Trial Outcomes & Findings for Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of the Monoclonal Antibody PGT121.414.LS Administered Alone and in Combination With VRC07-523LS Via Intravenous or Subcutaneous Infusions in Healthy, HIV-uninfected Adult Participants (NCT NCT04212091)
NCT ID: NCT04212091
Last Updated: 2024-12-13
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
33 participants
Primary outcome timeframe
Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224
Results posted on
2024-12-13
Participant Flow
One participant enrolled in Group 2 was later deemed ineligible due to a preexisting autoimmune condition that required immunosuppressive treatment at the time of enrollment. The participant was included in the PK, neutralization, and ADA analysis but was excluded from the safety analysis.
Participant milestones
| Measure |
Group 1: Vaccine
PGT121.414.LS 3 mg/kg IV mo(0)
|
Group 2: Vaccine
PGT121.414.LS 10 mg/kg IV mo(0)
|
Group 3: Vaccine
PGT121.414.LS 30 mg/kg IV mo(0)
|
Group 4: Vaccine
PGT121.414.LS 5 mg/kg SC mo(0)
|
Group 5: Vaccine
PGT121.414.LS 20 mg/kg and VRC07-523LS 20 mg/kg IV sequentially at Mo(0, 4, 8)
|
Group 6: Vaccine
PGT121.414.LS 5 mg/kg and VRC07-523LS 5 mg/kg SC sequentially at Mo(0, 4, 8)
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
3
|
3
|
10
|
10
|
|
Overall Study
COMPLETED
|
3
|
4
|
3
|
3
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
2
|
1
|
Reasons for withdrawal
| Measure |
Group 1: Vaccine
PGT121.414.LS 3 mg/kg IV mo(0)
|
Group 2: Vaccine
PGT121.414.LS 10 mg/kg IV mo(0)
|
Group 3: Vaccine
PGT121.414.LS 30 mg/kg IV mo(0)
|
Group 4: Vaccine
PGT121.414.LS 5 mg/kg SC mo(0)
|
Group 5: Vaccine
PGT121.414.LS 20 mg/kg and VRC07-523LS 20 mg/kg IV sequentially at Mo(0, 4, 8)
|
Group 6: Vaccine
PGT121.414.LS 5 mg/kg and VRC07-523LS 5 mg/kg SC sequentially at Mo(0, 4, 8)
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
Participant unable to adhere to visit
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of the Monoclonal Antibody PGT121.414.LS Administered Alone and in Combination With VRC07-523LS Via Intravenous or Subcutaneous Infusions in Healthy, HIV-uninfected Adult Participants
Baseline characteristics by cohort
| Measure |
Group 1: Vaccine
n=3 Participants
PGT121.414.LS 3 mg/kg IV mo(0)
|
Group 2: Vaccine
n=4 Participants
PGT121.414.LS 10 mg/kg IV mo(0)
|
Group 3: Vaccine
n=3 Participants
PGT121.414.LS 30 mg/kg IV mo(0)
|
Group 4: Vaccine
n=3 Participants
PGT121.414.LS 5 mg/kg SC mo(0)
|
Group 5: Vaccine
n=10 Participants
PGT121.414.LS 20 mg/kg and VRC07-523LS 20 mg/kg IV sequentially at Mo(0, 4, 8)
|
Group 6: Vaccine
n=10 Participants
PGT121.414.LS 5 mg/kg and VRC07-523LS 5 mg/kg SC sequentially at Mo(0, 4, 8)
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
29 years
n=5 Participants
|
29 years
n=7 Participants
|
39 years
n=5 Participants
|
39 years
n=4 Participants
|
34 years
n=21 Participants
|
29 years
n=8 Participants
|
31 years
n=8 Participants
|
|
Age, Customized
Less than 18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Customized
21 - 30 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
14 Participants
n=8 Participants
|
|
Age, Customized
31 - 40 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
|
Age, Customized
41 - 50 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Age, Customized
Above 50 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Customized
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
19 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
14 Participants
n=8 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
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
29 Participants
n=8 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
|
|
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
|
|
Race (NIH/OMB)
Asian
|
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
|
1 Participants
n=8 Participants
|
2 Participants
n=8 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
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
27 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
USA
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
33 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented
Outcome measures
| Measure |
Group 1: Vaccine
n=3 Participants
PGT121.414.LS 3 mg/kg IV mo(0)
|
Group 2: Vaccine
n=3 Participants
PGT121.414.LS 10 mg/kg IV mo(0)
|
Group 3: Vaccine
n=3 Participants
PGT121.414.LS 30 mg/kg IV mo(0)
|
Group 4: Vaccine
n=3 Participants
PGT121.414.LS 5 mg/kg SC mo(0)
|
Group 5: Vaccine
n=10 Participants
PGT121.414.LS 20 mg/kg and VRC07-523LS 20 mg/kg IV sequentially at Mo(0, 4, 8)
|
Group 6: Vaccine
n=10 Participants
PGT121.414.LS 5 mg/kg and VRC07-523LS 5 mg/kg SC sequentially at Mo(0, 4, 8)
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
None
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
7 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
PRIMARY outcome
Timeframe: Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented
Outcome measures
| Measure |
Group 1: Vaccine
n=3 Participants
PGT121.414.LS 3 mg/kg IV mo(0)
|
Group 2: Vaccine
n=3 Participants
PGT121.414.LS 10 mg/kg IV mo(0)
|
Group 3: Vaccine
n=3 Participants
PGT121.414.LS 30 mg/kg IV mo(0)
|
Group 4: Vaccine
n=3 Participants
