Trial Outcomes & Findings for A Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of PGDM1400LS Alone and in Combination With VRC07-523LS and PGT121.414.LS in Healthy, HIV-uninfected Adult Participants (NCT NCT05184452)
NCT ID: NCT05184452
Last Updated: 2025-02-10
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
95 participants
Primary outcome timeframe
Measured through Month Measured through 3 days after each vaccine dose at T1-T5: Day 0 and T6-T10: Days 0, 112
Results posted on
2025-02-10
Participant Flow
Participant milestones
| Measure |
T1: PGDM1400LS (IV) 5 mg/kg mo 0
PGDM1400LS 5 mg/kg to be administered IV at Month 0.
|
T2: PGDM1400LS (IV) 20 mg/kg mo 0
PGDM1400LS 20 mg/kg to be administered IV at Month 0.
|
T3: PGDM1400LS (SC) 20 mg/kg mo 0
PGDM1400LS 20 mg/kg to be administered SC at Month 0.
|
T4: PGDM1400LS (IV) 40 mg/kg mo 0
PGDM1400LS 40 mg/kg to be administered IV at Month 0.
|
T5: PGDM1400LS (SC) 40 mg/kg mo 0
PGDM1400LS 40 mg/kg to be administered SC at Month 0.
|
T6: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV) 2
PGDM1400LS 20 mg/kg AND VRC07-523LS 20 mg/kg AND PGT121.414LS 20 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
T7: PGDM1400LS + VRC07-523LS + PGT121.414LS (SC) 2
PGDM1400LS 20 mg/kg AND VRC07-523LS 20 mg/kg AND PGT121.414LS 20 mg/kg to be administered SC sequentially in this order at Month 0 and Month 4.
|
T8: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV) 1
PGDM1400LS 1.4 g AND VRC07-523LS 1.4 g AND PGT121.414LS 1.4 g to be administered IV sequentially in this order at Month 0 and Month 4.
|
T9: PGDM1400LS + VRC07-523LS + PGT121.414LS (SC) 1
PGDM1400LS 1.4 g AND VRC07-523LS 1.4 g AND PGT121.414LS 1.4 g to be administered SC sequentially in this order at Month 0 and Month 4.
|
T10: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV)
PGDM1400LS 40 mg/kg AND VRC07-523LS 40 mg/kg AND PGT121.414LS 40 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
3
|
3
|
16
|
16
|
16
|
16
|
16
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
13
|
16
|
16
|
16
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
T1: PGDM1400LS (IV) 5 mg/kg mo 0
PGDM1400LS 5 mg/kg to be administered IV at Month 0.
|
T2: PGDM1400LS (IV) 20 mg/kg mo 0
PGDM1400LS 20 mg/kg to be administered IV at Month 0.
|
T3: PGDM1400LS (SC) 20 mg/kg mo 0
PGDM1400LS 20 mg/kg to be administered SC at Month 0.
|
T4: PGDM1400LS (IV) 40 mg/kg mo 0
PGDM1400LS 40 mg/kg to be administered IV at Month 0.
|
T5: PGDM1400LS (SC) 40 mg/kg mo 0
PGDM1400LS 40 mg/kg to be administered SC at Month 0.
|
T6: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV) 2
PGDM1400LS 20 mg/kg AND VRC07-523LS 20 mg/kg AND PGT121.414LS 20 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
T7: PGDM1400LS + VRC07-523LS + PGT121.414LS (SC) 2
PGDM1400LS 20 mg/kg AND VRC07-523LS 20 mg/kg AND PGT121.414LS 20 mg/kg to be administered SC sequentially in this order at Month 0 and Month 4.
|
T8: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV) 1
PGDM1400LS 1.4 g AND VRC07-523LS 1.4 g AND PGT121.414LS 1.4 g to be administered IV sequentially in this order at Month 0 and Month 4.
|
T9: PGDM1400LS + VRC07-523LS + PGT121.414LS (SC) 1
PGDM1400LS 1.4 g AND VRC07-523LS 1.4 g AND PGT121.414LS 1.4 g to be administered SC sequentially in this order at Month 0 and Month 4.
|
T10: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV)
PGDM1400LS 40 mg/kg AND VRC07-523LS 40 mg/kg AND PGT121.414LS 40 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of PGDM1400LS Alone and in Combination With VRC07-523LS and PGT121.414.LS in Healthy, HIV-uninfected Adult Participants
Baseline characteristics by cohort
| Measure |
T1: PGDM1400LS (IV) 5 mg/kg mo 0
n=3 Participants
PGDM1400LS 5 mg/kg to be administered IV at Month 0.
|
T2: PGDM1400LS (IV) 20 mg/kg mo 0
n=3 Participants
PGDM1400LS 20 mg/kg to be administered IV at Month 0.
|
T3: PGDM1400LS (SC) 20 mg/kg mo 0
n=3 Participants
PGDM1400LS 20 mg/kg to be administered SC at Month 0.
|
T4: PGDM1400LS (IV) 40 mg/kg mo 0
n=3 Participants
PGDM1400LS 40 mg/kg to be administered IV at Month 0.
|
T5: PGDM1400LS (SC) 40 mg/kg mo 0
n=3 Participants
PGDM1400LS 40 mg/kg to be administered SC at Month 0.
|
T6: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV) 2
n=16 Participants
PGDM1400LS 20 mg/kg AND VRC07-523LS 20 mg/kg AND PGT121.414LS 20 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
T7: PGDM1400LS + VRC07-523LS + PGT121.414LS (SC) 2
n=16 Participants
PGDM1400LS 20 mg/kg AND VRC07-523LS 20 mg/kg AND PGT121.414LS 20 mg/kg to be administered SC sequentially in this order at Month 0 and Month 4.
|
T8: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV) 1
n=16 Participants
PGDM1400LS 1.4 g AND VRC07-523LS 1.4 g AND PGT121.414LS 1.4 g to be administered IV sequentially in this order at Month 0 and Month 4.
|
T9: PGDM1400LS + VRC07-523LS + PGT121.414LS (SC) 1
n=16 Participants
PGDM1400LS 1.4 g AND VRC07-523LS 1.4 g AND PGT121.414LS 1.4 g to be administered SC sequentially in this order at Month 0 and Month 4.
|
T10: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV)
n=16 Participants
PGDM1400LS 40 mg/kg AND VRC07-523LS 40 mg/kg AND PGT121.414LS 40 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
36 years
n=5 Participants
|
27 years
n=7 Participants
|
27 years
n=5 Participants
|
26 years
n=4 Participants
|
33 years
n=21 Participants
|
25.5 years
n=8 Participants
|
27.5 years
n=8 Participants
|
25.5 years
n=24 Participants
|
26 years
n=42 Participants
|
31 years
n=42 Participants
|
27 years
n=42 Participants
|
|
Age, Customized
18 - 20 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
|
3 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
|
Age, Customized
21 - 30 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
46 Participants
n=42 Participants
|
|
Age, Customized
31 - 40 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
21 Participants
n=42 Participants
|
|
Age, Customized
41 - 50 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
16 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
48 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
10 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
47 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
15 Participants
n=8 Participants
|
15 Participants
n=24 Participants
|
16 Participants
n=42 Participants
|
15 Participants
n=42 Participants
|
89 Participants
n=42 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
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
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
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
13 Participants
n=8 Participants
|
11 Participants
n=24 Participants
|
13 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
60 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
26 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
|
Region of Enrollment
USA
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
38 Participants
n=42 Participants
|
|
Region of Enrollment
Kenya
|
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
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
|
Region of Enrollment
South Africa
|
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
|
8 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
33 Participants
n=42 Participants
|
|
Region of Enrollment
Zimbabwe
|
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
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
15 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Measured through Month Measured through 3 days after each vaccine dose at T1-T5: Day 0 and T6-T10: Days 0, 112Graded 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 |
T1: PGDM1400LS (IV) 5 mg/kg mo 0
n=3 Participants
PGDM1400LS 5 mg/kg to be administered IV at Month 0.
|
T2: PGDM1400LS (IV) 20 mg/kg mo 0
n=3 Participants
PGDM1400LS 20 mg/kg to be administered IV at Month 0.
|
T3: PGDM1400LS (SC) 20 mg/kg mo 0
n=3 Participants
PGDM1400LS 20 mg/kg to be administered SC at Month 0.
|
T4: PGDM1400LS (IV) 40 mg/kg mo 0
n=3 Participants
PGDM1400LS 40 mg/kg to be administered IV at Month 0.
|
T5: PGDM1400LS (SC) 40 mg/kg mo 0
n=3 Participants
PGDM1400LS 40 mg/kg to be administered SC at Month 0.
|
T6: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV) 2
n=16 Participants
PGDM1400LS 20 mg/kg AND VRC07-523LS 20 mg/kg AND PGT121.414LS 20 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
T7: PGDM1400LS + VRC07-523LS + PGT121.414LS (SC) 2
n=16 Participants
PGDM1400LS 20 mg/kg AND VRC07-523LS 20 mg/kg AND PGT121.414LS 20 mg/kg to be administered SC sequentially in this order at Month 0 and Month 4.
|
T8: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV) 1
n=16 Participants
PGDM1400LS 1.4 g AND VRC07-523LS 1.4 g AND PGT121.414LS 1.4 g to be administered IV sequentially in this order at Month 0 and Month 4.
|
T9: PGDM1400LS + VRC07-523LS + PGT121.414LS (SC) 1
n=16 Participants
PGDM1400LS 1.4 g AND VRC07-523LS 1.4 g AND PGT121.414LS 1.4 g to be administered SC sequentially in this order at Month 0 and Month 4.
|
T10: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV)
n=16 Participants
PGDM1400LS 40 mg/kg AND VRC07-523LS 40 mg/kg AND PGT121.414LS 40 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
None
|
3 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
15 Participants
|
9 Participants
|
13 Participants
|
3 Participants
|
14 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Mild
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
6 Participants
|
3 Participants
|
12 Participants
|
2 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 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
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through Month Measured through 3 days after each vaccine dose at T1-T5: Day 0 and T6-T10: Days 0, 112Graded 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 |
T1: PGDM1400LS (IV) 5 mg/kg mo 0
n=3 Participants
PGDM1400LS 5 mg/kg to be administered IV at Month 0.
|
T2: PGDM1400LS (IV) 20 mg/kg mo 0
n=3 Participants
PGDM1400LS 20 mg/kg to be administered IV at Month 0.
|
T3: PGDM1400LS (SC) 20 mg/kg mo 0
n=3 Participants
PGDM1400LS 20 mg/kg to be administered SC at Month 0.
|
T4: PGDM1400LS (IV) 40 mg/kg mo 0
n=3 Participants
PGDM1400LS 40 mg/kg to be administered IV at Month 0.
|
T5: PGDM1400LS (SC) 40 mg/kg mo 0
n=3 Participants
PGDM1400LS 40 mg/kg to be administered SC at Month 0.
|
T6: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV) 2
n=16 Participants
PGDM1400LS 20 mg/kg AND VRC07-523LS 20 mg/kg AND PGT121.414LS 20 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
T7: PGDM1400LS + VRC07-523LS + PGT121.414LS (SC) 2
n=16 Participants
PGDM1400LS 20 mg/kg AND VRC07-523LS 20 mg/kg AND PGT121.414LS 20 mg/kg to be administered SC sequentially in this order at Month 0 and Month 4.
|
T8: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV) 1
n=16 Participants
PGDM1400LS 1.4 g AND VRC07-523LS 1.4 g AND PGT121.414LS 1.4 g to be administered IV sequentially in this order at Month 0 and Month 4.
|
T9: PGDM1400LS + VRC07-523LS + PGT121.414LS (SC) 1
n=16 Participants
PGDM1400LS 1.4 g AND VRC07-523LS 1.4 g AND PGT121.414LS 1.4 g to be administered SC sequentially in this order at Month 0 and Month 4.
|
T10: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV)
n=16 Participants
PGDM1400LS 40 mg/kg AND VRC07-523LS 40 mg/kg AND PGT121.414LS 40 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
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 · Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
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
Induration/Swelling · None
|
3 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
16 Participants
|
13 Participants
|
16 Participants
|
10 Participants
|
16 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
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
|
3 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
16 Participants
|
12 Participants
|
16 Participants
|
9 Participants
|
16 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
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
|
3 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
16 Participants
|
12 Participants
|
16 Participants
|
10 Participants
|
16 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through Month Measured through 3 days after each vaccine dose at T1-T5: Day 0 and T6-T10: Days 0, 112Graded 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 |
T1: PGDM1400LS (IV) 5 mg/kg mo 0
n=3 Participants
PGDM1400LS 5 mg/kg to be administered IV at Month 0.
|
T2: PGDM1400LS (IV) 20 mg/kg mo 0
n=3 Participants
PGDM1400LS 20 mg/kg to be administered IV at Month 0.
|
T3: PGDM1400LS (SC) 20 mg/kg mo 0
n=3 Participants
PGDM1400LS 20 mg/kg to be administered SC at Month 0.
|
T4: PGDM1400LS (IV) 40 mg/kg mo 0
n=3 Participants
PGDM1400LS 40 mg/kg to be administered IV at Month 0.
|
T5: PGDM1400LS (SC) 40 mg/kg mo 0
n=3 Participants
PGDM1400LS 40 mg/kg to be administered SC at Month 0.
|
T6: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV) 2
n=16 Participants
PGDM1400LS 20 mg/kg AND VRC07-523LS 20 mg/kg AND PGT121.414LS 20 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
T7: PGDM1400LS + VRC07-523LS + PGT121.414LS (SC) 2
n=16 Participants
PGDM1400LS 20 mg/kg AND VRC07-523LS 20 mg/kg AND PGT121.414LS 20 mg/kg to be administered SC sequentially in this order at Month 0 and Month 4.
|
T8: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV) 1
n=16 Participants
PGDM1400LS 1.4 g AND VRC07-523LS 1.4 g AND PGT121.414LS 1.4 g to be administered IV sequentially in this order at Month 0 and Month 4.
|
T9: PGDM1400LS + VRC07-523LS + PGT121.414LS (SC) 1
n=16 Participants
PGDM1400LS 1.4 g AND VRC07-523LS 1.4 g AND PGT121.414LS 1.4 g to be administered SC sequentially in this order at Month 0 and Month 4.
|
T10: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV)
n=16 Participants
PGDM1400LS 40 mg/kg AND VRC07-523LS 40 mg/kg AND PGT121.414LS 40 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · None
|
3 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
9 Participants
|
10 Participants
|
9 Participants
|
11 Participants
|
13 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Mild
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · None
|
3 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
7 Participants
|
10 Participants
|
10 Participants
|
12 Participants
|
10 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Mild
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
6 Participants
|
6 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
2 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
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · None
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
13 Participants
|
16 Participants
|
15 Participants
|
13 Participants
|
14 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Non-exertional dyspnea · None
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
16 Participants
|
16 Participants
|
15 Participants
|
16 Participants
|
16 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Non-exertional dyspnea · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Unexplained diaphoresis · None
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
12 Participants
|
16 Participants
|
15 Participants
|
16 Participants
|
16 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Unexplained diaphoresis · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Generalized Pruritus · None
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
15 Participants
|
16 Participants
|
15 Participants
|
16 Participants
|
16 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
|
0 Participants
|
0 Participants
|
0 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
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · None
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
7 Participants
|
7 Participants
|
6 Participants
|
7 Participants
|
10 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Mild
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
8 Participants
|
5 Participants
|
8 Participants
|
3 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
5 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · None
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
16 Participants
|
16 Participants
|
16 Participants
|
16 Participants
|
15 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 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
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
1 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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · None
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
13 Participants
|
12 Participants
|
12 Participants
|
14 Participants
|
13 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · None
|
2 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
11 Participants
|
15 Participants
|
14 Participants
|
12 Participants
|
14 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Mild
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 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
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · None
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
12 Participants
|
16 Participants
|
13 Participants
|
14 Participants
|
14 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Facial flushing · None
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
15 Participants
|
15 Participants
|
16 Participants
|
15 Participants
|
16 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Facial flushing · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 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
|
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
|
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
|
0 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
|
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
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Non-exertional tachycardia · None
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
16 Participants
|
16 Participants
|
16 Participants
|
16 Participants
|
16 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
|
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
|
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
|
0 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
|
1 Participants
|
0 Participants
|
1 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
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Generalized Pruritus · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Urticaria · None
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
16 Participants
|
16 Participants
|
16 Participants
|
16 Participants
|
16 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
|
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
|
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
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Measured during Screening, Days 0, 56, 112*, 168, and 280* Days with * are only available for T6-T10Population: '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: median and interquartile range were presented by treatment group and timepoint for the overall population.
Outcome measures
| Measure |
T1: PGDM1400LS (IV) 5 mg/kg mo 0
n=3 Participants
PGDM1400LS 5 mg/kg to be administered IV at Month 0.
|
T2: PGDM1400LS (IV) 20 mg/kg mo 0
n=3 Participants
PGDM1400LS 20 mg/kg to be administered IV at Month 0.
|
T3: PGDM1400LS (SC) 20 mg/kg mo 0
n=3 Participants
PGDM1400LS 20 mg/kg to be administered SC at Month 0.
|
T4: PGDM1400LS (IV) 40 mg/kg mo 0
n=3 Participants
PGDM1400LS 40 mg/kg to be administered IV at Month 0.
|
T5: PGDM1400LS (SC) 40 mg/kg mo 0
n=3 Participants
PGDM1400LS 40 mg/kg to be administered SC at Month 0.
|
T6: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV) 2
n=16 Participants
PGDM1400LS 20 mg/kg AND VRC07-523LS 20 mg/kg AND PGT121.414LS 20 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
T7: PGDM1400LS + VRC07-523LS + PGT121.414LS (SC) 2
n=16 Participants
PGDM1400LS 20 mg/kg AND VRC07-523LS 20 mg/kg AND PGT121.414LS 20 mg/kg to be administered SC sequentially in this order at Month 0 and Month 4.
|
T8: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV) 1
n=16 Participants
PGDM1400LS 1.4 g AND VRC07-523LS 1.4 g AND PGT121.414LS 1.4 g to be administered IV sequentially in this order at Month 0 and Month 4.
|
T9: PGDM1400LS + VRC07-523LS + PGT121.414LS (SC) 1
n=16 Participants
PGDM1400LS 1.4 g AND VRC07-523LS 1.4 g AND PGT121.414LS 1.4 g to be administered SC sequentially in this order at Month 0 and Month 4.
