Trial Outcomes & Findings for Dose Escalation, Open-Label Clinical Trial to Evaluate Safety, Tolerability and Immunogenicity of a Nipah Virus (NiV) mRNA Vaccine, mRNA-1215, in Healthy Adults (NCT NCT05398796)
NCT ID: NCT05398796
Last Updated: 2025-10-23
Results Overview
Participants recorded the occurrence of solicited local symptoms on a diary card for 7 days after study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of participants reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, modified from FDA Guidance - September 2007.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
7 days after product administration
Results posted on
2025-10-23
Participant Flow
Participant milestones
| Measure |
Group 1
mRNA-1215 25 mcg IM, 2 injections 4 weeks apart
|
Group 2
mRNA-1215 50 mcg IM, 2 injections 4 weeks apart
|
Group 3
mRNA-1215 100 mcg IM, 2 injections 4 weeks apart
|
Group 4
mRNA-1215 10 mcg IM, 2 injections 4 weeks apart
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
10
|
|
Overall Study
Completed Product Administration
|
10
|
10
|
10
|
9
|
|
Overall Study
COMPLETED
|
10
|
9
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Group 1
mRNA-1215 25 mcg IM, 2 injections 4 weeks apart
|
Group 2
mRNA-1215 50 mcg IM, 2 injections 4 weeks apart
|
Group 3
mRNA-1215 100 mcg IM, 2 injections 4 weeks apart
|
Group 4
mRNA-1215 10 mcg IM, 2 injections 4 weeks apart
|
|---|---|---|---|---|
|
Overall Study
Participant moved from the area
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Dose Escalation, Open-Label Clinical Trial to Evaluate Safety, Tolerability and Immunogenicity of a Nipah Virus (NiV) mRNA Vaccine, mRNA-1215, in Healthy Adults
Baseline characteristics by cohort
| Measure |
Group 1
n=10 Participants
mRNA -1215: 25 mcg IM, 2 injections 4 weeks apart
|
Group 2
n=10 Participants
mRNA -1215: 50 mcg IM, 2 injections 4 weeks apart
|
Group 3
n=10 Participants
mRNA -1215: 100 mcg IM, 2 injections 4 weeks apart
|
Group 4
n=10 Participants
mRNA -1215: 10 mcg IM, 2 injections 4 weeks apart
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
33.9 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
40.9 years
STANDARD_DEVIATION 11.1 • n=7 Participants
|
36.2 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
38.5 years
STANDARD_DEVIATION 11.1 • n=4 Participants
|
37.4 years
STANDARD_DEVIATION 10.6 • n=21 Participants
|
|
Age, Customized
18-20
|
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
|
|
Age, Customized
21-30
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Age, Customized
31-40
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Age, Customized
41-50
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Age, Customized
51-60
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
38 Participants
n=21 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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
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
|
|
Body Mass Index (BMI), Mean
|
27.4 kg/m^2
STANDARD_DEVIATION 2.9 • n=5 Participants
|
25.4 kg/m^2
STANDARD_DEVIATION 3.5 • n=7 Participants
|
26.2 kg/m^2
STANDARD_DEVIATION 4.1 • n=5 Participants
|
27.1 kg/m^2
STANDARD_DEVIATION 4.4 • n=4 Participants
|
26.5 kg/m^2
STANDARD_DEVIATION 3.7 • n=21 Participants
|
|
Body Mass Index (BMI)
Under 18.5
|
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
|
|
Body Mass Index (BMI)
18.5-24.9
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Body Mass Index (BMI)
25.0-29.9
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Body Mass Index (BMI)
30.0-35
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Body Mass Index (BMI)
Missing
|
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
|
|
Education
Less than high school graduate
|
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
|
|
Education
High school graduate/GED
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Education
College/University
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Education
Advanced degree
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Education
Not Collected
|
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
|
|
NIH Employee
No
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
NIH Employee
Yes
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
NIH Employee
Declined to Respond
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 7 days after product administrationPopulation: Population included all enrolled participants who received study product and provided safety data (via diary card and/or laboratory results) following vaccine administration (N=40).