PGT121.414.LS 5 mg/kg SC mo(0)
|
Group 5: Vaccine
n=10 Participants
PGT121.414.LS 20 mg/kg and VRC07-523LS 20 mg/kg IV sequentially at Mo(0, 4, 8)
|
Group 6: Vaccine
n=10 Participants
PGT121.414.LS 5 mg/kg and VRC07-523LS 5 mg/kg SC sequentially at Mo(0, 4, 8)
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · None
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
10 Participants
|
4 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · None
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
10 Participants
|
4 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 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
|
0 Participants
|
2 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
|
|
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
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · None
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
10 Participants
|
4 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 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
|
0 Participants
|
2 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
|
|
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
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 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
|
|
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
|
PRIMARY outcome
Timeframe: Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: malaise and/or fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and body temperature. The item Max. Systemic Symptoms is the maximum of the individual systemic reactogenicities excluding body temperature for a participant
Outcome measures
| Measure |
Group 1: Vaccine
n=3 Participants
PGT121.414.LS 3 mg/kg IV mo(0)
|
Group 2: Vaccine
n=3 Participants
PGT121.414.LS 10 mg/kg IV mo(0)
|
Group 3: Vaccine
n=3 Participants
PGT121.414.LS 30 mg/kg IV mo(0)
|
Group 4: Vaccine
n=3 Participants
PGT121.414.LS 5 mg/kg SC mo(0)
|
Group 5: Vaccine
n=10 Participants
PGT121.414.LS 20 mg/kg and VRC07-523LS 20 mg/kg IV sequentially at Mo(0, 4, 8)
|
Group 6: Vaccine
n=10 Participants
PGT121.414.LS 5 mg/kg and VRC07-523LS 5 mg/kg SC sequentially at Mo(0, 4, 8)
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · None
|
2 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
7 Participants
|
9 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · None
|
3 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Mild
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 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
|
|
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
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · None
|
3 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
8 Participants
|
9 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Severe
|
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
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · None
|
3 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
8 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Mild
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
5 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
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Mild
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · None
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
8 Participants
|
10 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · None
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
8 Participants
|
10 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Moderate
|
0 Participants
|
0 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
|
|
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
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Urticaria · None
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
10 Participants
|
10 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Urticaria · Mild
|
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
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Urticaria · Severe
|
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
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Generalized Pruritus · None
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
10 Participants
|
10 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Generalized Pruritus · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Generalized Pruritus · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Generalized Pruritus · Severe
|
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
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · None
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Mild
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 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
|
|
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
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · None
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
10 Participants
|
9 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Moderate
|
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
|
|
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
|
PRIMARY outcome
Timeframe: Measured during Screening, Days 0, 112, 168Population: '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. AST and Alkaline Phosphatase data were not collected at screening.