|
T10: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV)
n=16 Participants
PGDM1400LS 40 mg/kg AND VRC07-523LS 40 mg/kg AND PGT121.414LS 40 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
ALP (U/L) -Day 0/Enrollment
|
62 U/L
Interval 30.0 to 71.0
|
56 U/L
Interval 53.0 to 76.0
|
73 U/L
Interval 43.0 to 86.0
|
73 U/L
Interval 71.0 to 96.0
|
78 U/L
Interval 68.0 to 91.0
|
76.5 U/L
Interval 61.5 to 107.0
|
73.5 U/L
Interval 61.5 to 104.0
|
75 U/L
Interval 61.0 to 85.0
|
85 U/L
Interval 70.0 to 118.5
|
72 U/L
Interval 62.0 to 87.5
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
ALP (U/L) -Day 168
|
48 U/L
Interval 33.0 to 55.0
|
63 U/L
Interval 47.0 to 88.0
|
72 U/L
Interval 40.0 to 90.0
|
84 U/L
Interval 71.0 to 88.0
|
81 U/L
Interval 72.0 to 89.0
|
83.5 U/L
Interval 62.0 to 104.0
|
74 U/L
Interval 72.0 to 101.5
|
73 U/L
Interval 71.0 to 93.0
|
84 U/L
Interval 64.5 to 102.0
|
78 U/L
Interval 67.0 to 91.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
ALP (U/L) -Day 280
|
—
|
—
|
—
|
—
|
—
|
73 U/L
Interval 61.0 to 111.0
|
78 U/L
Interval 64.0 to 84.0
|
72 U/L
Interval 60.0 to 83.0
|
86.5 U/L
Interval 68.5 to 97.5
|
76 U/L
Interval 64.0 to 97.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
AST (U/L) -Day 0/Enrollment
|
19 U/L
Interval 17.0 to 26.0
|
16 U/L
Interval 14.0 to 18.0
|
21 U/L
Interval 14.0 to 22.0
|
20 U/L
Interval 16.0 to 20.0
|
21 U/L
Interval 13.0 to 25.0
|
21 U/L
Interval 18.0 to 26.0
|
20.5 U/L
Interval 17.0 to 24.5
|
18 U/L
Interval 16.0 to 21.5
|
24 U/L
Interval 16.0 to 29.0
|
20.5 U/L
Interval 17.0 to 24.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
ALP (U/L) -Day 56
|
40.5 U/L
Interval 32.0 to 49.0
|
65 U/L
Interval 51.0 to 81.0
|
68 U/L
Interval 45.0 to 79.0
|
75 U/L
Interval 74.0 to 86.0
|
59 U/L
Interval 59.0 to 79.0
|
77 U/L
Interval 55.0 to 101.0
|
68.5 U/L
Interval 65.5 to 95.5
|
74.5 U/L
Interval 65.5 to 91.5
|
81.5 U/L
Interval 67.0 to 107.0
|
83 U/L
Interval 70.0 to 89.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
ALP (U/L) -Day 112
|
—
|
—
|
—
|
—
|
—
|
77 U/L
Interval 59.0 to 97.0
|
72 U/L
Interval 65.0 to 107.0
|
70.5 U/L
Interval 56.0 to 96.0
|
84 U/L
Interval 67.5 to 109.0
|
76 U/L
Interval 65.0 to 102.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
AST (U/L) -Day 56
|
17.5 U/L
Interval 16.0 to 19.0
|
15 U/L
Interval 15.0 to 19.0
|
21 U/L
Interval 16.0 to 22.0
|
20 U/L
Interval 19.0 to 22.0
|
21 U/L
Interval 14.0 to 22.0
|
21 U/L
Interval 19.0 to 29.0
|
19 U/L
Interval 16.5 to 23.0
|
18.5 U/L
Interval 17.0 to 25.0
|
24 U/L
Interval 21.0 to 29.0
|
21 U/L
Interval 17.0 to 30.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
AST (U/L) -Day 112
|
—
|
—
|
—
|
—
|
—
|
20.5 U/L
Interval 19.0 to 30.0
|
20 U/L
Interval 16.0 to 22.0
|
18.5 U/L
Interval 16.5 to 27.0
|
24 U/L
Interval 19.0 to 27.0
|
24.5 U/L
Interval 17.0 to 42.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
AST (U/L) -Day 168
|
16 U/L
Interval 15.0 to 48.0
|
19 U/L
Interval 14.0 to 23.0
|
19 U/L
Interval 14.0 to 19.0
|
20 U/L
Interval 16.0 to 20.0
|
23 U/L
Interval 13.0 to 24.0
|
22.5 U/L
Interval 20.0 to 26.0
|
22.5 U/L
Interval 20.0 to 27.5
|
23.5 U/L
Interval 17.0 to 25.0
|
25 U/L
Interval 17.5 to 29.0
|
20 U/L
Interval 16.0 to 28.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
AST (U/L) -Day 280
|
—
|
—
|
—
|
—
|
—
|
23 U/L
Interval 17.0 to 28.0
|
21 U/L
Interval 18.0 to 25.5
|
18.5 U/L
Interval 16.0 to 22.0
|
22.5 U/L
Interval 19.0 to 27.5
|
21 U/L
Interval 18.0 to 24.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
ALT (U/L) -Screening
|
15 U/L
Interval 10.0 to 20.0
|
14 U/L
Interval 7.0 to 28.0
|
15 U/L
Interval 10.0 to 19.0
|
17 U/L
Interval 12.0 to 25.0
|
18 U/L
Interval 9.0 to 25.0
|
16.5 U/L
Interval 12.5 to 23.5
|
13.5 U/L
Interval 9.5 to 16.5
|
16.5 U/L
Interval 11.5 to 27.0
|
14 U/L
Interval 11.0 to 19.0
|
15 U/L
Interval 11.5 to 25.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
ALT (U/L) -Day 0/Enrollment
|
14 U/L
Interval 14.0 to 17.0
|
16 U/L
Interval 6.0 to 28.0
|
12 U/L
Interval 12.0 to 27.0
|
17 U/L
Interval 10.0 to 18.0
|
16 U/L
Interval 12.0 to 29.0
|
19.5 U/L
Interval 13.0 to 22.5
|
13 U/L
Interval 10.0 to 17.0
|
16 U/L
Interval 10.5 to 21.0
|
14 U/L
Interval 11.0 to 19.0
|
18.5 U/L
Interval 12.5 to 26.5
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
ALT (U/L) -Day 56
|
16 U/L
Interval 14.0 to 18.0
|
13 U/L
Interval 8.0 to 23.0
|
12 U/L
Interval 10.0 to 26.0
|
18 U/L
Interval 14.0 to 20.0
|
15 U/L
Interval 14.0 to 26.0
|
19 U/L
Interval 15.0 to 22.0
|
13 U/L
Interval 10.0 to 16.5
|
16 U/L
Interval 12.5 to 24.0
|
17.5 U/L
Interval 14.0 to 23.5
|
18 U/L
Interval 12.0 to 25.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
ALT (U/L) -Day 112
|
—
|
—
|
—
|
—
|
—
|
21 U/L
Interval 12.0 to 34.0
|
14 U/L
Interval 9.0 to 20.0
|
16 U/L
Interval 14.0 to 24.0
|
18.5 U/L
Interval 13.5 to 23.0
|
16 U/L
Interval 14.0 to 32.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
ALT (U/L) -Day 168
|
15 U/L
Interval 10.0 to 34.0
|
16 U/L
Interval 7.0 to 33.0
|
10 U/L
Interval 8.0 to 23.0
|
14 U/L
Interval 12.0 to 16.0
|
14 U/L
Interval 13.0 to 54.0
|
18.5 U/L
Interval 15.0 to 32.0
|
16 U/L
Interval 12.0 to 23.0
|
17 U/L
Interval 14.0 to 30.0
|
17 U/L
Interval 11.0 to 25.0
|
16.5 U/L
Interval 12.0 to 36.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
ALT (U/L) -Day 280
|
—
|
—
|
—
|
—
|
—
|
22 U/L
Interval 11.0 to 29.0
|
13.5 U/L
Interval 11.5 to 24.5
|
14.5 U/L
Interval 12.0 to 20.5
|
15.5 U/L
Interval 11.5 to 23.0
|
17.5 U/L
Interval 13.0 to 30.0
|
PRIMARY outcome
Timeframe: Measured during Screening, Days 0, 56, 112*, 168, and 280* Days with * are only available for T6-T10Population: '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 |
T1: PGDM1400LS (IV) 5 mg/kg mo 0
n=3 Participants
PGDM1400LS 5 mg/kg to be administered IV at Month 0.
|
T2: PGDM1400LS (IV) 20 mg/kg mo 0
n=3 Participants
PGDM1400LS 20 mg/kg to be administered IV at Month 0.
|
T3: PGDM1400LS (SC) 20 mg/kg mo 0
n=3 Participants
PGDM1400LS 20 mg/kg to be administered SC at Month 0.
|
T4: PGDM1400LS (IV) 40 mg/kg mo 0
n=3 Participants
PGDM1400LS 40 mg/kg to be administered IV at Month 0.
|
T5: PGDM1400LS (SC) 40 mg/kg mo 0
n=3 Participants
PGDM1400LS 40 mg/kg to be administered SC at Month 0.
|
T6: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV) 2
n=16 Participants
PGDM1400LS 20 mg/kg AND VRC07-523LS 20 mg/kg AND PGT121.414LS 20 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
T7: PGDM1400LS + VRC07-523LS + PGT121.414LS (SC) 2
n=16 Participants
PGDM1400LS 20 mg/kg AND VRC07-523LS 20 mg/kg AND PGT121.414LS 20 mg/kg to be administered SC sequentially in this order at Month 0 and Month 4.
|
T8: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV) 1
n=16 Participants
PGDM1400LS 1.4 g AND VRC07-523LS 1.4 g AND PGT121.414LS 1.4 g to be administered IV sequentially in this order at Month 0 and Month 4.
|
T9: PGDM1400LS + VRC07-523LS + PGT121.414LS (SC) 1
n=16 Participants
PGDM1400LS 1.4 g AND VRC07-523LS 1.4 g AND PGT121.414LS 1.4 g to be administered SC sequentially in this order at Month 0 and Month 4.
|
T10: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV)
n=16 Participants
PGDM1400LS 40 mg/kg AND VRC07-523LS 40 mg/kg AND PGT121.414LS 40 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Creatinine
Creatinine (mg/dL) -Screening
|
0.77 mg/dL
Interval 0.68 to 0.77
|
0.78 mg/dL
Interval 0.74 to 0.87
|
0.83 mg/dL
Interval 0.56 to 0.85
|
0.94 mg/dL
Interval 0.89 to 1.03
|
0.81 mg/dL
Interval 0.69 to 0.95
|
0.79 mg/dL
Interval 0.64 to 0.85
|
0.72 mg/dL
Interval 0.59 to 0.8
|
0.79 mg/dL
Interval 0.66 to 0.9
|
0.79 mg/dL
Interval 0.71 to 0.89
|
0.81 mg/dL
Interval 0.69 to 0.92
|
|
Chemistry and Hematology Laboratory Measures - Creatinine
Creatinine (mg/dL) -Day 0/Enrollment
|
0.75 mg/dL
Interval 0.74 to 0.8
|
0.79 mg/dL
Interval 0.65 to 0.87
|
0.81 mg/dL
Interval 0.64 to 0.99
|
0.85 mg/dL
Interval 0.83 to 0.89
|
0.9 mg/dL
Interval 0.72 to 0.91
|
0.8 mg/dL
Interval 0.64 to 0.91
|
0.74 mg/dL
Interval 0.65 to 0.81
|
0.7 mg/dL
Interval 0.66 to 0.88
|
0.81 mg/dL
Interval 0.77 to 0.89
|
0.82 mg/dL
Interval 0.71 to 0.96
|
|
Chemistry and Hematology Laboratory Measures - Creatinine
Creatinine (mg/dL) -Day 56
|
0.81 mg/dL
Interval 0.81 to 0.82
|
0.78 mg/dL
Interval 0.67 to 1.02
|
0.8 mg/dL
Interval 0.78 to 0.98
|
0.89 mg/dL
Interval 0.76 to 0.91
|
0.82 mg/dL
Interval 0.75 to 0.96
|
0.74 mg/dL
Interval 0.65 to 0.83
|
0.7 mg/dL
Interval 0.59 to 0.86
|
0.76 mg/dL
Interval 0.72 to 0.83
|
0.77 mg/dL
Interval 0.69 to 0.93
|
0.79 mg/dL
Interval 0.67 to 0.94
|
|
Chemistry and Hematology Laboratory Measures - Creatinine
Creatinine (mg/dL) -Day 112
|
—
|
—
|
—
|
—
|
—
|
0.73 mg/dL
Interval 0.59 to 0.84
|
0.74 mg/dL
Interval 0.61 to 0.84
|
0.76 mg/dL
Interval 0.68 to 0.83
|
0.79 mg/dL
Interval 0.7 to 0.87
|
0.8 mg/dL
Interval 0.7 to 0.88
|
|
Chemistry and Hematology Laboratory Measures - Creatinine
Creatinine (mg/dL) -Day 168
|
0.8 mg/dL
Interval 0.77 to 0.83
|
0.83 mg/dL
Interval 0.67 to 1.01
|
0.81 mg/dL
Interval 0.74 to 1.09
|
0.89 mg/dL
Interval 0.86 to 1.03
|
0.92 mg/dL
Interval 0.73 to 0.96
|
0.73 mg/dL
Interval 0.68 to 0.87
|
0.74 mg/dL
Interval 0.66 to 0.85
|
0.74 mg/dL
Interval 0.69 to 0.84
|
0.8 mg/dL
Interval 0.72 to 0.94
|
0.81 mg/dL
Interval 0.68 to 0.91
|
|
Chemistry and Hematology Laboratory Measures - Creatinine
Creatinine (mg/dL) -Day 280
|
—
|
—
|
—
|
—
|
—
|
0.74 mg/dL
Interval 0.68 to 0.85
|
0.76 mg/dL
Interval 0.6 to 0.89
|
0.81 mg/dL
Interval 0.7 to 0.94
|
0.84 mg/dL
Interval 0.7 to 0.89
|
0.78 mg/dL
Interval 0.71 to 0.91
|
PRIMARY outcome
Timeframe: Measured during Screening, Days 0, 56, 112*, 168, and 280* Days with * are only available for T6-T10Population: '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 |
T1: PGDM1400LS (IV) 5 mg/kg mo 0
n=3 Participants
PGDM1400LS 5 mg/kg to be administered IV at Month 0.
|
T2: PGDM1400LS (IV) 20 mg/kg mo 0
n=3 Participants
PGDM1400LS 20 mg/kg to be administered IV at Month 0.
|
T3: PGDM1400LS (SC) 20 mg/kg mo 0
n=3 Participants
PGDM1400LS 20 mg/kg to be administered SC at Month 0.
|
T4: PGDM1400LS (IV) 40 mg/kg mo 0
n=3 Participants
PGDM1400LS 40 mg/kg to be administered IV at Month 0.
|
T5: PGDM1400LS (SC) 40 mg/kg mo 0
n=3 Participants
PGDM1400LS 40 mg/kg to be administered SC at Month 0.
|
T6: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV) 2
n=16 Participants
PGDM1400LS 20 mg/kg AND VRC07-523LS 20 mg/kg AND PGT121.414LS 20 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
T7: PGDM1400LS + VRC07-523LS + PGT121.414LS (SC) 2
n=16 Participants
PGDM1400LS 20 mg/kg AND VRC07-523LS 20 mg/kg AND PGT121.414LS 20 mg/kg to be administered SC sequentially in this order at Month 0 and Month 4.
|
T8: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV) 1
n=16 Participants
PGDM1400LS 1.4 g AND VRC07-523LS 1.4 g AND PGT121.414LS 1.4 g to be administered IV sequentially in this order at Month 0 and Month 4.
|
T9: PGDM1400LS + VRC07-523LS + PGT121.414LS (SC) 1
n=16 Participants
PGDM1400LS 1.4 g AND VRC07-523LS 1.4 g AND PGT121.414LS 1.4 g to be administered SC sequentially in this order at Month 0 and Month 4.
|
T10: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV)
n=16 Participants
PGDM1400LS 40 mg/kg AND VRC07-523LS 40 mg/kg AND PGT121.414LS 40 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin
Hemoglobin (g/dL) -Day 56
|
12.9 g/dL
Interval 11.6 to 14.5
|
13.6 g/dL
Interval 11.7 to 15.2
|
13.3 g/dL
Interval 12.9 to 17.3
|
13.5 g/dL
Interval 12.5 to 15.8
|
13.5 g/dL
Interval 11.8 to 14.5
|
14.5 g/dL
Interval 13.9 to 15.3
|
13.85 g/dL
Interval 13.3 to 14.95
|
13.85 g/dL
Interval 12.9 to 15.35
|
14.9 g/dL
Interval 13.15 to 15.4
|
14.9 g/dL
Interval 13.9 to 17.2
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin
Hemoglobin (g/dL) -Day 112
|
—
|
—
|
—
|
—
|
—
|
14.3 g/dL
Interval 13.3 to 16.2
|
13.6 g/dL
Interval 13.4 to 15.1
|
14 g/dL
Interval 12.75 to 15.25
|
14.6 g/dL
Interval 12.8 to 15.5
|
15 g/dL
Interval 13.4 to 18.0
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin
Hemoglobin (g/dL) -Screening
|
13.6 g/dL
Interval 12.7 to 14.8
|
14.3 g/dL
Interval 12.3 to 15.5
|
15.1 g/dL
Interval 12.3 to 16.7
|
13.3 g/dL
Interval 13.3 to 16.2
|
14.3 g/dL
Interval 12.6 to 14.5
|
14.5 g/dL
Interval 13.8 to 16.05
|
14.05 g/dL
Interval 13.35 to 14.6
|
14.1 g/dL
Interval 13.45 to 15.55
|
14.8 g/dL
Interval 13.35 to 15.55
|
15.8 g/dL
Interval 14.1 to 17.1
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin
Hemoglobin (g/dL) -Day 0/Enrollment
|
12.3 g/dL
Interval 11.7 to 12.9
|
12.3 g/dL
Interval 11.8 to 15.1
|
13.7 g/dL
Interval 13.1 to 17.3
|
12.7 g/dL
Interval 11.5 to 16.0
|
13.6 g/dL
Interval 12.7 to 15.0
|
14.75 g/dL
Interval 14.2 to 16.75
|
13.5 g/dL
Interval 13.2 to 15.2
|
13.9 g/dL
Interval 12.6 to 15.7
|
14.35 g/dL
Interval 13.6 to 15.3
|
14.9 g/dL
Interval 13.5 to 16.75
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin
Hemoglobin (g/dL) -Day 168
|
12.5 g/dL
Interval 11.6 to 16.7
|
14.3 g/dL
Interval 11.5 to 14.7
|
13 g/dL
Interval 12.9 to 17.5
|
13.9 g/dL
Interval 12.1 to 16.3
|
13.8 g/dL
Interval 12.3 to 14.4
|
14.75 g/dL
Interval 13.5 to 16.0
|
13.95 g/dL
Interval 13.55 to 15.2
|
13.4 g/dL
Interval 13.0 to 14.7
|
14.35 g/dL
Interval 13.05 to 15.15
|
15.45 g/dL
Interval 13.9 to 17.4
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin
Hemoglobin (g/dL) -Day 280
|
—
|
—
|
—
|
—
|
—
|
13.8 g/dL
Interval 13.2 to 15.5
|
13.85 g/dL
Interval 13.4 to 15.25
|
13.8 g/dL
Interval 12.85 to 16.0
|
13.85 g/dL
Interval 13.1 to 14.75
|
15.05 g/dL
Interval 13.9 to 16.8
|
PRIMARY outcome
Timeframe: Measured during Screening, Days 0, 56, 112*, 168, and 280* Days with * are only available for T6-T10Population: '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 |
T1: PGDM1400LS (IV) 5 mg/kg mo 0
n=3 Participants
PGDM1400LS 5 mg/kg to be administered IV at Month 0.
|
T2: PGDM1400LS (IV) 20 mg/kg mo 0
n=3 Participants
PGDM1400LS 20 mg/kg to be administered IV at Month 0.
|
T3: PGDM1400LS (SC) 20 mg/kg mo 0
n=3 Participants
PGDM1400LS 20 mg/kg to be administered SC at Month 0.
|
T4: PGDM1400LS (IV) 40 mg/kg mo 0
n=3 Participants
PGDM1400LS 40 mg/kg to be administered IV at Month 0.
|
T5: PGDM1400LS (SC) 40 mg/kg mo 0
n=3 Participants
PGDM1400LS 40 mg/kg to be administered SC at Month 0.
|
T6: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV) 2
n=16 Participants
PGDM1400LS 20 mg/kg AND VRC07-523LS 20 mg/kg AND PGT121.414LS 20 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
T7: PGDM1400LS + VRC07-523LS + PGT121.414LS (SC) 2
n=16 Participants
PGDM1400LS 20 mg/kg AND VRC07-523LS 20 mg/kg AND PGT121.414LS 20 mg/kg to be administered SC sequentially in this order at Month 0 and Month 4.
|
T8: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV) 1
n=16 Participants
PGDM1400LS 1.4 g AND VRC07-523LS 1.4 g AND PGT121.414LS 1.4 g to be administered IV sequentially in this order at Month 0 and Month 4.
|
T9: PGDM1400LS + VRC07-523LS + PGT121.414LS (SC) 1
n=16 Participants
PGDM1400LS 1.4 g AND VRC07-523LS 1.4 g AND PGT121.414LS 1.4 g to be administered SC sequentially in this order at Month 0 and Month 4.
