systemic) were collected in the daily diary. 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 adverse events (SAEs) and all nonserious AEs ("Other"), regardless of causality, is in Reported "Adverse Events" section.
Outcome measures
| Measure |
Placebo
n=24 Participants
Participants received placebo matched to mRNA-1893 by IM injection on Days 1 and 29.
|
mRNA-1893 10 mcg
n=24 Participants
Participants received mRNA-1893 10 mcg by IM injection on Days 1 and 29.
|
mRNA-1893 30 mcg
n=23 Participants
Participants received mRNA-1893 30 mcg by IM injection on Days 1 and 29.
|
mRNA-1893 100 mcg
n=24 Participants
Participants received mRNA-1893 100 mcg by IM injection on Days 1 and 29.
|
mRNA-1893 250 mcg
n=24 Participants
Participants received mRNA-1893 250 mcg by IM injection on Days 1 and 29.
|
|---|---|---|---|---|---|
|
Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination
Local ARs- Swelling (Hardness)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination
Systemic ARs- Chills
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination
Systemic ARs- Fever
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination
Local ARs- Erythema (Redness)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination
Local ARs- Pain
|
1 Participants
|
12 Participants
|
12 Participants
|
17 Participants
|
14 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination
Systemic ARs- Arthralgia
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination
Systemic ARs- Fatigue
|
3 Participants
|
8 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination
Systemic ARs- Headache
|
4 Participants
|
7 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination
Systemic ARs- Myalgia
|
2 Participants
|
5 Participants
|
3 Participants
|
1 Participants
|
6 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination
Systemic ARs- Nausea
|
0 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination
Systemic ARs- Rash
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 7 after second vaccination (Day 29 to Day 36)Population: The Second Vaccination Solicited Safety Set consisted of all participants in the Safety Set who had received the second study vaccination and had contributed any solicited AR data (local or systemic reactogenicity events) from the time of first study vaccination through the following 7 days. Here, number analyzed signifies those participants who were evaluable at specified categories.
Solicited ARs (local and systemic) were collected in the daily diary. 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 adverse events (SAEs) and all nonserious AEs ("Other"), regardless of causality, is in Reported "Adverse Events" section.
Outcome measures
| Measure |
Placebo
n=23 Participants
Participants received placebo matched to mRNA-1893 by IM injection on Days 1 and 29.
|
mRNA-1893 10 mcg
n=23 Participants
Participants received mRNA-1893 10 mcg by IM injection on Days 1 and 29.
|
mRNA-1893 30 mcg
n=22 Participants
Participants received mRNA-1893 30 mcg by IM injection on Days 1 and 29.
|
mRNA-1893 100 mcg
n=24 Participants
Participants received mRNA-1893 100 mcg by IM injection on Days 1 and 29.
|
mRNA-1893 250 mcg
n=23 Participants
Participants received mRNA-1893 250 mcg by IM injection on Days 1 and 29.
|
|---|---|---|---|---|---|
|
Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination
Local ARs- Erythema (Redness)
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination
Local ARs- Pain
|
2 Participants
|
8 Participants
|
11 Participants
|
15 Participants
|
14 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination
Local ARs- Swelling (Hardness)
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination
Systemic ARs- Arthralgia
|
2 Participants
|
4 Participants
|
4 Participants
|
9 Participants
|
7 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination
Systemic ARs- Chills
|
3 Participants
|
1 Participants
|
5 Participants
|
11 Participants
|
14 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination
Systemic ARs- Fatigue
|
3 Participants
|
6 Participants
|
10 Participants
|
10 Participants
|
13 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination
Systemic ARs- Fever
|
1 Participants
|
1 Participants
|
3 Participants
|
7 Participants
|
11 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination
Systemic ARs- Headache
|
4 Participants
|
5 Participants
|
8 Participants
|
9 Participants
|
13 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination
Systemic ARs- Myalgia
|
1 Participants
|
7 Participants
|
4 Participants
|
10 Participants
|
15 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination
Systemic ARs- Nausea
|
2 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination
Systemic ARs- Rash
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 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 consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 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. A treatment-emergent adverse event (TEAE) was as any AE not present before exposure to vaccine or any AE already present that worsened in intensity or frequency after exposure. A summary of all SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Outcome measures
| Measure |
Placebo
n=24 Participants
Participants received placebo matched to mRNA-1893 by IM injection on Days 1 and 29.