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population
Outcome measures
| Measure |
Group 1: Vaccine
n=3 Participants
PGT121.414.LS 3 mg/kg IV mo(0)
|
Group 2: Vaccine
n=3 Participants
PGT121.414.LS 10 mg/kg IV mo(0)
|
Group 3: Vaccine
n=3 Participants
PGT121.414.LS 30 mg/kg IV mo(0)
|
Group 4: Vaccine
n=3 Participants
PGT121.414.LS 5 mg/kg SC mo(0)
|
Group 5: Vaccine
n=10 Participants
PGT121.414.LS 20 mg/kg and VRC07-523LS 20 mg/kg IV sequentially at Mo(0, 4, 8)
|
Group 6: Vaccine
n=10 Participants
PGT121.414.LS 5 mg/kg and VRC07-523LS 5 mg/kg SC sequentially at Mo(0, 4, 8)
|
|---|---|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L
ALT (SGPT) (U/L)- Screening
|
14.0 U/L
Interval 11.0 to 23.0
|
14.0 U/L
Interval 12.0 to 18.0
|
14.0 U/L
Interval 14.0 to 24.0
|
17.0 U/L
Interval 12.0 to 19.0
|
13.0 U/L
Interval 12.0 to 18.0
|
16.0 U/L
Interval 11.0 to 24.0
|
|
Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L
ALT (SGPT) (U/L)- Day 0/Enrollment
|
17.0 U/L
Interval 11.0 to 25.0
|
13.0 U/L
Interval 12.0 to 16.0
|
15.0 U/L
Interval 14.0 to 23.0
|
14.0 U/L
Interval 13.0 to 17.0
|
15.0 U/L
Interval 13.0 to 23.0
|
15.5 U/L
Interval 12.0 to 22.0
|
|
Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L
ALT (SGPT) (U/L)- Day 112
|
13.0 U/L
Interval 10.0 to 21.0
|
15.0 U/L
Interval 10.0 to 19.0
|
14.0 U/L
Interval 13.0 to 21.0
|
15.0 U/L
Interval 12.0 to 19.0
|
15.0 U/L
Interval 13.0 to 18.0
|
18.0 U/L
Interval 9.0 to 26.0
|
|
Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L
ALT (SGPT) (U/L)- Day 168
|
12.0 U/L
Interval 12.0 to 20.0
|
17.0 U/L
Interval 11.0 to 18.0
|
15.0 U/L
Interval 12.0 to 20.0
|
13.0 U/L
Interval 13.0 to 21.0
|
20.0 U/L
Interval 15.0 to 21.0
|
15.0 U/L
Interval 11.0 to 19.0
|
|
Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L
AST (U/L)- Day 0/Enrollment
|
18.0 U/L
Interval 14.0 to 23.0
|
20.0 U/L
Interval 19.0 to 22.0
|
18.0 U/L
Interval 16.0 to 19.0
|
19.0 U/L
Interval 14.0 to 20.0
|
19.0 U/L
Interval 16.0 to 23.0
|
17.0 U/L
Interval 13.0 to 24.0
|
|
Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L
AST (U/L)- Day 112
|
16.0 U/L
Interval 15.0 to 19.0
|
21.0 U/L
Interval 15.0 to 24.0
|
16.0 U/L
Interval 13.0 to 22.0
|
15.0 U/L
Interval 15.0 to 32.0
|
19.0 U/L
Interval 17.0 to 20.0
|
19.0 U/L
Interval 15.0 to 24.0
|
|
Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L
AST (U/L)- Day 168
|
15.0 U/L
Interval 14.0 to 19.0
|
23.0 U/L
Interval 19.0 to 23.0
|
15.0 U/L
Interval 14.0 to 21.0
|
15.0 U/L
Interval 12.0 to 24.0
|
19.0 U/L
Interval 18.0 to 21.0
|
17.0 U/L
Interval 15.0 to 18.0
|
|
Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L
Alkaline Phosphatase(U/L)- Day 0/Enrollment
|
55.0 U/L
Interval 52.0 to 77.0
|
46.0 U/L
Interval 43.0 to 59.0
|
57.0 U/L
Interval 36.0 to 72.0
|
63.0 U/L
Interval 40.0 to 72.0
|
61.5 U/L
Interval 54.0 to 76.0