Participants recorded the occurrence of solicited local symptoms on a diary card for 7 days after study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of participants reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, modified from FDA Guidance - September 2007.
Outcome measures
| Measure |
Group 1
n=10 Participants
mRNA-1215 25 mcg IM, 2 injections 4 weeks apart
|
Group 2
n=10 Participants
mRNA-1215 50 mcg IM, 2 injections 4 weeks apart
|
Group 3
n=10 Participants
mRNA-1215 100 mcg IM, 2 injections 4 weeks apart
|
Group 4
n=10 Participants
mRNA-1215 10 mcg IM, 2 injections 4 weeks apart
|
|---|---|---|---|---|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Pain/Tenderness · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Pain/Tenderness · None
|
1 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Pain/Tenderness · Mild
|
9 Participants
|
9 Participants
|
9 Participants
|
6 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Pain/Tenderness · Moderate
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Swelling · None
|
10 Participants
|
10 Participants
|
9 Participants
|
10 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Swelling · Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Swelling · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Swelling · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Redness · None
|
10 Participants
|
10 Participants
|
8 Participants
|
10 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Redness · Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Redness · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Redness · Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Pruritus · None
|
9 Participants
|
10 Participants
|
9 Participants
|
9 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Pruritus · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Pruritus · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Axillary Lymphadenopathy Ipsilateral · None
|
10 Participants
|
10 Participants
|
10 Participants
|
9 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Axillary Lymphadenopathy Ipsilateral · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Axillary Lymphadenopathy Ipsilateral · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Axillary Lymphadenopathy Ipsilateral · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Any Local Symptom · None
|
1 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Any Local Symptom · Mild
|
9 Participants
|
9 Participants
|
8 Participants
|
6 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Any Local Symptom · Moderate
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Pruritus · Mild
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Any Local Symptom · Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 7 days after product administrationPopulation: Population included all enrolled participants who received study product and provided safety data (via diary card and/or laboratory results) following vaccine administration (N=40)
Participants recorded the occurrence of solicited systemic symptoms on a diary card for 7 days after study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of participants reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, modified from FDA Guidance - September 2007.
Outcome measures
| Measure |
Group 1
n=10 Participants
mRNA-1215 25 mcg IM, 2 injections 4 weeks apart
|
Group 2
n=10 Participants
mRNA-1215 50 mcg IM, 2 injections 4 weeks apart
|
Group 3
n=10 Participants
mRNA-1215 100 mcg IM, 2 injections 4 weeks apart
|
Group 4
n=10 Participants
mRNA-1215 10 mcg IM, 2 injections 4 weeks apart
|
|---|---|---|---|---|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Temperature · Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Temperature · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Temperature · Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Joint Pain · None
|
9 Participants
|
9 Participants
|
7 Participants
|
9 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Joint Pain · Mild
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Joint Pain · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Joint Pain · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Any Systemic Symptom · Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Malaise · Mild
|
2 Participants
|
6 Participants
|
6 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Headache · None
|
6 Participants
|
6 Participants
|
4 Participants
|
9 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Headache · Mild
|
4 Participants
|
3 Participants
|
6 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Headache · Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Headache · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Chills · None
|
9 Participants
|
9 Participants
|
6 Participants
|
9 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Chills · Mild
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Chills · Moderate
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Chills · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Malaise · None
|
8 Participants
|
4 Participants
|
2 Participants
|
8 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Myalgia · None
|
9 Participants
|
6 Participants
|
4 Participants
|
8 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Malaise · Moderate
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Malaise · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Myalgia · Mild
|
1 Participants
|
4 Participants
|
5 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Myalgia · Moderate
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Myalgia · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Nausea · None
|
8 Participants
|
8 Participants
|
8 Participants
|
9 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Temperature · None
|
10 Participants
|
10 Participants
|
8 Participants
|
10 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Nausea · Mild
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Nausea · Moderate
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Nausea · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Any Systemic Symptom · None
|
6 Participants
|
4 Participants
|
2 Participants
|
7 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Any Systemic Symptom · Mild
|
4 Participants
|
5 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Any Systemic Symptom · Moderate
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 0 after product administration through Day 392, up to Week 56Population: Population included all enrolled participants who received study product (N=40).