|
mRNA-1893 10 mcg
n=24 Participants
Participants received mRNA-1893 10 mcg by IM injection on Days 1 and 29.
|
mRNA-1893 30 mcg
n=24 Participants
Participants received mRNA-1893 30 mcg by IM injection on Days 1 and 29.
|
mRNA-1893 100 mcg
n=24 Participants
Participants received mRNA-1893 100 mcg by IM injection on Days 1 and 29.
|
mRNA-1893 250 mcg
n=24 Participants
Participants received mRNA-1893 250 mcg by IM injection on Days 1 and 29.
|
|---|---|---|---|---|---|
|
Number of Participants With Unsolicited Adverse Events (AEs)
|
14 Participants
|
12 Participants
|
13 Participants
|
15 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: Day 1 to the end of study visit (up to Day 392)Population: The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 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 |
Placebo
n=24 Participants
Participants received placebo matched to mRNA-1893 by IM injection on Days 1 and 29.
|
mRNA-1893 10 mcg
n=24 Participants
Participants received mRNA-1893 10 mcg by IM injection on Days 1 and 29.
|
mRNA-1893 30 mcg
n=24 Participants
Participants received mRNA-1893 30 mcg by IM injection on Days 1 and 29.
|
mRNA-1893 100 mcg
n=24 Participants
Participants received mRNA-1893 100 mcg by IM injection on Days 1 and 29.
|
mRNA-1893 250 mcg
n=24 Participants
Participants received mRNA-1893 250 mcg by IM injection on Days 1 and 29.
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Event of Special Interest (AESI) and Serious Adverse Events (SAEs)
SAEs
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Event of Special Interest (AESI) and Serious Adverse Events (SAEs)
AESI
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1, 29, 57, Month 7 and 13Population: Per-Protocol Set consisted of all participants who did not had a major protocol deviation, received vaccine within the acceptable vaccination window and received full dose of assigned vaccine, had immunogenicity samples taken within acceptable visit windows, had a pre-vaccination and the corresponding 1 post-vaccination serum sample available for testing. Here, number analyzed signifies those participants 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 |
Placebo
n=24 Participants
Participants received placebo matched to mRNA-1893 by IM injection on Days 1 and 29.
|
mRNA-1893 10 mcg
n=24 Participants
Participants received mRNA-1893 10 mcg by IM injection on Days 1 and 29.
|
mRNA-1893 30 mcg
n=23 Participants
Participants received mRNA-1893 30 mcg by IM injection on Days 1 and 29.
|
mRNA-1893 100 mcg
n=24 Participants
Participants received mRNA-1893 100 mcg by IM injection on Days 1 and 29.
|
mRNA-1893 250 mcg
n=24 Participants
Participants received mRNA-1893 250 mcg by IM injection on Days 1 and 29.
|
|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Neutralizing Antibody (nAb) Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50)
Month 7
|
8.9 Titer
Interval 7.1 to 11.1
|
42.7 Titer
Interval 23.0 to 79.3
|
68.0 Titer
Interval 39.7 to 116.3
|
174.8 Titer
Interval 114.6 to 266.7
|
116.7 Titer
Interval 75.4 to 180.6
|
|
Geometric Mean Titer (GMT) of Neutralizing Antibody (nAb) Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50)
Month 13
|
9.0 Titer
Interval 7.1 to 11.4
|
41.0 Titer
Interval 21.7 to 77.4
|
47.8 Titer
Interval 23.9 to 95.6
|
100.8 Titer
Interval 56.3 to 180.4
|
100.2 Titer
Interval 64.5 to 155.7
|
|
Geometric Mean Titer (GMT) of Neutralizing Antibody (nAb) Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50)
Day 1
|
9.1 Titer
Interval 7.0 to 11.8
|
10.1 Titer
Interval 7.2 to 14.1
|
8.9 Titer
Interval 7.1 to 11.3
|
9.1 Titer
Interval 7.0 to 11.9
|
8.0 Titer
All values were equal to 8.0, therefore CI (upper and lower limit) could not be calculated.
