Trial Outcomes & Findings for Evaluating the Safety and Serum Concentrations of a Human Monoclonal Antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), Administered in Multiple Doses and Routes to Healthy, HIV-uninfected Adults (NCT NCT03387150)
NCT ID: NCT03387150
Last Updated: 2023-04-05
Results Overview
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
124 participants
Primary outcome timeframe
Measured through 3 days after each vaccine dose at Weeks 0, 16, 32, 48, 64
Results posted on
2023-04-05
Participant Flow
Participant milestones
| Measure |
Group 1: Vaccine
VRC07-523LS IV-2.5 mg/kg wks(0,16,32,48,64)
|
Group 2: Vaccine
VRC07-523LS IV-5 mg/kg wks(0,16,32,48,64)
|
Group 3: Vaccine
VRC07-523LS IV-20 mg/kg wks(0,16,32,48,64)
|
Group 4: Vaccine
VRC07-523LS SC-2.5 mg/kg wks(0,16,32,48,64)
|
Group 5: Vaccine
VRC07-523LS SC-5 mg/kg wks(0,16,32,48,64)
|
Group 6: Vaccine
VRC07-523LS IM-2.5 mg/kg wks(0,16,32,48,64)
|
Group 7: Placebo
IM-0.9% Sodium Chloride wks(0,16,32,48,64)
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
19
|
19
|
21
|
21
|
20
|
21
|
3
|
|
Overall Study
Safety Population
|
19
|
19
|
21
|
21
|
20
|
21
|
3
|
|
Overall Study
COMPLETED
|
13
|
16
|
16
|
14
|
14
|
14
|
3
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
5
|
7
|
6
|
7
|
0
|
Reasons for withdrawal
| Measure |
Group 1: Vaccine
VRC07-523LS IV-2.5 mg/kg wks(0,16,32,48,64)
|
Group 2: Vaccine
VRC07-523LS IV-5 mg/kg wks(0,16,32,48,64)
|
Group 3: Vaccine
VRC07-523LS IV-20 mg/kg wks(0,16,32,48,64)
|
Group 4: Vaccine
VRC07-523LS SC-2.5 mg/kg wks(0,16,32,48,64)
|
Group 5: Vaccine
VRC07-523LS SC-5 mg/kg wks(0,16,32,48,64)
|
Group 6: Vaccine
VRC07-523LS IM-2.5 mg/kg wks(0,16,32,48,64)
|
Group 7: Placebo
IM-0.9% Sodium Chloride wks(0,16,32,48,64)
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
3
|
4
|
1
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
2
|
3
|
3
|
3
|
0
|
|
Overall Study
Participant unable to adhere to visit
|
0
|
1
|
0
|
0
|
2
|
2
|
0
|
Baseline Characteristics
Evaluating the Safety and Serum Concentrations of a Human Monoclonal Antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), Administered in Multiple Doses and Routes to Healthy, HIV-uninfected Adults
Baseline characteristics by cohort
| Measure |
Group 1: Vaccine
n=19 Participants
VRC07-523LS IV-2.5 mg/kg wks(0,16,32,48,64)
|
Group 2: Vaccine
n=19 Participants
VRC07-523LS IV-5 mg/kg wks(0,16,32,48,64)
|
Group 3: Vaccine
n=21 Participants
VRC07-523LS IV-20 mg/kg wks(0,16,32,48,64)
|
Group 4: Vaccine
n=21 Participants
VRC07-523LS SC-2.5 mg/kg wks(0,16,32,48,64)
|
Group 5: Vaccine
n=20 Participants
VRC07-523LS SC-5 mg/kg wks(0,16,32,48,64)
|
Group 6: Vaccine
n=21 Participants
VRC07-523LS IM-2.5 mg/kg wks(0,16,32,48,64)
|
Group 7: Placebo
n=3 Participants
IM-0.9% Sodium Chloride wks(0,16,32,48,64)
|
Total
n=124 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
30 years
n=5 Participants
|
30 years
n=7 Participants
|
23 years
n=5 Participants
|
29 years
n=4 Participants
|
27 years
n=21 Participants
|
27 years
n=8 Participants
|
31 years
n=8 Participants
|
28 years
n=24 Participants
|
|
Age, Customized
Less than 18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Age, Customized
18 - 20 years
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
14 Participants
n=24 Participants
|
|
Age, Customized
21 - 30 years
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
66 Participants
n=24 Participants
|
|
Age, Customized
31 - 40 years
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
28 Participants
n=24 Participants
|
|
Age, Customized
41 - 50 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
16 Participants
n=24 Participants
|
|
Age, Customized
Above 50 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Age, Customized
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
75 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
49 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
12 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
112 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
28 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
71 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
11 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
|
Region of Enrollment
USA
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
124 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Measured through 3 days after each vaccine dose at Weeks 0, 16, 32, 48, 64Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented
Outcome measures
| Measure |
Group 1: Vaccine
n=19 Participants
VRC07-523LS IV-2.5 mg/kg wks(0,16,32,48,64)
|
Group 2: Vaccine
n=19 Participants
VRC07-523LS IV-5 mg/kg wks(0,16,32,48,64)
|
Group 3: Vaccine
n=21 Participants
VRC07-523LS IV-20 mg/kg wks(0,16,32,48,64)
|
Group 4: Vaccine
n=21 Participants
VRC07-523LS SC-2.5 mg/kg wks(0,16,32,48,64)
|
Group 5: Vaccine
n=20 Participants
VRC07-523LS SC-5 mg/kg wks(0,16,32,48,64)
|
Group 6: Vaccine
n=21 Participants
VRC07-523LS IM-2.5 mg/kg wks(0,16,32,48,64)
|
Group 7: Placebo
n=3 Participants
IM-0.9% Sodium Chloride wks(0,16,32,48,64)
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
None
|
12 Participants
|
11 Participants
|
15 Participants
|
8 Participants
|
5 Participants
|
7 Participants
|
2 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Mild
|
6 Participants
|
8 Participants
|
5 Participants
|
11 Participants
|
15 Participants
|
13 Participants
|
1 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Moderate
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through 3 days after each vaccine dose at Weeks 0, 16, 32, 48, 64Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented
Outcome measures
| Measure |
Group 1: Vaccine
n=19 Participants
VRC07-523LS IV-2.5 mg/kg wks(0,16,32,48,64)
|
Group 2: Vaccine
n=19 Participants
VRC07-523LS IV-5 mg/kg wks(0,16,32,48,64)
|
Group 3: Vaccine
n=21 Participants
VRC07-523LS IV-20 mg/kg wks(0,16,32,48,64)
|
Group 4: Vaccine
n=21 Participants
VRC07-523LS SC-2.5 mg/kg wks(0,16,32,48,64)
|
Group 5: Vaccine
n=20 Participants
VRC07-523LS SC-5 mg/kg wks(0,16,32,48,64)
|
Group 6: Vaccine
n=21 Participants
VRC07-523LS IM-2.5 mg/kg wks(0,16,32,48,64)
|
Group 7: Placebo
n=3 Participants
IM-0.9% Sodium Chloride wks(0,16,32,48,64)
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Gr 4: complications AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · None
|
14 Participants
|
15 Participants
|
16 Participants
|
7 Participants
|
7 Participants
|
19 Participants
|
3 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Not gradable
|
3 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Gr 1: 2.5 - less than 5cm dim.
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Gr 1: 6.25 - less than 25cm^2 area
|
1 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Gr 2: 5 - less than 10cm dim.
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Gr 2: 25 - less than 100cm^2 area
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Gr 3: >= 10cm dim.
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Gr 3: >= 100cm^2 area
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Gr 3: complications AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Gr 4: complications AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · None
|
19 Participants
|
16 Participants
|
20 Participants
|
12 Participants
|
12 Participants
|
18 Participants
|
3 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Not gradable
|
0 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Gr 1: 2.5 - less than 5cm dim.
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Gr 1: 6.25 - less than 25cm^2 area
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Gr 2: 5 - less than 10cm dim.
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Gr 2: 25 - less than 100cm^2 area
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Gr 3: >= 10cm dim.
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Gr 3: >= 100cm^2 area
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Gr 3: complications AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Gr 4: complications AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · None
|
14 Participants
|
15 Participants
|
16 Participants
|
6 Participants
|
6 Participants
|
17 Participants
|
3 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Not gradable
|
3 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Gr 1: 2.5 - less than 5cm dim.
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Gr 1: 6.25 - less than 25cm^2 area
|
1 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Gr 2: 5 - less than 10cm dim.
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Gr 2: 25 - less than 100cm^2 area
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Gr 3: >= 10cm dim.
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Gr 3: >= 100cm^2 area
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Gr 3: complications AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through 3 days after each vaccine dose at Weeks 0, 16, 32, 48, 64Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: malaise and/or fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and body temperature. The item Max. Systemic Symptoms is the maximum of the individual systemic reactogenicities excluding body temperature for a participant.
Outcome measures
| Measure |
Group 1: Vaccine
n=19 Participants
VRC07-523LS IV-2.5 mg/kg wks(0,16,32,48,64)
|
Group 2: Vaccine
n=19 Participants
VRC07-523LS IV-5 mg/kg wks(0,16,32,48,64)
|
Group 3: Vaccine
n=21 Participants
VRC07-523LS IV-20 mg/kg wks(0,16,32,48,64)
|
Group 4: Vaccine
n=21 Participants
VRC07-523LS SC-2.5 mg/kg wks(0,16,32,48,64)
|
Group 5: Vaccine
n=20 Participants
VRC07-523LS SC-5 mg/kg wks(0,16,32,48,64)
|
Group 6: Vaccine
n=21 Participants
VRC07-523LS IM-2.5 mg/kg wks(0,16,32,48,64)
|
Group 7: Placebo
n=3 Participants
IM-0.9% Sodium Chloride wks(0,16,32,48,64)
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · None
|
13 Participants
|
11 Participants
|
4 Participants
|
12 Participants
|
16 Participants
|
13 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Generalized Pruritus · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · None
|
10 Participants
|
10 Participants
|
7 Participants
|
12 Participants
|
13 Participants
|
14 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Mild
|
6 Participants
|
5 Participants
|
7 Participants
|
6 Participants
|