SAEs were recorded from receipt of product administration through the last study visit at Week 56. The relationship between a SAE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Outcome measures
| Measure |
Group 1
n=10 Participants
mRNA-1215 25 mcg IM, 2 injections 4 weeks apart
|
Group 2
n=10 Participants
mRNA-1215 50 mcg IM, 2 injections 4 weeks apart
|
Group 3
n=10 Participants
mRNA-1215 100 mcg IM, 2 injections 4 weeks apart
|
Group 4
n=10 Participants
mRNA-1215 10 mcg IM, 2 injections 4 weeks apart
|
|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events Following Product Administration
Unrelated to Study Product
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Serious Adverse Events Following Product Administration
Total Number of Participants who had SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Serious Adverse Events Following Product Administration
Total number of Participants who did not have SAE
|
10 Participants
|
10 Participants
|
10 Participants
|
10 Participants
|
|
Number of Participants With Serious Adverse Events Following Product Administration
Related to Study Product
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 0 through 28 days post product administration, up to Week 4Population: Population included all enrolled participants who received study product (N=40).
Unsolicited AEs and attribution assessments were recorded in the study database from receipt of study product administration through the visit scheduled for 4 weeks after study product administration. At other time periods greater than 4 weeks after the study product administration, only serious AEs (SAEs reported as a separate outcome and in the AE module) and new chronic medical conditions were recorded through the last study visit. The relationship between an AE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Outcome measures
| Measure |
Group 1
n=10 Participants
mRNA-1215 25 mcg IM, 2 injections 4 weeks apart
|
Group 2
n=10 Participants
mRNA-1215 50 mcg IM, 2 injections 4 weeks apart
|
Group 3
n=10 Participants
mRNA-1215 100 mcg IM, 2 injections 4 weeks apart
|
Group 4
n=10 Participants
mRNA-1215 10 mcg IM, 2 injections 4 weeks apart
|
|---|---|---|---|---|
|
Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration
Related to Study Product
|
0 participants
|
1 participants
|
5 participants
|
3 participants
|
|
Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration
Unrelated to Study Product
|
5 participants
|
5 participants
|
7 participants
|
7 participants
|
|
Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration
Total Number of Participants who had One or More Non-Serious Unsolicited AE
|
5 participants
|
5 participants
|
7 participants
|
8 participants
|
PRIMARY outcome
Timeframe: Day 0 after product administration through Day 392, up to Week 56Population: Population included all enrolled participants who received study product (N=40)
New chronic medical conditions that required ongoing medical management were recorded from receipt of study product administration through the last expected study visit through Day 392, up to Week 56. The relationship between a new chronic medical condition and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity
Outcome measures
| Measure |
Group 1
n=10 Participants
mRNA-1215 25 mcg IM, 2 injections 4 weeks apart
|
Group 2
n=10 Participants
mRNA-1215 50 mcg IM, 2 injections 4 weeks apart
|
Group 3
n=10 Participants
mRNA-1215 100 mcg IM, 2 injections 4 weeks apart
|
Group 4
n=10 Participants
mRNA-1215 10 mcg IM, 2 injections 4 weeks apart
|
|---|---|---|---|---|
|
Number of Participants With New Chronic Medical Conditions Following Product Administration
Related to Study Product
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With New Chronic Medical Conditions Following Product Administration
Unrelated to Study Product
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With New Chronic Medical Conditions Following Product Administration
Number of Participants With New Chronic Medical Condition
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With New Chronic Medical Conditions Following Product Administration
Number of Participants With No New Chronic Medical Condition
|
10 Participants
|
10 Participants
|
10 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: Day 0 after product administration through Day 392, up to Week 56Population: Population included all enrolled participants who received study product (N=40)
An AESI is an AE (serious or nonserious) of scientific medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the investigator to the Sponsor is required.