|
|
Geometric Mean Titer (GMT) of Neutralizing Antibody (nAb) Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50)
Day 57
|
9.3 Titer
Interval 6.8 to 12.5
|
200.5 Titer
Interval 121.1 to 331.9
|
267.2 Titer
Interval 161.6 to 441.8
|
393.0 Titer
Interval 273.1 to 565.7
|
230.0 Titer
Interval 148.9 to 355.3
|
|
Geometric Mean Titer (GMT) of Neutralizing Antibody (nAb) Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50)
Day 29
|
9.1 Titer
Interval 6.9 to 12.0
|
13.6 Titer
Interval 7.8 to 23.8
|
19.8 Titer
Interval 11.5 to 33.8
|
54.6 Titer
Interval 29.4 to 101.3
|
29.2 Titer
Interval 17.2 to 49.3
|
SECONDARY outcome
Timeframe: Day 1, 29, 57, Month 7 and 13Population: Per-Protocol Set: All participants who did not had a major protocol deviation, received vaccine within acceptable vaccination window and received full dose of assigned vaccine, had immunogenicity samples taken within acceptable visit windows, had a pre-vaccination and the corresponding 1 post-vaccination serum sample available for testing. Number of participants analyzed signifies who were evaluable for this endpoint and number analyzed signifies 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 |
Placebo
n=20 Participants
Participants received placebo matched to mRNA-1893 by IM injection on Days 1 and 29.
|
mRNA-1893 10 mcg
n=20 Participants
Participants received mRNA-1893 10 mcg by IM injection on Days 1 and 29.
|
mRNA-1893 30 mcg
n=19 Participants
Participants received mRNA-1893 30 mcg by IM injection on Days 1 and 29.
|
mRNA-1893 100 mcg
n=20 Participants
Participants received mRNA-1893 100 mcg by IM injection on Days 1 and 29.
|
mRNA-1893 250 mcg
n=20 Participants
Participants received mRNA-1893 250 mcg by IM injection on Days 1 and 29.
|
|---|---|---|---|---|---|
|
Geometric Mean Titer of Neutralizing Antibody in Initially Seronegative Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50)
Day 1
|
8.0 Titer
All values were equal to 8.0, therefore CI (upper and lower limit) could not be calculated.
|
8.0 Titer
All values were equal to 8.0, therefore CI (upper and lower limit) could not be calculated.
|
8.0 Titer
All values were equal to 8.0, therefore CI (upper and lower limit) could not be calculated.
|
8.0 Titer
All values were equal to 8.0, therefore CI (upper and lower limit) could not be calculated.
|
8.0 Titer
All values were equal to 8.0, therefore CI (upper and lower limit) could not be calculated.
|
|
Geometric Mean Titer of Neutralizing Antibody in Initially Seronegative Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50)
Day 29
|
8.0 Titer
All values were equal to 8.0, therefore CI (upper and lower limit) could not be calculated.
|
8.5 Titer
Interval 7.5 to 9.5
|
14.4 Titer
Interval 9.9 to 21.0
|
45.9 Titer
Interval 23.4 to 89.9
|
27.6 Titer
Interval 15.5 to 49.2
|
|
Geometric Mean Titer of Neutralizing Antibody in Initially Seronegative Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50)
Day 57
|
8.0 Titer
All values were equal to 8.0, therefore CI (upper and lower limit) could not be calculated.
|
195.6 Titer
Interval 108.4 to 352.8
|
303.4 Titer
Interval 195.5 to 470.9
|
454.2 Titer
Interval 333.0 to 619.6
|
273.6 Titer
Interval 195.3 to 383.2
|
|
Geometric Mean Titer of Neutralizing Antibody in Initially Seronegative Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50)
Month 7
|
8.0 Titer
All values were equal to 8.0, therefore CI (upper and lower limit) could not be calculated.