6 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Moderate
|
3 Participants
|
4 Participants
|
5 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Severe
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · None
|
18 Participants
|
16 Participants
|
14 Participants
|
18 Participants
|
17 Participants
|
17 Participants
|
3 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Mild
|
1 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Moderate
|
0 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Mild
|
4 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
4 Participants
|
7 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Moderate
|
2 Participants
|
2 Participants
|
5 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · None
|
15 Participants
|
15 Participants
|
17 Participants
|
16 Participants
|
18 Participants
|
18 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Mild
|
4 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Moderate
|
0 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · None
|
19 Participants
|
17 Participants
|
13 Participants
|
20 Participants
|
18 Participants
|
20 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Mild
|
0 Participants
|
1 Participants
|
5 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Moderate
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · None
|
19 Participants
|
16 Participants
|
14 Participants
|
19 Participants
|
19 Participants
|
19 Participants
|
3 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Mild
|
0 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Moderate
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Facial flushing · None
|
19 Participants
|
18 Participants
|
17 Participants
|
19 Participants
|
19 Participants
|
19 Participants
|
3 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Facial flushing · Mild
|
0 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Facial flushing · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Facial flushing · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Facial flushing · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Non-exertional dyspnea · None
|
19 Participants
|
18 Participants
|
19 Participants
|
21 Participants
|
19 Participants
|
21 Participants
|
3 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Non-exertional dyspnea · Mild
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Non-exertional dyspnea · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Non-exertional dyspnea · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Non-exertional dyspnea · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Non-exertional tachycardia · None
|
19 Participants
|
19 Participants
|
21 Participants
|
21 Participants
|
20 Participants
|
21 Participants
|
3 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Non-exertional tachycardia · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Non-exertional tachycardia · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Non-exertional tachycardia · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Non-exertional tachycardia · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Unexplained diaphoresis · None
|
19 Participants
|
19 Participants
|
19 Participants
|
20 Participants
|
19 Participants
|
21 Participants
|
3 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Unexplained diaphoresis · Mild
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Unexplained diaphoresis · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Unexplained diaphoresis · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Unexplained diaphoresis · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Generalized Pruritus · None
|
19 Participants
|
19 Participants
|
21 Participants
|
21 Participants
|
19 Participants
|
21 Participants
|
3 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Generalized Pruritus · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Generalized Pruritus · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Generalized Pruritus · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Urticaria · None
|
19 Participants
|
19 Participants
|
21 Participants
|
21 Participants
|
20 Participants
|
21 Participants
|
3 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Urticaria · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Urticaria · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Urticaria · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Urticaria · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · None
|
8 Participants
|
5 Participants
|
4 Participants
|
10 Participants
|
11 Participants
|
8 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Mild
|
7 Participants
|
9 Participants
|
8 Participants
|
5 Participants
|
8 Participants
|
10 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Moderate
|
4 Participants
|
5 Participants
|
7 Participants
|
6 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Severe
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · None
|
17 Participants
|
18 Participants
|
18 Participants
|
21 Participants
|
20 Participants
|
20 Participants
|
3 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Mild
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured during screening, Days 0, 56, 112, 168, 224, 280, 336, 392, 448, 504, 728Population: 'Overall Number of Participants Analyzed' represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Outcome measures
| Measure |
Group 1: Vaccine
n=19 Participants
VRC07-523LS IV-2.5 mg/kg wks(0,16,32,48,64)
|
Group 2: Vaccine
n=19 Participants
VRC07-523LS IV-5 mg/kg wks(0,16,32,48,64)
|
Group 3: Vaccine
n=21 Participants
VRC07-523LS IV-20 mg/kg wks(0,16,32,48,64)
|
Group 4: Vaccine
n=21 Participants
VRC07-523LS SC-2.5 mg/kg wks(0,16,32,48,64)
|
Group 5: Vaccine
n=20 Participants
VRC07-523LS SC-5 mg/kg wks(0,16,32,48,64)
|
Group 6: Vaccine
n=21 Participants
VRC07-523LS IM-2.5 mg/kg wks(0,16,32,48,64)
|
Group 7: Placebo
n=3 Participants
IM-0.9% Sodium Chloride wks(0,16,32,48,64)
|
|---|---|---|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT)
ALT (SGPT) (U/L)- Screening
|
16 U/L
Interval 11.0 to 21.0
|
16 U/L
Interval 13.0 to 21.0
|
16 U/L
Interval 12.0 to 21.0
|
14 U/L
Interval 12.0 to 17.0
|
18 U/L
Interval 10.5 to 20.0
|
13 U/L
Interval 13.0 to 20.0
|
13 U/L
Interval 12.0 to 16.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT)
ALT (SGPT) (U/L)- 0/Enrollment
|
14 U/L
Interval 9.0 to 17.0
|
16 U/L
Interval 12.0 to 17.0
|
19 U/L
Interval 12.0 to 22.0
|
13.5 U/L
Interval 10.0 to 21.0
|
13 U/L
Interval 11.5 to 21.5
|
12 U/L
Interval 10.0 to 20.0
|
17 U/L
Interval 15.0 to 33.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT)
ALT (SGPT) (U/L)- 56
|
15 U/L
Interval 10.0 to 23.0
|
16 U/L
Interval 12.0 to 21.0
|
15 U/L
Interval 12.5 to 23.0
|
13 U/L
Interval 10.0 to 21.0
|
15 U/L
Interval 11.0 to 24.0
|
13 U/L
Interval 11.0 to 23.0
|
31 U/L
Interval 13.0 to 114.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT)
ALT (SGPT) (U/L)- 112
|
16 U/L
Interval 11.0 to 18.0
|
20 U/L
Interval 13.0 to 23.0
|
13 U/L
Interval 11.5 to 20.5
|
12 U/L
Interval 12.0 to 18.0
|
16 U/L
Interval 14.0 to 25.0
|
14 U/L
Interval 10.5 to 20.5
|
19 U/L
Interval 16.0 to 42.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT)
ALT (SGPT) (U/L)- 168
|
13.5 U/L
Interval 11.0 to 21.0
|
14.5 U/L
Interval 13.0 to 23.0
|
15 U/L
Interval 10.0 to 21.0
|
14 U/L
Interval 10.0 to 24.5
|
16.5 U/L
Interval 14.0 to 28.0
|
15 U/L
Interval 12.0 to 23.0
|
19 U/L
Interval 13.0 to 38.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT)
ALT (SGPT) (U/L)- 224
|
18 U/L
Interval 10.5 to 22.5
|
17 U/L
Interval 13.0 to 21.0
|
15.5 U/L
Interval 11.5 to 19.5
|
13 U/L
Interval 11.0 to 25.0
|
14 U/L
Interval 12.0 to 20.0
|
14.5 U/L
Interval 12.5 to 19.0
|
17 U/L
Interval 13.0 to 39.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT)
ALT (SGPT) (U/L)- 280
|
16 U/L
Interval 10.0 to 29.0
|
18 U/L
Interval 14.0 to 25.0
|
15 U/L
Interval 13.0 to 20.0
|
15 U/L
Interval 11.0 to 23.0
|
17 U/L
Interval 11.0 to 22.0
|
14 U/L
Interval 11.0 to 23.0
|
18 U/L
Interval 14.0 to 22.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT)
ALT (SGPT) (U/L)- 336
|
15 U/L
Interval 11.0 to 23.0
|
17 U/L
Interval 15.0 to 18.0
|
14.5 U/L
Interval 11.0 to 22.0
|
15 U/L
Interval 11.0 to 20.0
|
16 U/L
Interval 11.5 to 20.0
|
15 U/L
Interval 13.0 to 18.0
|
13 U/L
Interval 11.0 to 41.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT)
ALT (SGPT) (U/L)- 392
|
17 U/L
Interval 10.0 to 34.0
|
16 U/L
Interval 12.0 to 21.0
|
19 U/L
Interval 11.0 to 23.0
|
15 U/L
Interval 10.0 to 24.0
|
16 U/L
Interval 14.0 to 28.0
|
15 U/L
Interval 12.0 to 17.0
|
18 U/L
Interval 14.0 to 39.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT)
ALT (SGPT) (U/L)- 448
|
13 U/L
Interval 11.0 to 20.0
|
16.5 U/L
Interval 13.5 to 20.5
|
17.5 U/L
Interval 13.0 to 19.5
|
16 U/L
Interval 10.0 to 22.0
|
18 U/L
Interval 11.0 to 32.0
|
13 U/L
Interval 11.0 to 18.0
|
16 U/L
Interval 14.0 to 38.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT)
ALT (SGPT) (U/L)- 504
|
12 U/L
Interval 9.0 to 16.0
|
15 U/L
Interval 12.5 to 31.0
|
13.5 U/L
Interval 11.0 to 16.5
|
14.5 U/L
Interval 10.0 to 22.0
|
16.5 U/L
Interval 10.0 to 20.5
|
17 U/L
Interval 12.0 to 21.0
|
15 U/L
Interval 11.0 to 53.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT)
ALT (SGPT) (U/L)- 728
|
19 U/L
Interval 19.0 to 19.0
|
16 U/L
Interval 15.0 to 26.0
|
16 U/L
Interval 13.0 to 28.5
|
18.5 U/L
Interval 15.0 to 20.0
|
18 U/L
Interval 12.5 to 25.0
|
14 U/L
Interval 9.0 to 26.0
|
26 U/L
Interval 26.0 to 26.0
|
PRIMARY outcome
Timeframe: Measured during screening, Days 0, 56, 112, 168, 224, 280, 336, 392, 448, 504, 728Population: 'Overall Number of Participants Analyzed' represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Outcome measures
| Measure |
Group 1: Vaccine
n=19 Participants
VRC07-523LS IV-2.5 mg/kg wks(0,16,32,48,64)
|
Group 2: Vaccine
n=19 Participants
VRC07-523LS IV-5 mg/kg wks(0,16,32,48,64)
|
Group 3: Vaccine
n=21 Participants
VRC07-523LS IV-20 mg/kg wks(0,16,32,48,64)
|
Group 4: Vaccine
n=21 Participants
VRC07-523LS SC-2.5 mg/kg wks(0,16,32,48,64)
|
Group 5: Vaccine
n=20 Participants
VRC07-523LS SC-5 mg/kg wks(0,16,32,48,64)
|
Group 6: Vaccine
n=21 Participants
VRC07-523LS IM-2.5 mg/kg wks(0,16,32,48,64)
|
Group 7: Placebo
n=3 Participants
IM-0.9% Sodium Chloride wks(0,16,32,48,64)
|