|
58.0 U/L
Interval 50.0 to 75.0
|
|
Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L
Alkaline Phosphatase(U/L)- Day 112
|
57.0 U/L
Interval 55.0 to 77.0
|
52.0 U/L
Interval 46.0 to 65.0
|
55.0 U/L
Interval 45.0 to 80.0
|
60.0 U/L
Interval 38.0 to 72.0
|
68.0 U/L
Interval 61.0 to 70.0
|
57.5 U/L
Interval 41.0 to 71.0
|
|
Chemistry and Hematology Laboratory Measures - Alkaline Phosphatase, AST, ALT in U/L
Alkaline Phosphatase(U/L)- Day 168
|
57.0 U/L
Interval 55.0 to 72.0
|
57.0 U/L
Interval 40.0 to 65.0
|
54.0 U/L
Interval 37.0 to 79.0
|
57.0 U/L
Interval 39.0 to 71.0
|
73.5 U/L
Interval 62.0 to 81.0
|
58.0 U/L
Interval 50.0 to 79.0
|
PRIMARY outcome
Timeframe: Measured during Screening, Days 0, 112, 168Population: 'Overall Number of Participants Analyzed' represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population
Outcome measures
| Measure |
Group 1: Vaccine
n=3 Participants
PGT121.414.LS 3 mg/kg IV mo(0)
|
Group 2: Vaccine
n=3 Participants
PGT121.414.LS 10 mg/kg IV mo(0)
|
Group 3: Vaccine
n=3 Participants
PGT121.414.LS 30 mg/kg IV mo(0)
|
Group 4: Vaccine
n=3 Participants
PGT121.414.LS 5 mg/kg SC mo(0)
|
Group 5: Vaccine
n=10 Participants
PGT121.414.LS 20 mg/kg and VRC07-523LS 20 mg/kg IV sequentially at Mo(0, 4, 8)
|
Group 6: Vaccine
n=10 Participants
PGT121.414.LS 5 mg/kg and VRC07-523LS 5 mg/kg SC sequentially at Mo(0, 4, 8)
|
|---|---|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL
Creatinine (g/dL)- Screening
|
1.0200 mg/dL
Interval 0.86 to 1.17
|
.60000 mg/dL
Interval 0.46 to 0.83
|
.97000 mg/dL
Interval 0.85 to 1.04
|
.73000 mg/dL
Interval 0.72 to 0.87
|
.78500 mg/dL
Interval 0.63 to 0.86
|
.89000 mg/dL
Interval 0.78 to 0.95
|
|
Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL
Creatinine (g/dL)- Day 0/Enrollment
|
.90000 mg/dL
Interval 0.8 to 1.08
|
.70000 mg/dL
Interval 0.58 to 0.71
|
.94000 mg/dL
Interval 0.78 to 1.12
|
.75000 mg/dL
Interval 0.66 to 0.97
|
.78000 mg/dL
Interval 0.71 to 0.85
|
.82000 mg/dL
Interval 0.71 to 1.0
|
|
Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL
Creatinine (g/dL)- Day 112
|
.91000 mg/dL
Interval 0.68 to 1.15
|
.68000 mg/dL
Interval 0.59 to 0.81
|
.94000 mg/dL
Interval 0.78 to 1.31
|
.81000 mg/dL
Interval 0.78 to 0.99
|
.80000 mg/dL
Interval 0.77 to 0.88
|
.79000 mg/dL
Interval 0.65 to 0.97
|
|
Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL
Creatinine (g/dL)- Day 168
|
.81000 mg/dL
Interval 0.61 to 1.08
|
.71000 mg/dL
Interval 0.6 to 0.82
|
.90000 mg/dL
Interval 0.85 to 1.03
|
.82000 mg/dL
Interval 0.68 to 0.96
|
.82000 mg/dL
Interval 0.7 to 0.92
|
.83000 mg/dL
Interval 0.79 to 0.97
|
PRIMARY outcome
Timeframe: Measured during Screening, Days 0, 112, 168Population: 'Overall Number of Participants Analyzed' represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population
Outcome measures
| Measure |