|
38.2 Titer
Interval 20.0 to 73.0
|
66.7 Titer
Interval 38.5 to 115.4
|
170.1 Titer
Interval 112.1 to 258.0
|
137.7 Titer
Interval 94.6 to 200.5
|
|
Geometric Mean Titer of Neutralizing Antibody in Initially Seronegative Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50)
Month 13
|
8.0 Titer
All values were equal to 8.0, therefore CI (upper and lower limit) could not be calculated.
|
35.0 Titer
Interval 18.4 to 66.5
|
48.3 Titer
Interval 23.0 to 101.7
|
112.3 Titer
Interval 63.6 to 198.4
|
113.2 Titer
Interval 77.7 to 164.9
|
SECONDARY outcome
Timeframe: Day 1, 29, 57, Month 7 and 13Population: Per-Protocol Set: All participants who did not had a major protocol deviation, received vaccine within acceptable vaccination window and received full dose of assigned vaccine, had immunogenicity samples taken within acceptable visit windows, had a pre-vaccination and the corresponding 1 post-vaccination serum sample available for testing. Number of participants analyzed signifies who were evaluable for this endpoint and number analyzed signifies 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 |
Placebo
n=4 Participants
Participants received placebo matched to mRNA-1893 by IM injection on Days 1 and 29.
|
mRNA-1893 10 mcg
n=4 Participants
Participants received mRNA-1893 10 mcg by IM injection on Days 1 and 29.
|
mRNA-1893 30 mcg
n=4 Participants
Participants received mRNA-1893 30 mcg by IM injection on Days 1 and 29.
|
mRNA-1893 100 mcg
n=4 Participants
Participants received mRNA-1893 100 mcg by IM injection on Days 1 and 29.
|
mRNA-1893 250 mcg
n=4 Participants
Participants received mRNA-1893 250 mcg by IM injection on Days 1 and 29.
|
|---|---|---|---|---|---|
|
Geometric Mean Titer of Neutralizing Antibody in Initially Seropositive Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50)
Day 1
|
17.0 Titer
Interval 1.5 to 188.2
|
32.2 Titer
Interval 2.5 to 417.7
|
15.2 Titer
Interval 2.0 to 115.7
|
17.4 Titer
Interval 1.5 to 203.9
|
8.0 Titer
All values were equal to 8.0, therefore CI (upper and lower limit) could not be calculated.
|
|
Geometric Mean Titer of Neutralizing Antibody in Initially Seropositive Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50)
Day 29
|
17.8 Titer
Interval 1.4 to 226.8
|
147.9 Titer
Interval 6.2 to 3507.8
|
88.1 Titer
Interval 3.6 to 2166.7
|
130.6 Titer
Interval 13.0 to 1306.4
|
38.2 Titer
Interval 3.7 to 398.6
|
|
Geometric Mean Titer of Neutralizing Antibody in Initially Seropositive Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50)
Day 57
|
18.6 Titer
Interval 1.3 to 270.5
|
224.1 Titer
Interval 43.5 to 1153.5
|
150.9 Titer
Interval 6.2 to 3699.1
|
190.5 Titer
Interval 19.2 to 1887.2
|
100.9 Titer
Interval 5.4 to 1886.3
|
|
Geometric Mean Titer of Neutralizing Antibody in Initially Seropositive Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50)
Month 7
|
15.2 Titer
Interval 2.0 to 116.9
|
68.8 Titer
Interval 3.6 to 1231.4
|
74.2 Titer
Interval 4.0 to 1362.9
|
196.3 Titer
Interval 18.3 to 2102.4
|
53.2 Titer
Interval 3.7 to 774.9
|
|
Geometric Mean Titer of Neutralizing Antibody in Initially Seropositive Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50)
Month 13
|
15.9 Titer
Interval 1.8 to 142.9
|
77.6 Titer
Interval 3.6 to 1670.2
|
45.6 Titer
Interval 1.7 to 1237.6
|
60.9 Titer
Interval 0.6 to 6248.0
|
59.6 Titer
Interval 3.9 to 922.0
|
SECONDARY outcome
Timeframe: Day 1 (baseline) to Day 29, from Day 1 to Day 57, from Day 1 to Month 7, and from Day 1 to Month 13.Population: Per-Protocol Set consisted of all participants who did not had a major protocol deviation, received vaccine within the acceptable vaccination window and received full dose of assigned vaccine, had immunogenicity samples taken within acceptable visit windows, had a pre-vaccination and the corresponding 1 post-vaccination serum sample available for testing.