|---|---|---|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Creatinine
Creatinine (mg/dL)- Screening
|
0.85 mg/dL
Interval 0.69 to 1.0
|
0.92 mg/dL
Interval 0.78 to 1.0
|
0.84 mg/dL
Interval 0.76 to 0.96
|
0.79 mg/dL
Interval 0.7 to 0.9
|
0.84 mg/dL
Interval 0.77 to 0.91
|
0.86 mg/dL
Interval 0.72 to 0.98
|
0.74 mg/dL
Interval 0.66 to 0.78
|
|
Chemistry and Hematology Laboratory Measures - Creatinine
Creatinine (mg/dL)- 0/Enrollment
|
0.8 mg/dL
Interval 0.76 to 1.05
|
0.93 mg/dL
Interval 0.81 to 1.0
|
0.83 mg/dL
Interval 0.72 to 0.93
|
0.83 mg/dL
Interval 0.78 to 1.02
|
0.8 mg/dL
Interval 0.65 to 0.9
|
0.83 mg/dL
Interval 0.71 to 0.93
|
0.77 mg/dL
Interval 0.64 to 0.81
|
|
Chemistry and Hematology Laboratory Measures - Creatinine
Creatinine (mg/dL)- 56
|
0.84 mg/dL
Interval 0.7 to 1.0
|
0.9 mg/dL
Interval 0.8 to 0.98
|
0.94 mg/dL
Interval 0.75 to 1.02
|
0.82 mg/dL
Interval 0.74 to 0.91
|
0.82 mg/dL
Interval 0.68 to 1.0
|
0.8 mg/dL
Interval 0.74 to 0.97
|
0.7 mg/dL
Interval 0.66 to 0.74
|
|
Chemistry and Hematology Laboratory Measures - Creatinine
Creatinine (mg/dL)- 112
|
0.8 mg/dL
Interval 0.69 to 0.89
|
0.88 mg/dL
Interval 0.79 to 0.94
|
0.88 mg/dL
Interval 0.71 to 1.02
|
0.86 mg/dL
Interval 0.76 to 0.93
|
0.79 mg/dL
Interval 0.7 to 0.96
|
0.84 mg/dL
Interval 0.74 to 0.96
|
0.72 mg/dL
Interval 0.64 to 0.75
|
|
Chemistry and Hematology Laboratory Measures - Creatinine
Creatinine (mg/dL)- 168
|
0.86 mg/dL
Interval 0.75 to 0.92
|
0.91 mg/dL
Interval 0.8 to 1.0
|
0.81 mg/dL
Interval 0.73 to 0.93
|
0.83 mg/dL
Interval 0.77 to 1.0
|
0.81 mg/dL
Interval 0.7 to 0.95
|
0.9 mg/dL
Interval 0.75 to 1.0
|
0.7 mg/dL
Interval 0.68 to 0.79
|
|
Chemistry and Hematology Laboratory Measures - Creatinine
Creatinine (mg/dL)- 224
|
0.79 mg/dL
Interval 0.69 to 0.9
|
0.86 mg/dL
Interval 0.72 to 0.99
|
0.81 mg/dL
Interval 0.72 to 0.95
|
0.81 mg/dL
Interval 0.77 to 0.89
|
0.83 mg/dL
Interval 0.67 to 0.94
|
0.82 mg/dL
Interval 0.73 to 0.97
|
0.72 mg/dL
Interval 0.68 to 0.8
|
|
Chemistry and Hematology Laboratory Measures - Creatinine
Creatinine (mg/dL)- 280
|
0.81 mg/dL
Interval 0.71 to 0.88
|
0.89 mg/dL
Interval 0.77 to 1.07
|
0.78 mg/dL
Interval 0.72 to 0.95
|
0.81 mg/dL
Interval 0.76 to 0.95
|
0.85 mg/dL
Interval 0.7 to 0.9
|
0.89 mg/dL
Interval 0.73 to 0.96
|
0.72 mg/dL
Interval 0.7 to 0.74
|
|
Chemistry and Hematology Laboratory Measures - Creatinine
Creatinine (mg/dL)- 336
|
0.84 mg/dL
Interval 0.69 to 0.9
|
0.85 mg/dL
Interval 0.76 to 0.99
|
0.85 mg/dL
Interval 0.72 to 0.93
|
0.84 mg/dL
Interval 0.77 to 0.95
|
0.87 mg/dL
Interval 0.77 to 1.01
|
0.87 mg/dL
Interval 0.77 to 0.99
|
0.78 mg/dL
Interval 0.7 to 0.89
|
|
Chemistry and Hematology Laboratory Measures - Creatinine
Creatinine (mg/dL)- 392
|
0.88 mg/dL
Interval 0.7 to 0.9
|
0.95 mg/dL
Interval 0.8 to 1.02
|
0.82 mg/dL
Interval 0.8 to 0.96
|
0.85 mg/dL
Interval 0.72 to 0.96
|
0.89 mg/dL
Interval 0.76 to 1.0
|
0.89 mg/dL
Interval 0.8 to 1.0
|
0.75 mg/dL
Interval 0.71 to 0.9
|
|
Chemistry and Hematology Laboratory Measures - Creatinine
Creatinine (mg/dL)- 448
|
0.82 mg/dL
Interval 0.76 to 0.91
|
0.9 mg/dL
Interval 0.81 to 1.0
|
0.8 mg/dL
Interval 0.72 to 0.91
|
0.81 mg/dL
Interval 0.74 to 0.96
|
0.9 mg/dL
Interval 0.74 to 0.97
|
0.84 mg/dL
Interval 0.75 to 0.97
|
0.75 mg/dL
Interval 0.7 to 0.76
|
|
Chemistry and Hematology Laboratory Measures - Creatinine
Creatinine (mg/dL)- 504
|
0.87 mg/dL
Interval 0.76 to 1.06
|
0.92 mg/dL
Interval 0.78 to 1.08
|
0.78 mg/dL
Interval 0.71 to 0.98
|
0.85 mg/dL
Interval 0.78 to 0.95
|
0.8 mg/dL
Interval 0.72 to 0.86
|
0.88 mg/dL
Interval 0.7 to 0.99
|
0.81 mg/dL
Interval 0.7 to 0.84
|
|
Chemistry and Hematology Laboratory Measures - Creatinine
Creatinine (mg/dL)- 728
|
1.1 mg/dL
Interval 1.1 to 1.1
|
1.1 mg/dL
Interval 0.96 to 1.15
|
0.77 mg/dL
Interval 0.68 to 0.92
|
0.87 mg/dL
Interval 0.8 to 1.14
|
0.81 mg/dL
Interval 0.77 to 0.86
|
0.89 mg/dL
Interval 0.78 to 0.92
|
0.66 mg/dL
Interval 0.66 to 0.66
|
PRIMARY outcome
Timeframe: Measured during screening, Days 0, 56, 112, 168, 224, 280, 336, 392, 448, 504, 728Population: 'Overall Number of Participants Analyzed' represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Outcome measures
| Measure |
Group 1: Vaccine
n=19 Participants
VRC07-523LS IV-2.5 mg/kg wks(0,16,32,48,64)
|
Group 2: Vaccine
n=19 Participants
VRC07-523LS IV-5 mg/kg wks(0,16,32,48,64)
|
Group 3: Vaccine
n=21 Participants
VRC07-523LS IV-20 mg/kg wks(0,16,32,48,64)
|
Group 4: Vaccine
n=21 Participants
VRC07-523LS SC-2.5 mg/kg wks(0,16,32,48,64)
|
Group 5: Vaccine
n=20 Participants
VRC07-523LS SC-5 mg/kg wks(0,16,32,48,64)
|
Group 6: Vaccine
n=21 Participants
VRC07-523LS IM-2.5 mg/kg wks(0,16,32,48,64)
|
Group 7: Placebo
n=3 Participants
IM-0.9% Sodium Chloride wks(0,16,32,48,64)
|
|---|---|---|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin
Hemoglobin (g/dL)- 112
|
12.7 g/dL
Interval 11.9 to 13.9
|
13.95 g/dL
Interval 13.1 to 14.7
|
13.6 g/dL
Interval 12.55 to 15.15
|
13.1 g/dL
Interval 12.4 to 13.7
|
13.7 g/dL
Interval 12.6 to 14.6
|
14.45 g/dL
Interval 13.1 to 15.2
|
12.6 g/dL
Interval 12.2 to 14.1
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin
Hemoglobin (g/dL)- 168
|
13.7 g/dL
Interval 12.65 to 14.75
|
14.1 g/dL
Interval 13.0 to 14.8
|
13.65 g/dL
Interval 13.1 to 15.5
|
13.25 g/dL
Interval 12.05 to 13.85
|
13.5 g/dL
Interval 13.0 to 14.7
|
14.5 g/dL
Interval 12.4 to 15.1
|
12.8 g/dL
Interval 12.3 to 13.8
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin
Hemoglobin (g/dL)- 224
|
12.95 g/dL
Interval 12.3 to 13.8
|
13.7 g/dL
Interval 12.9 to 14.8
|
13.2 g/dL
Interval 12.5 to 14.95
|
13.5 g/dL
Interval 11.9 to 14.2
|
13.6 g/dL
Interval 13.3 to 14.7
|
14.15 g/dL
Interval 12.3 to 15.0
|
13.1 g/dL
Interval 11.8 to 13.3
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin
Hemoglobin (g/dL)- Screening
|
13.3 g/dL
Interval 12.7 to 14.0
|
14.2 g/dL
Interval 13.5 to 15.3
|
13.8 g/dL
Interval 13.3 to 14.8
|
13.1 g/dL
Interval 12.7 to 14.1
|
13.8 g/dL
Interval 13.15 to 15.1
|
14.4 g/dL
Interval 13.0 to 15.2
|
13.4 g/dL
Interval 12.1 to 14.1
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin
Hemoglobin (g/dL)- 0/Enrollment
|
13.1 g/dL
Interval 12.3 to 14.2
|
13.9 g/dL
Interval 12.6 to 14.7
|
13.8 g/dL
Interval 12.8 to 14.5
|
13 g/dL
Interval 12.25 to 13.7
|
13.55 g/dL
Interval 13.0 to 15.2
|
14.1 g/dL
Interval 12.6 to 15.0
|
12.5 g/dL
Interval 11.7 to 13.4
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin
Hemoglobin (g/dL)- 56
|
13.35 g/dL
Interval 12.7 to 13.8
|
14.25 g/dL
Interval 13.6 to 15.1
|
13.4 g/dL
Interval 12.45 to 14.85
|
12.9 g/dL
Interval 12.5 to 13.9
|
13.8 g/dL
Interval 12.8 to 14.6
|
14.4 g/dL
Interval 12.0 to 14.9
|
12.6 g/dL
Interval 12.0 to 13.1
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin
Hemoglobin (g/dL)- 280
|
13.3 g/dL
Interval 12.6 to 14.0
|
13.7 g/dL
Interval 13.1 to 14.4
|
13.1 g/dL
Interval 12.9 to 14.7
|
13.3 g/dL
Interval 12.1 to 14.3
|
13.6 g/dL
Interval 12.9 to 14.6
|
14.2 g/dL
Interval 11.8 to 14.9
|
13.3 g/dL
Interval 12.2 to 14.4
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin
Hemoglobin (g/dL)- 336
|
13.3 g/dL
Interval 12.5 to 14.4
|
13.6 g/dL
Interval 12.4 to 14.8
|
13.3 g/dL
Interval 12.3 to 15.0
|
13.3 g/dL
Interval 12.5 to 14.2
|
13.5 g/dL
Interval 12.75 to 15.2
|
14.2 g/dL
Interval 13.4 to 15.1
|
12.9 g/dL
Interval 12.2 to 13.5
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin
Hemoglobin (g/dL)- 392
|
13.3 g/dL
Interval 12.4 to 14.2
|
14.2 g/dL
Interval 13.2 to 14.8
|
13.5 g/dL
Interval 12.6 to 15.3
|
13.4 g/dL
Interval 12.5 to 14.3
|
13.5 g/dL
Interval 13.0 to 14.7
|
14.3 g/dL
Interval 12.6 to 14.9
|
12.6 g/dL
Interval 12.6 to 14.9
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin
Hemoglobin (g/dL)- 448
|
12.9 g/dL
Interval 12.5 to 13.5
|
13.95 g/dL
Interval 12.85 to 14.55
|
13.3 g/dL
Interval 12.2 to 14.4
|
13.3 g/dL
Interval 12.3 to 13.9
|
13.6 g/dL
Interval 12.7 to 14.8
|
14.2 g/dL
Interval 12.3 to 14.9
|
13 g/dL
Interval 11.9 to 13.7
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin
Hemoglobin (g/dL)- 504
|
13.25 g/dL
Interval 12.3 to 14.05
|
14.35 g/dL
Interval 13.2 to 14.8
|
13.4 g/dL
Interval 12.6 to 13.9
|
13 g/dL
Interval 12.4 to 14.6
|
13.9 g/dL
Interval 12.85 to 14.75
|
14.4 g/dL
Interval 13.2 to 15.6
|
12.9 g/dL
Interval 12.1 to 14.0
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin
Hemoglobin (g/dL)- 728
|
12.7 g/dL
Interval 12.7 to 12.7
|
14.7 g/dL
Interval 13.4 to 15.0
|
13.1 g/dL
Interval 12.45 to 14.55
|
14.9 g/dL
Interval 12.8 to 15.4
|
14.6 g/dL
Interval 13.65 to 15.5
|
14 g/dL
Interval 12.65 to 15.05
|
12.5 g/dL
Interval 12.5 to 12.5
|
PRIMARY outcome
Timeframe: Measured during screening, Days 0, 56, 112, 168, 224, 280, 336, 392, 448, 504, 728Population: 'Overall Number of Participants Analyzed' represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Outcome measures
| Measure |
Group 1: Vaccine
n=19 Participants
VRC07-523LS IV-2.5 mg/kg wks(0,16,32,48,64)
|
Group 2: Vaccine
n=19 Participants
VRC07-523LS IV-5 mg/kg wks(0,16,32,48,64)
|
Group 3: Vaccine
n=21 Participants
VRC07-523LS IV-20 mg/kg wks(0,16,32,48,64)
|
Group 4: Vaccine
n=21 Participants
VRC07-523LS SC-2.5 mg/kg wks(0,16,32,48,64)
|
Group 5: Vaccine
n=20 Participants
VRC07-523LS SC-5 mg/kg wks(0,16,32,48,64)
|
Group 6: Vaccine
n=21 Participants
VRC07-523LS IM-2.5 mg/kg wks(0,16,32,48,64)
|
Group 7: Placebo
n=3 Participants
IM-0.9% Sodium Chloride wks(0,16,32,48,64)
|
|---|---|---|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Neutrophils (1000/cubic mm)- Screening
|
3.84 1000 cells /cubic mm
Interval 2.6 to 5.0
|
3.7 1000 cells /cubic mm
Interval 2.95 to 4.15
|
3.72 1000 cells /cubic mm
Interval 2.8 to 4.19
|
3.24 1000 cells /cubic mm
Interval 2.7 to 3.93
|
3.76 1000 cells /cubic mm
Interval 2.77 to 5.19
|
2.82 1000 cells /cubic mm
Interval 2.3 to 4.51
|
3.37 1000 cells /cubic mm
Interval 3.3 to 7.32
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Neutrophils (1000/cubic mm)- 0/Enrollment
|
2.95 1000 cells /cubic mm
Interval 2.49 to 4.67
|
4.01 1000 cells /cubic mm
Interval 3.16 to 4.73
|
3.92 1000 cells /cubic mm
Interval 2.62 to 4.95
|
2.98 1000 cells /cubic mm
Interval 2.3 to 3.97
|
3.31 1000 cells /cubic mm
Interval 2.92 to 4.17
|
3.16 1000 cells /cubic mm
Interval 2.42 to 3.94
|
5.82 1000 cells /cubic mm
Interval 2.98 to 6.61
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Neutrophils (1000/cubic mm)- 56