Group 1: Vaccine
n=3 Participants
PGT121.414.LS 3 mg/kg IV mo(0)
|
Group 2: Vaccine
n=3 Participants
PGT121.414.LS 10 mg/kg IV mo(0)
|
Group 3: Vaccine
n=3 Participants
PGT121.414.LS 30 mg/kg IV mo(0)
|
Group 4: Vaccine
n=3 Participants
PGT121.414.LS 5 mg/kg SC mo(0)
|
Group 5: Vaccine
n=10 Participants
PGT121.414.LS 20 mg/kg and VRC07-523LS 20 mg/kg IV sequentially at Mo(0, 4, 8)
|
Group 6: Vaccine
n=10 Participants
PGT121.414.LS 5 mg/kg and VRC07-523LS 5 mg/kg SC sequentially at Mo(0, 4, 8)
|
|---|---|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
Hemoglobin (g/dL)- Screening
|
14.1 g/dL
Interval 12.7 to 16.7
|
13.1 g/dL
Interval 11.1 to 13.7
|
13.8 g/dL
Interval 13.0 to 16.4
|
12.9 g/dL
Interval 11.3 to 14.9
|
13.6 g/dL
Interval 12.1 to 14.7
|
14.1 g/dL
Interval 13.5 to 14.8
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
Hemoglobin (g/dL)- Day 0/Enrollment
|
13.5 g/dL
Interval 11.4 to 17.7
|
12.9 g/dL
Interval 11.2 to 13.2
|
13.4 g/dL
Interval 12.4 to 16.7
|
12.4 g/dL
Interval 11.5 to 15.0
|
12.6 g/dL
Interval 12.1 to 14.6
|
14.2 g/dL
Interval 13.0 to 15.0
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
Hemoglobin (g/dL)- Day 112
|
13.9 g/dL
Interval 12.5 to 16.6
|
12.9 g/dL
Interval 12.4 to 13.7
|
14.2 g/dL
Interval 12.5 to 14.4
|
12.7 g/dL
Interval 10.1 to 14.1
|
12.6 g/dL
Interval 11.5 to 14.7
|
14.1 g/dL
Interval 12.9 to 15.4
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
Hemoglobin (g/dL)- Day 168
|
13.5 g/dL
Interval 12.1 to 17.3
|
13.3 g/dL
Interval 12.2 to 13.5
|
14.0 g/dL
Interval 11.8 to 14.8
|
12.3 g/dL
Interval 10.9 to 14.4
|
12.7 g/dL
Interval 12.4 to 14.3
|
14.2 g/dL
Interval 13.5 to 14.6
|
PRIMARY outcome
Timeframe: Measured during Screening, Days 0, 112, 168Population: "Overall Number of Participants Analyzed" represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population
Outcome measures
| Measure |
Group 1: Vaccine
n=3 Participants
PGT121.414.LS 3 mg/kg IV mo(0)
|
Group 2: Vaccine
n=3 Participants
PGT121.414.LS 10 mg/kg IV mo(0)
|
Group 3: Vaccine
n=3 Participants
PGT121.414.LS 30 mg/kg IV mo(0)
|
Group 4: Vaccine
n=3 Participants
PGT121.414.LS 5 mg/kg SC mo(0)
|
Group 5: Vaccine
n=10 Participants
PGT121.414.LS 20 mg/kg and VRC07-523LS 20 mg/kg IV sequentially at Mo(0, 4, 8)
|
Group 6: Vaccine
n=10 Participants
PGT121.414.LS 5 mg/kg and VRC07-523LS 5 mg/kg SC sequentially at Mo(0, 4, 8)
|
|---|---|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm
Neutrophils (1000 cells/cubic mm)- Screening
|
5.05 1000 cells/cubic mm
Interval 1.8 to 9.42
|
4.31 1000 cells/cubic mm
Interval 3.8 to 4.92
|
2.83 1000 cells/cubic mm
Interval 2.07 to 4.9
|
4.20 1000 cells/cubic mm
Interval 2.05 to 7.33
|
3.92 1000 cells/cubic mm
Interval 2.8 to 5.39
|
3.50 1000 cells/cubic mm
Interval 2.37 to 5.12
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm
Neutrophils (1000 cells/cubic mm)- Day 0/Enrollment
|
2.60 1000 cells/cubic mm
Interval 1.7 to 3.95
|
3.59 1000 cells/cubic mm
Interval 3.29 to 5.8
|
2.88 1000 cells/cubic mm
Interval 1.63 to 4.2
|
3.70 1000 cells/cubic mm
Interval 2.4 to 6.09
|
4.01 1000 cells/cubic mm
Interval 2.53 to 4.36
|
3.32 1000 cells/cubic mm
Interval 2.22 to 4.52
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm
Neutrophils (1000 cells/cubic mm)- Day 112
|
3.80 1000 cells/cubic mm
Interval 1.9 to 5.06
|
4.20 1000 cells/cubic mm
Interval 2.66 to 4.38
|
2.11 1000 cells/cubic mm
Interval 1.84 to 3.8
|
3.50 1000 cells/cubic mm
Interval 1.99 to 5.26
|
3.65 1000 cells/cubic mm
Interval 2.59 to 5.77
|
3.26 1000 cells/cubic mm
Interval 3.06 to 5.32
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm
Neutrophils (1000 cells/cubic mm)- Day 168
|
4.51 1000 cells/cubic mm
Interval 2.5 to 5.93
|
4.37 1000 cells/cubic mm
Interval 4.04 to 5.2
|
2.42 1000 cells/cubic mm
Interval 1.88 to 4.9
|
3.20 1000 cells/cubic mm
Interval 2.01 to 5.72
|
3.71 1000 cells/cubic mm
Interval 3.17 to 4.5
|
2.88 1000 cells/cubic mm
Interval 2.59 to 4.39
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm
Lymphocytes (1000 cells/cubic mm)- Screening
|
2.14 1000 cells/cubic mm
Interval 1.17 to 2.2
|
2.06 1000 cells/cubic mm
Interval 1.86 to 2.3
|
2.10 1000 cells/cubic mm
Interval 1.23 to 4.15
|
2.00 1000 cells/cubic mm
Interval 1.66 to 2.7
|
2.06 1000 cells/cubic mm
Interval 1.7 to 2.3
|
1.68 1000 cells/cubic mm
Interval 1.24 to 1.91
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm
Lymphocytes (1000 cells/cubic mm)- Day 0/Enrollment
|
2.26 1000 cells/cubic mm
Interval 2.22 to 2.6
|
1.55 1000 cells/cubic mm
Interval 1.46 to 2.2
|
1.90 1000 cells/cubic mm
Interval 1.44 to 3.04
|
1.98 1000 cells/cubic mm
Interval 1.68 to 2.0
|
1.68 1000 cells/cubic mm
Interval 1.4 to 2.28
|
1.89 1000 cells/cubic mm
Interval 1.33 to 2.3
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm
Lymphocytes (1000 cells/cubic mm)- Day 112
|
2.20 1000 cells/cubic mm
Interval 1.72 to 2.4
|
1.66 1000 cells/cubic mm
Interval 1.31 to 2.8
|
2.12 1000 cells/cubic mm
Interval 1.96 to 2.2
|
1.99 1000 cells/cubic mm
Interval 1.46 to 2.1
|
1.76 1000 cells/cubic mm
Interval 1.48 to 2.06
|
1.81 1000 cells/cubic mm
Interval 1.47 to 1.92
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm
Lymphocytes (1000 cells/cubic mm)- Day 168
|
2.10 1000 cells/cubic mm
Interval 1.75 to 2.59
|
1.99 1000 cells/cubic mm
Interval 1.89 to 2.7
|
2.40 1000 cells/cubic mm
Interval 1.44 to 2.7
|
1.65 1000 cells/cubic mm
Interval 1.56 to 2.3
|
1.68 1000 cells/cubic mm
Interval 1.55 to 2.24
|
1.86 1000 cells/cubic mm
Interval 1.67 to 2.1
|
PRIMARY outcome
Timeframe: Measured during Screening, Days 0, 112, 168Population: "Overall Number of Participants Analyzed" represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population