Outcome measures
| Measure |
Group 1
n=10 Participants
mRNA-1215 25 mcg IM, 2 injections 4 weeks apart
|
Group 2
n=10 Participants
mRNA-1215 50 mcg IM, 2 injections 4 weeks apart
|
Group 3
n=10 Participants
mRNA-1215 100 mcg IM, 2 injections 4 weeks apart
|
Group 4
n=10 Participants
mRNA-1215 10 mcg IM, 2 injections 4 weeks apart
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events of Special Interest (AESI) Following Product Administration
Anaphylaxis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events of Special Interest (AESI) Following Product Administration
Myocarditis and Pericarditis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: First vaccination to 6 monthsPopulation: Population included all enrolled participants who received study product (N=40)
MAAEs are defined as adverse events leading to hospitalization, an emergency room visit or an otherwise unscheduled visit to or from medical personnel, for any reason.
Outcome measures
| Measure |
Group 1
n=10 Participants
mRNA-1215 25 mcg IM, 2 injections 4 weeks apart
|
Group 2
n=10 Participants
mRNA-1215 50 mcg IM, 2 injections 4 weeks apart
|
Group 3
n=10 Participants
mRNA-1215 100 mcg IM, 2 injections 4 weeks apart
|
Group 4
n=10 Participants
mRNA-1215 10 mcg IM, 2 injections 4 weeks apart
|
|---|---|---|---|---|
|
Number of Participants With Medically Attended Adverse Events (MAAEs) Following Product Administration
VERTEBRAL DISC HERNIATION
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Medically Attended Adverse Events (MAAEs) Following Product Administration
MUSCLE STRAIN
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Medically Attended Adverse Events (MAAEs) Following Product Administration
UPPER RESPIRATORY INFECTION
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Medically Attended Adverse Events (MAAEs) Following Product Administration
LIGAMENT TEAR
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Medically Attended Adverse Events (MAAEs) Following Product Administration
URTICARIA
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Medically Attended Adverse Events (MAAEs) Following Product Administration
PARONYCHIA
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Medically Attended Adverse Events (MAAEs) Following Product Administration
WHIPLASH
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 0 after product administration through Day 392, up to Week 56Population: \*Abnormal Laboratory Measures of Safety Following Product Administration. Participants are counted once for each category at the highest severity of AE regardless of the number of events or attribution to study vaccine.
Abnormal lab results recorded as unsolicited adverse events (AEs) are summarized\*. Safety lab parameters included pregnancy test, hematology and chemistry labs, and HIV Serology diagnostic test. Institutional lab normal ranges as well as Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials FDA Guidance, September 2007 were used.
Outcome measures
| Measure |
Group 1
n=10 Participants
mRNA-1215 25 mcg IM, 2 injections 4 weeks apart
|
Group 2
n=10 Participants
mRNA-1215 50 mcg IM, 2 injections 4 weeks apart
|
Group 3
n=10 Participants
mRNA-1215 100 mcg IM, 2 injections 4 weeks apart
|
Group 4
n=10 Participants
mRNA-1215 10 mcg IM, 2 injections 4 weeks apart
|
|---|---|---|---|---|
|
Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration
ELEVATED AST : Total
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration
ANEMIA : Severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration
ANEMIA : Total
|
1 participants
|
3 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration
ELEVATED AST : Mild
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration
ELEVATED AST : Severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration
HYPERBILIRUBINEMIA : Severe
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration
LEUKOPENIA : Mild
|
1 participants
|
1 participants
|
2 participants
|
1 participants
|
|
Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration
LEUKOPENIA : Moderate
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration
LEUKOPENIA : Severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration
NEUTROPENIA : Severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration
NEUTROPENIA : Total
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration
ELEVATED AST : Moderate
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration
ANEMIA : Mild
|
1 participants
|
2 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration
ANEMIA : Moderate
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration
HYPERBILIRUBINEMIA : Mild
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration
HYPERBILIRUBINEMIA : Moderate
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration
HYPERBILIRUBINEMIA : Total
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration
LEUKOPENIA : Total
|
1 participants
|
1 participants
|
2 participants
|
2 participants
|
|
Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration
NEUTROPENIA : Mild
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration
NEUTROPENIA : Moderate
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Serum samples collected at baseline (Week 0) and at two weeks after the second product administration (Week 6).Population: Baseline analyses included all study participants who received the first dose (N=40) and Week 6 analyses included all study participants who received both the first and the second doses (N=38). One participant in 10 mcg dose group received only one vaccination and one participant in 25 mcg dose group missed Week 6 visit.