|
3.12 1000 cells /cubic mm
Interval 2.18 to 3.8
|
3.83 1000 cells /cubic mm
Interval 3.02 to 4.94
|
4 1000 cells /cubic mm
Interval 2.84 to 4.61
|
2.78 1000 cells /cubic mm
Interval 2.4 to 4.06
|
3.47 1000 cells /cubic mm
Interval 2.74 to 4.2
|
3.28 1000 cells /cubic mm
Interval 2.27 to 4.07
|
7.27 1000 cells /cubic mm
Interval 6.07 to 7.95
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Neutrophils (1000/cubic mm)- 112
|
3.65 1000 cells /cubic mm
Interval 3.0 to 4.07
|
3.87 1000 cells /cubic mm
Interval 3.25 to 4.61
|
3.89 1000 cells /cubic mm
Interval 2.8 to 5.28
|
3.03 1000 cells /cubic mm
Interval 2.4 to 3.35
|
3.02 1000 cells /cubic mm
Interval 2.62 to 3.61
|
3.17 1000 cells /cubic mm
Interval 2.5 to 4.1
|
5.9 1000 cells /cubic mm
Interval 4.9 to 6.6
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Neutrophils (1000/cubic mm)- 168
|
3.35 1000 cells /cubic mm
Interval 2.07 to 4.77
|
3.1 1000 cells /cubic mm
Interval 2.66 to 3.87
|
3.61 1000 cells /cubic mm
Interval 2.65 to 4.35
|
3.17 1000 cells /cubic mm
Interval 2.68 to 4.42
|
3.19 1000 cells /cubic mm
Interval 2.75 to 4.06
|
2.84 1000 cells /cubic mm
Interval 2.4 to 4.2
|
6.19 1000 cells /cubic mm
Interval 4.85 to 7.03
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Neutrophils (1000/cubic mm)- 224
|
2.94 1000 cells /cubic mm
Interval 1.95 to 3.82
|
3.55 1000 cells /cubic mm
Interval 2.66 to 3.9
|
3.53 1000 cells /cubic mm
Interval 2.73 to 4.29
|
2.89 1000 cells /cubic mm
Interval 2.33 to 3.66
|
3.02 1000 cells /cubic mm
Interval 2.44 to 3.7
|
2.75 1000 cells /cubic mm
Interval 2.31 to 3.53
|
4.96 1000 cells /cubic mm
Interval 4.85 to 6.87
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Neutrophils (1000/cubic mm)- 280
|
2.69 1000 cells /cubic mm
Interval 2.02 to 3.9
|
3.64 1000 cells /cubic mm
Interval 2.7 to 4.72
|
3.57 1000 cells /cubic mm
Interval 2.98 to 4.6
|
3.12 1000 cells /cubic mm
Interval 2.5 to 4.06
|
3.15 1000 cells /cubic mm
Interval 2.53 to 4.83
|
2.94 1000 cells /cubic mm
Interval 2.21 to 3.72
|
5.27 1000 cells /cubic mm
Interval 4.54 to 5.99
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Neutrophils (1000/cubic mm)- 336
|
3.06 1000 cells /cubic mm
Interval 2.2 to 4.69
|
3.55 1000 cells /cubic mm
Interval 2.5 to 3.99
|
4.17 1000 cells /cubic mm
Interval 3.14 to 4.52
|
3.04 1000 cells /cubic mm
Interval 2.3 to 3.59
|
3.08 1000 cells /cubic mm
Interval 2.33 to 3.66
|
2.83 1000 cells /cubic mm
Interval 2.46 to 3.47
|
6.51 1000 cells /cubic mm
Interval 5.0 to 7.58
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Neutrophils (1000/cubic mm)- 392
|
3.13 1000 cells /cubic mm
Interval 2.34 to 4.34
|
3.61 1000 cells /cubic mm
Interval 2.86 to 4.26
|
3.69 1000 cells /cubic mm
Interval 2.85 to 4.27
|
2.86 1000 cells /cubic mm
Interval 2.51 to 3.5
|
3.53 1000 cells /cubic mm
Interval 2.7 to 3.94
|
2.84 1000 cells /cubic mm
Interval 2.42 to 3.75
|
6.13 1000 cells /cubic mm
Interval 5.04 to 7.56
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Neutrophils (1000/cubic mm)- 448
|
3.11 1000 cells /cubic mm
Interval 2.34 to 4.16
|
3.76 1000 cells /cubic mm
Interval 2.75 to 4.9
|
3.74 1000 cells /cubic mm
Interval 3.14 to 5.09
|
3.05 1000 cells /cubic mm
Interval 2.5 to 3.89
|
2.97 1000 cells /cubic mm
Interval 2.18 to 4.47
|
3.04 1000 cells /cubic mm
Interval 2.24 to 4.24
|
6.24 1000 cells /cubic mm
Interval 5.09 to 6.46
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Neutrophils (1000/cubic mm)- 504
|
3.38 1000 cells /cubic mm
Interval 1.97 to 3.66
|
3.86 1000 cells /cubic mm
Interval 2.8 to 4.59
|
3.91 1000 cells /cubic mm
Interval 2.53 to 5.81
|
2.81 1000 cells /cubic mm
Interval 2.39 to 3.44
|
3.39 1000 cells /cubic mm
Interval 2.72 to 3.71
|
3.02 1000 cells /cubic mm
Interval 2.1 to 3.65
|
6.42 1000 cells /cubic mm
Interval 4.95 to 8.12
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Neutrophils (1000/cubic mm)- 728
|
4.56 1000 cells /cubic mm
Interval 4.56 to 4.56
|
4.25 1000 cells /cubic mm
Interval 2.7 to 4.95
|
4.02 1000 cells /cubic mm
Interval 3.25 to 5.21
|
2.3 1000 cells /cubic mm
Interval 2.2 to 2.6
|
2.93 1000 cells /cubic mm
Interval 2.45 to 3.78
|
3.63 1000 cells /cubic mm
Interval 3.13 to 4.64
|
4.8 1000 cells /cubic mm
Interval 4.8 to 4.8
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Lymphocytes (1000/cubic mm)- Screening
|
2 1000 cells /cubic mm
Interval 1.64 to 2.4
|
1.98 1000 cells /cubic mm
Interval 1.7 to 2.44
|
2.04 1000 cells /cubic mm
Interval 1.48 to 2.14
|
1.6 1000 cells /cubic mm
Interval 1.4 to 2.07
|
1.92 1000 cells /cubic mm
Interval 1.71 to 2.26
|
1.86 1000 cells /cubic mm
Interval 1.66 to 2.67
|
3.06 1000 cells /cubic mm
Interval 2.14 to 3.25
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Lymphocytes (1000/cubic mm)- 0/Enrollment
|
1.86 1000 cells /cubic mm
Interval 1.72 to 2.1
|
1.85 1000 cells /cubic mm
Interval 1.6 to 2.25
|
1.87 1000 cells /cubic mm
Interval 1.56 to 2.04
|
1.64 1000 cells /cubic mm
Interval 1.44 to 2.21
|
1.86 1000 cells /cubic mm
Interval 1.63 to 2.23
|
1.95 1000 cells /cubic mm
Interval 1.55 to 2.29
|
2.94 1000 cells /cubic mm
Interval 2.22 to 3.22
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Lymphocytes (1000/cubic mm)- 56
|
1.98 1000 cells /cubic mm
Interval 1.57 to 2.25
|
1.94 1000 cells /cubic mm
Interval 1.56 to 2.11
|
1.99 1000 cells /cubic mm
Interval 1.33 to 2.5
|
1.86 1000 cells /cubic mm
Interval 1.55 to 2.0
|
2.12 1000 cells /cubic mm
Interval 1.78 to 2.48
|
1.87 1000 cells /cubic mm
Interval 1.68 to 2.44
|
2.97 1000 cells /cubic mm
Interval 2.05 to 3.38
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Lymphocytes (1000/cubic mm)- 112
|
1.82 1000 cells /cubic mm
Interval 1.59 to 2.07
|
1.8 1000 cells /cubic mm
Interval 1.5 to 2.24
|
2.04 1000 cells /cubic mm
Interval 1.55 to 2.46
|
1.77 1000 cells /cubic mm
Interval 1.4 to 2.03
|
1.91 1000 cells /cubic mm
Interval 1.76 to 2.16
|
1.93 1000 cells /cubic mm
Interval 1.51 to 2.36
|
3.46 1000 cells /cubic mm
Interval 2.34 to 3.55
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Lymphocytes (1000/cubic mm)- 168
|
1.76 1000 cells /cubic mm
Interval 1.53 to 1.99
|
1.8 1000 cells /cubic mm
Interval 1.53 to 1.96
|
1.86 1000 cells /cubic mm
Interval 1.53 to 2.07
|
1.61 1000 cells /cubic mm
Interval 1.31 to 1.97
|
1.97 1000 cells /cubic mm
Interval 1.65 to 2.26
|
1.89 1000 cells /cubic mm
Interval 1.4 to 2.33
|
3.27 1000 cells /cubic mm
Interval 2.17 to 3.33
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Lymphocytes (1000/cubic mm)- 224
|
1.65 1000 cells /cubic mm
Interval 1.44 to 2.12
|
1.91 1000 cells /cubic mm
Interval 1.6 to 2.1
|
2.01 1000 cells /cubic mm
Interval 1.68 to 2.51
|
1.61 1000 cells /cubic mm
Interval 1.41 to 1.99
|
1.94 1000 cells /cubic mm
Interval 1.68 to 2.23
|
1.74 1000 cells /cubic mm
Interval 1.49 to 2.37
|
3.13 1000 cells /cubic mm
Interval 1.91 to 3.85
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Lymphocytes (1000/cubic mm)- 280
|
1.93 1000 cells /cubic mm
Interval 1.75 to 2.13
|
1.71 1000 cells /cubic mm
Interval 1.59 to 2.1
|
1.73 1000 cells /cubic mm
Interval 1.3 to 2.32
|
1.7 1000 cells /cubic mm
Interval 1.4 to 1.9
|
2.1 1000 cells /cubic mm
Interval 1.81 to 2.66
|
1.92 1000 cells /cubic mm
Interval 1.78 to 2.54
|
2.86 1000 cells /cubic mm
Interval 2.15 to 3.58
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Lymphocytes (1000/cubic mm)- 336
|
2 1000 cells /cubic mm
Interval 1.62 to 2.06
|
1.69 1000 cells /cubic mm
Interval 1.5 to 2.05
|
2.16 1000 cells /cubic mm
Interval 1.63 to 3.01
|
1.76 1000 cells /cubic mm
Interval 1.21 to 2.18
|
2.12 1000 cells /cubic mm
Interval 1.81 to 2.41
|
1.82 1000 cells /cubic mm
Interval 1.54 to 2.21
|
2.95 1000 cells /cubic mm
Interval 1.79 to 3.82
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Lymphocytes (1000/cubic mm)- 392
|
1.79 1000 cells /cubic mm
Interval 1.53 to 2.08
|
1.8 1000 cells /cubic mm
Interval 1.51 to 2.1
|
2.01 1000 cells /cubic mm
Interval 1.43 to 2.85
|
1.58 1000 cells /cubic mm
Interval 1.38 to 1.93
|
1.91 1000 cells /cubic mm
Interval 1.7 to 2.3
|
1.82 1000 cells /cubic mm
Interval 1.39 to 2.3
|
2.82 1000 cells /cubic mm
Interval 1.46 to 3.1
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Lymphocytes (1000/cubic mm)- 448
|
1.89 1000 cells /cubic mm
Interval 1.68 to 2.0
|
1.83 1000 cells /cubic mm
Interval 1.52 to 2.11
|
1.96 1000 cells /cubic mm
Interval 1.34 to 2.44
|
1.8 1000 cells /cubic mm
Interval 1.4 to 1.96
|
1.89 1000 cells /cubic mm
Interval 1.63 to 2.39
|
1.99 1000 cells /cubic mm
Interval 1.44 to 2.31
|
2.87 1000 cells /cubic mm
Interval 1.94 to 3.52
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Lymphocytes (1000/cubic mm)- 504
|
1.92 1000 cells /cubic mm
Interval 1.54 to 2.28
|
1.89 1000 cells /cubic mm
Interval 1.65 to 2.12
|
1.84 1000 cells /cubic mm
Interval 1.5 to 2.26
|
1.79 1000 cells /cubic mm
Interval 1.42 to 2.09
|
1.94 1000 cells /cubic mm
Interval 1.85 to 2.29
|
1.76 1000 cells /cubic mm
Interval 1.4 to 2.3
|
2.96 1000 cells /cubic mm
Interval 1.3 to 3.02
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Lymphocytes (1000/cubic mm)- 728
|
1.85 1000 cells /cubic mm
Interval 1.85 to 1.85
|
1.7 1000 cells /cubic mm
Interval 1.5 to 1.95
|
2.24 1000 cells /cubic mm
Interval 1.79 to 3.0
|
1.5 1000 cells /cubic mm
Interval 1.4 to 1.51
|
2.65 1000 cells /cubic mm
Interval 1.95 to 3.45
|
1.69 1000 cells /cubic mm
Interval 1.52 to 2.03
|
3.89 1000 cells /cubic mm
Interval 3.89 to 3.89
|
PRIMARY outcome
Timeframe: Measured during screening, Days 0, 56, 112, 168, 224, 280, 336, 392, 448, 504, 728Population: 'Overall Number of Participants Analyzed' represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Outcome measures
| Measure |
Group 1: Vaccine
n=19 Participants
VRC07-523LS IV-2.5 mg/kg wks(0,16,32,48,64)
|
Group 2: Vaccine
n=19 Participants
VRC07-523LS IV-5 mg/kg wks(0,16,32,48,64)
|
Group 3: Vaccine
n=21 Participants
VRC07-523LS IV-20 mg/kg wks(0,16,32,48,64)
|
Group 4: Vaccine
n=21 Participants
VRC07-523LS SC-2.5 mg/kg wks(0,16,32,48,64)
|
Group 5: Vaccine
n=20 Participants
VRC07-523LS SC-5 mg/kg wks(0,16,32,48,64)
|
Group 6: Vaccine
n=21 Participants
VRC07-523LS IM-2.5 mg/kg wks(0,16,32,48,64)
|
Group 7: Placebo
n=3 Participants
IM-0.9% Sodium Chloride wks(0,16,32,48,64)
|
|---|---|---|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
WBC (1000/cubic mm)- Screening
|
6.4 1000 cells/cubic mm