Outcome measures
| Measure |
Group 1: Vaccine
n=3 Participants
PGT121.414.LS 3 mg/kg IV mo(0)
|
Group 2: Vaccine
n=3 Participants
PGT121.414.LS 10 mg/kg IV mo(0)
|
Group 3: Vaccine
n=3 Participants
PGT121.414.LS 30 mg/kg IV mo(0)
|
Group 4: Vaccine
n=3 Participants
PGT121.414.LS 5 mg/kg SC mo(0)
|
Group 5: Vaccine
n=10 Participants
PGT121.414.LS 20 mg/kg and VRC07-523LS 20 mg/kg IV sequentially at Mo(0, 4, 8)
|
Group 6: Vaccine
n=10 Participants
PGT121.414.LS 5 mg/kg and VRC07-523LS 5 mg/kg SC sequentially at Mo(0, 4, 8)
|
|---|---|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
WBC (1000 cells/cubic mm)- Screening
|
7.80 1000 cells/cubic mm
Interval 4.5 to 10.9
|
7.20 1000 cells/cubic mm
Interval 6.8 to 7.3
|
7.70 1000 cells/cubic mm
Interval 3.71 to 8.0
|
7.50 1000 cells/cubic mm
Interval 4.33 to 10.3
|
6.37 1000 cells/cubic mm
Interval 5.09 to 8.02
|
5.46 1000 cells/cubic mm
Interval 4.2 to 7.95
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
WBC (1000 cells/cubic mm)- Day 0/Enrollment
|
5.60 1000 cells/cubic mm
Interval 4.7 to 6.8
|
5.70 1000 cells/cubic mm
Interval 5.6 to 8.7
|
6.70 1000 cells/cubic mm
Interval 3.51 to 6.9
|
6.20 1000 cells/cubic mm
Interval 4.61 to 9.0
|
6.28 1000 cells/cubic mm
Interval 5.44 to 7.43
|
5.63 1000 cells/cubic mm
Interval 4.69 to 7.27
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
WBC (1000 cells/cubic mm)- Day 112
|
6.60 1000 cells/cubic mm
Interval 4.7 to 7.4
|
6.90 1000 cells/cubic mm
Interval 4.6 to 7.6
|
4.80 1000 cells/cubic mm
Interval 4.59 to 6.9
|
6.40 1000 cells/cubic mm
Interval 4.7 to 7.6
|
5.95 1000 cells/cubic mm
Interval 4.54 to 8.06
|
5.89 1000 cells/cubic mm
Interval 5.1 to 6.82
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
WBC (1000 cells/cubic mm)- Day 168
|
6.90 1000 cells/cubic mm
Interval 5.0 to 9.5
|
7.30 1000 cells/cubic mm
Interval 6.5 to 8.7
|
6.10 1000 cells/cubic mm
Interval 3.75 to 8.4
|
6.10 1000 cells/cubic mm
Interval 4.36 to 8.2
|
6.73 1000 cells/cubic mm
Interval 5.12 to 6.95
|
6.38 1000 cells/cubic mm
Interval 4.71 to 9.1
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
Platelets (1000 cells/cubic mm)- Screening
|
234 1000 cells/cubic mm
Interval 203.0 to 281.0
|
307 1000 cells/cubic mm
Interval 251.0 to 353.0
|
252 1000 cells/cubic mm
Interval 250.0 to 274.0
|
303 1000 cells/cubic mm
Interval 195.0 to 372.0
|
297 1000 cells/cubic mm
Interval 268.0 to 314.0
|
253 1000 cells/cubic mm
Interval 234.0 to 365.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
Platelets (1000 cells/cubic mm)- Day 0/Enrollment
|
229 1000 cells/cubic mm
Interval 185.0 to 254.0
|
273 1000 cells/cubic mm
Interval 222.0 to 379.0
|
244 1000 cells/cubic mm
Interval 241.0 to 290.0
|
296 1000 cells/cubic mm
Interval 183.0 to 297.0
|
273 1000 cells/cubic mm
Interval 260.0 to 287.0