Seroconversion is defined as a change of PRNT from below the lower limit of quantification (LLOQ) to a PRNT equal to or above LLOQ for the assay, or a multiplication by at least 4 in participants with pre-existing PRNT titers.
Outcome measures
| Measure |
Placebo
n=24 Participants
Participants received placebo matched to mRNA-1893 by IM injection on Days 1 and 29.
|
mRNA-1893 10 mcg
n=24 Participants
Participants received mRNA-1893 10 mcg by IM injection on Days 1 and 29.
|
mRNA-1893 30 mcg
n=23 Participants
Participants received mRNA-1893 30 mcg by IM injection on Days 1 and 29.
|
mRNA-1893 100 mcg
n=24 Participants
Participants received mRNA-1893 100 mcg by IM injection on Days 1 and 29.
|
mRNA-1893 250 mcg
n=24 Participants
Participants received mRNA-1893 250 mcg by IM injection on Days 1 and 29.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Seroconverted From Day 1 (Baseline) to Day 29, From Day 1 to Day 57, From Day 1 to Month 7, and From Day 1 to Month 13
Day 1 (baseline) to Day 29
|
0 percentage of participants
|
12.5 percentage of participants
|
47.8 percentage of participants
|
75.0 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants Who Seroconverted From Day 1 (Baseline) to Day 29, From Day 1 to Day 57, From Day 1 to Month 7, and From Day 1 to Month 13
Day 1 to Day 57
|
0 percentage of participants
|
90.9 percentage of participants
|
95.5 percentage of participants
|
100.0 percentage of participants
|
95.7 percentage of participants
|
|
Percentage of Participants Who Seroconverted From Day 1 (Baseline) to Day 29, From Day 1 to Day 57, From Day 1 to Month 7, and From Day 1 to Month 13
Day 1 to Month 7
|
0 percentage of participants
|
66.7 percentage of participants
|
81.8 percentage of participants
|
100.0 percentage of participants
|
95.7 percentage of participants
|
|
Percentage of Participants Who Seroconverted From Day 1 (Baseline) to Day 29, From Day 1 to Day 57, From Day 1 to Month 7, and From Day 1 to Month 13
Day 1 to Month 13
|
0 percentage of participants
|
60.0 percentage of participants
|
61.9 percentage of participants
|
94.1 percentage of participants
|
95.2 percentage of participants
|
SECONDARY outcome
Timeframe: Day 29, Day 57, Month 7, and Month 13Population: Per-Protocol Set: All participants who did not had a major protocol deviation, received vaccine within the acceptable vaccination window and received full dose of assigned vaccine, had immunogenicity samples taken within acceptable visit windows, had a pre-vaccination and the corresponding 1 post-vaccination serum sample available for testing. Number of participants analyzed signifies who were evaluable for this endpoint and number analyzed signifies who were evaluable at specified time points.
Seroconversion is defined as a change of PRNT from below the LLOQ to a PRNT equal to or above LLOQ for the assay, or a multiplication by at least 4 in participants with pre-existing PRNT titers.