Interval 5.0 to 7.8
|
6.15 1000 cells/cubic mm
Interval 5.36 to 7.44
|
6.8 1000 cells/cubic mm
Interval 5.1 to 7.6
|
6.06 1000 cells/cubic mm
Interval 4.54 to 6.59
|
6.7 1000 cells/cubic mm
Interval 5.08 to 7.6
|
5.9 1000 cells/cubic mm
Interval 4.71 to 8.5
|
7.1 1000 cells/cubic mm
Interval 5.9 to 11.4
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
WBC (1000/cubic mm)- 0/Enrollment
|
6.2 1000 cells/cubic mm
Interval 4.7 to 7.37
|
6.9 1000 cells/cubic mm
Interval 5.4 to 7.7
|
6.51 1000 cells/cubic mm
Interval 4.9 to 7.5
|
5.65 1000 cells/cubic mm
Interval 4.56 to 6.43
|
6.1 1000 cells/cubic mm
Interval 5.56 to 6.85
|
5.9 1000 cells/cubic mm
Interval 4.73 to 6.79
|
9.8 1000 cells/cubic mm
Interval 5.7 to 10.2
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
WBC (1000/cubic mm)- 56
|
5.41 1000 cells/cubic mm
Interval 4.6 to 7.1
|
6.76 1000 cells/cubic mm
Interval 5.5 to 7.69
|
6.45 1000 cells/cubic mm
Interval 5.34 to 8.39
|
5.44 1000 cells/cubic mm
Interval 4.98 to 6.44
|
6.1 1000 cells/cubic mm
Interval 5.6 to 7.5
|
5.9 1000 cells/cubic mm
Interval 4.72 to 6.9
|
10.1 1000 cells/cubic mm
Interval 9.9 to 11.8
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
WBC (1000/cubic mm)- 112
|
6.23 1000 cells/cubic mm
Interval 5.1 to 6.7
|
6.39 1000 cells/cubic mm
Interval 5.71 to 7.7
|
6.67 1000 cells/cubic mm
Interval 5.44 to 7.98
|
5.4 1000 cells/cubic mm
Interval 4.34 to 6.21
|
5.85 1000 cells/cubic mm
Interval 5.09 to 6.7
|
6 1000 cells/cubic mm
Interval 5.05 to 7.78
|
9.7 1000 cells/cubic mm
Interval 8.9 to 10.1
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
WBC (1000/cubic mm)- 168
|
5.81 1000 cells/cubic mm
Interval 4.61 to 7.1
|
5.51 1000 cells/cubic mm
Interval 5.2 to 5.96
|
6.03 1000 cells/cubic mm
Interval 5.25 to 7.6
|
5.28 1000 cells/cubic mm
Interval 4.6 to 7.33
|
5.87 1000 cells/cubic mm
Interval 4.71 to 7.01
|
5.7 1000 cells/cubic mm
Interval 4.7 to 7.47
|
8.9 1000 cells/cubic mm
Interval 8.7 to 10.9
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
WBC (1000/cubic mm)- 224
|
6.5 1000 cells/cubic mm
Interval 4.47 to 6.8
|
5.93 1000 cells/cubic mm
Interval 5.17 to 6.7
|
6.35 1000 cells/cubic mm
Interval 4.88 to 7.52
|
5.3 1000 cells/cubic mm
Interval 4.32 to 6.0
|
6 1000 cells/cubic mm
Interval 5.2 to 6.6
|
5.4 1000 cells/cubic mm
Interval 4.42 to 7.62
|
8.8 1000 cells/cubic mm
Interval 7.2 to 11.3
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
WBC (1000/cubic mm)- 280
|
6.26 1000 cells/cubic mm
Interval 5.3 to 7.18
|
6.59 1000 cells/cubic mm
Interval 5.6 to 7.21
|
7 1000 cells/cubic mm
Interval 5.13 to 7.5
|
5.56 1000 cells/cubic mm
Interval 4.9 to 6.3
|
6.4 1000 cells/cubic mm
Interval 5.0 to 7.3
|
5.8 1000 cells/cubic mm
Interval 4.55 to 6.83
|
8.7 1000 cells/cubic mm
Interval 7.2 to 10.2
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
WBC (1000/cubic mm)- 336
|
5.39 1000 cells/cubic mm
Interval 4.3 to 7.57
|
6 1000 cells/cubic mm
Interval 4.95 to 6.84
|
7.04 1000 cells/cubic mm
Interval 5.74 to 8.4
|
5.43 1000 cells/cubic mm
Interval 4.3 to 6.1
|
5.76 1000 cells/cubic mm
Interval 5.37 to 6.39
|
5.49 1000 cells/cubic mm
Interval 4.7 to 6.13
|
8.8 1000 cells/cubic mm
Interval 8.6 to 12.1
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
WBC (1000/cubic mm)- 392
|
5.43 1000 cells/cubic mm
Interval 4.4 to 6.9
|
5.9 1000 cells/cubic mm
Interval 5.53 to 7.03
|
6.6 1000 cells/cubic mm
Interval 5.29 to 7.31
|
5.08 1000 cells/cubic mm
Interval 4.4 to 5.93
|
6.13 1000 cells/cubic mm
Interval 5.2 to 7.5
|
5.6 1000 cells/cubic mm
Interval 4.9 to 6.35
|
9.5 1000 cells/cubic mm
Interval 8.5 to 9.9
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
WBC (1000/cubic mm)- 448
|
5.66 1000 cells/cubic mm
Interval 4.6 to 6.6
|
6.26 1000 cells/cubic mm
Interval 5.35 to 7.3
|
6 1000 cells/cubic mm
Interval 5.23 to 8.22
|
5.45 1000 cells/cubic mm
Interval 4.66 to 6.71
|
6.7 1000 cells/cubic mm
Interval 4.45 to 7.1
|
5.7 1000 cells/cubic mm
Interval 4.46 to 7.0
|
8.6 1000 cells/cubic mm
Interval 8.5 to 10.6
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
WBC (1000/cubic mm)- 504
|
5.67 1000 cells/cubic mm
Interval 4.51 to 6.65
|
6.3 1000 cells/cubic mm
Interval 5.32 to 7.28
|
6.32 1000 cells/cubic mm
Interval 5.2 to 8.91
|
5.55 1000 cells/cubic mm
Interval 4.4 to 6.16
|
6.16 1000 cells/cubic mm
Interval 5.51 to 6.7
|
5.05 1000 cells/cubic mm
Interval 4.0 to 6.2
|
8.7 1000 cells/cubic mm
Interval 8.2 to 11.9
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
WBC (1000/cubic mm)- 728
|
7.12 1000 cells/cubic mm
Interval 7.12 to 7.12
|
6.6 1000 cells/cubic mm
Interval 5.0 to 7.39
|
7.02 1000 cells/cubic mm
Interval 5.52 to 56.95
|
4.8 1000 cells/cubic mm
Interval 3.86 to 6.0
|
6.6 1000 cells/cubic mm
Interval 6.15 to 7.0
|
6.18 1000 cells/cubic mm
Interval 5.8 to 7.08
|
9.3 1000 cells/cubic mm
Interval 9.3 to 9.3
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
Platelets (1000/cubic mm)- Screening
|
260 1000 cells/cubic mm
Interval 234.9 to 295.1
|
251 1000 cells/cubic mm
Interval 233.6 to 265.0
|
271 1000 cells/cubic mm
Interval 228.0 to 328.3
|
273 1000 cells/cubic mm
Interval 209.8 to 332.0
|
244.5 1000 cells/cubic mm
Interval 214.5 to 289.5
|
240.1 1000 cells/cubic mm
Interval 223.1 to 276.0
|
315 1000 cells/cubic mm
Interval 246.0 to 334.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
Platelets (1000/cubic mm)- 0/Enrollment
|
254.9 1000 cells/cubic mm
Interval 229.1 to 291.1
|
239 1000 cells/cubic mm
Interval 224.0 to 274.0
|
254 1000 cells/cubic mm
Interval 219.0 to 317.0
|
270 1000 cells/cubic mm
Interval 207.95 to 313.5
|
247 1000 cells/cubic mm
Interval 210.5 to 281.75
|
244.5 1000 cells/cubic mm
Interval 221.0 to 275.0
|
283 1000 cells/cubic mm
Interval 249.0 to 294.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
Platelets (1000/cubic mm)- 56
|
262.65 1000 cells/cubic mm
Interval 235.0 to 278.7
|
255 1000 cells/cubic mm
Interval 244.0 to 273.0
|
275.5 1000 cells/cubic mm
Interval 238.5 to 346.1
|
283 1000 cells/cubic mm
Interval 201.0 to 309.0
|
246 1000 cells/cubic mm
Interval 218.0 to 293.0
|
246 1000 cells/cubic mm
Interval 217.0 to 272.4
|
326 1000 cells/cubic mm
Interval 284.0 to 337.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
Platelets (1000/cubic mm)- 112
|
244.45 1000 cells/cubic mm
Interval 221.0 to 276.0
|
250 1000 cells/cubic mm
Interval 231.0 to 268.0
|
284.5 1000 cells/cubic mm
Interval 252.5 to 337.65
|
267 1000 cells/cubic mm
Interval 196.0 to 303.0
|
252.8 1000 cells/cubic mm
Interval 204.0 to 283.0
|
261.5 1000 cells/cubic mm
Interval 209.55 to 286.8
|
316 1000 cells/cubic mm
Interval 279.0 to 338.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
Platelets (1000/cubic mm)- 168
|
255.5 1000 cells/cubic mm
Interval 234.65 to 269.05
|
255.5 1000 cells/cubic mm
Interval 229.0 to 282.0
|
278.5 1000 cells/cubic mm
Interval 242.0 to 311.0
|
271 1000 cells/cubic mm
Interval 202.2 to 319.5
|
240.5 1000 cells/cubic mm
Interval 203.0 to 299.0
|
257 1000 cells/cubic mm
Interval 205.7 to 280.0
|
303 1000 cells/cubic mm
Interval 302.0 to 328.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
Platelets (1000/cubic mm)- 224
|
264 1000 cells/cubic mm
Interval 227.5 to 277.95
|
252 1000 cells/cubic mm
Interval 228.0 to 277.0
|
283 1000 cells/cubic mm
Interval 250.5 to 348.5
|
252 1000 cells/cubic mm
Interval 198.0 to 324.0
|
234 1000 cells/cubic mm
Interval 195.0 to 303.0
|
256.5 1000 cells/cubic mm
Interval 205.15 to 281.1
|
341 1000 cells/cubic mm
Interval 288.0 to 350.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
Platelets (1000/cubic mm)- 280
|
252.9 1000 cells/cubic mm
Interval 229.6 to 303.0
|
249 1000 cells/cubic mm
Interval 221.0 to 278.0
|
278 1000 cells/cubic mm
Interval 222.0 to 338.0
|
250 1000 cells/cubic mm
Interval 195.0 to 333.0
|
254.45 1000 cells/cubic mm
Interval 215.0 to 287.0
|
257 1000 cells/cubic mm
Interval 209.0 to 303.3
|
284.5 1000 cells/cubic mm
Interval 243.0 to 326.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
Platelets (1000/cubic mm)- 336
|
242 1000 cells/cubic mm
Interval 210.0 to 275.0
|
246 1000 cells/cubic mm
Interval 217.0 to 277.0
|
270.5 1000 cells/cubic mm
Interval 246.0 to 314.0
|
256 1000 cells/cubic mm
Interval 193.0 to 348.0
|
238.5 1000 cells/cubic mm
Interval 200.0 to 293.15
|
233 1000 cells/cubic mm
Interval 206.3 to 259.0
|
310 1000 cells/cubic mm
Interval 286.0 to 324.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
Platelets (1000/cubic mm)- 392
|
255.85 1000 cells/cubic mm
Interval 234.6 to 282.0
|
255.5 1000 cells/cubic mm
Interval 237.0 to 283.0
|
265 1000 cells/cubic mm
Interval 244.0 to 311.0
|
251 1000 cells/cubic mm
Interval 181.0 to 332.0
|
252 1000 cells/cubic mm
Interval 213.0 to 294.0
|
250 1000 cells/cubic mm
Interval 210.5 to 279.1
|
319 1000 cells/cubic mm
Interval 283.0 to 321.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
Platelets (1000/cubic mm)- 448
|
249 1000 cells/cubic mm
Interval 241.0 to 276.8
|
243.5 1000 cells/cubic mm
Interval 233.0 to 272.5
|
264 1000 cells/cubic mm
Interval 223.5 to 306.0
|
260 1000 cells/cubic mm
Interval 212.0 to 300.0
|
254.4 1000 cells/cubic mm
Interval 188.0 to 308.0
|
255 1000 cells/cubic mm
Interval 214.7 to 296.0
|
336 1000 cells/cubic mm
Interval 293.0 to 346.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
Platelets (1000/cubic mm)- 504
|
271.35 1000 cells/cubic mm
Interval 244.5 to 289.6
|
252.65 1000 cells/cubic mm
Interval 234.75 to 285.0
|
257.5 1000 cells/cubic mm
Interval 246.0 to 338.0
|
268.5 1000 cells/cubic mm
Interval 210.05 to 296.0
|
248.5 1000 cells/cubic mm
Interval 193.5 to 280.5
|
251 1000 cells/cubic mm
Interval 208.2 to 284.0
|
323 1000 cells/cubic mm
Interval 251.0 to 325.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
Platelets (1000/cubic mm)- 728
|
283.2 1000 cells/cubic mm
Interval 283.2 to 283.2
|
278 1000 cells/cubic mm
Interval 210.4 to 297.0
|
250 1000 cells/cubic mm
Interval 208.0 to 283.0
|
233 1000 cells/cubic mm
Interval 191.0 to 249.0
|
263.5 1000 cells/cubic mm
Interval 243.95 to 295.5
|
302 1000 cells/cubic mm
Interval 273.5 to 382.5
|
327 1000 cells/cubic mm
Interval 327.0 to 327.0
|
PRIMARY outcome
Timeframe: Measured during screening, Days 0, 56, 112, 168, 224, 280, 336, 392, 448, 504, 728Population: 'Overall Number of Participants Analyzed' represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