Vaccine-induced binding antibody titers against Pre-F antigen of Nipah virus Malaysia strain (NiV(M)) were measured by ELISA. The value of the antibody response was determined by obtaining half of the maximum effective concentration (EC50) titer from the optical density 450 nm curves for the function of the reciprocal dilution using a four-parameter logistic curve fit in Prism (version 10.2.2). NiV Pre-F EC50 titers were normalized using the World Health Organization (WHO)/National Institute for Biological Standards and Control (NIBSC) international standard (IS, NIBSC code 22/130) and are reported as group geometric mean titers (GMTs) and 95% confidence intervals (CIs) in international units per milliliter (IU/ml).
Outcome measures
| Measure |
Group 1
n=10 Participants
mRNA-1215 25 mcg IM, 2 injections 4 weeks apart
|
Group 2
n=10 Participants
mRNA-1215 50 mcg IM, 2 injections 4 weeks apart
|
Group 3
n=10 Participants
mRNA-1215 100 mcg IM, 2 injections 4 weeks apart
|
Group 4
n=10 Participants
mRNA-1215 10 mcg IM, 2 injections 4 weeks apart
|
|---|---|---|---|---|
|
Geometric Mean NiV(M) Pre-F Binding Antibody Titer (GMTs) and 95% Confidence Intervals (CIs).
Week 0
|
4.44 IU/mL
Interval 1.98 to 9.95
|
1.28 IU/mL
Interval 0.83 to 1.97
|
1.83 IU/mL
Interval 1.2 to 2.8
|
3.03 IU/mL
Interval 1.94 to 4.74
|
|
Geometric Mean NiV(M) Pre-F Binding Antibody Titer (GMTs) and 95% Confidence Intervals (CIs).
Week 6
|
1941.62 IU/mL
Interval 1168.0 to 3227.66
|
1885.99 IU/mL
Interval 1025.75 to 3467.66
|
1411.64 IU/mL
Interval 1008.13 to 1976.66
|
923.47 IU/mL
Interval 526.95 to 1618.34
|
SECONDARY outcome
Timeframe: Serum samples collected at baseline (Week 0) and at two weeks after the second product administration (Week 6).Population: Baseline analyses included all study participants who received the first dose (N=40) and Week 6 analyses included all study participants who received both the first and the second doses (N=38). One participant in 10 mcg dose group received only one vaccination and one participant in 25 mcg dose group missed Week 6 visit.
Vaccine-induced binding antibody titers against G antigen of Nipah virus Malaysia strain (NiV(M)) were measured by ELISA. The value of the antibody response was determined by obtaining half of the maximum effective concentration (EC50) titer from the optical density 450 nm curves for the function of the reciprocal dilution using a four-parameter logistic curve fit in Prism (version 10.2.2). NiV G EC50 titers were normalized using the World Health Organization (WHO)/National Institute for Biological Standards and Control (NIBSC) international standard (IS, NIBSC code 22/130) and are reported as group geometric mean titers (GMTs) and 95% confidence intervals (CIs) in international units per milliliter (IU/ml).
Outcome measures
| Measure |
Group 1
n=10 Participants
mRNA-1215 25 mcg IM, 2 injections 4 weeks apart
|
Group 2
n=10 Participants
mRNA-1215 50 mcg IM, 2 injections 4 weeks apart
|
Group 3
n=10 Participants
mRNA-1215 100 mcg IM, 2 injections 4 weeks apart
|
Group 4
n=10 Participants
mRNA-1215 10 mcg IM, 2 injections 4 weeks apart
|
|---|---|---|---|---|
|
Geometric Mean NiV(M) G Binding Antibody Titer (GMTs) and 95% Confidence Intervals (CIs).