Outcome measures
| Measure |
Placebo
n=20 Participants
Participants received placebo matched to mRNA-1893 by IM injection on Days 1 and 29.
|
mRNA-1893 10 mcg
n=20 Participants
Participants received mRNA-1893 10 mcg by IM injection on Days 1 and 29.
|
mRNA-1893 30 mcg
n=19 Participants
Participants received mRNA-1893 30 mcg by IM injection on Days 1 and 29.
|
mRNA-1893 100 mcg
n=20 Participants
Participants received mRNA-1893 100 mcg by IM injection on Days 1 and 29.
|
mRNA-1893 250 mcg
n=20 Participants
Participants received mRNA-1893 250 mcg by IM injection on Days 1 and 29.
|
|---|---|---|---|---|---|
|
Number of Initially Seronegative Participants With a Seroresponse as Measured by Plaque Reduction Neutralization Test
Day 29
|
0 Participants
|
1 Participants
|
8 Participants
|
14 Participants
|
13 Participants
|
|
Number of Initially Seronegative Participants With a Seroresponse as Measured by Plaque Reduction Neutralization Test
Day 57
|
0 Participants
|
17 Participants
|
18 Participants
|
20 Participants
|
19 Participants
|
|
Number of Initially Seronegative Participants With a Seroresponse as Measured by Plaque Reduction Neutralization Test
Month 7
|
0 Participants
|
12 Participants
|
15 Participants
|
17 Participants
|
19 Participants
|
|
Number of Initially Seronegative Participants With a Seroresponse as Measured by Plaque Reduction Neutralization Test
Month 13
|
0 Participants
|
10 Participants
|
11 Participants
|
14 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Day 29, Day 57, Month 7, and Month 13Population: Per-Protocol Set consisted of all participants who did not had a major protocol deviation, received vaccine within the acceptable vaccination window and received full dose of assigned vaccine, had immunogenicity samples taken within acceptable visit windows, had a pre-vaccination and the corresponding 1 post-vaccination serum sample available for testing. Here, Number of participants analyzed signifies those participants who were evaluable for this endpoint.
Seroconversion is defined as a change of Plaque Reduction Neutralization Test from below the lower limit of quantification (LLOQ) to a PRNT equal to or above LLOQ for the assay, or a multiplication by at least 4 in participants with pre-existing PRNT titers.
Outcome measures
| Measure |
Placebo
n=4 Participants
Participants received placebo matched to mRNA-1893 by IM injection on Days 1 and 29.
|
mRNA-1893 10 mcg
n=4 Participants
Participants received mRNA-1893 10 mcg by IM injection on Days 1 and 29.
|
mRNA-1893 30 mcg
n=4 Participants
Participants received mRNA-1893 30 mcg by IM injection on Days 1 and 29.
|
mRNA-1893 100 mcg
n=4 Participants
Participants received mRNA-1893 100 mcg by IM injection on Days 1 and 29.
|
mRNA-1893 250 mcg
n=4 Participants
Participants received mRNA-1893 250 mcg by IM injection on Days 1 and 29.
|
|---|---|---|---|---|---|
|
Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test
Day 29: >= 2-fold increase
|
0 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
|
Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test
Day 29: >= 4-fold increase
|
0 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test
Day 57: >= 2-fold increase
|
0 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
|
Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test
Day 57: >= 4-fold increase
|
0 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
|
Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test
Month 7: >= 2-fold increase
|
0 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
|
Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test
Month 7: >= 4-fold increase
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test
Month 13: >= 2-fold increase
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test
Month 13: >= 4-fold increase
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
Adverse Events
Placebo
Serious events: 3 serious events
Other events: 17 other events
Deaths: 0 deaths
mRNA-1893 10 mcg
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
mRNA-1893 30 mcg
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
mRNA-1893 100 mcg
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
mRNA-1893 250 mcg
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=24 participants at risk
Participants received placebo matched to mRNA-1893 by IM injection on Days 1 and 29.
|
mRNA-1893 10 mcg
n=24 participants at risk
Participants received mRNA-1893 10 mcg by IM injection on Days 1 and 29.
|
mRNA-1893 30 mcg
n=24 participants at risk
Participants received mRNA-1893 30 mcg by IM injection on Days 1 and 29.
|
mRNA-1893 100 mcg
n=24 participants at risk
Participants received mRNA-1893 100 mcg by IM injection on Days 1 and 29.
|
mRNA-1893 250 mcg
n=24 participants at risk
Participants received mRNA-1893 250 mcg by IM injection on Days 1 and 29.