The number (percentage) of participants with lab grade \>= 1 for alanine aminotransferase (ALT), creatinine, hemoglobin, lymphocyte count, neutrophil count, platelets, white blood cells (WBC) was summarized by arm
Outcome measures
| Measure |
Group 1: Vaccine
n=19 Participants
VRC07-523LS IV-2.5 mg/kg wks(0,16,32,48,64)
|
Group 2: Vaccine
n=19 Participants
VRC07-523LS IV-5 mg/kg wks(0,16,32,48,64)
|
Group 3: Vaccine
n=21 Participants
VRC07-523LS IV-20 mg/kg wks(0,16,32,48,64)
|
Group 4: Vaccine
n=21 Participants
VRC07-523LS SC-2.5 mg/kg wks(0,16,32,48,64)
|
Group 5: Vaccine
n=20 Participants
VRC07-523LS SC-5 mg/kg wks(0,16,32,48,64)
|
Group 6: Vaccine
n=21 Participants
VRC07-523LS IM-2.5 mg/kg wks(0,16,32,48,64)
|
Group 7: Placebo
n=3 Participants
IM-0.9% Sodium Chloride wks(0,16,32,48,64)
|
|---|---|---|---|---|---|---|---|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
WBC (1000/cubic mm)- 728
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
WBC (1000/cubic mm)- Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
WBC (1000/cubic mm)- 0/Enrollment
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
WBC (1000/cubic mm)- 56
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
WBC (1000/cubic mm)- 112
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
WBC (1000/cubic mm)- 168
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
WBC (1000/cubic mm)- 224
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
WBC (1000/cubic mm)- 280
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
WBC (1000/cubic mm)- 336
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
WBC (1000/cubic mm)- 392
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
WBC (1000/cubic mm)- 448
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
WBC (1000/cubic mm)- 504
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Neutrophils (1000/cubic mm)- Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Neutrophils (1000/cubic mm)- 0/Enrollment
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Neutrophils (1000/cubic mm)- 56
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Neutrophils (1000/cubic mm)- 112
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Neutrophils (1000/cubic mm)- 168
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Neutrophils (1000/cubic mm)- 224
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Neutrophils (1000/cubic mm)- 280
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Neutrophils (1000/cubic mm)- 336
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Neutrophils (1000/cubic mm)- 392
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Neutrophils (1000/cubic mm)- 448
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Neutrophils (1000/cubic mm)- 504
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Neutrophils (1000/cubic mm)- 728
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Hemoglobin (g/dL)- Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Hemoglobin (g/dL)- 0/Enrollment
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Hemoglobin (g/dL)- 56
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Hemoglobin (g/dL)- 112
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Hemoglobin (g/dL)- 168
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Hemoglobin (g/dL)- 224
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Hemoglobin (g/dL)- 280
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Hemoglobin (g/dL)- 336
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Hemoglobin (g/dL)- 392
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Hemoglobin (g/dL)- 448
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Hemoglobin (g/dL)- 504
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Hemoglobin (g/dL)- 728
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Lymphocytes (1000/cubic mm)- Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Lymphocytes (1000/cubic mm)- 0/Enrollment
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Lymphocytes (1000/cubic mm)- 56
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Lymphocytes (1000/cubic mm)- 112
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Lymphocytes (1000/cubic mm)- 168
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Lymphocytes (1000/cubic mm)- 224
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Lymphocytes (1000/cubic mm)- 280
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Lymphocytes (1000/cubic mm)- 336
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Lymphocytes (1000/cubic mm)- 392
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Lymphocytes (1000/cubic mm)- 448
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Lymphocytes (1000/cubic mm)- 504
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Lymphocytes (1000/cubic mm)- 728
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Platelets (1000/cubic mm)- Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Platelets (1000/cubic mm)- 0/Enrollment
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Platelets (1000/cubic mm)- 56
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Platelets (1000/cubic mm)- 112
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Platelets (1000/cubic mm)- 168
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Platelets (1000/cubic mm)- 224
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Platelets (1000/cubic mm)- 280
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Platelets (1000/cubic mm)- 336
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Platelets (1000/cubic mm)- 392
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Platelets (1000/cubic mm)- 448
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Platelets (1000/cubic mm)- 504
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Platelets (1000/cubic mm)- 728
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
ALT (SGPT) (U/L)- Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
ALT (SGPT) (U/L)- 0/Enrollment
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
ALT (SGPT) (U/L)- 56
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
ALT (SGPT) (U/L)- 112
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
ALT (SGPT) (U/L)- 168
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
ALT (SGPT) (U/L)- 224
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
ALT (SGPT) (U/L)- 280
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
ALT (SGPT) (U/L)- 336
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
ALT (SGPT) (U/L)- 392
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
ALT (SGPT) (U/L)- 448
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
ALT (SGPT) (U/L)- 504
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
ALT (SGPT) (U/L)- 728
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Creatinine (mg/dL)- Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Creatinine (mg/dL)- 0/Enrollment
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Creatinine (mg/dL)- 56
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Creatinine (mg/dL)- 112
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Creatinine (mg/dL)- 168
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Creatinine (mg/dL)- 224
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Creatinine (mg/dL)- 280
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Creatinine (mg/dL)- 336
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Creatinine (mg/dL)- 392
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Creatinine (mg/dL)- 448
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Creatinine (mg/dL)- 504
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Creatinine (mg/dL)- 728
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Target Visit Days 0, 3, 6, 28, 56, 84, 112, 168, 224, 280, 336, 392, 448, 504, 560, 616, 672, 728, 784 (i.e., visit numbers 2 through 20)Population: Overall Number of Participants Analyzed represents the number of enrolled participants. Number Analyzed shows the number of participants with available data after filtering for assay specific quality control criteria at each timepoint.
VRC07523LS serum concentrations measured in healthy human subjects after up to five administrations of the study product via the IV, SC or IM routes at various doses. Serum concentrations between the first and second study product administrations (Target Visit Day 0-112) were measured using ELISA assay in all enrolled participants. Serum concentrations after the second study product administrations (Target Visit Day 168-784) were measured using BAMA (LUMINEX) assay in a subset of participants enrolled in each treatment group and all particiants in plocebo group. serum concentrations below the lower limit of quantification (LLoQ) were replaced by half the LLoQ. Thus, concentrations below the LLoQ when measured by the ELISA assay were replaced by 0.5 ug/ml and concentrations below the LLoQ when measured by the BAMA assay were replaced by 0.02285 ug/ml.
Outcome measures
| Measure |
Group 1: Vaccine
n=19 Participants
VRC07-523LS IV-2.5 mg/kg wks(0,16,32,48,64)
|
Group 2: Vaccine
n=19 Participants
VRC07-523LS IV-5 mg/kg wks(0,16,32,48,64)
|
Group 3: Vaccine
n=21 Participants
VRC07-523LS IV-20 mg/kg wks(0,16,32,48,64)
|
Group 4: Vaccine
n=21 Participants
VRC07-523LS SC-2.5 mg/kg wks(0,16,32,48,64)
|
Group 5: Vaccine
n=20 Participants
VRC07-523LS SC-5 mg/kg wks(0,16,32,48,64)
|
Group 6: Vaccine
n=21 Participants
VRC07-523LS IM-2.5 mg/kg wks(0,16,32,48,64)
|
Group 7: Placebo
n=3 Participants
IM-0.9% Sodium Chloride wks(0,16,32,48,64)
|
|---|---|---|---|---|---|---|---|
|
VRC07523LS Serum Concentrations
IDVRC07-523LS (Day-504)
|
14.18 ug/ml
Interval 8.37 to 14.92
|
23.4 ug/ml
Interval 20.28 to 28.7
|
98.2 ug/ml
Interval 93.78 to 106.21
|
6.11 ug/ml
Interval 4.77 to 8.11
|
13.22 ug/ml
Interval 10.63 to 15.47
|
7.61 ug/ml
Interval 6.58 to 8.92
|
0.02 ug/ml
Interval 0.02 to 0.02
|
|
VRC07523LS Serum Concentrations
IDVRC07-523LS (Day-280)
|
12.17 ug/ml
Interval 11.3 to 14.1
|
25.77 ug/ml
Interval 20.13 to 27.8
|
93.35 ug/ml
Interval 81.62 to 100.24
|
7.52 ug/ml
Interval 3.42 to 8.66
|
13.65 ug/ml
Interval 10.92 to 17.55
|
7.79 ug/ml
Interval 5.88 to 10.33
|
0.02 ug/ml
Interval 0.02 to 0.02
|
|
VRC07523LS Serum Concentrations
IDVRC07-523LS (Day-336)
|
5.5 ug/ml
Interval 3.8 to 6.52
|
11.15 ug/ml
Interval 7.74 to 12.77
|
38.01 ug/ml
Interval 25.6 to 48.67
|
2.16 ug/ml
Interval 1.49 to 3.2
|
6.39 ug/ml
Interval 4.86 to 8.61
|