|
T10: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV)
n=16 Participants
PGDM1400LS 40 mg/kg AND VRC07-523LS 40 mg/kg AND PGT121.414LS 40 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Neutrophils (1000 cells/cubic mm) -Screening
|
4.3 1000 cells/cubic mm
Interval 3.31 to 5.06
|
2.88 1000 cells/cubic mm
Interval 2.19 to 3.7
|
5.36 1000 cells/cubic mm
Interval 3.9 to 5.79
|
3.6 1000 cells/cubic mm
Interval 3.1 to 4.58
|
4.28 1000 cells/cubic mm
Interval 3.7 to 4.4
|
3.5 1000 cells/cubic mm
Interval 2.58 to 4.5
|
3.48 1000 cells/cubic mm
Interval 2.59 to 4.31
|
3.54 1000 cells/cubic mm
Interval 2.91 to 3.79
|
2.95 1000 cells/cubic mm
Interval 2.09 to 4.25
|
3 1000 cells/cubic mm
Interval 2.15 to 3.5
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Neutrophils (1000 cells/cubic mm) -Day 0/Enrollment
|
2.88 1000 cells/cubic mm
Interval 1.74 to 4.02
|
2.81 1000 cells/cubic mm
Interval 2.61 to 3.03
|
5.2 1000 cells/cubic mm
Interval 4.22 to 5.53
|
2.8 1000 cells/cubic mm
Interval 2.5 to 4.28
|
3.68 1000 cells/cubic mm
Interval 2.91 to 4.18
|
3.35 1000 cells/cubic mm
Interval 2.55 to 3.81
|
2.25 1000 cells/cubic mm
Interval 1.78 to 3.48
|
3.01 1000 cells/cubic mm
Interval 2.33 to 3.77
|
3.27 1000 cells/cubic mm
Interval 1.54 to 4.28
|
2.77 1000 cells/cubic mm
Interval 2.32 to 3.98
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Neutrophils (1000 cells/cubic mm) -Day 56
|
2.76 1000 cells/cubic mm
Interval 2.48 to 3.47
|
2.68 1000 cells/cubic mm
Interval 2.5 to 2.92
|
4.87 1000 cells/cubic mm
Interval 3.9 to 5.09
|
4.7 1000 cells/cubic mm
Interval 3.0 to 5.02
|
4.81 1000 cells/cubic mm
Interval 4.22 to 5.18
|
2.66 1000 cells/cubic mm
Interval 2.1 to 4.54
|
2.87 1000 cells/cubic mm
Interval 2.27 to 4.14
|
3.28 1000 cells/cubic mm
Interval 2.36 to 4.07
|
2.72 1000 cells/cubic mm
Interval 1.82 to 5.02
|
3.13 1000 cells/cubic mm
Interval 2.19 to 3.7
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Neutrophils (1000 cells/cubic mm) -Day 112
|
—
|
—
|
—
|
—
|
—
|
2.54 1000 cells/cubic mm
Interval 1.87 to 3.8
|
2.54 1000 cells/cubic mm
Interval 1.69 to 3.85
|
2.84 1000 cells/cubic mm
Interval 2.4 to 3.5
|
2.57 1000 cells/cubic mm
Interval 1.63 to 3.62
|
2.73 1000 cells/cubic mm
Interval 2.47 to 3.27
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Neutrophils (1000 cells/cubic mm) -Day 280
|
—
|
—
|
—
|
—
|
—
|
2.05 1000 cells/cubic mm
Interval 1.71 to 2.91
|
2.72 1000 cells/cubic mm
Interval 2.17 to 4.25
|
3.38 1000 cells/cubic mm
Interval 2.74 to 4.48
|
3.29 1000 cells/cubic mm
Interval 2.13 to 4.11
|
2.76 1000 cells/cubic mm
Interval 2.54 to 3.13
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Neutrophils (1000 cells/cubic mm) -Day 168
|
3.44 1000 cells/cubic mm
Interval 2.01 to 3.61
|
2.32 1000 cells/cubic mm
Interval 1.47 to 3.49
|
4.66 1000 cells/cubic mm
Interval 3.29 to 4.9
|
4.16 1000 cells/cubic mm
Interval 3.5 to 4.5
|
5.53 1000 cells/cubic mm
Interval 2.58 to 7.71
|
2.65 1000 cells/cubic mm
Interval 1.92 to 3.76
|
2.8 1000 cells/cubic mm
Interval 1.93 to 3.59
|
3.39 1000 cells/cubic mm
Interval 2.98 to 4.11
|
2.92 1000 cells/cubic mm
Interval 1.68 to 4.53
|
2.77 1000 cells/cubic mm
Interval 2.05 to 3.11
|
PRIMARY outcome
Timeframe: Measured during Screening, Days 0, 56, 112*, 168, and 280* Days with * are only available for T6-T10Population: '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 |
T1: PGDM1400LS (IV) 5 mg/kg mo 0
n=3 Participants
PGDM1400LS 5 mg/kg to be administered IV at Month 0.
|
T2: PGDM1400LS (IV) 20 mg/kg mo 0
n=3 Participants
PGDM1400LS 20 mg/kg to be administered IV at Month 0.
|
T3: PGDM1400LS (SC) 20 mg/kg mo 0
n=3 Participants
PGDM1400LS 20 mg/kg to be administered SC at Month 0.
|
T4: PGDM1400LS (IV) 40 mg/kg mo 0
n=3 Participants
PGDM1400LS 40 mg/kg to be administered IV at Month 0.
|
T5: PGDM1400LS (SC) 40 mg/kg mo 0
n=3 Participants
PGDM1400LS 40 mg/kg to be administered SC at Month 0.
|
T6: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV) 2
n=16 Participants
PGDM1400LS 20 mg/kg AND VRC07-523LS 20 mg/kg AND PGT121.414LS 20 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
T7: PGDM1400LS + VRC07-523LS + PGT121.414LS (SC) 2
n=16 Participants
PGDM1400LS 20 mg/kg AND VRC07-523LS 20 mg/kg AND PGT121.414LS 20 mg/kg to be administered SC sequentially in this order at Month 0 and Month 4.
|
T8: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV) 1
n=16 Participants
PGDM1400LS 1.4 g AND VRC07-523LS 1.4 g AND PGT121.414LS 1.4 g to be administered IV sequentially in this order at Month 0 and Month 4.
|
T9: PGDM1400LS + VRC07-523LS + PGT121.414LS (SC) 1
n=16 Participants
PGDM1400LS 1.4 g AND VRC07-523LS 1.4 g AND PGT121.414LS 1.4 g to be administered SC sequentially in this order at Month 0 and Month 4.
|
T10: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV)
n=16 Participants
PGDM1400LS 40 mg/kg AND VRC07-523LS 40 mg/kg AND PGT121.414LS 40 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
WBC (1000 cells/cubic mm) -Screening
|
7100 1000 cells/cubic mm
Interval 6800.0 to 7200.0
|
5300 1000 cells/cubic mm
Interval 4600.0 to 6600.0
|
7600 1000 cells/cubic mm
Interval 6800.0 to 9300.0
|
6300 1000 cells/cubic mm
Interval 5500.0 to 6600.0
|
6700 1000 cells/cubic mm
Interval 6100.0 to 7700.0
|
6475 1000 cells/cubic mm
Interval 5160.0 to 7050.0
|
6330 1000 cells/cubic mm
Interval 5280.0 to 7290.0
|
6040 1000 cells/cubic mm
Interval 5020.0 to 6650.0
|
5555 1000 cells/cubic mm
Interval 4985.0 to 7280.0
|
5515 1000 cells/cubic mm
Interval 4750.0 to 6400.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
WBC (1000 cells/cubic mm) -Day 0/Enrollment
|
5900 1000 cells/cubic mm
Interval 4900.0 to 6900.0
|
5300 1000 cells/cubic mm
Interval 4700.0 to 5800.0
|
7900 1000 cells/cubic mm
Interval 7600.0 to 10100.0
|
5900 1000 cells/cubic mm
Interval 4400.0 to 7300.0
|
6400 1000 cells/cubic mm
Interval 5400.0 to 7700.0
|
6045 1000 cells/cubic mm
Interval 4805.0 to 6840.0
|
5110 1000 cells/cubic mm
Interval 3800.0 to 6640.0
|
5320 1000 cells/cubic mm
Interval 4640.0 to 6400.0
|
5255 1000 cells/cubic mm
Interval 4020.0 to 7160.0
|
5470 1000 cells/cubic mm
Interval 4795.0 to 6945.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
WBC (1000 cells/cubic mm) -Day 168
|
5700 1000 cells/cubic mm
Interval 4800.0 to 5800.0
|
4900 1000 cells/cubic mm
Interval 3800.0 to 6000.0
|
6700 1000 cells/cubic mm
Interval 5900.0 to 9100.0
|
6100 1000 cells/cubic mm
Interval 6100.0 to 8000.0
|
8600 1000 cells/cubic mm
Interval 5400.0 to 11200.0
|
5335 1000 cells/cubic mm
Interval 4030.0 to 6400.0
|
5425 1000 cells/cubic mm
Interval 4055.0 to 6700.0
|
5690 1000 cells/cubic mm
Interval 4800.0 to 6440.0
|
5575 1000 cells/cubic mm
Interval 4115.0 to 7200.0
|
5085 1000 cells/cubic mm
Interval 3880.0 to 6300.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
WBC (1000 cells/cubic mm) -Day 280
|
—
|
—
|
—
|
—
|
—
|
4240 1000 cells/cubic mm
Interval 3880.0 to 5900.0
|
5385 1000 cells/cubic mm
Interval 4295.0 to 6805.0
|
5550 1000 cells/cubic mm
Interval 4895.0 to 6895.0
|
5845 1000 cells/cubic mm
Interval 4180.0 to 7170.0
|
5025 1000 cells/cubic mm
Interval 4500.0 to 5540.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
Platelets (1000 cells/cubic mm) -Screening
|
252000 1000 cells/cubic mm
Interval 192000.0 to 257000.0
|
304000 1000 cells/cubic mm
Interval 243000.0 to 416000.0
|
288000 1000 cells/cubic mm
Interval 281000.0 to 310000.0
|
324000 1000 cells/cubic mm
Interval 227000.0 to 326000.0
|
298000 1000 cells/cubic mm
Interval 274000.0 to 313000.0
|
282000 1000 cells/cubic mm
Interval 250000.0 to 291500.0
|
299000 1000 cells/cubic mm
Interval 255500.0 to 347000.0
|
280000 1000 cells/cubic mm
Interval 257000.0 to 332500.0
|
275500 1000 cells/cubic mm
Interval 217500.0 to 329000.0
|
249000 1000 cells/cubic mm
Interval 229500.0 to 281500.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
Platelets (1000 cells/cubic mm) -Day 0/Enrollment
|
207000 1000 cells/cubic mm
Interval 190000.0 to 224000.0
|
281000 1000 cells/cubic mm
Interval 247000.0 to 405000.0
|
283000 1000 cells/cubic mm
Interval 270000.0 to 323000.0
|
288000 1000 cells/cubic mm
Interval 210000.0 to 338000.0
|
317000 1000 cells/cubic mm
Interval 278000.0 to 349000.0
|
286000 1000 cells/cubic mm
Interval 254500.0 to 306500.0
|
285000 1000 cells/cubic mm
Interval 237000.0 to 322000.0
|
265000 1000 cells/cubic mm
Interval 233000.0 to 283000.0
|
266000 1000 cells/cubic mm
Interval 221000.0 to 334000.0
|
241500 1000 cells/cubic mm
Interval 216000.0 to 283000.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
Platelets (1000 cells/cubic mm) -Day 56
|
237000 1000 cells/cubic mm
Interval 171000.0 to 256000.0
|
295000 1000 cells/cubic mm
Interval 243000.0 to 435000.0
|
289000 1000 cells/cubic mm
Interval 288000.0 to 362000.0
|
293000 1000 cells/cubic mm
Interval 211000.0 to 309000.0
|
294000 1000 cells/cubic mm
Interval 264000.0 to 346000.0
|
277000 1000 cells/cubic mm
Interval 248000.0 to 310000.0
|
293000 1000 cells/cubic mm
Interval 242500.0 to 318000.0
|
287000 1000 cells/cubic mm
Interval 261500.0 to 336500.0
|
268000 1000 cells/cubic mm
Interval 248000.0 to 357000.0
|
263000 1000 cells/cubic mm
Interval 230000.0 to 277000.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
WBC (1000 cells/cubic mm) -Day 56
|
5700 1000 cells/cubic mm
Interval 5300.0 to 6100.0
|
5200 1000 cells/cubic mm
Interval 4300.0 to 5200.0
|
8500 1000 cells/cubic mm
Interval 6900.0 to 9200.0
|
7000 1000 cells/cubic mm
Interval 5400.0 to 7500.0
|
7200 1000 cells/cubic mm
Interval 6900.0 to 7300.0
|
5000 1000 cells/cubic mm
Interval 4110.0 to 7400.0
|
5110 1000 cells/cubic mm
Interval 4480.0 to 6960.0
|
5285 1000 cells/cubic mm
Interval 4735.0 to 7515.0
|
5120 1000 cells/cubic mm
Interval 4525.0 to 7315.0
|
5240 1000 cells/cubic mm
Interval 4300.0 to 6330.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
WBC (1000 cells/cubic mm) -Day 112
|
—
|
—
|
—
|
—
|
—
|
4880 1000 cells/cubic mm
Interval 3950.0 to 6700.0
|
5570 1000 cells/cubic mm
Interval 3955.0 to 6400.0
|
5210 1000 cells/cubic mm
Interval 4450.0 to 6075.0
|
5210 1000 cells/cubic mm
Interval 4130.0 to 5840.0
|
5320 1000 cells/cubic mm
Interval 4440.0 to 5900.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
Platelets (1000 cells/cubic mm) -Day 112
|
—
|
—
|
—
|
—
|
—
|
283500 1000 cells/cubic mm
Interval 243000.0 to 301000.0
|
285500 1000 cells/cubic mm
Interval 254000.0 to 317000.0
|
278500 1000 cells/cubic mm
Interval 222500.0 to 302000.0
|
253500 1000 cells/cubic mm
Interval 231000.0 to 355500.0
|
261000 1000 cells/cubic mm
Interval 225000.0 to 302000.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
Platelets (1000 cells/cubic mm) -Day 168
|
213000 1000 cells/cubic mm
Interval 208000.0 to 241000.0
|
296000 1000 cells/cubic mm
Interval 256000.0 to 387000.0
|
283000 1000 cells/cubic mm
Interval 278000.0 to 336000.0
|
306000 1000 cells/cubic mm
Interval 231000.0 to 385000.0
|
399000 1000 cells/cubic mm
Interval 261000.0 to 420000.0
|
276500 1000 cells/cubic mm
Interval 259000.0 to 293000.0
|
300500 1000 cells/cubic mm
Interval 244000.0 to 364000.0
|
265500 1000 cells/cubic mm
Interval 242000.0 to 298000.0
|
298000 1000 cells/cubic mm
Interval 251500.0 to 329000.0
|
251000 1000 cells/cubic mm
Interval 220000.0 to 329000.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
Platelets (1000 cells/cubic mm) -Day 280
|
—
|
—
|
—
|
—
|
—
|
267000 1000 cells/cubic mm
Interval 207000.0 to 290000.0
|
300000 1000 cells/cubic mm
Interval 253000.0 to 346000.0
|
293500 1000 cells/cubic mm
Interval 259000.0 to 340500.0
|
296500 1000 cells/cubic mm
Interval 243500.0 to 327000.0
|
248000 1000 cells/cubic mm
Interval 224000.0 to 325000.0
|
PRIMARY outcome
Timeframe: Measured during Screening, Days 0, 56, 112*, 168, and 280* Days with * are only available for T6-T10Population: '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 |
T1: PGDM1400LS (IV) 5 mg/kg mo 0
n=3 Participants
PGDM1400LS 5 mg/kg to be administered IV at Month 0.
|
T2: PGDM1400LS (IV) 20 mg/kg mo 0
n=3 Participants
PGDM1400LS 20 mg/kg to be administered IV at Month 0.
|
T3: PGDM1400LS (SC) 20 mg/kg mo 0
n=3 Participants
PGDM1400LS 20 mg/kg to be administered SC at Month 0.
|
T4: PGDM1400LS (IV) 40 mg/kg mo 0
n=3 Participants
PGDM1400LS 40 mg/kg to be administered IV at Month 0.
|
T5: PGDM1400LS (SC) 40 mg/kg mo 0
n=3 Participants
PGDM1400LS 40 mg/kg to be administered SC at Month 0.
|
T6: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV) 2
n=16 Participants
PGDM1400LS 20 mg/kg AND VRC07-523LS 20 mg/kg AND PGT121.414LS 20 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
T7: PGDM1400LS + VRC07-523LS + PGT121.414LS (SC) 2
n=16 Participants
PGDM1400LS 20 mg/kg AND VRC07-523LS 20 mg/kg AND PGT121.414LS 20 mg/kg to be administered SC sequentially in this order at Month 0 and Month 4.
|
T8: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV) 1
n=16 Participants
PGDM1400LS 1.4 g AND VRC07-523LS 1.4 g AND PGT121.414LS 1.4 g to be administered IV sequentially in this order at Month 0 and Month 4.
|
T9: PGDM1400LS + VRC07-523LS + PGT121.414LS (SC) 1
n=16 Participants
PGDM1400LS 1.4 g AND VRC07-523LS 1.4 g AND PGT121.414LS 1.4 g to be administered SC sequentially in this order at Month 0 and Month 4.
|
T10: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV)
n=16 Participants
PGDM1400LS 40 mg/kg AND VRC07-523LS 40 mg/kg AND PGT121.414LS 40 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
WBC (1000 cells/cubic mm) -Day 0/Enrollment
|
0 Participants
|
0 Participants
|
0 Participants
|
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 cells/cubic mm) -Day 56
|
0 Participants
|
0 Participants
|
0 Participants
|
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) -Day 280
|
0 Participants
|
0 Participants
|
0 Participants
|
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).
WBC (1000 cells/cubic mm) -Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
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).
ALP (U/L) -Day 0/Enrollment
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
ALP (U/L) -Day 56
|
0 Participants
|
0 Participants
|
0 Participants
|
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).
ALP (U/L) -Day 112
|
0 Participants
|
0 Participants
|
0 Participants
|
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).
ALP (U/L) -Day 168
|
0 Participants
|
0 Participants
|
0 Participants
|
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).
ALP (U/L) -Day 280
|
0 Participants
|
0 Participants
|
0 Participants
|
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).
AST (U/L) -Day 0/Enrollment
|
0 Participants
|
0 Participants
|
0 Participants
|
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).
AST (U/L) -Day 56
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 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).
AST (U/L) -Day 112
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
AST (U/L) -Day 168
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
AST (U/L) -Day 280
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 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 (U/L) -Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
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 (U/L) -Day 0/Enrollment
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 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).
ALT (U/L) -Day 56
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
ALT (U/L) -Day 112
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
ALT (U/L) -Day 168
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
ALT (U/L) -Day 280
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 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).
Hemoglobin (g/dL) -Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
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) -Day 0/Enrollment
|
0 Participants
|
0 Participants
|
0 Participants
|
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) -Day 168
|
0 Participants
|
0 Participants
|
0 Participants
|
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) -Day 280
|
0 Participants
|
0 Participants
|
0 Participants
|
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
|
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) -Day 0/Enrollment
|
0 Participants
|
0 Participants
|
0 Participants
|
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) -Day 56
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 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) -Day 112
|
0 Participants
|
0 Participants
|
0 Participants
|
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).
WBC (1000 cells/cubic mm) -Day 168
|
0 Participants
|
0 Participants
|
0 Participants
|
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 cells/cubic mm) -Day 280
|
0 Participants
|
0 Participants
|
0 Participants
|
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 cells/cubic mm) -Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
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 cells/cubic mm) -Day 0/Enrollment
|
0 Participants
|
0 Participants
|
0 Participants
|
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 cells/cubic mm) -Day 56
|
0 Participants
|
0 Participants
|
0 Participants
|
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 cells/cubic mm) -Day 112
|
0 Participants
|
0 Participants
|
0 Participants
|
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 cells/cubic mm) -Day 168
|
0 Participants
|
0 Participants
|
0 Participants
|
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 cells/cubic mm) -Day 280
|
0 Participants
|
0 Participants
|
0 Participants
|
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 cells/cubic mm) -Day 0/Enrollment
|
0 Participants
|
0 Participants
|
0 Participants
|
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 cells/cubic mm) -Day 56
|
0 Participants
|
0 Participants
|
0 Participants
|
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 cells/cubic mm) -Day 112
|
0 Participants
|
0 Participants
|
0 Participants
|
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 cells/cubic mm) -Day 168
|
0 Participants
|
0 Participants
|
0 Participants
|
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 cells/cubic mm) -Day 280
|
0 Participants
|
0 Participants
|
0 Participants
|
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 cells/cubic mm) -Day 0/Enrollment
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 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).
Neutrophils (1000 cells/cubic mm) -Day 56
|
0 Participants
|
0 Participants
|
0 Participants
|
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 cells/cubic mm) -Day 168
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 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).
Neutrophils (1000 cells/cubic mm) -Day 280
|
0 Participants
|
0 Participants
|
0 Participants
|
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) -Day 168
|
0 Participants
|
0 Participants
|
2 Participants
|
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).