|
|---|---|---|---|---|---|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Infections and infestations
Diverticulitis
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Psychiatric disorders
Anxiety
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
Other adverse events
| Measure |
Placebo
n=24 participants at risk
Participants received placebo matched to mRNA-1893 by IM injection on Days 1 and 29.
|
mRNA-1893 10 mcg
n=24 participants at risk
Participants received mRNA-1893 10 mcg by IM injection on Days 1 and 29.
|
mRNA-1893 30 mcg
n=24 participants at risk
Participants received mRNA-1893 30 mcg by IM injection on Days 1 and 29.
|
mRNA-1893 100 mcg
n=24 participants at risk
Participants received mRNA-1893 100 mcg by IM injection on Days 1 and 29.
|
mRNA-1893 250 mcg
n=24 participants at risk
Participants received mRNA-1893 250 mcg by IM injection on Days 1 and 29.
|
|---|---|---|---|---|---|
|
Infections and infestations
Influenza
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
4/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
8.3%
2/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Infections and infestations
Sinusitis
|
8.3%
2/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Infections and infestations
Viral infection
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
12.5%
3/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Infections and infestations
Gastroenteritis viral
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Infections and infestations
Urinary tract infection
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
8.3%
2/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Infections and infestations
COVID-19
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Infections and infestations
Diverticulitis
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Infections and infestations
Infected bite
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Infections and infestations
Mycoplasma infection
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Infections and infestations
Otosalpingitis
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Infections and infestations
Staphylococcal skin infection
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Infections and infestations
Nipple infection
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Infections and infestations
Trichomoniasis
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
8.3%
2/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Psychiatric disorders
Anxiety
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Psychiatric disorders
Generalised anxiety disorder
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Psychiatric disorders
Depression
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Nervous system disorders
Headache
|
33.3%
8/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
50.0%
12/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
50.0%
12/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
45.8%
11/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
54.2%
13/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Nervous system disorders
Presyncope
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Eye disorders
Eye pain
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Vascular disorders
Flushing
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
8.3%
2/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
8.3%
2/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Gastrointestinal disorders
Nausea
|
8.3%
2/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
20.8%
5/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
12.5%
3/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
25.0%
6/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
25.0%
6/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
8.3%
2/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Skin and subcutaneous tissue disorders
Dermatosis
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.3%
2/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
50.0%
12/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
29.2%
7/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
45.8%
11/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
66.7%
16/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
3/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
25.0%
6/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
20.8%
5/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
37.5%
9/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
33.3%
8/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
8.3%
2/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
8.3%
2/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Reproductive system and breast disorders
Oligomenorrhoea
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
General disorders
Injection site pain
|
12.5%
3/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
58.3%
14/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
66.7%
16/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
83.3%
20/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
70.8%
17/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
General disorders
Fatigue
|
20.8%
5/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
37.5%
9/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
45.8%
11/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
45.8%
11/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
58.3%
14/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
General disorders
Chills
|
12.5%
3/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
8.3%
2/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
25.0%
6/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
45.8%
11/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
58.3%
14/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
General disorders
Pyrexia
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
8.3%
2/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
16.7%
4/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
33.3%
8/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
45.8%
11/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
General disorders
Injection site erythema
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
12.5%
3/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
12.5%
3/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
General disorders
Injection site swelling
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
8.3%
2/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
8.3%
2/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
12.5%
3/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
General disorders
Infusion site rash
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
General disorders
Feeling hot
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
General disorders
Chest discomfort
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
General disorders
Injection site pruritus
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
General disorders
Chest pain
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Investigations
Blood glucose increased
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
8.3%
2/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Investigations
Haemoglobin decreased
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
8.3%
2/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Investigations
Alanine aminotransferase increased
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Investigations
Blood pressure increased
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Investigations
Platelet count increased
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Investigations
Blood glucose decreased
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Investigations
Blood pressure diastolic increased
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Investigations
Blood pressure systolic increased
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
0.00%
0/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
4.2%
1/24 • Day 1 to the end of study visit (up to Day 392)
The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered as an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57.
|
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