3.62 ug/ml
Interval 2.82 to 4.01
|
0.02 ug/ml
Interval 0.02 to 0.02
|
|
VRC07523LS Serum Concentrations
IDVRC07-523LS (Day-392)
|
13.31 ug/ml
Interval 10.04 to 14.6
|
25.88 ug/ml
Interval 22.09 to 30.52
|
98.93 ug/ml
Interval 86.92 to 113.48
|
6.12 ug/ml
Interval 3.94 to 8.47
|
12.76 ug/ml
Interval 11.08 to 15.29
|
8.13 ug/ml
Interval 6.66 to 9.47
|
0.02 ug/ml
Interval 0.02 to 0.02
|
|
VRC07523LS Serum Concentrations
IDVRC07-523LS (Day-560)
|
5.08 ug/ml
Interval 3.62 to 6.69
|
10.67 ug/ml
Interval 9.21 to 15.27
|
41.17 ug/ml
Interval 32.3 to 49.84
|
1.65 ug/ml
Interval 1.42 to 3.68
|
7.17 ug/ml
Interval 6.18 to 8.09
|
3.92 ug/ml
Interval 3.56 to 4.32
|
0.02 ug/ml
Interval 0.02 to 0.02
|
|
VRC07523LS Serum Concentrations
IDVRC07-523LS (Day-616)
|
2.7 ug/ml
Interval 2.36 to 3.68
|
5.74 ug/ml
Interval 4.59 to 6.72
|
20.78 ug/ml
Interval 16.32 to 27.46
|
1.52 ug/ml
Interval 0.58 to 1.96
|
3.63 ug/ml
Interval 2.8 to 3.83
|
1.36 ug/ml
Interval 0.89 to 1.69
|
—
|
|
VRC07523LS Serum Concentrations
IDVRC07-523LS (Day-672)
|
1.14 ug/ml
Interval 0.95 to 1.18
|
2.81 ug/ml
Interval 1.67 to 3.63
|
10.68 ug/ml
Interval 9.02 to 11.7
|
0.78 ug/ml
Interval 0.61 to 1.45
|
1.29 ug/ml
Interval 0.91 to 1.52
|
1.25 ug/ml
Interval 0.95 to 1.56
|
—
|
|
VRC07523LS Serum Concentrations
IDVRC07-523LS (Day-728)
|
0.47 ug/ml
Interval 0.33 to 0.62
|
1.68 ug/ml
Interval 0.59 to 2.27
|
5.87 ug/ml
Interval 3.11 to 5.94
|
0.45 ug/ml
Interval 0.45 to 0.85
|
0.74 ug/ml
Interval 0.69 to 0.83
|
0.44 ug/ml
Interval 0.33 to 0.47
|
0.02 ug/ml
Interval 0.02 to 0.02
|
|
VRC07523LS Serum Concentrations
IDVRC07-523LS (Day-784)
|
0.51 ug/ml
Interval 0.26 to 0.54
|
0.94 ug/ml
Interval 0.72 to 1.09
|
2.17 ug/ml
Interval 1.76 to 3.01
|
0.17 ug/ml
Interval 0.1 to 0.33
|
0.36 ug/ml
Interval 0.34 to 0.52
|
0.27 ug/ml
Interval 0.2 to 0.29
|
0.02 ug/ml
Interval 0.02 to 0.02
|
|
VRC07523LS Serum Concentrations
IDVRC07-523LS (Day-448)
|
5.6 ug/ml
Interval 4.24 to 6.81
|
10.29 ug/ml
Interval 9.04 to 15.12
|
40.22 ug/ml
Interval 36.47 to 46.45
|
2.71 ug/ml
Interval 2.0 to 4.39
|
6.06 ug/ml
Interval 5.28 to 6.88
|
3.59 ug/ml
Interval 3.23 to 4.26
|
0.02 ug/ml
Interval 0.02 to 0.02
|
|
VRC07523LS Serum Concentrations
IDVRC07-523LS (Day-084)
|
5.43 ug/ml
Interval 4.69 to 6.9
|
12.19 ug/ml
Interval 10.33 to 14.17
|
45.27 ug/ml
Interval 36.41 to 52.23
|
2.99 ug/ml
Interval 0.86 to 4.12
|
5.9 ug/ml
Interval 4.89 to 7.23
|
4.29 ug/ml
Interval 3.48 to 5.33
|
0.5 ug/ml
Interval 0.5 to 0.5
|
|
VRC07523LS Serum Concentrations
IDVRC07-523LS (Day-000)
|
0.5 ug/ml
Interval 0.5 to 0.5
|
0.5 ug/ml
Interval 0.5 to 0.5
|
0.5 ug/ml
Interval 0.5 to 0.5
|
0.5 ug/ml
Interval 0.5 to 0.5
|
0.5 ug/ml
Interval 0.5 to 0.5
|
0.5 ug/ml
Interval 0.5 to 0.5
|
0.5 ug/ml
Interval 0.5 to 0.5
|
|
VRC07523LS Serum Concentrations
IDVRC07-523LS (Day-003)
|
43.13 ug/ml
Interval 38.57 to 52.81
|
80.7 ug/ml
Interval 73.52 to 101.15
|
332.57 ug/ml
Interval 260.0 to 455.77
|
11.06 ug/ml
Interval 7.95 to 15.28
|
17.81 ug/ml
Interval 14.57 to 26.49
|
16.71 ug/ml
Interval 15.16 to 19.14
|
0.5 ug/ml
Interval 0.5 to 0.5
|
|
VRC07523LS Serum Concentrations
IDVRC07-523LS (Day-006)
|
27.71 ug/ml
Interval 23.7 to 33.64
|
59.05 ug/ml
Interval 49.91 to 71.34
|
224 ug/ml
Interval 200.96 to 261.88
|
11.04 ug/ml
Interval 8.26 to 13.21
|
22.22 ug/ml
Interval 18.81 to 26.26
|
16.03 ug/ml
Interval 13.89 to 17.81
|
0.5 ug/ml
Interval 0.5 to 0.5
|
|
VRC07523LS Serum Concentrations
IDVRC07-523LS (Day-028)
|
14.56 ug/ml
Interval 13.48 to 17.86
|
27.86 ug/ml
Interval 25.92 to 36.53
|
125.17 ug/ml
Interval 110.6 to 132.2
|
6.79 ug/ml
Interval 5.63 to 8.36
|
13.37 ug/ml
Interval 11.89 to 17.65
|
10.03 ug/ml
Interval 8.91 to 11.87
|
0.5 ug/ml
Interval 0.5 to 0.5
|
|
VRC07523LS Serum Concentrations
IDVRC07-523LS (Day-056)
|
10.67 ug/ml
Interval 8.26 to 12.76
|
17.08 ug/ml
Interval 15.32 to 21.55
|
68.97 ug/ml
Interval 59.45 to 75.21
|
5.02 ug/ml
Interval 3.81 to 5.7
|
7.63 ug/ml
Interval 6.57 to 10.43
|
6.27 ug/ml
Interval 5.72 to 7.39
|
0.5 ug/ml
Interval 0.5 to 0.5
|
|
VRC07523LS Serum Concentrations
IDVRC07-523LS (Day-112)
|
4.08 ug/ml
Interval 3.09 to 4.84
|
6.51 ug/ml
Interval 5.33 to 7.59
|
26.83 ug/ml
Interval 22.83 to 30.69
|
0.5 ug/ml
Interval 0.5 to 2.14
|
3.95 ug/ml
Interval 2.72 to 4.58
|
2.98 ug/ml
Interval 1.88 to 3.53
|
0.5 ug/ml
Interval 0.5 to 0.5
|
|
VRC07523LS Serum Concentrations
IDVRC07-523LS (Day-168)
|
13.14 ug/ml
Interval 8.75 to 14.82
|
22.46 ug/ml
Interval 19.66 to 24.95
|
98.34 ug/ml
Interval 93.59 to 111.17
|
5.77 ug/ml
Interval 4.19 to 6.56
|
10.99 ug/ml
Interval 10.15 to 12.2
|
8.09 ug/ml
Interval 6.07 to 8.74
|
0.02 ug/ml
Interval 0.02 to 0.02
|
|
VRC07523LS Serum Concentrations
IDVRC07-523LS (Day-224)
|
5.55 ug/ml
Interval 5.12 to 7.08
|
9.83 ug/ml
Interval 8.89 to 11.74
|
36.11 ug/ml
Interval 29.29 to 49.15
|
2.31 ug/ml
Interval 1.11 to 3.17
|
5.95 ug/ml
Interval 4.95 to 7.17
|
3.53 ug/ml
Interval 2.41 to 4.52
|
0.02 ug/ml
Interval 0.02 to 0.02
|
SECONDARY outcome
Timeframe: Day 0, 6, 112, 224, 448Population: Overall Number of Participants Analyzed presents the number of enrolled participants in each treatment arm. Number Analyzed shows the number of samples available and tested in the certain tier and timepoint.
Antidrug antibodies (ADA) are most typically detected and characterized using a tiered testing strategy. In Tier I, a sensitive binding assay is used to determine if samples may have ADA present. In Tier II, the response is confirmed, typically by establishing the specificity of the response by competition with free drug. In Tier III, the response is characterized, typically with a neutralization reduction assay and/or a titering assay.
Outcome measures
| Measure |
Group 1: Vaccine
n=19 Participants
VRC07-523LS IV-2.5 mg/kg wks(0,16,32,48,64)
|
Group 2: Vaccine
n=19 Participants
VRC07-523LS IV-5 mg/kg wks(0,16,32,48,64)
|
Group 3: Vaccine
n=21 Participants
VRC07-523LS IV-20 mg/kg wks(0,16,32,48,64)
|
Group 4: Vaccine
n=21 Participants
VRC07-523LS SC-2.5 mg/kg wks(0,16,32,48,64)
|
Group 5: Vaccine
n=20 Participants
VRC07-523LS SC-5 mg/kg wks(0,16,32,48,64)
|
Group 6: Vaccine
n=21 Participants
VRC07-523LS IM-2.5 mg/kg wks(0,16,32,48,64)
|
Group 7: Placebo
n=3 Participants
IM-0.9% Sodium Chloride wks(0,16,32,48,64)
|
|---|---|---|---|---|---|---|---|
|
Occurrence of Antidrug Antibodies (ADA)
0 - Tier I
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Occurrence of Antidrug Antibodies (ADA)
0 - Tier II
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
|
Occurrence of Antidrug Antibodies (ADA)
112 - Tier I
|
—
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Occurrence of Antidrug Antibodies (ADA)
224 - Tier I
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Antidrug Antibodies (ADA)
224 - Tier II
|
—
|
—
|
—
|
1 Participants
|
—
|
—
|
—
|
|
Occurrence of Antidrug Antibodies (ADA)
224 - Tier III
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Occurrence of Antidrug Antibodies (ADA)
448 - Tier I
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Antidrug Antibodies (ADA)
448 - Tier II
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Occurrence of Antidrug Antibodies (ADA)
6 - Tier I
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 8, 72, and 88 following the first study product administrationPopulation: Overall Number of Participants Analyzed- represents the number of sampled participants. Number Analyzed shows the number of participants with available nAb data after filtering for assay specific quality control criteria at each timepoint.
Magnitude-breadth characterize the magnitude (ID50 or ID80 titers) and breadth (number of virus isolates) of each individual serum sample assayed against a panel of virus isolates. MB curves show, for each possible magnitude threshold, the fraction of assays with magnitudes greater than this threshold. The area under the magnitude-breadth curve (AUC-MB) is calculated as the average of the log10-based ID50 or ID80 titers over the panel of isolates. Isolates includes: H703\_0646\_051sN, H703\_1471\_190s, H703\_1750\_140Es, H704\_0726\_080sN, H704\_1535\_030sN, H704\_2544\_140eN01, PVO.4.
Outcome measures
| Measure |
Group 1: Vaccine
n=19 Participants
VRC07-523LS IV-2.5 mg/kg wks(0,16,32,48,64)
|
Group 2: Vaccine
n=19 Participants
VRC07-523LS IV-5 mg/kg wks(0,16,32,48,64)
|
Group 3: Vaccine
n=21 Participants
VRC07-523LS IV-20 mg/kg wks(0,16,32,48,64)
|
Group 4: Vaccine
n=21 Participants
VRC07-523LS SC-2.5 mg/kg wks(0,16,32,48,64)
|
Group 5: Vaccine
n=20 Participants
VRC07-523LS SC-5 mg/kg wks(0,16,32,48,64)
|
Group 6: Vaccine
n=21 Participants
VRC07-523LS IM-2.5 mg/kg wks(0,16,32,48,64)
|
Group 7: Placebo
IM-0.9% Sodium Chloride wks(0,16,32,48,64)
|
|---|---|---|---|---|---|---|---|
|
Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 8, 72, 88 Weeks After the First Study Product Administration.
ID50 (Week-08)
|
1.56 log10(titer)
Interval 1.44 to 1.56
|
1.89 log10(titer)
Interval 1.74 to 2.0
|
2.46 log10(titer)
Interval 2.38 to 2.54
|
1.34 log10(titer)
Interval 1.23 to 1.54
|
1.54 log10(titer)
Interval 1.4 to 1.55
|
1.39 log10(titer)
Interval 1.26 to 1.45
|
—
|
|
Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 8, 72, 88 Weeks After the First Study Product Administration.
ID50 (Week-72)
|
1.62 log10(titer)
Interval 1.57 to 1.81
|
2.03 log10(titer)
Interval 1.79 to 2.12
|
2.6 log10(titer)
Interval 2.5 to 2.67
|
1.36 log10(titer)
Interval 1.25 to 1.55
|
1.6 log10(titer)
Interval 1.48 to 1.71
|
1.49 log10(titer)
Interval 1.42 to 1.57
|
—
|
|
Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 8, 72, 88 Weeks After the First Study Product Administration.
ID50 (Week-88)
|
0.98 log10(titer)
Interval 0.96 to 1.11
|
1.4 log10(titer)
Interval 1.26 to 1.4
|
1.93 log10(titer)
Interval 1.85 to 2.07
|
0.8 log10(titer)
Interval 0.7 to 0.94
|
0.97 log10(titer)
Interval 0.89 to 0.98
|
0.9 log10(titer)
Interval 0.8 to 0.96
|
—
|
|
Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 8, 72, 88 Weeks After the First Study Product Administration.
ID80 (Week-08)
|
1.14 log10(titer)
Interval 1.04 to 1.19
|
1.37 log10(titer)
Interval 1.33 to 1.42
|
1.97 log10(titer)
Interval 1.89 to 2.03
|
0.93 log10(titer)
Interval 0.89 to 1.11
|
1.15 log10(titer)
Interval 1.03 to 1.2
|
1.01 log10(titer)
Interval 0.91 to 1.08
|
—
|
|
Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 8, 72, 88 Weeks After the First Study Product Administration.