Neutrophils (1000 cells/cubic mm) -Day 112
|
0 Participants
|
0 Participants
|
0 Participants
|
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 cells/cubic mm) -Day 112
|
0 Participants
|
0 Participants
|
0 Participants
|
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 cells/cubic mm) -Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
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 cells/cubic mm) -Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
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) -Day 56
|
0 Participants
|
0 Participants
|
0 Participants
|
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) -Day 112
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through Month 4Population: Safety population
The number (percentage) of participants with early discontinuation of vaccinations and reason for discontinuation was summarized by arm
Outcome measures
| Measure |
T1: PGDM1400LS (IV) 5 mg/kg mo 0
n=3 Participants
PGDM1400LS 5 mg/kg to be administered IV at Month 0.
|
T2: PGDM1400LS (IV) 20 mg/kg mo 0
n=3 Participants
PGDM1400LS 20 mg/kg to be administered IV at Month 0.
|
T3: PGDM1400LS (SC) 20 mg/kg mo 0
n=3 Participants
PGDM1400LS 20 mg/kg to be administered SC at Month 0.
|
T4: PGDM1400LS (IV) 40 mg/kg mo 0
n=3 Participants
PGDM1400LS 40 mg/kg to be administered IV at Month 0.
|
T5: PGDM1400LS (SC) 40 mg/kg mo 0
n=3 Participants
PGDM1400LS 40 mg/kg to be administered SC at Month 0.
|
T6: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV) 2
n=16 Participants
PGDM1400LS 20 mg/kg AND VRC07-523LS 20 mg/kg AND PGT121.414LS 20 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
T7: PGDM1400LS + VRC07-523LS + PGT121.414LS (SC) 2
n=16 Participants
PGDM1400LS 20 mg/kg AND VRC07-523LS 20 mg/kg AND PGT121.414LS 20 mg/kg to be administered SC sequentially in this order at Month 0 and Month 4.
|
T8: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV) 1
n=16 Participants
PGDM1400LS 1.4 g AND VRC07-523LS 1.4 g AND PGT121.414LS 1.4 g to be administered IV sequentially in this order at Month 0 and Month 4.
|
T9: PGDM1400LS + VRC07-523LS + PGT121.414LS (SC) 1
n=16 Participants
PGDM1400LS 1.4 g AND VRC07-523LS 1.4 g AND PGT121.414LS 1.4 g to be administered SC sequentially in this order at Month 0 and Month 4.
|
T10: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV)
n=16 Participants
PGDM1400LS 40 mg/kg AND VRC07-523LS 40 mg/kg AND PGT121.414LS 40 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Lost to Follow-Up
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Withdrawal by Subject
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Investigator reason
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Unsolicited AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Solicited AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Did not discontinue SPA
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
13 Participants
|
15 Participants
|
15 Participants
|
14 Participants
|
14 Participants
|
PRIMARY outcome
Timeframe: Measured through Month 6 in Part A and Month 10 in Part BThe number (percentage) of participants with early termination of study and reason for early termination was summarized by arm
Outcome measures
| Measure |
T1: PGDM1400LS (IV) 5 mg/kg mo 0
n=3 Participants
PGDM1400LS 5 mg/kg to be administered IV at Month 0.
|
T2: PGDM1400LS (IV) 20 mg/kg mo 0
n=3 Participants
PGDM1400LS 20 mg/kg to be administered IV at Month 0.
|
T3: PGDM1400LS (SC) 20 mg/kg mo 0
n=3 Participants
PGDM1400LS 20 mg/kg to be administered SC at Month 0.
|
T4: PGDM1400LS (IV) 40 mg/kg mo 0
n=3 Participants
PGDM1400LS 40 mg/kg to be administered IV at Month 0.
|
T5: PGDM1400LS (SC) 40 mg/kg mo 0
n=3 Participants
PGDM1400LS 40 mg/kg to be administered SC at Month 0.
|
T6: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV) 2
n=16 Participants
PGDM1400LS 20 mg/kg AND VRC07-523LS 20 mg/kg AND PGT121.414LS 20 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
T7: PGDM1400LS + VRC07-523LS + PGT121.414LS (SC) 2
n=16 Participants
PGDM1400LS 20 mg/kg AND VRC07-523LS 20 mg/kg AND PGT121.414LS 20 mg/kg to be administered SC sequentially in this order at Month 0 and Month 4.
|
T8: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV) 1
n=16 Participants
PGDM1400LS 1.4 g AND VRC07-523LS 1.4 g AND PGT121.414LS 1.4 g to be administered IV sequentially in this order at Month 0 and Month 4.
|
T9: PGDM1400LS + VRC07-523LS + PGT121.414LS (SC) 1
n=16 Participants
PGDM1400LS 1.4 g AND VRC07-523LS 1.4 g AND PGT121.414LS 1.4 g to be administered SC sequentially in this order at Month 0 and Month 4.
|
T10: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV)
n=16 Participants
PGDM1400LS 40 mg/kg AND VRC07-523LS 40 mg/kg AND PGT121.414LS 40 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Early Termination of Study and Reason for Early Termination
Lost to Follow-Up
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Early Termination of Study and Reason for Early Termination
Withdrawal by Subject
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Early Termination of Study and Reason for Early Termination
Did not terminate Study
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
13 Participants
|
16 Participants
|
16 Participants
|
16 Participants
|
14 Participants
|
PRIMARY outcome
Timeframe: Measured during Days 0, 0.0417 (1hr post 1st infusion), 3, 6, 28, 56, 112, 112.0417 (1hr post 2nd infusion)*, 168, 224*, and 280* Days with * are only available for T6-T10Population: 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.
Serum concentrations of PGDM1400LS at prespecified timepoints among participants who received all scheduled product administrations
Outcome measures
| Measure |
T1: PGDM1400LS (IV) 5 mg/kg mo 0
n=3 Participants
PGDM1400LS 5 mg/kg to be administered IV at Month 0.
|
T2: PGDM1400LS (IV) 20 mg/kg mo 0
n=3 Participants
PGDM1400LS 20 mg/kg to be administered IV at Month 0.
|
T3: PGDM1400LS (SC) 20 mg/kg mo 0
n=3 Participants
PGDM1400LS 20 mg/kg to be administered SC at Month 0.
|
T4: PGDM1400LS (IV) 40 mg/kg mo 0
n=3 Participants
PGDM1400LS 40 mg/kg to be administered IV at Month 0.
|
T5: PGDM1400LS (SC) 40 mg/kg mo 0
n=3 Participants
PGDM1400LS 40 mg/kg to be administered SC at Month 0.
|
T6: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV) 2
n=16 Participants
PGDM1400LS 20 mg/kg AND VRC07-523LS 20 mg/kg AND PGT121.414LS 20 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
T7: PGDM1400LS + VRC07-523LS + PGT121.414LS (SC) 2
n=16 Participants
PGDM1400LS 20 mg/kg AND VRC07-523LS 20 mg/kg AND PGT121.414LS 20 mg/kg to be administered SC sequentially in this order at Month 0 and Month 4.
|
T8: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV) 1
n=16 Participants
PGDM1400LS 1.4 g AND VRC07-523LS 1.4 g AND PGT121.414LS 1.4 g to be administered IV sequentially in this order at Month 0 and Month 4.
|
T9: PGDM1400LS + VRC07-523LS + PGT121.414LS (SC) 1
n=16 Participants
PGDM1400LS 1.4 g AND VRC07-523LS 1.4 g AND PGT121.414LS 1.4 g to be administered SC sequentially in this order at Month 0 and Month 4.
|
T10: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV)
n=16 Participants
PGDM1400LS 40 mg/kg AND VRC07-523LS 40 mg/kg AND PGT121.414LS 40 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Serum Concentration Levels of PGDM1400LS Among Participants Who Received All Scheduled Product Administrations
PGDM1400LS - 0
|
0.04 ug/ml
Interval 0.04 to 0.04
|
0.04 ug/ml
Interval 0.04 to 0.04
|
0.04 ug/ml
Interval 0.04 to 0.04
|
0.04 ug/ml
Interval 0.04 to 0.04
|
0.04 ug/ml
Interval 0.04 to 0.04
|
0.04 ug/ml
Interval 0.04 to 0.06
|
0.04 ug/ml
Interval 0.04 to 0.04
|
0.04 ug/ml
Interval 0.04 to 0.04
|
0.04 ug/ml
Interval 0.04 to 0.04
|
0.04 ug/ml
Interval 0.04 to 0.04
|
|
Serum Concentration Levels of PGDM1400LS Among Participants Who Received All Scheduled Product Administrations
PGDM1400LS - 0.0417 (Day 0 1 hr post-infusion)
|
96.49 ug/ml
Interval 95.78 to 107.94
|
375.39 ug/ml
Interval 348.03 to 385.94
|
1.19 ug/ml
Interval 0.79 to 1.27
|
685.85 ug/ml
Interval 673.75 to 708.24
|
2.92 ug/ml
Interval 2.61 to 3.82
|
553.60 ug/ml
Interval 514.21 to 689.08
|
6.38 ug/ml
Interval 2.17 to 10.72
|
612.47 ug/ml
Interval 545.95 to 662.88
|
11.36 ug/ml
Interval 5.67 to 32.3
|
1190.49 ug/ml
Interval 1107.99 to 1364.68
|
|
Serum Concentration Levels of PGDM1400LS Among Participants Who Received All Scheduled Product Administrations
PGDM1400LS - 28
|
69.81 ug/ml
Interval 64.83 to 72.96
|
209.91 ug/ml
Interval 206.92 to 265.82
|
140.04 ug/ml
Interval 132.0 to 172.58
|
510.53 ug/ml
Interval 490.21 to 532.83
|
313.98 ug/ml
Interval 287.34 to 368.93
|
165.77 ug/ml
Interval 154.51 to 192.02
|
113.85 ug/ml
Interval 86.38 to 149.17
|
183.47 ug/ml
Interval 177.72 to 186.74
|
154.89 ug/ml
Interval 117.34 to 176.31
|
304.70 ug/ml
Interval 281.78 to 364.51
|
|
Serum Concentration Levels of PGDM1400LS Among Participants Who Received All Scheduled Product Administrations
PGDM1400LS - 112
|
19.24 ug/ml
Interval 18.32 to 21.32
|
95.78 ug/ml
Interval 89.48 to 104.45
|
50.75 ug/ml
Interval 47.53 to 60.2
|
157.13 ug/ml
Interval 155.26 to 166.78
|
105.81 ug/ml
Interval 99.96 to 128.13
|
54.73 ug/ml
Interval 48.45 to 67.89
|
42.29 ug/ml
Interval 30.81 to 55.25
|
66.50 ug/ml
Interval 53.14 to 76.49
|
46.32 ug/ml
Interval 35.65 to 62.0
|
98.76 ug/ml
Interval 82.29 to 128.24
|
|
Serum Concentration Levels of PGDM1400LS Among Participants Who Received All Scheduled Product Administrations
PGDM1400LS - 168
|
9.26 ug/ml
Interval 8.56 to 10.05
|
46.08 ug/ml
Interval 41.34 to 49.57
|
19.19 ug/ml
Interval 18.75 to 24.31
|
80.29 ug/ml
Interval 72.14 to 94.05
|
46.78 ug/ml
Interval 46.74 to 50.77
|
145.70 ug/ml
Interval 117.67 to 152.43
|
120.50 ug/ml
Interval 82.29 to 137.07
|
161.22 ug/ml
Interval 132.14 to 169.46
|
123.02 ug/ml
Interval 94.73 to 154.08
|
262.73 ug/ml
Interval 231.67 to 311.74
|
|
Serum Concentration Levels of PGDM1400LS Among Participants Who Received All Scheduled Product Administrations
PGDM1400LS - 224
|
—
|
—
|
—
|
—
|
—
|
62.34 ug/ml
Interval 54.2 to 69.56
|
57.01 ug/ml
Interval 39.58 to 68.37
|
71.55 ug/ml
Interval 63.09 to 87.07
|
59.31 ug/ml
Interval 44.62 to 75.73
|
124.27 ug/ml
Interval 102.89 to 150.22
|
|
Serum Concentration Levels of PGDM1400LS Among Participants Who Received All Scheduled Product Administrations
PGDM1400LS - 280
|
—
|
—
|
—
|
—
|
—
|
28.91 ug/ml
Interval 26.39 to 34.65
|
23.87 ug/ml
Interval 15.17 to 33.18
|
41.15 ug/ml
Interval 32.14 to 44.2
|
32.96 ug/ml
Interval 19.19 to 42.58
|
65.37 ug/ml
Interval 50.14 to 72.4
|
|
Serum Concentration Levels of PGDM1400LS Among Participants Who Received All Scheduled Product Administrations
PGDM1400LS - 3
|
95.69 ug/ml
Interval 94.3 to 98.9
|
432.62 ug/ml
Interval 404.4 to 467.57
|
146.40 ug/ml
Interval 138.72 to 195.27
|
727.44 ug/ml
Interval 699.95 to 753.49
|
447.90 ug/ml
Interval 339.69 to 497.52
|
307.89 ug/ml
Interval 274.47 to 336.27
|
141.12 ug/ml
Interval 112.09 to 183.21
|
339.86 ug/ml
Interval 298.13 to 379.21
|
212.99 ug/ml
Interval 159.4 to 250.61
|
594.72 ug/ml
Interval 537.59 to 760.35
|
|
Serum Concentration Levels of PGDM1400LS Among Participants Who Received All Scheduled Product Administrations
PGDM1400LS - 6
|
88.87 ug/ml
Interval 83.0 to 89.43
|
361.09 ug/ml
Interval 324.2 to 401.39
|
205.63 ug/ml
Interval 181.88 to 244.03
|
603.62 ug/ml
Interval 586.36 to 607.43
|
429.97 ug/ml
Interval 343.03 to 508.78
|
266.18 ug/ml
Interval 247.48 to 281.38
|
151.45 ug/ml
Interval 129.36 to 209.5
|
265.27 ug/ml
Interval 254.55 to 306.57
|
219.97 ug/ml
Interval 168.17 to 274.74
|
499.59 ug/ml
Interval 468.3 to 549.73
|
|
Serum Concentration Levels of PGDM1400LS Among Participants Who Received All Scheduled Product Administrations
PGDM1400LS - 56
|
43.02 ug/ml
Interval 40.87 to 43.25
|
159.59 ug/ml
Interval 149.7 to 171.8
|
97.86 ug/ml
Interval 86.34 to 121.86
|
344.23 ug/ml
Interval 325.91 to 366.04
|
214.17 ug/ml
Interval 188.22 to 272.13
|
112.02 ug/ml
Interval 102.31 to 127.35
|
75.03 ug/ml
Interval 62.09 to 100.44
|
128.23 ug/ml
Interval 109.13 to 137.01
|
102.92 ug/ml
Interval 84.18 to 141.03
|
215.93 ug/ml
Interval 182.69 to 257.77
|
|
Serum Concentration Levels of PGDM1400LS Among Participants Who Received All Scheduled Product Administrations
PGDM1400LS - 112.0417 (Day 112 1 hr post-infusion)
|
—
|
—
|
—
|
—
|
—
|
538.95 ug/ml
Interval 405.11 to 606.24
|
55.77 ug/ml
Interval 35.15 to 68.47
|
655.22 ug/ml
Interval 598.31 to 755.91
|
63.50 ug/ml
Interval 46.9 to 68.82
|
1347.38 ug/ml
Interval 1120.57 to 1502.24
|
PRIMARY outcome
Timeframe: Measured during Days 0, 0.0417 (1hr post 1st infusion), 3, 6, 28, 56, 112, 112.0417 (1hr post 2nd infusion), 168, 224, and 280Population: 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.
Serum concentrations of PGT121.414.LS at prespecified timepoints among participants who received all scheduled product administrations
Outcome measures
| Measure |
T1: PGDM1400LS (IV) 5 mg/kg mo 0
n=16 Participants
PGDM1400LS 5 mg/kg to be administered IV at Month 0.
|
T2: PGDM1400LS (IV) 20 mg/kg mo 0
n=16 Participants
PGDM1400LS 20 mg/kg to be administered IV at Month 0.
|
T3: PGDM1400LS (SC) 20 mg/kg mo 0
n=16 Participants
PGDM1400LS 20 mg/kg to be administered SC at Month 0.
|
T4: PGDM1400LS (IV) 40 mg/kg mo 0
n=16 Participants
PGDM1400LS 40 mg/kg to be administered IV at Month 0.
|
T5: PGDM1400LS (SC) 40 mg/kg mo 0
n=16 Participants
PGDM1400LS 40 mg/kg to be administered SC at Month 0.
|
T6: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV) 2
PGDM1400LS 20 mg/kg AND VRC07-523LS 20 mg/kg AND PGT121.414LS 20 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
T7: PGDM1400LS + VRC07-523LS + PGT121.414LS (SC) 2
PGDM1400LS 20 mg/kg AND VRC07-523LS 20 mg/kg AND PGT121.414LS 20 mg/kg to be administered SC sequentially in this order at Month 0 and Month 4.
|
T8: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV) 1
PGDM1400LS 1.4 g AND VRC07-523LS 1.4 g AND PGT121.414LS 1.4 g to be administered IV sequentially in this order at Month 0 and Month 4.
|
T9: PGDM1400LS + VRC07-523LS + PGT121.414LS (SC) 1
PGDM1400LS 1.4 g AND VRC07-523LS 1.4 g AND PGT121.414LS 1.4 g to be administered SC sequentially in this order at Month 0 and Month 4.
|
T10: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV)
PGDM1400LS 40 mg/kg AND VRC07-523LS 40 mg/kg AND PGT121.414LS 40 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Serum Concentration Levels of PGT121.414LS Among Participants Who Received All Scheduled Product Administrations
PGT121.414.LS - 56
|
148.41 ug/ml
Interval 138.8 to 175.11
|
104.16 ug/ml
Interval 86.28 to 132.88
|
174.96 ug/ml
Interval 155.05 to 191.54
|
144.98 ug/ml
Interval 124.41 to 188.72
|
275.85 ug/ml
Interval 241.89 to 345.03
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentration Levels of PGT121.414LS Among Participants Who Received All Scheduled Product Administrations
PGT121.414.LS - 112
|
87.90 ug/ml
Interval 69.71 to 102.35
|
58.88 ug/ml
Interval 46.42 to 66.86
|
104.02 ug/ml
Interval 73.83 to 118.95
|
72.58 ug/ml
Interval 52.47 to 91.8
|
159.04 ug/ml
Interval 129.42 to 190.73
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentration Levels of PGT121.414LS Among Participants Who Received All Scheduled Product Administrations
PGT121.414.LS - 112.0417 (Day 112 1 hr post-infusion)
|
651.90 ug/ml
Interval 537.81 to 809.14
|
72.48 ug/ml
Interval 47.67 to 91.06
|
831.75 ug/ml
Interval 760.79 to 888.09
|
80.52 ug/ml
Interval 54.52 to 100.09
|
1759.82 ug/ml
Interval 1585.83 to 1979.14
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentration Levels of PGT121.414LS Among Participants Who Received All Scheduled Product Administrations
PGT121.414.LS - 168
|
188.24 ug/ml
Interval 164.37 to 206.13
|
171.21 ug/ml
Interval 108.5 to 194.51
|
235.47 ug/ml
Interval 203.57 to 248.16
|
172.71 ug/ml
Interval 128.87 to 207.83
|
386.92 ug/ml
Interval 310.7 to 474.22
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentration Levels of PGT121.414LS Among Participants Who Received All Scheduled Product Administrations
PGT121.414.LS - 280
|
55.87 ug/ml
Interval 42.92 to 64.22
|
57.47 ug/ml
Interval 34.73 to 64.47
|
75.78 ug/ml
Interval 63.71 to 92.74
|
57.10 ug/ml
Interval 28.27 to 80.37
|
111.83 ug/ml
Interval 99.52 to 142.23
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentration Levels of PGT121.414LS Among Participants Who Received All Scheduled Product Administrations
PGT121.414.LS - 0
|
0.10 ug/ml
Interval 0.1 to 0.49
|
0.10 ug/ml
Interval 0.1 to 0.1
|
0.10 ug/ml
Interval 0.1 to 0.1
|
0.10 ug/ml
Interval 0.1 to 0.1
|
0.10 ug/ml
Interval 0.1 to 0.1
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentration Levels of PGT121.414LS Among Participants Who Received All Scheduled Product Administrations
PGT121.414.LS - 0.0417 (Day 0 1 hr post-infusion)
|
903.30 ug/ml
Interval 738.08 to 1176.36
|
4.97 ug/ml
Interval 2.59 to 6.01
|
1021.49 ug/ml
Interval 819.03 to 1158.71
|
7.22 ug/ml
Interval 3.62 to 14.3
|
1875.25 ug/ml
Interval 1518.96 to 2000.91
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentration Levels of PGT121.414LS Among Participants Who Received All Scheduled Product Administrations
PGT121.414.LS - 3
|
386.38 ug/ml
Interval 344.05 to 467.41
|
229.12 ug/ml
Interval 149.99 to 249.87
|
431.97 ug/ml
Interval 388.14 to 517.63
|
264.14 ug/ml
Interval 210.82 to 308.86
|
679.23 ug/ml
Interval 632.61 to 853.46
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentration Levels of PGT121.414LS Among Participants Who Received All Scheduled Product Administrations
PGT121.414.LS - 6
|
336.42 ug/ml
Interval 302.65 to 361.19
|
210.82 ug/ml
Interval 166.11 to 257.88
|
348.90 ug/ml
Interval 317.48 to 364.36
|
269.04 ug/ml
Interval 239.84 to 302.81
|
623.84 ug/ml
Interval 522.68 to 670.41
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentration Levels of PGT121.414LS Among Participants Who Received All Scheduled Product Administrations
PGT121.414.LS - 28
|
218.67 ug/ml
Interval 196.79 to 232.36
|
155.20 ug/ml
Interval 120.04 to 185.84
|
240.20 ug/ml
Interval 230.27 to 247.46
|
199.02 ug/ml
Interval 167.91 to 231.83
|
398.70 ug/ml
Interval 371.81 to 520.71
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentration Levels of PGT121.414LS Among Participants Who Received All Scheduled Product Administrations
PGT121.414.LS - 224
|
104.50 ug/ml
Interval 78.01 to 112.77
|
96.83 ug/ml
Interval 54.28 to 102.47
|
120.60 ug/ml
Interval 101.41 to 135.18
|
95.66 ug/ml
Interval 62.73 to 126.24
|
217.87 ug/ml
Interval 179.77 to 244.66
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Measured during Days 0, 0.0417 (1hr post 1st infusion), 3, 6, 28, 56, 112, 112.0417 (1hr post 2nd infusion), 168, 224, and 280Population: 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.