Week 0
|
12.48 IU/mL
Interval 4.93 to 31.57
|
2.84 IU/mL
Interval 1.72 to 4.68
|
4.12 IU/mL
Interval 2.48 to 6.86
|
6.91 IU/mL
Interval 4.14 to 11.54
|
|
Geometric Mean NiV(M) G Binding Antibody Titer (GMTs) and 95% Confidence Intervals (CIs).
Week 6
|
4626.43 IU/mL
Interval 2962.81 to 7224.18
|
5013 IU/mL
Interval 2717.16 to 9248.69
|
4279.39 IU/mL
Interval 3293.62 to 5560.2
|
2403.1 IU/mL
Interval 1311.35 to 4403.76
|
Adverse Events
Group 1
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Group 2
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Group 3
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Group 4
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1
n=10 participants at risk
mRNA-1215 25 mcg IM, 2 injections 4 weeks apart
|
Group 2
n=10 participants at risk
mRNA-1215 50 mcg IM, 2 injections 4 weeks apart
|
Group 3
n=10 participants at risk
mRNA-1215 100 mcg IM, 2 injections 4 weeks apart
|
Group 4
n=10 participants at risk
mRNA-1215 10 mcg IM, 2 injections 4 weeks apart
|
|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
10.0%
1/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
10.0%
1/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
10.0%
1/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
20.0%
2/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
10.0%
1/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Vascular disorders
Hypertension
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
10.0%
1/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
20.0%
2/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
General disorders
Malaise
|
20.0%
2/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
60.0%
6/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
80.0%
8/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
20.0%
2/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
1/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
40.0%
4/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
60.0%
6/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
20.0%
2/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Nervous system disorders
Headache
|
40.0%
4/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
40.0%
4/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
60.0%
6/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
10.0%
1/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
General disorders
Chills
|
10.0%
1/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
10.0%
1/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
40.0%
4/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
10.0%
1/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
2/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
20.0%
2/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
20.0%
2/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
10.0%
1/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
General disorders
Pyrexia
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
20.0%
2/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
1/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
10.0%
1/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
30.0%
3/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
10.0%
1/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
General disorders
Administration site pain
|
90.0%
9/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
90.0%
9/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
90.0%
9/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
60.0%
6/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
General disorders
Administration site swelling
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
10.0%
1/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
General disorders
Administration site erythema
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
20.0%
2/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
General disorders
Administration site pruritus
|
10.0%
1/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
10.0%
1/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
10.0%
1/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Blood and lymphatic system disorders
Axillary Lymphadenopathy ipsilateral to the injection site
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
10.0%
1/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Blood and lymphatic system disorders
Anemia
|
10.0%
1/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
30.0%
3/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
10.0%
1/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Blood and lymphatic system disorders
Leukopenia
|
10.0%
1/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
10.0%
1/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
20.0%
2/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
20.0%
2/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Blood and lymphatic system disorders
Neutropenia
|
10.0%
1/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
10.0%
1/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
10.0%
1/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
General disorders
Injection site bruising
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
10.0%
1/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
10.0%
1/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
10.0%
1/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Infections and infestations
COVID-19
|
10.0%
1/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Infections and infestations
Paronychia
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
10.0%
1/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Infections and infestations
Respiratory synctial virus infection
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
10.0%
1/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Infections and infestations
Upper Respiratory Tract infection
|
20.0%
2/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
10.0%
1/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
20.0%
2/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Injury, poisoning and procedural complications
Anthropod sting
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
10.0%
1/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
10.0%
1/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
10.0%
1/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
10.0%
1/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
10.0%
1/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
1/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
10.0%
1/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/10 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 56)
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
Additional Information
Lesia K. Dropulic, M.D./Principal Investigator; Laura Novik, R.N., M.A./Study Coordinator
Vaccine Research Center Clinical Trials Program, NIAID
Phone: 301-451-8717
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place