ID80 (Week-72)
|
1.27 log10(titer)
Interval 1.16 to 1.33
|
1.49 log10(titer)
Interval 1.35 to 1.55
|
2.14 log10(titer)
Interval 2.02 to 2.16
|
1 log10(titer)
Interval 0.88 to 1.12
|
1.21 log10(titer)
Interval 1.12 to 1.29
|
1.13 log10(titer)
Interval 1.02 to 1.18
|
—
|
|
Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 8, 72, 88 Weeks After the First Study Product Administration.
ID80 (Week-88)
|
0.85 log10(titer)
Interval 0.77 to 0.88
|
0.91 log10(titer)
Interval 0.88 to 0.95
|
1.45 log10(titer)
Interval 1.41 to 1.55
|
0.7 log10(titer)
Interval 0.7 to 0.74
|
0.84 log10(titer)
Interval 0.8 to 0.84
|
0.75 log10(titer)
Interval 0.72 to 0.79
|
—
|
Adverse Events
Group 1: Vaccine
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Group 2: Vaccine
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Group 3: Vaccine
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Group 4: Vaccine
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Group 5: Vaccine
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Group 6: Vaccine
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Group 7: Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: Vaccine
n=19 participants at risk
VRC07-523LS IV-2.5 mg/kg wks(0,16,32,48,64)
|
Group 2: Vaccine
n=19 participants at risk
VRC07-523LS IV-5 mg/kg wks(0,16,32,48,64)
|
Group 3: Vaccine
n=21 participants at risk
VRC07-523LS IV-20 mg/kg wks(0,16,32,48,64)
|
Group 4: Vaccine
n=21 participants at risk
VRC07-523LS SC-2.5 mg/kg wks(0,16,32,48,64)
|
Group 5: Vaccine
n=20 participants at risk
VRC07-523LS SC-5 mg/kg wks(0,16,32,48,64)
|
Group 6: Vaccine
n=21 participants at risk
VRC07-523LS IM-2.5 mg/kg wks(0,16,32,48,64)
|
Group 7: Placebo
n=3 participants at risk
IM-0.9% Sodium Chloride wks(0,16,32,48,64)
|
|---|---|---|---|---|---|---|---|
|
General disorders
Any Event in SOC
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
General disorders
Pyrexia
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Infections and infestations
Any Event in SOC
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Renal and urinary disorders
Any Event in SOC
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Renal and urinary disorders
Calculus urinary
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
Other adverse events
| Measure |
Group 1: Vaccine
n=19 participants at risk
VRC07-523LS IV-2.5 mg/kg wks(0,16,32,48,64)
|
Group 2: Vaccine
n=19 participants at risk
VRC07-523LS IV-5 mg/kg wks(0,16,32,48,64)
|
Group 3: Vaccine
n=21 participants at risk
VRC07-523LS IV-20 mg/kg wks(0,16,32,48,64)
|
Group 4: Vaccine
n=21 participants at risk
VRC07-523LS SC-2.5 mg/kg wks(0,16,32,48,64)
|
Group 5: Vaccine
n=20 participants at risk
VRC07-523LS SC-5 mg/kg wks(0,16,32,48,64)
|
Group 6: Vaccine
n=21 participants at risk
VRC07-523LS IM-2.5 mg/kg wks(0,16,32,48,64)
|
Group 7: Placebo
n=3 participants at risk
IM-0.9% Sodium Chloride wks(0,16,32,48,64)
|
|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
33.3%
1/3 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
33.3%
1/3 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Eye disorders
Eczema eyelids
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
33.3%
1/3 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Eye disorders
Eyelid rash
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.0%
1/20 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Gastrointestinal disorders
Any Event in SOC
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
36.8%
7/19 • Number of events 8 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
23.8%
5/21 • Number of events 5 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
9.5%
2/21 • Number of events 3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
30.0%
6/20 • Number of events 7 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
14.3%
3/21 • Number of events 3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
33.3%
1/3 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
14.3%
3/21 • Number of events 3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Infections and infestations
Influenza
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
10.0%
2/20 • Number of events 3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Infections and infestations
Otitis media
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Nervous system disorders
Nerve compression
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Blood and lymphatic system disorders
Any Event in SOC
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Cardiac disorders
Any Event in SOC
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Cardiac disorders
Mitral valve prolapse
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Endocrine disorders
Any Event in SOC
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Eye disorders
Any Event in SOC
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.0%
1/20 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
33.3%
1/3 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.0%
1/20 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.0%
1/20 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
10.0%
2/20 • Number of events 3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.3%
1/19 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
33.3%
1/3 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.0%
1/20 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Gastrointestinal disorders
Plicated tongue
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Gastrointestinal disorders
Rectal fissure
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.0%
1/20 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
General disorders
Any Event in SOC
|
15.8%
3/19 • Number of events 3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
15.8%
3/19 • Number of events 4 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
9.5%
2/21 • Number of events 3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.0%
1/20 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
9.5%
2/21 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
General disorders
Chest discomfort
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
General disorders
Chest pain
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
General disorders
Fatigue
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
General disorders
Feeling hot
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
General disorders
Influenza like illness
|
10.5%
2/19 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
General disorders
Injection site erythema
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
General disorders
Injection site induration
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
General disorders
Injection site pruritus
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
General disorders
Malaise
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.0%
1/20 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
General disorders
Pain
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Hepatobiliary disorders
Any Event in SOC
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.0%
1/20 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.0%
1/20 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.0%
1/20 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Immune system disorders
Any Event in SOC
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Infections and infestations
Any Event in SOC
|
47.4%
9/19 • Number of events 12 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
52.6%
10/19 • Number of events 31 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
52.4%
11/21 • Number of events 27 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
42.9%
9/21 • Number of events 15 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
50.0%
10/20 • Number of events 14 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
57.1%
12/21 • Number of events 21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
100.0%
3/3 • Number of events 9 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Infections and infestations
Anorectal human papilloma virus infection
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Infections and infestations
Bacterial vulvovaginitis
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
9.5%
2/21 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Infections and infestations
COVID-19
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Infections and infestations
Cellulitis
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.3%
1/19 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Infections and infestations
Conjunctivitis viral
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Infections and infestations
Cystitis
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Infections and infestations
Epstein-Barr virus infection
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Infections and infestations
Fungal infection
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
33.3%
1/3 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Infections and infestations
Gastroenteritis
|
10.5%
2/19 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
10.5%
2/19 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
9.5%
2/21 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.0%
1/20 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
33.3%
1/3 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.0%
1/20 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Infections and infestations
Impetigo
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
33.3%
1/3 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.0%
1/20 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Infections and infestations
Paronychia
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Infections and infestations
Pharyngitis
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Infections and infestations
Pharyngitis streptococcal
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
10.0%
2/20 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Infections and infestations
Pilonidal cyst
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Infections and infestations
Pyuria
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.0%
1/20 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Infections and infestations
Sinusitis
|
10.5%
2/19 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.0%
1/20 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
33.3%
1/3 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Infections and infestations
Suspected COVID-19
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Infections and infestations
Tinea cruris
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Infections and infestations
Tinea infection
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.0%
1/20 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Infections and infestations
Upper respiratory tract infection
|
5.3%
1/19 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
26.3%
5/19 • Number of events 9 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
33.3%
7/21 • Number of events 10 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
14.3%
3/21 • Number of events 4 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
20.0%
4/20 • Number of events 5 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
28.6%
6/21 • Number of events 7 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
100.0%
3/3 • Number of events 4 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
10.5%
2/19 • Number of events 5 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.0%
1/20 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Infections and infestations
Viral infection
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
10.5%
2/19 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
14.3%
3/21 • Number of events 7 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
14.3%
3/21 • Number of events 3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
10.5%
2/19 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
9.5%
2/21 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
14.3%
3/21 • Number of events 3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Injury, poisoning and procedural complications
Any Event in SOC
|
15.8%
3/19 • Number of events 4 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
21.1%
4/19 • Number of events 4 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
19.0%
4/21 • Number of events 7 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
19.0%
4/21 • Number of events 6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
20.0%
4/20 • Number of events 4 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
19.0%
4/21 • Number of events 4 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Injury, poisoning and procedural complications
Concussion
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.0%
1/20 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
9.5%
2/21 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.0%
1/20 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
14.3%
3/21 • Number of events 3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.0%
1/20 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.0%
1/20 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Investigations
Any Event in SOC
|
21.1%
4/19 • Number of events 7 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
15.8%
3/19 • Number of events 5 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
38.1%
8/21 • Number of events 15 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
42.9%
9/21 • Number of events 19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
25.0%
5/20 • Number of events 11 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
23.8%
5/21 • Number of events 7 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
66.7%
2/3 • Number of events 6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Investigations
Alanine aminotransferase abnormal
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.0%
1/20 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Investigations
Alanine aminotransferase increased
|
15.8%
3/19 • Number of events 5 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.3%
1/19 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
14.3%
3/21 • Number of events 4 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
14.3%
3/21 • Number of events 4 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
10.0%
2/20 • Number of events 4 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
9.5%
2/21 • Number of events 3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
66.7%
2/3 • Number of events 3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
9.5%
2/21 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.0%
1/20 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
33.3%
1/3 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
33.3%
1/3 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Investigations
Blood creatinine increased
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
14.3%
3/21 • Number of events 3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
23.8%
5/21 • Number of events 8 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
15.0%
3/20 • Number of events 4 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Investigations
Blood glucose increased
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Investigations
Blood pressure increased
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.3%
1/19 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
9.5%
2/21 • Number of events 3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 4 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.0%
1/20 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
9.5%
2/21 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Investigations
Neutrophil count decreased
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Investigations
Platelet count decreased
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Investigations
Red blood cells urine positive
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Investigations
Smear cervix abnormal
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
33.3%
1/3 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Metabolism and nutrition disorders
Any Event in SOC
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
10.5%
2/19 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
10.5%
2/19 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Musculoskeletal and connective tissue disorders
Any Event in SOC
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
21.1%
4/19 • Number of events 6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
28.6%
6/21 • Number of events 9 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
20.0%
4/20 • Number of events 6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
9.5%
2/21 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
66.7%
2/3 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.0%
1/20 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.0%
1/20 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
9.5%
2/21 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.0%
1/20 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis stenosans
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Any Event in SOC
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Osteochondroma
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Nervous system disorders
Any Event in SOC
|
10.5%
2/19 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
10.5%
2/19 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
9.5%
2/21 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
15.0%
3/20 • Number of events 4 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
9.5%
2/21 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
10.5%
2/19 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Nervous system disorders
Headache
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.0%
1/20 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.0%
1/20 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Nervous system disorders
Hypoaesthesia
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Nervous system disorders
Post-traumatic headache
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.0%
1/20 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Nervous system disorders
Presyncope
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.0%
1/20 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Nervous system disorders
Sciatica
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Nervous system disorders
Syncope
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Psychiatric disorders
Any Event in SOC
|
10.5%
2/19 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.0%
1/20 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.0%
1/20 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Psychiatric disorders
Anxiety
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Psychiatric disorders
Bruxism
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Psychiatric disorders
Burnout syndrome
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Psychiatric disorders
Depression
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Renal and urinary disorders
Any Event in SOC
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
9.5%
2/21 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Reproductive system and breast disorders
Any Event in SOC
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.0%
1/20 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.0%
1/20 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Respiratory, thoracic and mediastinal disorders
Any Event in SOC
|
5.3%
1/19 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
10.5%
2/19 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
14.3%
3/21 • Number of events 3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
15.0%
3/20 • Number of events 5 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.0%
1/20 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
9.5%
2/21 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.0%
1/20 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.0%
1/20 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.0%
1/20 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Skin and subcutaneous tissue disorders
Any Event in SOC
|
10.5%
2/19 • Number of events 3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
21.1%
4/19 • Number of events 4 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
19.0%
4/21 • Number of events 4 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
15.0%
3/20 • Number of events 3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
33.3%
1/3 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.0%
1/20 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.3%
1/19 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
33.3%
1/3 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Skin and subcutaneous tissue disorders
Pityriasis rosea
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.0%
1/20 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
5.0%
1/20 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Vascular disorders
Any Event in SOC
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Vascular disorders
Hot flush
|
5.3%
1/19 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
|
Vascular disorders
Hypertension
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/19 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
4.8%
1/21 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/20 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/21 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
|
Additional Information
Jessica Andriesen, PhD, Associate Director of HVTN SDMC Operations
Fred Hutchinson Cancer Center
Phone: 206-667-5812
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place