Serum concentrations of VRC07-523LS at prespecified timepoints among participants who received all scheduled product administrations
Outcome measures
| Measure |
T1: PGDM1400LS (IV) 5 mg/kg mo 0
n=16 Participants
PGDM1400LS 5 mg/kg to be administered IV at Month 0.
|
T2: PGDM1400LS (IV) 20 mg/kg mo 0
n=16 Participants
PGDM1400LS 20 mg/kg to be administered IV at Month 0.
|
T3: PGDM1400LS (SC) 20 mg/kg mo 0
n=16 Participants
PGDM1400LS 20 mg/kg to be administered SC at Month 0.
|
T4: PGDM1400LS (IV) 40 mg/kg mo 0
n=16 Participants
PGDM1400LS 40 mg/kg to be administered IV at Month 0.
|
T5: PGDM1400LS (SC) 40 mg/kg mo 0
n=16 Participants
PGDM1400LS 40 mg/kg to be administered SC at Month 0.
|
T6: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV) 2
PGDM1400LS 20 mg/kg AND VRC07-523LS 20 mg/kg AND PGT121.414LS 20 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
T7: PGDM1400LS + VRC07-523LS + PGT121.414LS (SC) 2
PGDM1400LS 20 mg/kg AND VRC07-523LS 20 mg/kg AND PGT121.414LS 20 mg/kg to be administered SC sequentially in this order at Month 0 and Month 4.
|
T8: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV) 1
PGDM1400LS 1.4 g AND VRC07-523LS 1.4 g AND PGT121.414LS 1.4 g to be administered IV sequentially in this order at Month 0 and Month 4.
|
T9: PGDM1400LS + VRC07-523LS + PGT121.414LS (SC) 1
PGDM1400LS 1.4 g AND VRC07-523LS 1.4 g AND PGT121.414LS 1.4 g to be administered SC sequentially in this order at Month 0 and Month 4.
|
T10: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV)
PGDM1400LS 40 mg/kg AND VRC07-523LS 40 mg/kg AND PGT121.414LS 40 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Serum Concentration Levels of VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
VRC07-523LS - 0
|
0.02 ug/ml
Interval 0.02 to 0.06
|
0.02 ug/ml
Interval 0.02 to 0.03
|
0.02 ug/ml
Interval 0.02 to 0.02
|
0.02 ug/ml
Interval 0.02 to 0.02
|
0.02 ug/ml
Interval 0.02 to 0.02
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentration Levels of VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
VRC07-523LS - 3
|
302.96 ug/ml
Interval 266.68 to 362.2
|
129.45 ug/ml
Interval 87.83 to 178.88
|
324.02 ug/ml
Interval 280.57 to 349.53
|
188.96 ug/ml
Interval 126.09 to 249.46
|
482.08 ug/ml
Interval 435.83 to 610.29
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentration Levels of VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
VRC07-523LS - 6
|
221.59 ug/ml
Interval 205.34 to 245.54
|
129.81 ug/ml
Interval 110.37 to 187.66
|
220.64 ug/ml
Interval 210.89 to 237.89
|
191.63 ug/ml
Interval 139.77 to 221.6
|
370.32 ug/ml
Interval 328.89 to 447.89
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentration Levels of VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
VRC07-523LS - 28
|
109.16 ug/ml
Interval 92.54 to 122.88
|
75.29 ug/ml
Interval 51.1 to 80.35
|
109.48 ug/ml
Interval 97.32 to 124.65
|
98.05 ug/ml
Interval 71.57 to 106.97
|
182.31 ug/ml
Interval 158.46 to 210.75
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentration Levels of VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
VRC07-523LS - 224
|
31.52 ug/ml
Interval 20.62 to 39.09
|
25.14 ug/ml
Interval 17.75 to 31.48
|
31.16 ug/ml
Interval 27.27 to 42.73
|
28.68 ug/ml
Interval 18.01 to 37.42
|
42.35 ug/ml
Interval 37.57 to 67.41
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentration Levels of VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
VRC07-523LS - 280
|
11.32 ug/ml
Interval 9.71 to 12.2
|
9.26 ug/ml
Interval 7.16 to 12.18
|
12.84 ug/ml
Interval 11.06 to 15.87
|
10.43 ug/ml
Interval 5.51 to 20.38
|
17.33 ug/ml
Interval 11.75 to 29.32
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentration Levels of VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
VRC07-523LS - 56
|
64.22 ug/ml
Interval 54.59 to 71.72
|
41.90 ug/ml
Interval 31.72 to 48.41
|
64.04 ug/ml
Interval 60.04 to 78.78
|
58.30 ug/ml
Interval 39.57 to 73.23
|
103.01 ug/ml
Interval 92.3 to 116.08
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentration Levels of VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
VRC07-523LS - 0.0417 (Day 0 1 hr post-infusion)
|
663.07 ug/ml
Interval 597.75 to 802.03
|
4.44 ug/ml
Interval 2.53 to 5.3
|
695.08 ug/ml
Interval 632.95 to 784.68
|
6.84 ug/ml
Interval 4.48 to 10.38
|
1289.22 ug/ml
Interval 1166.28 to 1462.65
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentration Levels of VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
VRC07-523LS - 112
|
27.81 ug/ml
Interval 24.59 to 37.18
|
17.58 ug/ml
Interval 13.5 to 20.69
|
29.89 ug/ml
Interval 22.43 to 39.49
|
21.99 ug/ml
Interval 15.22 to 28.92
|
41.09 ug/ml
Interval 34.66 to 58.76
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentration Levels of VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
VRC07-523LS - 112.0417 (Day 112 1 hr post-infusion)
|
660.51 ug/ml
Interval 511.46 to 796.07
|
22.38 ug/ml
Interval 16.73 to 33.48
|
671.49 ug/ml
Interval 578.23 to 761.13
|
29.32 ug/ml
Interval 23.47 to 42.68
|
1344.90 ug/ml
Interval 1149.85 to 1605.62
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentration Levels of VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
VRC07-523LS - 168
|
74.16 ug/ml
Interval 63.66 to 88.9
|
64.42 ug/ml
Interval 40.86 to 74.97
|
81.72 ug/ml
Interval 73.57 to 90.37
|
68.32 ug/ml
Interval 51.44 to 86.28
|
124.88 ug/ml
Interval 109.72 to 140.12
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Measured during Days 0, 3, 6, 28, 56, 112, 168, 224*, and 280* Days with * are only available for T6-T10Population: 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.
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for Parts A and B
Outcome measures
| Measure |
T1: PGDM1400LS (IV) 5 mg/kg mo 0
n=3 Participants
PGDM1400LS 5 mg/kg to be administered IV at Month 0.
|
T2: PGDM1400LS (IV) 20 mg/kg mo 0
n=3 Participants
PGDM1400LS 20 mg/kg to be administered IV at Month 0.
|
T3: PGDM1400LS (SC) 20 mg/kg mo 0
n=3 Participants
PGDM1400LS 20 mg/kg to be administered SC at Month 0.
|
T4: PGDM1400LS (IV) 40 mg/kg mo 0
n=3 Participants
PGDM1400LS 40 mg/kg to be administered IV at Month 0.
|
T5: PGDM1400LS (SC) 40 mg/kg mo 0
n=3 Participants
PGDM1400LS 40 mg/kg to be administered SC at Month 0.
|
T6: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV) 2
n=16 Participants
PGDM1400LS 20 mg/kg AND VRC07-523LS 20 mg/kg AND PGT121.414LS 20 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
T7: PGDM1400LS + VRC07-523LS + PGT121.414LS (SC) 2
n=16 Participants
PGDM1400LS 20 mg/kg AND VRC07-523LS 20 mg/kg AND PGT121.414LS 20 mg/kg to be administered SC sequentially in this order at Month 0 and Month 4.
|
T8: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV) 1
n=16 Participants
PGDM1400LS 1.4 g AND VRC07-523LS 1.4 g AND PGT121.414LS 1.4 g to be administered IV sequentially in this order at Month 0 and Month 4.
|
T9: PGDM1400LS + VRC07-523LS + PGT121.414LS (SC) 1
n=16 Participants
PGDM1400LS 1.4 g AND VRC07-523LS 1.4 g AND PGT121.414LS 1.4 g to be administered SC sequentially in this order at Month 0 and Month 4.
|
T10: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV)
n=16 Participants
PGDM1400LS 40 mg/kg AND VRC07-523LS 40 mg/kg AND PGT121.414LS 40 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
6540.v4.c1 - 50 - 3
|
18004.25 titer
Interval 16296.52 to 18714.19
|
86169.30 titer
Interval 72170.9 to 90818.29
|
37356.09 titer
Interval 33373.16 to 46693.84
|
210641.18 titer
Interval 176592.28 to 236319.49
|
104138.90 titer
Interval 82207.69 to 113630.0
|
78082.03 titer
Interval 60951.83 to 121013.02
|
38090.89 titer
Interval 26324.08 to 38905.2
|
94187.86 titer
Interval 76442.89 to 102587.67
|
44190.21 titer
Interval 38523.86 to 72645.07
|
155263.94 titer
Interval 145559.21 to 254422.8
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
6540.v4.c1 - 50 - 6
|
19536.62 titer
Interval 15684.2 to 19822.91
|
60315.19 titer
Interval 47368.3 to 60615.63
|
25318.17 titer
Interval 23065.01 to 32567.71
|
190567.11 titer
Interval 182226.74 to 211171.4
|
136086.26 titer
Interval 96705.97 to 173663.45
|
65735.36 titer
Interval 60026.66 to 80840.87
|
43426.88 titer
Interval 23192.42 to 60820.22
|
59253.58 titer
Interval 55517.03 to 75929.69
|
56244.87 titer
Interval 42079.23 to 67246.46
|
130118.65 titer
Interval 111524.54 to 175054.67
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
6540.v4.c1 - 50 - 28
|
11526.31 titer
Interval 9254.35 to 20291.81
|
35352.88 titer
Interval 33862.73 to 210041.52
|
20515.29 titer
Interval 17712.2 to 57337.84
|
95958.61 titer
Interval 85192.7 to 102149.48
|
228540.05 titer
Interval 132938.75 to 244799.1
|
32034.53 titer
Interval 29134.27 to 48227.96
|
23502.68 titer
Interval 19271.71 to 36751.52
|
46024.02 titer
Interval 31702.4 to 64639.69
|
40152.25 titer
Interval 31047.77 to 62268.95
|
63877.56 titer
Interval 60968.27 to 86642.55
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
6540.v4.c1 - 50 - 56
|
3731.64 titer
Interval 3718.98 to 5700.14
|
32088.99 titer
Interval 25106.71 to 328424.34
|
18546.43 titer
Interval 14097.28 to 21778.94
|
35905.88 titer
Interval 29178.82 to 42702.5
|
48197.90 titer
Interval 31245.64 to 233644.78
|
17553.23 titer
Interval 15339.2 to 19304.85
|
10267.77 titer
Interval 8750.1 to 13263.23
|
17437.11 titer
Interval 13980.94 to 24584.85
|
15761.35 titer
Interval 10796.49 to 20269.17
|
31424.52 titer
Interval 21450.14 to 34972.42
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
6540.v4.c1 - 50 - 280
|
—
|
—
|
—
|
—
|
—
|
1948.28 titer
Interval 1795.74 to 2402.63
|
1744.59 titer
Interval 1508.26 to 2413.28
|
2578.49 titer
Interval 2011.2 to 2803.74
|
2679.28 titer
Interval 2216.32 to 4615.38
|
4869.88 titer
Interval 3888.36 to 5759.75
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
6540.v4.c1 - 80 - 0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
150.00 titer
Interval 150.0 to 150.0
|
150.00 titer
Interval 150.0 to 150.0
|
150.00 titer
Interval 150.0 to 150.0
|
150.00 titer
Interval 150.0 to 150.0
|
150.00 titer
Interval 150.0 to 150.0
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
6540.v4.c1 - 80 - 3
|
4082.03 titer
Interval 3780.97 to 4265.98
|
18493.04 titer
Interval 15740.43 to 22035.52
|
6240.04 titer
Interval 5594.48 to 9338.3
|
38798.72 titer
Interval 36760.95 to 40611.61
|
16592.14 titer
Interval 13807.15 to 19986.46
|
23888.60 titer
Interval 17946.81 to 26204.21
|
8557.98 titer
Interval 6109.14 to 11696.77
|
20973.90 titer
Interval 19764.67 to 27220.65
|
10271.32 titer
Interval 7561.49 to 13069.24
|
42729.83 titer
Interval 32289.85 to 44389.46
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
6540.v4.c1 - 80 - 6
|
2890.20 titer
Interval 2784.12 to 3454.59
|
12699.51 titer
Interval 10238.51 to 13433.49
|
5965.47 titer
Interval 5170.04 to 8664.14
|
32217.59 titer
Interval 27030.31 to 32290.66
|
16526.64 titer
Interval 14367.75 to 21616.09
|
14844.38 titer
Interval 13397.01 to 20732.3
|
10843.79 titer
Interval 6389.07 to 14803.96
|
14559.28 titer
Interval 13221.35 to 18078.01
|
11285.60 titer
Interval 9943.26 to 15950.23
|
34219.06 titer
Interval 29156.53 to 49083.65
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
6540.v4.c1 - 80 - 56
|
746.39 titer
Interval 696.58 to 783.69
|
2718.94 titer
Interval 2711.53 to 2910.56
|
2672.84 titer
Interval 2221.22 to 2842.15
|
4626.30 titer
Interval 4091.12 to 4757.32
|
6475.97 titer
Interval 4503.69 to 7251.02
|
4039.11 titer
Interval 3949.73 to 5393.52
|
2175.54 titer
Interval 2055.93 to 3399.28
|
3958.18 titer
Interval 3111.29 to 4738.42
|
4572.76 titer
Interval 2837.1 to 5415.44
|
8098.32 titer
Interval 5523.62 to 9171.35
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
6540.v4.c1 - 80 - 112
|
192.85 titer
Interval 186.48 to 276.98
|
826.94 titer
Interval 685.28 to 940.14
|
437.47 titer
Interval 406.28 to 632.04
|
2065.96 titer
Interval 1913.21 to 3264.76
|
1283.49 titer
Interval 1157.58 to 1922.85
|
1384.65 titer
Interval 979.44 to 1459.86
|
754.64 titer
Interval 567.02 to 1262.59
|
1179.07 titer
Interval 904.1 to 1858.06
|
1245.31 titer
Interval 808.02 to 2033.39
|
1425.73 titer
Interval 1235.6 to 3642.0
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
6540.v4.c1 - 80 - 168
|
24.02 titer
Interval 14.51 to 26.64
|
492.93 titer
Interval 364.62 to 575.8
|
183.14 titer
Interval 176.99 to 212.84
|
493.97 titer
Interval 438.7 to 827.81
|
442.94 titer
Interval 395.34 to 478.23
|
6030.57 titer
Interval 5008.24 to 6270.58
|
4132.63 titer
Interval 2366.8 to 5047.1
|
4763.95 titer
Interval 4601.31 to 6325.77
|
5709.83 titer
Interval 4855.07 to 7392.76
|
8816.20 titer
Interval 8355.48 to 9975.19
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
CH505TF.N334S.N160A.N280D.1 - 50 - 0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
150.00 titer
Interval 5.0 to 150.0
|
150.00 titer
Interval 150.0 to 150.0
|
150.00 titer
Interval 41.25 to 150.0
|
150.00 titer
Interval 5.0 to 150.0
|
150.00 titer
Interval 150.0 to 150.0
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
CH505TF.N334S.N160A.N280D.1 - 50 - 3
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
111359.04 titer
Interval 92054.13 to 174231.52
|
31531.64 titer
Interval 22933.66 to 41518.28
|
101622.05 titer
Interval 65815.14 to 155208.76
|
42738.95 titer
Interval 35264.24 to 80896.35
|
174911.25 titer
Interval 145783.28 to 268899.36
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
CH505TF.N334S.N160A.N280D.1 - 50 - 6
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
76729.85 titer
Interval 67368.47 to 89654.37
|
53408.16 titer
Interval 37946.27 to 62285.8
|
63097.95 titer
Interval 59894.01 to 126480.51
|
63289.84 titer
Interval 42740.43 to 76527.82
|
114514.34 titer
Interval 97655.9 to 187033.29
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
CH505TF.N334S.N160A.N280D.1 - 50 - 28
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
42765.16 titer
Interval 24583.81 to 60909.27
|
29399.28 titer
Interval 22355.27 to 37150.95
|
43229.29 titer
Interval 31019.3 to 56172.37
|
44216.61 titer
Interval 35731.35 to 50090.9
|
75530.56 titer
Interval 67863.44 to 90113.66
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
CH505TF.N334S.N160A.N280D.1 - 50 - 56
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
26446.02 titer
Interval 20358.58 to 34208.79
|
15139.18 titer
Interval 12628.24 to 17021.59
|
26799.63 titer
Interval 20592.7 to 38198.19
|
20066.68 titer
Interval 17046.16 to 26833.93
|
58752.83 titer
Interval 32646.43 to 79415.94
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
CH505TF.N334S.N160A.N280D.1 - 50 - 112
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
12.63 titer
Interval 8.81 to 13.61
|
5.00 titer
Interval 5.0 to 8.04
|
9790.75 titer
Interval 7723.35 to 11072.58
|
8621.43 titer
Interval 4924.97 to 11629.46
|
12309.30 titer
Interval 8580.9 to 16389.17
|
10878.05 titer
Interval 6001.01 to 21303.79
|
23825.19 titer
Interval 15108.51 to 28662.83
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
CH505TF.N334S.N160A.N280D.1 - 50 - 168
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
11.35 titer
Interval 10.93 to 11.55
|
5.00 titer
Interval 5.0 to 11.16
|
36402.30 titer
Interval 29858.83 to 36428.19
|
40368.23 titer
Interval 29784.33 to 47492.89
|
39562.48 titer
Interval 27812.93 to 49942.15
|
36565.68 titer
Interval 31725.14 to 52573.96
|
88221.37 titer
Interval 81072.3 to 109631.9
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
CH505TF.N334S.N160A.N280D.1 - 80 - 0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
150.00 titer
Interval 5.0 to 150.0
|
150.00 titer
Interval 150.0 to 150.0
|
150.00 titer
Interval 41.25 to 150.0
|
150.00 titer
Interval 41.25 to 150.0
|
150.00 titer
Interval 150.0 to 150.0
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
CH505TF.N334S.N160A.N280D.1 - 80 - 6
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
23276.79 titer
Interval 19493.6 to 28243.02
|
14051.96 titer
Interval 11299.73 to 16681.05
|
22619.87 titer
Interval 18319.07 to 39552.68
|
18368.24 titer
Interval 12960.45 to 26431.58
|
36881.20 titer
Interval 29376.52 to 53533.46
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
CH505TF.N334S.N160A.N280D.1 - 80 - 28
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
11808.90 titer
Interval 8701.84 to 17426.27
|
11401.34 titer
Interval 7795.13 to 13566.3
|
16750.64 titer
Interval 9477.15 to 17986.88
|
15171.56 titer
Interval 11153.22 to 16016.7
|
22791.38 titer
Interval 20499.22 to 31307.64
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
CH505TF.N334S.N160A.N280D.1 - 80 - 56
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
9310.84 titer
Interval 7458.89 to 12333.71
|
5301.73 titer
Interval 4489.83 to 5820.16
|
10545.50 titer
Interval 7477.06 to 13598.23
|
5803.64 titer
Interval 5477.07 to 9610.62
|
18420.21 titer
Interval 14420.38 to 22793.06
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
CH505TF.N334S.N160A.N280D.1 - 80 - 112
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
3115.33 titer
Interval 2633.93 to 4133.73
|
2222.96 titer
Interval 1775.74 to 4060.71
|
4217.73 titer
Interval 2659.19 to 5629.76
|
3491.96 titer
Interval 2380.38 to 6432.59
|
6910.25 titer
Interval 4918.82 to 9930.57
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
CH505TF.N334S.N160A.N280D.1 - 80 - 168
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
14050.60 titer
Interval 13619.78 to 14086.03
|
13435.34 titer
Interval 8391.38 to 16451.07
|
13643.32 titer
Interval 11034.37 to 16974.48
|
12171.52 titer
Interval 10663.22 to 14135.5
|
29423.14 titer
Interval 24552.36 to 29831.69
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
CNE55.N160K - 50 - 0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
CNE55.N160K - 50 - 3
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5724.38 titer
Interval 2998.04 to 6742.43
|
1454.65 titer
Interval 987.44 to 1883.54
|
3654.32 titer
Interval 3549.5 to 4492.37
|
2816.67 titer
Interval 1877.01 to 5026.68
|
7184.43 titer
Interval 5402.77 to 9699.2
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
CNE55.N160K - 50 - 6
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
2036.61 titer
Interval 1502.85 to 2518.73
|
882.99 titer
Interval 785.07 to 1531.96
|
2376.08 titer
Interval 1770.84 to 3485.61
|
3008.78 titer
Interval 1402.43 to 5193.25
|
5362.34 titer
Interval 3440.08 to 6842.72
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
CNE55.N160K - 50 - 28
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
690.34 titer
Interval 627.11 to 2405.47
|
512.34 titer
Interval 470.85 to 694.57
|
1071.55 titer
Interval 1024.2 to 1467.32
|
1138.94 titer
Interval 426.97 to 1388.66
|
1692.69 titer
Interval 1361.81 to 2219.53
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
CNE55.N160K - 50 - 280
|
—
|
—
|
—
|
—
|
—
|
47.06 titer
Interval 41.59 to 49.03
|
45.88 titer
Interval 34.13 to 61.55
|
67.95 titer
Interval 47.76 to 112.81
|
59.54 titer
Interval 28.72 to 87.74
|
130.02 titer
Interval 86.39 to 141.12
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
CNE55.N160K - 80 - 28
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
179.90 titer
Interval 170.46 to 213.35
|
81.67 titer
Interval 42.26 to 101.45
|
207.57 titer
Interval 136.87 to 282.3
|
125.74 titer
Interval 82.92 to 188.61
|
352.64 titer
Interval 308.74 to 458.91
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
CNE55.N160K - 80 - 112
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
17.74 titer
Interval 6.3 to 37.49
|
23.96 titer
Interval 18.12 to 27.87
|
27.53 titer
Interval 25.92 to 53.4
|
31.34 titer
Interval 22.25 to 37.02
|
55.81 titer
Interval 27.29 to 60.05
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
CNE55.N160K - 80 - 224
|
—
|
—
|
—
|
—
|
—
|
24.20 titer
Interval 22.44 to 32.11
|
18.20 titer
Interval 14.24 to 25.21
|
39.01 titer
Interval 33.56 to 49.5
|
28.50 titer
Interval 20.84 to 44.34
|
43.58 titer
Interval 34.61 to 66.82
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
CNE55.N160K - 80 - 280
|
—
|
—
|
—
|
—
|
—
|
22.66 titer
Interval 19.63 to 28.22
|
15.08 titer
Interval 13.42 to 19.11
|
18.48 titer
Interval 16.03 to 23.03
|
17.11 titer
Interval 5.0 to 21.63
|
23.39 titer
Interval 20.32 to 24.47
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
6540.v4.c1 - 50 - 0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
150.00 titer
Interval 150.0 to 150.0
|
150.00 titer
Interval 150.0 to 150.0
|
150.00 titer
Interval 150.0 to 150.0
|
150.00 titer
Interval 150.0 to 150.0
|
150.00 titer
Interval 150.0 to 150.0
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
6540.v4.c1 - 50 - 112
|
1294.45 titer
Interval 1075.53 to 1437.85
|
4856.32 titer
Interval 3780.45 to 6133.58
|
4108.53 titer
Interval 2842.06 to 4321.7
|
15403.44 titer
Interval 12837.51 to 24427.24
|
11323.91 titer
Interval 9460.0 to 11396.13
|
4452.10 titer
Interval 3725.43 to 5137.95
|
3652.50 titer
Interval 2112.79 to 4972.82
|
5287.92 titer
Interval 4595.94 to 8630.26
|
5614.97 titer
Interval 3629.3 to 9188.76
|
7748.86 titer
Interval 5045.92 to 13736.16
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
6540.v4.c1 - 50 - 168
|
633.13 titer
Interval 621.97 to 676.89
|
3477.51 titer
Interval 2384.1 to 3522.28
|
1055.97 titer
Interval 929.6 to 1226.42
|
3949.41 titer
Interval 3310.09 to 4618.12
|
1934.01 titer
Interval 1815.36 to 2030.59
|
22678.23 titer
Interval 18282.05 to 23955.4
|
18256.29 titer
Interval 9483.63 to 22053.37
|
21147.90 titer
Interval 19182.36 to 23969.75
|
21375.24 titer
Interval 19662.17 to 32268.48
|
40924.44 titer
Interval 35126.47 to 47267.91
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
6540.v4.c1 - 50 - 224
|
—
|
—
|
—
|
—
|
—
|
7043.13 titer
Interval 5521.12 to 7712.26
|
4334.66 titer
Interval 2670.65 to 5512.28
|
6044.29 titer
Interval 5545.63 to 7605.48
|
5932.23 titer
Interval 5332.42 to 6993.82
|
12390.13 titer
Interval 11247.53 to 14418.62
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
6540.v4.c1 - 80 - 28
|
1868.90 titer
Interval 1333.74 to 2335.96
|
5386.78 titer
Interval 4995.89 to 10173.7
|
3491.99 titer
Interval 2598.65 to 4133.99
|
14157.79 titer
Interval 13112.44 to 14741.65
|
10784.72 titer
Interval 9354.51 to 13264.06
|
7454.26 titer
Interval 6398.33 to 11592.09
|
6265.17 titer
Interval 3874.41 to 9890.65
|
10272.30 titer
Interval 7772.83 to 11426.41
|
11379.60 titer
Interval 7213.88 to 11735.73
|
15821.39 titer
Interval 12844.24 to 18105.67
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
6540.v4.c1 - 80 - 224
|
—
|
—
|
—
|
—
|
—
|
1492.16 titer
Interval 1274.73 to 1529.01
|
890.67 titer
Interval 628.01 to 964.92
|
1536.64 titer
Interval 1388.43 to 1800.76
|
1375.26 titer
Interval 1227.32 to 1629.2
|
2624.72 titer
Interval 2289.68 to 2875.02
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
6540.v4.c1 - 80 - 280
|
—
|
—
|
—
|
—
|
—
|
504.34 titer
Interval 460.99 to 576.34
|
468.48 titer
Interval 398.69 to 553.73
|
626.33 titer
Interval 450.05 to 716.94
|
620.44 titer
Interval 479.35 to 995.12
|
957.91 titer
Interval 782.2 to 1124.43
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
CH505TF.N334S.N160A.N280D.1 - 50 - 224
|
—
|
—
|
—
|
—
|
—
|
19975.51 titer
Interval 13481.68 to 21054.36
|
12846.42 titer
Interval 8262.33 to 15054.9
|
21710.66 titer
Interval 16086.53 to 24826.44
|
19689.54 titer
Interval 12874.1 to 22199.23
|
37227.47 titer
Interval 36036.61 to 44972.22
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
CH505TF.N334S.N160A.N280D.1 - 50 - 280
|
—
|
—
|
—
|
—
|
—
|
6386.89 titer
Interval 6059.01 to 7838.87
|
7614.93 titer
Interval 5751.88 to 9392.22
|
10111.45 titer
Interval 8816.9 to 11593.81
|
11651.39 titer
Interval 6453.99 to 17367.78
|
15470.09 titer
Interval 13140.16 to 26177.69
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
CH505TF.N334S.N160A.N280D.1 - 80 - 3
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
39720.65 titer
Interval 25883.4 to 54402.57
|
12451.16 titer
Interval 10170.48 to 15957.46
|
30936.66 titer
Interval 23216.2 to 59865.17
|
13229.33 titer
Interval 11411.01 to 21676.6
|
56218.55 titer
Interval 38214.75 to 81900.83
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
CH505TF.N334S.N160A.N280D.1 - 80 - 224
|
—
|
—
|
—
|
—
|
—
|
5670.50 titer
Interval 4203.45 to 6305.68
|
4087.73 titer
Interval 3157.6 to 5263.09
|
6640.69 titer
Interval 5430.59 to 8694.89
|
7348.03 titer
Interval 4254.03 to 8059.42
|
13020.14 titer
Interval 11544.71 to 14707.77
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
CH505TF.N334S.N160A.N280D.1 - 80 - 280
|
—
|
—
|
—
|
—
|
—
|
2210.13 titer
Interval 1794.48 to 2311.82
|
2308.80 titer
Interval 1820.2 to 3199.86
|
3869.87 titer
Interval 3306.85 to 4252.37
|
4586.73 titer
Interval 2657.94 to 5574.31
|
5429.12 titer
Interval 4566.64 to 7689.83
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
CNE55.N160K - 50 - 56
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
712.10 titer
Interval 437.32 to 1188.64
|
330.68 titer
Interval 204.09 to 451.92
|
733.53 titer
Interval 629.29 to 902.64
|
465.56 titer
Interval 411.48 to 672.54
|
1173.82 titer
Interval 857.74 to 1451.62
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
CNE55.N160K - 50 - 112
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
142.06 titer
Interval 128.69 to 209.17
|
82.83 titer
Interval 77.4 to 90.45
|
216.97 titer
Interval 113.83 to 277.82
|
277.60 titer
Interval 123.67 to 505.04
|
564.30 titer
Interval 318.38 to 700.87
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
CNE55.N160K - 50 - 168
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 12.24
|
13.95 titer
Interval 9.47 to 14.01
|
580.36 titer
Interval 348.99 to 648.33
|
452.05 titer
Interval 270.81 to 691.32
|
398.50 titer
Interval 376.88 to 598.77
|
395.85 titer
Interval 249.97 to 596.12
|
803.11 titer
Interval 623.97 to 836.58
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
CNE55.N160K - 50 - 224
|
—
|
—
|
—
|
—
|
—
|
112.82 titer
Interval 91.56 to 153.43
|
145.43 titer
Interval 76.98 to 202.42
|
123.78 titer
Interval 110.59 to 251.4
|
262.75 titer
Interval 140.25 to 387.68
|
277.69 titer
Interval 183.23 to 565.76
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
CNE55.N160K - 80 - 0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
CNE55.N160K - 80 - 3
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
728.14 titer
Interval 589.6 to 946.91
|
171.01 titer
Interval 143.12 to 288.02
|
623.34 titer
Interval 596.54 to 763.48
|
341.19 titer
Interval 233.12 to 431.25
|
1590.53 titer
Interval 1283.27 to 1755.0
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
CNE55.N160K - 80 - 6
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
321.65 titer
Interval 272.4 to 397.22
|
150.73 titer
Interval 121.58 to 339.99
|
483.85 titer
Interval 355.86 to 530.1
|
344.46 titer
Interval 200.75 to 488.87
|
881.45 titer
Interval 728.12 to 960.47
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
CNE55.N160K - 80 - 56
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
75.92 titer
Interval 62.83 to 145.79
|
29.74 titer
Interval 26.05 to 53.11
|
101.47 titer
Interval 72.92 to 123.23
|
76.61 titer
Interval 42.93 to 115.27
|
162.81 titer
Interval 143.03 to 172.93
|
|
Magnitude of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for
CNE55.N160K - 80 - 168
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
5.00 titer
Interval 5.0 to 5.0
|
84.51 titer
Interval 59.66 to 85.65
|
59.59 titer
Interval 48.22 to 72.27
|
74.82 titer
Interval 64.99 to 108.97
|
64.31 titer
Interval 44.73 to 82.4
|
103.93 titer
Interval 81.38 to 113.65
|
PRIMARY outcome
Timeframe: Measured during Days 56 and 168* Days with * are only available for T6-T10Population: 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.
Magnitude breadth of neutralizing activity measured with Env pseudotyped viruses specific for either PGDM1400LS, VRC07-523LS or PGT121.414LS in TZM-bl cells at prespecified timepoints among participants who received all scheduled product administrations for Parts A and B.
Outcome measures
| Measure |
T1: PGDM1400LS (IV) 5 mg/kg mo 0
n=3 Participants
PGDM1400LS 5 mg/kg to be administered IV at Month 0.
|
T2: PGDM1400LS (IV) 20 mg/kg mo 0
n=3 Participants
PGDM1400LS 20 mg/kg to be administered IV at Month 0.
|
T3: PGDM1400LS (SC) 20 mg/kg mo 0
n=3 Participants
PGDM1400LS 20 mg/kg to be administered SC at Month 0.
|
T4: PGDM1400LS (IV) 40 mg/kg mo 0
n=3 Participants
PGDM1400LS 40 mg/kg to be administered IV at Month 0.
|
T5: PGDM1400LS (SC) 40 mg/kg mo 0
n=3 Participants
PGDM1400LS 40 mg/kg to be administered SC at Month 0.
|
T6: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV) 2
n=16 Participants
PGDM1400LS 20 mg/kg AND VRC07-523LS 20 mg/kg AND PGT121.414LS 20 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
T7: PGDM1400LS + VRC07-523LS + PGT121.414LS (SC) 2
n=16 Participants
PGDM1400LS 20 mg/kg AND VRC07-523LS 20 mg/kg AND PGT121.414LS 20 mg/kg to be administered SC sequentially in this order at Month 0 and Month 4.
|
T8: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV) 1
n=16 Participants
PGDM1400LS 1.4 g AND VRC07-523LS 1.4 g AND PGT121.414LS 1.4 g to be administered IV sequentially in this order at Month 0 and Month 4.
|
T9: PGDM1400LS + VRC07-523LS + PGT121.414LS (SC) 1
n=16 Participants
PGDM1400LS 1.4 g AND VRC07-523LS 1.4 g AND PGT121.414LS 1.4 g to be administered SC sequentially in this order at Month 0 and Month 4.
|
T10: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV)
n=16 Participants
PGDM1400LS 40 mg/kg AND VRC07-523LS 40 mg/kg AND PGT121.414LS 40 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Magnitude Breadth of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for Parts A and B
50 - 56
|
1.83 log10(titer)
Interval 1.82 to 1.88
|
2.35 log10(titer)
Interval 2.34 to 2.36
|
2.19 log10(titer)
Interval 2.09 to 2.19
|
2.33 log10(titer)
Interval 2.31 to 2.35
|
2.26 log10(titer)
Interval 2.26 to 2.39
|
4.24 log10(titer)
Interval 4.2 to 4.34
|
3.97 log10(titer)
Interval 3.9 to 4.04
|
4.22 log10(titer)
Interval 4.14 to 4.3
|
4.06 log10(titer)
Interval 3.99 to 4.29
|
4.50 log10(titer)
Interval 4.43 to 4.61
|
|
Magnitude Breadth of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for Parts A and B
80 - 56
|
1.42 log10(titer)
Interval 1.42 to 1.47
|
1.76 log10(titer)
Interval 1.74 to 1.78
|
1.60 log10(titer)
Interval 1.53 to 1.67
|
1.77 log10(titer)
Interval 1.76 to 1.78
|
1.81 log10(titer)
Interval 1.73 to 1.86
|
3.62 log10(titer)
Interval 3.57 to 3.72
|
3.40 log10(titer)
Interval 3.31 to 3.51
|
3.69 log10(titer)
Interval 3.59 to 3.72
|
3.49 log10(titer)
Interval 3.36 to 3.63
|
3.92 log10(titer)
Interval 3.85 to 3.98
|
|
Magnitude Breadth of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for Parts A and B
80 - 168
|
—
|
—
|
—
|
—
|
—
|
3.57 log10(titer)
Interval 3.42 to 3.7
|
3.41 log10(titer)
Interval 3.31 to 3.57
|
3.71 log10(titer)
Interval 3.63 to 3.75
|
3.54 log10(titer)
Interval 3.34 to 3.67
|
3.87 log10(titer)
Interval 3.84 to 4.05
|
|
Magnitude Breadth of Serum Neutralizing Activity (ie, Neutralizing Antibody Titers, Including ID50, ID80) for Parts A and B
50 - 168
|
—
|
—
|
—
|
—
|
—
|
4.17 log10(titer)
Interval 4.06 to 4.28
|
4.07 log10(titer)
Interval 3.94 to 4.15
|
4.36 log10(titer)
Interval 4.31 to 4.4
|
4.17 log10(titer)
Interval 3.91 to 4.28
|
4.42 log10(titer)
Interval 4.4 to 4.68
|
SECONDARY outcome
Timeframe: Day 56 and Day 168* corresponding to Month 2 and Month 6* of the study. Days with * are only available for T6-T10Population: 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.
Magnitude of neutralizing activity against a panel of Env-pseudotyped reference viruses that are sensitive to all three bnAbs in TZM-bl cells at selected timepoints for all participants in all groups regardless of how many product administrations and how much product they received
Outcome measures
| Measure |
T1: PGDM1400LS (IV) 5 mg/kg mo 0
n=3 Participants
PGDM1400LS 5 mg/kg to be administered IV at Month 0.
|
T2: PGDM1400LS (IV) 20 mg/kg mo 0
n=3 Participants
PGDM1400LS 20 mg/kg to be administered IV at Month 0.
|
T3: PGDM1400LS (SC) 20 mg/kg mo 0
n=3 Participants
PGDM1400LS 20 mg/kg to be administered SC at Month 0.
|
T4: PGDM1400LS (IV) 40 mg/kg mo 0
n=3 Participants
PGDM1400LS 40 mg/kg to be administered IV at Month 0.
|
T5: PGDM1400LS (SC) 40 mg/kg mo 0
n=3 Participants
PGDM1400LS 40 mg/kg to be administered SC at Month 0.
|
T6: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV) 2
n=16 Participants
PGDM1400LS 20 mg/kg AND VRC07-523LS 20 mg/kg AND PGT121.414LS 20 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
T7: PGDM1400LS + VRC07-523LS + PGT121.414LS (SC) 2
n=16 Participants
PGDM1400LS 20 mg/kg AND VRC07-523LS 20 mg/kg AND PGT121.414LS 20 mg/kg to be administered SC sequentially in this order at Month 0 and Month 4.
|
T8: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV) 1
n=16 Participants
PGDM1400LS 1.4 g AND VRC07-523LS 1.4 g AND PGT121.414LS 1.4 g to be administered IV sequentially in this order at Month 0 and Month 4.
|
T9: PGDM1400LS + VRC07-523LS + PGT121.414LS (SC) 1
n=16 Participants
PGDM1400LS 1.4 g AND VRC07-523LS 1.4 g AND PGT121.414LS 1.4 g to be administered SC sequentially in this order at Month 0 and Month 4.
|
T10: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV)
n=16 Participants
PGDM1400LS 40 mg/kg AND VRC07-523LS 40 mg/kg AND PGT121.414LS 40 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Magnitude of Neutralizing Activity Against Env-pseudotyped Viruses in TZM-bl Cells for Part A and B and Clinical Product Assayed at Same Time.
H704_0445_180_RE_con_s - 80 - 56
|
10.00 titer
Interval 10.0 to 10.0
|
49.04 titer
Interval 47.6 to 50.33
|
20.64 titer
Interval 15.32 to 28.33
|
88.96 titer
Interval 84.17 to 95.94
|
70.41 titer
Interval 61.04 to 78.91
|
357.98 titer
Interval 274.26 to 409.14
|
176.65 titer
Interval 164.67 to 236.61
|
365.00 titer
Interval 308.22 to 404.53
|
300.98 titer
Interval 190.35 to 347.92
|
488.52 titer
Interval 413.64 to 674.45
|
|
Magnitude of Neutralizing Activity Against Env-pseudotyped Viruses in TZM-bl Cells for Part A and B and Clinical Product Assayed at Same Time.
H703_0472_030s - 50 - 56
|
10.00 titer
Interval 10.0 to 10.0
|
133.29 titer
Interval 132.09 to 191.11
|
10.00 titer
Interval 10.0 to 151.06
|
10.00 titer
Interval 10.0 to 10.0
|
48.80 titer
Interval 29.4 to 391.07
|
28867.34 titer
Interval 20743.95 to 39580.1
|
9124.56 titer
Interval 7448.63 to 12654.71
|
19418.37 titer
Interval 15353.7 to 26741.45
|
13043.79 titer
Interval 8991.62 to 20691.21
|
29487.53 titer
Interval 20734.74 to 36956.15
|
|
Magnitude of Neutralizing Activity Against Env-pseudotyped Viruses in TZM-bl Cells for Part A and B and Clinical Product Assayed at Same Time.
H703_0472_030s - 80 - 56
|
10.00 titer
Interval 10.0 to 10.0
|
10.00 titer
Interval 10.0 to 10.0
|
10.00 titer
Interval 10.0 to 10.0
|
10.00 titer
Interval 10.0 to 10.0
|
10.00 titer
Interval 10.0 to 10.0
|
9199.85 titer
Interval 6368.56 to 9834.28
|
2649.77 titer
Interval 2481.71 to 4100.21
|
6707.18 titer
Interval 4557.14 to 8128.45
|
4266.58 titer
Interval 2497.77 to 7337.54
|
9751.86 titer
Interval 6866.64 to 12886.76
|
|
Magnitude of Neutralizing Activity Against Env-pseudotyped Viruses in TZM-bl Cells for Part A and B and Clinical Product Assayed at Same Time.
H703_2117_110_RE_e2A10s - 50 - 168
|
—
|
—
|
—
|
—
|
—
|
86881.47 titer
Interval 78522.12 to 90414.47
|
71999.91 titer
Interval 43000.38 to 81379.06
|
132113.38 titer
Interval 112056.82 to 163289.85
|
81157.57 titer
Interval 52587.55 to 139949.62
|
148145.98 titer
Interval 127852.9 to 1209608.52
|
|
Magnitude of Neutralizing Activity Against Env-pseudotyped Viruses in TZM-bl Cells for Part A and B and Clinical Product Assayed at Same Time.
H703_2117_110_RE_e2A10s - 80 - 56
|
7831.73 titer
Interval 6782.93 to 8475.95
|
42634.56 titer
Interval 36579.79 to 44503.08
|
13815.72 titer
Interval 12398.39 to 21192.79
|
29824.76 titer
Interval 28415.28 to 29956.7
|
19004.67 titer
Interval 16573.19 to 21171.18
|
41391.40 titer
Interval 31015.41 to 42404.04
|
21151.88 titer
Interval 17098.51 to 24883.17
|
33571.08 titer
Interval 29386.77 to 47067.16
|
28888.77 titer
Interval 18829.88 to 46316.27
|
64290.02 titer
Interval 49632.03 to 107726.55
|
|
Magnitude of Neutralizing Activity Against Env-pseudotyped Viruses in TZM-bl Cells for Part A and B and Clinical Product Assayed at Same Time.
H703_2304_150_RE_cs - 50 - 56
|
1208.31 titer
Interval 1190.68 to 1327.46
|
7065.76 titer
Interval 6006.06 to 7167.62
|
3238.87 titer
Interval 2524.67 to 3867.71
|
5823.93 titer
Interval 5125.95 to 7568.17
|
8454.64 titer
Interval 5854.08 to 13182.48
|
33327.66 titer
Interval 29725.61 to 89182.04
|
19116.20 titer
Interval 14812.53 to 27698.26
|
29807.82 titer
Interval 21350.86 to 39150.71
|
23789.32 titer
Interval 18834.67 to 42987.41
|
57599.35 titer
Interval 41356.47 to 110040.0
|
|
Magnitude of Neutralizing Activity Against Env-pseudotyped Viruses in TZM-bl Cells for Part A and B and Clinical Product Assayed at Same Time.
H703_2304_150_RE_cs - 80 - 56
|
10.00 titer
Interval 10.0 to 44.69
|
141.31 titer
Interval 140.79 to 220.81
|
126.83 titer
Interval 68.41 to 128.15
|
10.00 titer
Interval 10.0 to 10.0
|
120.68 titer
Interval 65.34 to 324.43
|
10157.60 titer
Interval 6278.87 to 11793.02
|
5333.96 titer
Interval 3559.08 to 6638.95
|
8684.03 titer
Interval 5706.35 to 10290.43
|
5054.29 titer
Interval 3918.81 to 9293.38
|
15033.13 titer
Interval 9364.53 to 23332.9
|
|
Magnitude of Neutralizing Activity Against Env-pseudotyped Viruses in TZM-bl Cells for Part A and B and Clinical Product Assayed at Same Time.
H703_2805_080Es - 50 - 56
|
10.00 titer
Interval 10.0 to 10.0
|
10.00 titer
Interval 10.0 to 10.0
|
10.00 titer
Interval 10.0 to 10.0
|
10.00 titer
Interval 10.0 to 10.0
|
10.00 titer
Interval 10.0 to 10.0
|
6702.06 titer
Interval 5866.82 to 9301.05
|
3827.22 titer
Interval 2613.18 to 4515.86
|
7284.91 titer
Interval 5625.4 to 8149.53
|
5429.73 titer
Interval 2748.64 to 8202.83
|
11642.31 titer
Interval 10249.54 to 13495.04
|
|
Magnitude of Neutralizing Activity Against Env-pseudotyped Viruses in TZM-bl Cells for Part A and B and Clinical Product Assayed at Same Time.
H703_2805_080Es - 50 - 168
|
—
|
—
|
—
|
—
|
—
|
8055.72 titer
Interval 7407.58 to 8275.73
|
4998.26 titer
Interval 2925.21 to 6797.41
|
8771.74 titer
Interval 6855.85 to 12328.36
|
5430.58 titer
Interval 2646.49 to 10889.28
|
14806.94 titer
Interval 14317.38 to 17968.28
|
|
Magnitude of Neutralizing Activity Against Env-pseudotyped Viruses in TZM-bl Cells for Part A and B and Clinical Product Assayed at Same Time.
H703_2805_080Es - 80 - 56
|
10.00 titer
Interval 10.0 to 10.0
|
10.00 titer
Interval 10.0 to 10.0
|
10.00 titer
Interval 10.0 to 10.0
|
10.00 titer
Interval 10.0 to 10.0
|
10.00 titer
Interval 10.0 to 10.0
|
1550.43 titer
Interval 1368.54 to 1955.72
|
844.66 titer
Interval 627.56 to 989.87
|
1720.99 titer
Interval 1297.38 to 1997.91
|
1147.58 titer
Interval 604.6 to 1901.81
|
2766.88 titer
Interval 2166.58 to 3882.55
|
|
Magnitude of Neutralizing Activity Against Env-pseudotyped Viruses in TZM-bl Cells for Part A and B and Clinical Product Assayed at Same Time.
H704_0128_220_RE_pb001_s - 80 - 56
|
639.49 titer
Interval 604.61 to 660.92
|
3051.10 titer
Interval 2940.96 to 3347.66
|
1349.82 titer
Interval 1218.83 to 1942.0
|
5744.76 titer
Interval 5525.98 to 6284.43
|
5206.67 titer
Interval 4037.48 to 5315.05
|
10658.64 titer
Interval 8477.88 to 12474.23
|
6686.16 titer
Interval 5025.48 to 8240.72
|
11570.84 titer
Interval 9389.13 to 14516.57
|
10688.77 titer
Interval 6119.35 to 17534.53
|
20826.12 titer
Interval 18873.78 to 30079.57
|
|
Magnitude of Neutralizing Activity Against Env-pseudotyped Viruses in TZM-bl Cells for Part A and B and Clinical Product Assayed at Same Time.
H704_0445_180_RE_con_s - 50 - 56
|
42.32 titer
Interval 40.58 to 48.76
|
147.95 titer
Interval 147.0 to 155.33
|
82.59 titer
Interval 74.56 to 98.71
|
278.40 titer
Interval 272.15 to 287.49
|
267.65 titer
Interval 217.9 to 300.79
|
1238.90 titer
Interval 899.9 to 1365.14
|
543.16 titer
Interval 504.13 to 708.99
|
1061.53 titer
Interval 945.13 to 1237.5
|
921.85 titer
Interval 573.52 to 1091.16
|
1798.57 titer
Interval 1367.9 to 2022.31
|
|
Magnitude of Neutralizing Activity Against Env-pseudotyped Viruses in TZM-bl Cells for Part A and B and Clinical Product Assayed at Same Time.
H704_0855_080_EsN - 50 - 56
|
10.00 titer
Interval 10.0 to 10.0
|
10.00 titer
Interval 10.0 to 10.0
|
10.00 titer
Interval 10.0 to 10.0
|
10.00 titer
Interval 10.0 to 10.0
|
10.00 titer
Interval 10.0 to 10.0
|
16066.82 titer
Interval 14056.31 to 18402.66
|
8998.09 titer
Interval 7166.75 to 13034.63
|
17822.44 titer
Interval 14363.41 to 23859.96
|
14887.80 titer
Interval 9984.72 to 22224.24
|
32917.33 titer
Interval 25943.41 to 44162.82
|
|
Magnitude of Neutralizing Activity Against Env-pseudotyped Viruses in TZM-bl Cells for Part A and B and Clinical Product Assayed at Same Time.
H704_0855_080_EsN - 50 - 168
|
—
|
—
|
—
|
—
|
—
|
22218.02 titer
Interval 17371.37 to 25701.41
|
17928.86 titer
Interval 12155.92 to 27828.3
|
54853.25 titer
Interval 15500.39 to 58327.93
|
18946.53 titer
Interval 14197.96 to 29900.68
|
33836.22 titer
Interval 20677.29 to 53724.66
|
|
Magnitude of Neutralizing Activity Against Env-pseudotyped Viruses in TZM-bl Cells for Part A and B and Clinical Product Assayed at Same Time.
H704_0855_080_EsN - 80 - 56
|
10.00 titer
Interval 10.0 to 10.0
|
10.00 titer
Interval 10.0 to 10.0
|
10.00 titer
Interval 10.0 to 10.0
|
10.00 titer
Interval 10.0 to 10.0
|
10.00 titer
Interval 10.0 to 10.0
|
4007.12 titer
Interval 3657.42 to 4586.1
|
1816.41 titer
Interval 1583.17 to 2498.04
|
4663.11 titer
Interval 3704.39 to 5220.77
|
2628.16 titer
Interval 1661.81 to 4970.95
|
7924.07 titer
Interval 5528.17 to 11016.89
|
|
Magnitude of Neutralizing Activity Against Env-pseudotyped Viruses in TZM-bl Cells for Part A and B and Clinical Product Assayed at Same Time.
H704_0855_080_EsN - 80 - 168
|
—
|
—
|
—
|
—
|
—
|
3730.92 titer
Interval 3175.84 to 5717.46
|
2646.71 titer
Interval 1857.93 to 3914.69
|
4616.80 titer
Interval 3601.84 to 8276.7
|
2649.60 titer
Interval 1277.53 to 4680.81
|
5920.02 titer
Interval 5246.91 to 8247.29
|
|
Magnitude of Neutralizing Activity Against Env-pseudotyped Viruses in TZM-bl Cells for Part A and B and Clinical Product Assayed at Same Time.
H704_0907_130sN - 50 - 56
|
10.00 titer
Interval 10.0 to 10.0
|
10.00 titer
Interval 10.0 to 10.0
|
10.00 titer
Interval 10.0 to 10.0
|
10.00 titer
Interval 10.0 to 10.0
|
10.00 titer
Interval 10.0 to 10.0
|
40369.74 titer
Interval 33405.71 to 51442.82
|
24700.41 titer
Interval 16859.64 to 29059.94
|
40507.06 titer
Interval 27692.8 to 58739.96
|
23847.08 titer
Interval 20555.6 to 48305.5
|
76855.39 titer
Interval 49863.71 to 106651.34
|
|
Magnitude of Neutralizing Activity Against Env-pseudotyped Viruses in TZM-bl Cells for Part A and B and Clinical Product Assayed at Same Time.
H704_0907_130sN - 50 - 168
|
—
|
—
|
—
|
—
|
—
|
31018.25 titer
Interval 28416.5 to 37206.64
|
33646.19 titer
Interval 23296.9 to 42967.9
|
46842.83 titer
Interval 40163.41 to 50937.11
|
27190.76 titer
Interval 20791.79 to 54818.19
|
85799.88 titer
Interval 79542.43 to 157961.18
|
|
Magnitude of Neutralizing Activity Against Env-pseudotyped Viruses in TZM-bl Cells for Part A and B and Clinical Product Assayed at Same Time.
H704_0907_130sN - 80 - 56
|
10.00 titer
Interval 10.0 to 10.0
|
10.00 titer
Interval 10.0 to 10.0
|
10.00 titer
Interval 10.0 to 10.0
|
10.00 titer
Interval 10.0 to 10.0
|
10.00 titer
Interval 10.0 to 10.0
|
11734.09 titer
Interval 9715.46 to 13570.48
|
8733.83 titer
Interval 6040.65 to 10087.01
|
13241.02 titer
Interval 9901.32 to 17689.99
|
7957.70 titer
Interval 6355.6 to 13878.02
|
24924.38 titer
Interval 22576.48 to 28079.32
|
|
Magnitude of Neutralizing Activity Against Env-pseudotyped Viruses in TZM-bl Cells for Part A and B and Clinical Product Assayed at Same Time.
H704_0907_130sN - 80 - 168
|
—
|
—
|
—
|
—
|
—
|
10566.71 titer
Interval 9337.6 to 12113.74
|
11294.94 titer
Interval 8173.07 to 12895.74
|
12934.70 titer
Interval 12590.47 to 14107.93
|
10396.23 titer
Interval 8686.59 to 16761.83
|
31529.07 titer
Interval 26401.86 to 36070.9
|
|
Magnitude of Neutralizing Activity Against Env-pseudotyped Viruses in TZM-bl Cells for Part A and B and Clinical Product Assayed at Same Time.
H704_1180_070EsN - 50 - 56
|
52.48 titer
Interval 41.62 to 65.44
|
479.06 titer
Interval 437.2 to 504.66
|
264.99 titer
Interval 174.37 to 315.37
|
796.76 titer
Interval 640.43 to 914.98
|
481.05 titer
Interval 394.15 to 663.23
|
2124.99 titer
Interval 1635.18 to 2432.53
|
755.24 titer
Interval 681.67 to 1107.32
|
1688.12 titer
Interval 1219.06 to 2025.41
|
1368.86 titer
Interval 967.52 to 2020.95
|
2690.94 titer
Interval 1796.42 to 3132.6
|
|
Magnitude of Neutralizing Activity Against Env-pseudotyped Viruses in TZM-bl Cells for Part A and B and Clinical Product Assayed at Same Time.
H704_1180_070EsN - 80 - 168
|
—
|
—
|
—
|
—
|
—
|
253.39 titer
Interval 149.75 to 335.9
|
218.16 titer
Interval 139.95 to 302.97
|
348.17 titer
Interval 201.95 to 395.01
|
245.61 titer
Interval 152.22 to 348.2
|
399.61 titer
Interval 343.4 to 480.31
|
|
Magnitude of Neutralizing Activity Against Env-pseudotyped Viruses in TZM-bl Cells for Part A and B and Clinical Product Assayed at Same Time.
H704_1528_240_RE_pblib_001_s - 50 - 56
|
10.00 titer
Interval 10.0 to 10.0
|
10.00 titer
Interval 10.0 to 10.0
|
10.00 titer
Interval 10.0 to 10.0
|
10.00 titer
Interval 10.0 to 10.0
|
10.00 titer
Interval 10.0 to 10.0
|
36426.42 titer
Interval 34043.5 to 55625.24
|
23445.12 titer
Interval 17608.38 to 28520.47
|
50167.98 titer
Interval 21797.78 to 78616.61
|
27489.85 titer
Interval 19627.8 to 41960.91
|
106157.59 titer
Interval 71385.41 to 142954.07
|
|
Magnitude of Neutralizing Activity Against Env-pseudotyped Viruses in TZM-bl Cells for Part A and B and Clinical Product Assayed at Same Time.
H704_1528_240_RE_pblib_001_s - 80 - 56
|
10.00 titer
Interval 10.0 to 10.0
|
10.00 titer
Interval 10.0 to 10.0
|
10.00 titer
Interval 10.0 to 10.0
|
10.00 titer
Interval 10.0 to 10.0
|
10.00 titer
Interval 10.0 to 10.0
|
11959.12 titer
Interval 10432.91 to 14039.98
|
6762.32 titer
Interval 5403.51 to 9386.48
|
15756.62 titer
Interval 6676.25 to 18379.6
|
7703.47 titer
Interval 6423.19 to 9241.14
|
29557.51 titer
Interval 19574.58 to 36531.86
|
|
Magnitude of Neutralizing Activity Against Env-pseudotyped Viruses in TZM-bl Cells for Part A and B and Clinical Product Assayed at Same Time.
H704_1528_240_RE_pblib_001_s - 80 - 168
|
—
|
—
|
—
|
—
|
—
|
10865.19 titer
Interval 3217.66 to 12999.99
|
7091.64 titer
Interval 3178.85 to 9617.96
|
16773.85 titer
Interval 13168.14 to 18620.83
|
7753.47 titer
Interval 3915.85 to 13653.99
|
29248.76 titer
Interval 16641.2 to 38732.32
|
|
Magnitude of Neutralizing Activity Against Env-pseudotyped Viruses in TZM-bl Cells for Part A and B and Clinical Product Assayed at Same Time.
H704_1535_030sN - 50 - 56
|
10.00 titer
Interval 10.0 to 15.57
|
73.40 titer
Interval 65.48 to 83.4
|
53.90 titer
Interval 48.68 to 61.44
|
163.91 titer
Interval 145.08 to 164.93
|
121.63 titer
Interval 115.95 to 123.87
|
18072.17 titer
Interval 14792.44 to 20837.51
|
12696.91 titer
Interval 9827.76 to 19332.55
|
23023.75 titer
Interval 16462.06 to 31406.05
|
17665.67 titer
Interval 11514.08 to 34508.2
|
35536.25 titer
Interval 29386.75 to 59298.64
|
|
Magnitude of Neutralizing Activity Against Env-pseudotyped Viruses in TZM-bl Cells for Part A and B and Clinical Product Assayed at Same Time.
H704_1535_030sN - 50 - 168
|
—
|
—
|
—
|
—
|
—
|
20762.95 titer
Interval 15689.0 to 28093.73
|
19437.06 titer
Interval 16763.35 to 22415.96
|
30148.06 titer
Interval 25744.12 to 37295.43
|
18777.41 titer
Interval 13746.93 to 28200.16
|
45959.19 titer
Interval 36503.06 to 107531.61
|
|
Magnitude of Neutralizing Activity Against Env-pseudotyped Viruses in TZM-bl Cells for Part A and B and Clinical Product Assayed at Same Time.
H704_1535_030sN - 80 - 56
|
10.00 titer
Interval 10.0 to 10.0
|
10.00 titer
Interval 10.0 to 10.0
|
10.00 titer
Interval 10.0 to 10.0
|
26.97 titer
Interval 26.16 to 28.07
|
10.00 titer
Interval 10.0 to 17.35
|
4856.43 titer
Interval 3691.72 to 5130.6
|
3318.05 titer
Interval 2464.59 to 4052.66
|
6369.54 titer
Interval 5236.11 to 9197.6
|
4460.89 titer
Interval 3900.14 to 6849.22
|
10429.26 titer
Interval 9712.2 to 14126.49
|
|
Magnitude of Neutralizing Activity Against Env-pseudotyped Viruses in TZM-bl Cells for Part A and B and Clinical Product Assayed at Same Time.
H704_1535_030sN - 80 - 168
|
—
|
—
|
—
|
—
|
—
|
4578.94 titer
Interval 3360.51 to 9386.05
|
3858.60 titer
Interval 3498.92 to 4658.16
|
7070.55 titer
Interval 6571.35 to 8506.66
|
3735.43 titer
Interval 2624.14 to 6140.06
|
14169.87 titer
Interval 12229.59 to 19884.28
|
|
Magnitude of Neutralizing Activity Against Env-pseudotyped Viruses in TZM-bl Cells for Part A and B and Clinical Product Assayed at Same Time.
H703_0472_030s - 50 - 168
|
—
|
—
|
—
|
—
|
—
|
15360.16 titer
Interval 13131.22 to 18028.6
|
10917.47 titer
Interval 8209.55 to 12007.01
|
18239.03 titer
Interval 13007.53 to 21793.19
|
11090.80 titer
Interval 7072.91 to 17886.5
|
20497.50 titer
Interval 17559.38 to 26140.18
|
|
Magnitude of Neutralizing Activity Against Env-pseudotyped Viruses in TZM-bl Cells for Part A and B and Clinical Product Assayed at Same Time.
H703_0472_030s - 80 - 168
|
—
|
—
|
—
|
—
|
—
|
4947.38 titer
Interval 4807.1 to 5843.26
|
3553.36 titer
Interval 2820.22 to 4158.4
|
5255.50 titer
Interval 4585.44 to 8058.0
|
3885.02 titer
Interval 2367.69 to 5345.99
|
8034.77 titer
Interval 7410.92 to 9130.71
|
|
Magnitude of Neutralizing Activity Against Env-pseudotyped Viruses in TZM-bl Cells for Part A and B and Clinical Product Assayed at Same Time.
H703_2117_110_RE_e2A10s - 50 - 56
|
44472.66 titer
Interval 29406.06 to 46797.85
|
170780.42 titer
Interval 122746.39 to 173544.27
|
41897.36 titer
Interval 36512.97 to 76003.51
|
107823.15 titer
Interval 104194.71 to 111675.54
|
77124.52 titer
Interval 64268.48 to 78146.68
|
168357.12 titer
Interval 100766.88 to 196927.7
|
66253.95 titer
Interval 60899.93 to 82832.43
|
107878.92 titer
Interval 70813.58 to 137241.39
|
102278.55 titer
Interval 75056.44 to 114569.94
|
256420.14 titer
Interval 203041.94 to 545729.61
|
|
Magnitude of Neutralizing Activity Against Env-pseudotyped Viruses in TZM-bl Cells for Part A and B and Clinical Product Assayed at Same Time.
H703_2117_110_RE_e2A10s - 80 - 168
|
—
|
—
|
—
|
—
|
—
|
28897.55 titer
Interval 25500.79 to 31831.18
|
23002.49 titer
Interval 16945.94 to 31779.52
|
39488.60 titer
Interval 37566.74 to 40215.25
|
26000.40 titer
Interval 20112.19 to 33882.23
|
58317.53 titer
Interval 44928.83 to 130565.38
|
|
Magnitude of Neutralizing Activity Against Env-pseudotyped Viruses in TZM-bl Cells for Part A and B and Clinical Product Assayed at Same Time.
H703_2304_150_RE_cs - 50 - 168
|
—
|
—
|
—
|
—
|
—
|
23924.35 titer
Interval 19423.14 to 40216.8
|
15632.62 titer
Interval 13448.63 to 22284.53
|
26314.31 titer
Interval 24931.64 to 33052.24
|
16910.80 titer
Interval 11004.2 to 25598.01
|
39775.62 titer
Interval 26215.22 to 47397.58
|
|
Magnitude of Neutralizing Activity Against Env-pseudotyped Viruses in TZM-bl Cells for Part A and B and Clinical Product Assayed at Same Time.
H703_2304_150_RE_cs - 80 - 168
|
—
|
—
|
—
|
—
|
—
|
5888.07 titer
Interval 4796.79 to 8184.63
|
4043.14 titer
Interval 3259.53 to 5743.73
|
6921.19 titer
Interval 6026.46 to 9194.93
|
5397.31 titer
Interval 3636.99 to 7495.72
|
9955.22 titer
Interval 9218.46 to 13984.86
|
|
Magnitude of Neutralizing Activity Against Env-pseudotyped Viruses in TZM-bl Cells for Part A and B and Clinical Product Assayed at Same Time.
H703_2805_080Es - 80 - 168
|
—
|
—
|
—
|
—
|
—
|
1681.16 titer
Interval 1421.99 to 2164.35
|
995.89 titer
Interval 824.91 to 1326.43
|
1882.14 titer
Interval 1081.2 to 2409.03
|
1683.91 titer
Interval 797.11 to 2371.55
|
3200.56 titer
Interval 2846.06 to 3408.02
|
|
Magnitude of Neutralizing Activity Against Env-pseudotyped Viruses in TZM-bl Cells for Part A and B and Clinical Product Assayed at Same Time.
H704_0128_220_RE_pb001_s - 50 - 56
|
2054.33 titer
Interval 2003.3 to 2169.36
|
8993.79 titer
Interval 8560.45 to 9703.1
|
3980.77 titer
Interval 3969.29 to 6453.81
|
18366.52 titer
Interval 16650.38 to 20584.03
|
11331.69 titer
Interval 9614.73 to 11934.66
|
39127.87 titer
Interval 29796.73 to 56970.43
|
22594.30 titer
Interval 18778.06 to 31045.85
|
39373.01 titer
Interval 30382.05 to 60718.47
|
45781.87 titer
Interval 31494.28 to 65215.52
|
80954.57 titer
Interval 60919.34 to 112568.94
|
|
Magnitude of Neutralizing Activity Against Env-pseudotyped Viruses in TZM-bl Cells for Part A and B and Clinical Product Assayed at Same Time.
H704_0128_220_RE_pb001_s - 50 - 168
|
—
|
—
|
—
|
—
|
—
|
45487.53 titer
Interval 32930.99 to 52015.3
|
31670.23 titer
Interval 21910.04 to 38112.08
|
49696.36 titer
Interval 47116.69 to 61935.77
|
33050.62 titer
Interval 22841.22 to 44745.34
|
77026.80 titer
Interval 57622.62 to 82921.82
|
|
Magnitude of Neutralizing Activity Against Env-pseudotyped Viruses in TZM-bl Cells for Part A and B and Clinical Product Assayed at Same Time.
H704_0128_220_RE_pb001_s - 80 - 168
|
—
|
—
|
—
|
—
|
—
|
9737.36 titer
Interval 8355.11 to 13038.3
|
8441.28 titer
Interval 5095.94 to 10008.53
|
14323.05 titer
Interval 14107.54 to 14602.08
|
8126.62 titer
Interval 4361.08 to 10869.81
|
20457.55 titer
Interval 18349.9 to 28056.34
|
|
Magnitude of Neutralizing Activity Against Env-pseudotyped Viruses in TZM-bl Cells for Part A and B and Clinical Product Assayed at Same Time.
H704_0445_180_RE_con_s - 50 - 168
|
—
|
—
|
—
|
—
|
—
|
1047.87 titer
Interval 838.46 to 1222.54
|
837.65 titer
Interval 514.52 to 930.68
|
1120.53 titer
Interval 883.26 to 1404.03
|
867.36 titer
Interval 477.86 to 1100.31
|
1932.03 titer
Interval 1806.4 to 2650.67
|
|
Magnitude of Neutralizing Activity Against Env-pseudotyped Viruses in TZM-bl Cells for Part A and B and Clinical Product Assayed at Same Time.
H704_0445_180_RE_con_s - 80 - 168
|
—
|
—
|
—
|
—
|
—
|
322.12 titer
Interval 265.83 to 363.06
|
252.05 titer
Interval 179.13 to 286.69
|
316.37 titer
Interval 291.65 to 390.11
|
287.66 titer
Interval 177.14 to 372.87
|
581.13 titer
Interval 538.99 to 659.41
|
|
Magnitude of Neutralizing Activity Against Env-pseudotyped Viruses in TZM-bl Cells for Part A and B and Clinical Product Assayed at Same Time.
H704_1180_070EsN - 80 - 56
|
10.00 titer
Interval 10.0 to 10.0
|
21.85 titer
Interval 15.92 to 41.97
|
10.00 titer
Interval 10.0 to 22.71
|
79.78 titer
Interval 70.96 to 86.48
|
84.29 titer
Interval 69.94 to 96.6
|
291.52 titer
Interval 268.66 to 345.28
|
157.57 titer
Interval 136.86 to 225.98
|
330.84 titer
Interval 281.9 to 419.48
|
157.47 titer
Interval 135.15 to 361.39
|
416.93 titer
Interval 369.52 to 675.25
|
|
Magnitude of Neutralizing Activity Against Env-pseudotyped Viruses in TZM-bl Cells for Part A and B and Clinical Product Assayed at Same Time.
H704_1180_070EsN - 50 - 168
|
—
|
—
|
—
|
—
|
—
|
1698.60 titer
Interval 1337.49 to 1841.09
|
1328.75 titer
Interval 1025.4 to 1958.07
|
2019.75 titer
Interval 1740.66 to 4478.74
|
1448.31 titer
Interval 677.06 to 2041.07
|
2596.69 titer
Interval 1798.41 to 3678.49
|
|
Magnitude of Neutralizing Activity Against Env-pseudotyped Viruses in TZM-bl Cells for Part A and B and Clinical Product Assayed at Same Time.
H704_1528_240_RE_pblib_001_s - 50 - 168
|
—
|
—
|
—
|
—
|
—
|
38260.68 titer
Interval 17684.51 to 43129.21
|
22333.24 titer
Interval 11198.84 to 29278.06
|
61237.42 titer
Interval 46009.12 to 127217.07
|
22870.26 titer
Interval 12696.1 to 40185.65
|
108220.51 titer
Interval 58749.69 to 168168.59
|
SECONDARY outcome
Timeframe: Measured during Screening, Days 0, 112*, 168†, and 280* Days with † are only available for T1-T5 Days with * are only available for T6-T10Population: 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.
Anti-drug Antibodies (ADA) occurrence in each group measured at prespecified timepoints for all participants in all groups regardless of how many product administrations and how much product they received. Tier 2 responses are only generated for participants who had positive responses to Tier 1.
Outcome measures
| Measure |
T1: PGDM1400LS (IV) 5 mg/kg mo 0
n=3 Participants
PGDM1400LS 5 mg/kg to be administered IV at Month 0.
|
T2: PGDM1400LS (IV) 20 mg/kg mo 0
n=3 Participants
PGDM1400LS 20 mg/kg to be administered IV at Month 0.
|
T3: PGDM1400LS (SC) 20 mg/kg mo 0
n=3 Participants
PGDM1400LS 20 mg/kg to be administered SC at Month 0.
|
T4: PGDM1400LS (IV) 40 mg/kg mo 0
n=3 Participants
PGDM1400LS 40 mg/kg to be administered IV at Month 0.
|
T5: PGDM1400LS (SC) 40 mg/kg mo 0
n=3 Participants
PGDM1400LS 40 mg/kg to be administered SC at Month 0.
|
T6: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV) 2
n=16 Participants
PGDM1400LS 20 mg/kg AND VRC07-523LS 20 mg/kg AND PGT121.414LS 20 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
T7: PGDM1400LS + VRC07-523LS + PGT121.414LS (SC) 2
n=16 Participants
PGDM1400LS 20 mg/kg AND VRC07-523LS 20 mg/kg AND PGT121.414LS 20 mg/kg to be administered SC sequentially in this order at Month 0 and Month 4.
|
T8: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV) 1
n=16 Participants
PGDM1400LS 1.4 g AND VRC07-523LS 1.4 g AND PGT121.414LS 1.4 g to be administered IV sequentially in this order at Month 0 and Month 4.
|
T9: PGDM1400LS + VRC07-523LS + PGT121.414LS (SC) 1
n=16 Participants
PGDM1400LS 1.4 g AND VRC07-523LS 1.4 g AND PGT121.414LS 1.4 g to be administered SC sequentially in this order at Month 0 and Month 4.
|
T10: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV)
n=16 Participants
PGDM1400LS 40 mg/kg AND VRC07-523LS 40 mg/kg AND PGT121.414LS 40 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Occurrence of Anti-drug Antibodies (ADA) for Participants in Parts A and B
PGT121.414.LS - Tier 1 - 280
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Anti-drug Antibodies (ADA) for Participants in Parts A and B
PGT121.414.LS - Tier 2 - 0
|
—
|
—
|
—
|
—
|
—
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Occurrence of Anti-drug Antibodies (ADA) for Participants in Parts A and B
VRC07-523LS - Tier 1 - 112
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Anti-drug Antibodies (ADA) for Participants in Parts A and B
PGDM1400LS - Tier 1 - 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Occurrence of Anti-drug Antibodies (ADA) for Participants in Parts A and B
PGDM1400LS - Tier 1 - 112
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Anti-drug Antibodies (ADA) for Participants in Parts A and B
PGDM1400LS - Tier 1 - 168
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Occurrence of Anti-drug Antibodies (ADA) for Participants in Parts A and B
PGDM1400LS - Tier 1 - 280
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Anti-drug Antibodies (ADA) for Participants in Parts A and B
PGDM1400LS - Tier 2 - 0
|
—
|
—
|
—
|
—
|
—
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
—
|
|
Occurrence of Anti-drug Antibodies (ADA) for Participants in Parts A and B
PGDM1400LS - Tier 2 - 280
|
—
|
—
|
—
|
—
|
—
|
—
|
1 Participants
|
—
|
—
|
—
|
|
Occurrence of Anti-drug Antibodies (ADA) for Participants in Parts A and B
PGT121.414.LS - Tier 1 - 0
|
—
|
—
|
—
|
—
|
—
|
5 Participants
|
6 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
|
Occurrence of Anti-drug Antibodies (ADA) for Participants in Parts A and B
PGT121.414.LS - Tier 1 - 112
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Anti-drug Antibodies (ADA) for Participants in Parts A and B
PGT121.414.LS - Tier 2 - 280
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Occurrence of Anti-drug Antibodies (ADA) for Participants in Parts A and B
VRC07-523LS - Tier 1 - 0
|
—
|
—
|
—
|
—
|
—
|
1 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
|
Occurrence of Anti-drug Antibodies (ADA) for Participants in Parts A and B
VRC07-523LS - Tier 1 - 280
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Occurrence of Anti-drug Antibodies (ADA) for Participants in Parts A and B
VRC07-523LS - Tier 2 - 0
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Occurrence of Anti-drug Antibodies (ADA) for Participants in Parts A and B
VRC07-523LS - Tier 2 - 112
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Occurrence of Anti-drug Antibodies (ADA) for Participants in Parts A and B
VRC07-523LS - Tier 2 - 280
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Measured during Screening, Days 0, 112*, 168†, and 280* Days with † are only available for T1-T5 Days with * are only available for T6-T10Population: 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.
Anti-drug Antibodies (ADA) tier 3 titers in each group measured at prespecified timepoints for all participants in all groups regardless of how many product administrations and how much product they received. Tier 3 titers are only available for those participants who had positive for ADA Tiers 1 and 2.
Outcome measures
| Measure |
T1: PGDM1400LS (IV) 5 mg/kg mo 0
n=2 Participants
PGDM1400LS 5 mg/kg to be administered IV at Month 0.
|
T2: PGDM1400LS (IV) 20 mg/kg mo 0
n=5 Participants
PGDM1400LS 20 mg/kg to be administered IV at Month 0.
|
T3: PGDM1400LS (SC) 20 mg/kg mo 0
n=2 Participants
PGDM1400LS 20 mg/kg to be administered SC at Month 0.
|
T4: PGDM1400LS (IV) 40 mg/kg mo 0
n=4 Participants
PGDM1400LS 40 mg/kg to be administered IV at Month 0.
|
T5: PGDM1400LS (SC) 40 mg/kg mo 0
n=2 Participants
PGDM1400LS 40 mg/kg to be administered SC at Month 0.
|
T6: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV) 2
PGDM1400LS 20 mg/kg AND VRC07-523LS 20 mg/kg AND PGT121.414LS 20 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
T7: PGDM1400LS + VRC07-523LS + PGT121.414LS (SC) 2
PGDM1400LS 20 mg/kg AND VRC07-523LS 20 mg/kg AND PGT121.414LS 20 mg/kg to be administered SC sequentially in this order at Month 0 and Month 4.
|
T8: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV) 1
PGDM1400LS 1.4 g AND VRC07-523LS 1.4 g AND PGT121.414LS 1.4 g to be administered IV sequentially in this order at Month 0 and Month 4.
|
T9: PGDM1400LS + VRC07-523LS + PGT121.414LS (SC) 1
PGDM1400LS 1.4 g AND VRC07-523LS 1.4 g AND PGT121.414LS 1.4 g to be administered SC sequentially in this order at Month 0 and Month 4.
|
T10: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV)
PGDM1400LS 40 mg/kg AND VRC07-523LS 40 mg/kg AND PGT121.414LS 40 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Anti-drug Antibodies (ADA) Titers for Participants in Parts A and B
PGT121.414.LS - Tier 3 - 0
|
9 titer
Interval 9.0 to 9.0
|
3 titer
Interval 2.0 to 15.0
|
2187 titer
Interval 2187.0 to 2187.0
|
1 titer
Interval 1.0 to 1.0
|
1 titer
Interval 1.0 to 1.0
|
—
|
—
|
—
|
—
|
—
|
|
Anti-drug Antibodies (ADA) Titers for Participants in Parts A and B
PGDM1400LS - Tier 3 - 0
|
1 titer
Interval 1.0 to 1.0
|
243 titer
Interval 243.0 to 243.0
|
27 titer
Interval 27.0 to 27.0
|
3 titer
Interval 3.0 to 3.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-drug Antibodies (ADA) Titers for Participants in Parts A and B
PGDM1400LS - Tier 3 - 280
|
—
|
3 titer
Interval 3.0 to 3.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-drug Antibodies (ADA) Titers for Participants in Parts A and B
VRC07-523LS - Tier 3 - 0
|
—
|
15 titer
Interval 9.0 to 21.0
|
1 titer
Interval 1.0 to 1.0
|
1 titer
Interval 1.0 to 1.0
|
1 titer
Interval 1.0 to 1.0
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
T1: PGDM1400LS (IV) 5 mg/kg mo 0
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
T2: PGDM1400LS (IV) 20 mg/kg mo 0
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
T3: PGDM1400LS (SC) 20 mg/kg mo 0
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
T4: PGDM1400LS (IV) 40 mg/kg mo 0
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
T5: PGDM1400LS (SC) 40 mg/kg mo 0
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
T6: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV) 2
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
T7: PGDM1400LS + VRC07-523LS + PGT121.414LS (SC) 2
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
T8: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV) 1
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
T9: PGDM1400LS + VRC07-523LS + PGT121.414LS (SC) 1
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
T10: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
T1: PGDM1400LS (IV) 5 mg/kg mo 0
n=3 participants at risk
PGDM1400LS 5 mg/kg to be administered IV at Month 0.
|
T2: PGDM1400LS (IV) 20 mg/kg mo 0
n=3 participants at risk
PGDM1400LS 20 mg/kg to be administered IV at Month 0.
|
T3: PGDM1400LS (SC) 20 mg/kg mo 0
n=3 participants at risk
PGDM1400LS 20 mg/kg to be administered SC at Month 0.
|
T4: PGDM1400LS (IV) 40 mg/kg mo 0
n=3 participants at risk
PGDM1400LS 40 mg/kg to be administered IV at Month 0.
|
T5: PGDM1400LS (SC) 40 mg/kg mo 0
n=3 participants at risk
PGDM1400LS 40 mg/kg to be administered SC at Month 0.
|
T6: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV) 2
n=16 participants at risk
PGDM1400LS 20 mg/kg AND VRC07-523LS 20 mg/kg AND PGT121.414LS 20 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
T7: PGDM1400LS + VRC07-523LS + PGT121.414LS (SC) 2
n=16 participants at risk
PGDM1400LS 20 mg/kg AND VRC07-523LS 20 mg/kg AND PGT121.414LS 20 mg/kg to be administered SC sequentially in this order at Month 0 and Month 4.
|
T8: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV) 1
n=16 participants at risk
PGDM1400LS 1.4 g AND VRC07-523LS 1.4 g AND PGT121.414LS 1.4 g to be administered IV sequentially in this order at Month 0 and Month 4.
|
T9: PGDM1400LS + VRC07-523LS + PGT121.414LS (SC) 1
n=16 participants at risk
PGDM1400LS 1.4 g AND VRC07-523LS 1.4 g AND PGT121.414LS 1.4 g to be administered SC sequentially in this order at Month 0 and Month 4.
|
T10: PGDM1400LS + VRC07-523LS + PGT121.414LS (IV)
n=16 participants at risk
PGDM1400LS 40 mg/kg AND VRC07-523LS 40 mg/kg AND PGT121.414LS 40 mg/kg to be administered IV sequentially in this order at Month 0 and Month 4.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Blepharitis
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Eye disorders
Eye pruritus
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Gastrointestinal disorders
Nausea(Solicited)
|
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) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
31.2%
5/16 • Number of events 5 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
12.5%
2/16 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
25.0%
4/16 • Number of events 4 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
12.5%
2/16 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Gastrointestinal disorders
Oral mucosal blistering
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
General disorders
Administration site erythema
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
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) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
General disorders
Administration site induration
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
12.5%
2/16 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
General disorders
Administration site pain
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
12.5%
2/16 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
General disorders
Administration site pruritus
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
12.5%
2/16 • Number of events 4 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
General disorders
Chest discomfort
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
General disorders
Chills(Solicited)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
25.0%
4/16 • Number of events 4 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
18.8%
3/16 • Number of events 3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
12.5%
2/16 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
12.5%
2/16 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
General disorders
Fatigue
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
General disorders
Infusion site bruising
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
General disorders
Infusion site erythema
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
25.0%
4/16 • Number of events 11 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
General disorders
Infusion site erythema(Solicited)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
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) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
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) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
25.0%
4/16 • Number of events 4 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
37.5%
6/16 • Number of events 6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
General disorders
Infusion site induration
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
General disorders
Infusion site inflammation
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
General disorders
Infusion site pain
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
12.5%
2/16 • Number of events 4 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
12.5%
2/16 • Number of events 3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
General disorders
Infusion site pain(Solicited)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
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) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
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) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
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) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
43.8%
7/16 • Number of events 7 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
18.8%
3/16 • Number of events 3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
81.2%
13/16 • Number of events 13 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
12.5%
2/16 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
General disorders
Infusion site pruritus
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
General disorders
Infusion site rash
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
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) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
General disorders
Infusion site swelling
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 5 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
12.5%
2/16 • Number of events 4 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
General disorders
Infusion site swelling(Solicited)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
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) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
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) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
18.8%
3/16 • Number of events 3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
37.5%
6/16 • Number of events 6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
General disorders
Infusion site urticaria
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
General disorders
Malaise(Solicited)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
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) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
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) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
43.8%
7/16 • Number of events 7 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
37.5%
6/16 • Number of events 6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
43.8%
7/16 • Number of events 7 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
31.2%
5/16 • Number of events 5 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
18.8%
3/16 • Number of events 3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Infections and infestations
Body tinea
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
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) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
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) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
12.5%
2/16 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
18.8%
3/16 • Number of events 3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
12.5%
2/16 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
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) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Infections and infestations
Ear infection
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
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) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
12.5%
2/16 • Number of events 3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Infections and infestations
Furuncle
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
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) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Infections and infestations
Hepatitis A
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Infections and infestations
Nail infection
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Infections and infestations
Oral herpes
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Infections and infestations
Upper respiratory tract infection
|
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) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
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) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
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) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
18.8%
3/16 • Number of events 4 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
18.8%
3/16 • Number of events 3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Injury, poisoning and procedural complications
Eye contusion
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
25.0%
4/16 • Number of events 4 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
18.8%
3/16 • Number of events 3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
18.8%
3/16 • Number of events 3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
12.5%
2/16 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
18.8%
3/16 • Number of events 4 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
12.5%
2/16 • Number of events 3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Investigations
Blood pressure increased
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
12.5%
2/16 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Investigations
Body temperature increased(Solicited)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia(Solicited)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
18.8%
3/16 • Number of events 3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
18.8%
3/16 • Number of events 3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
12.5%
2/16 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
12.5%
2/16 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
12.5%
2/16 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Musculoskeletal and connective tissue disorders
Myalgia(Solicited)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
18.8%
3/16 • Number of events 3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
25.0%
4/16 • Number of events 4 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
25.0%
4/16 • Number of events 4 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
12.5%
2/16 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
18.8%
3/16 • Number of events 3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
12.5%
2/16 • Number of events 4 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
12.5%
2/16 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
12.5%
2/16 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Nervous system disorders
Headache(Solicited)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
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) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
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) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
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) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
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) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
56.2%
9/16 • Number of events 9 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
37.5%
6/16 • Number of events 6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
37.5%
6/16 • Number of events 6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
25.0%
4/16 • Number of events 4 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
37.5%
6/16 • Number of events 6 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Psychiatric disorders
Burnout syndrome
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea(Solicited)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 2 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis(Solicited)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
25.0%
4/16 • Number of events 4 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Skin and subcutaneous tissue disorders
Pruritus(Solicited)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Vascular disorders
Flushing(Solicited)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/3 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
6.2%
1/16 • Number of events 1 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
0.00%
0/16 • The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 168 for T1-T5 and Day 280 for T6-T10. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T5 and Days 0 and 112 for T6-T10)
|
Additional Information
Jessica Andriesen, PhD, Associate Director of HVTN SDMC Operations
Fred Hutchinson Cancer Research Center
Phone: 206-667-5812
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place