|
271 1000 cells/cubic mm
Interval 259.0 to 293.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
Platelets (1000 cells/cubic mm)- Day 112
|
246 1000 cells/cubic mm
Interval 221.0 to 330.0
|
271 1000 cells/cubic mm
Interval 240.0 to 403.0
|
291 1000 cells/cubic mm
Interval 266.0 to 294.0
|
296 1000 cells/cubic mm
Interval 189.0 to 339.0
|
290 1000 cells/cubic mm
Interval 249.0 to 307.0
|
284 1000 cells/cubic mm
Interval 255.0 to 323.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
Platelets (1000 cells/cubic mm)- Day 168
|
226 1000 cells/cubic mm
Interval 187.0 to 253.0
|
313 1000 cells/cubic mm
Interval 248.0 to 380.0
|
266 1000 cells/cubic mm
Interval 237.0 to 331.0
|
296 1000 cells/cubic mm
Interval 178.0 to 406.0
|
297 1000 cells/cubic mm
Interval 265.0 to 317.0
|
291 1000 cells/cubic mm
Interval 256.0 to 334.0
|
PRIMARY outcome
Timeframe: Measured through Month 24Population: Max severity reported per participant over visit
The number (percentage) of Participants Reporting Unsolicited Adverse Events (AEs) was summarized by arm
Outcome measures
| Measure |
Group 1: Vaccine
n=3 Participants
PGT121.414.LS 3 mg/kg IV mo(0)
|
Group 2: Vaccine
n=3 Participants
PGT121.414.LS 10 mg/kg IV mo(0)
|
Group 3: Vaccine
n=3 Participants
PGT121.414.LS 30 mg/kg IV mo(0)
|
Group 4: Vaccine
n=3 Participants
PGT121.414.LS 5 mg/kg SC mo(0)
|
Group 5: Vaccine
n=10 Participants
PGT121.414.LS 20 mg/kg and VRC07-523LS 20 mg/kg IV sequentially at Mo(0, 4, 8)
|
Group 6: Vaccine
n=10 Participants
PGT121.414.LS 5 mg/kg and VRC07-523LS 5 mg/kg SC sequentially at Mo(0, 4, 8)
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs)
Potentially life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs)
Mild
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs)
Moderate
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
6 Participants
|
8 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs)
Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs)
No AE reported
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Measured through Month 8The number (percentage) of participants with early discontinuation of vaccinations and reason for discontinuation was summarized by arm
Outcome measures
| Measure |
Group 1: Vaccine
n=3 Participants
PGT121.414.LS 3 mg/kg IV mo(0)
|
Group 2: Vaccine
n=3 Participants
PGT121.414.LS 10 mg/kg IV mo(0)
|
Group 3: Vaccine
n=3 Participants
PGT121.414.LS 30 mg/kg IV mo(0)
|
Group 4: Vaccine
n=3 Participants
PGT121.414.LS 5 mg/kg SC mo(0)
|
Group 5: Vaccine
n=10 Participants
PGT121.414.LS 20 mg/kg and VRC07-523LS 20 mg/kg IV sequentially at Mo(0, 4, 8)
|
Group 6: Vaccine
n=10 Participants
PGT121.414.LS 5 mg/kg and VRC07-523LS 5 mg/kg SC sequentially at Mo(0, 4, 8)
|
|---|---|---|---|---|---|---|
|
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Participant unable to adhere to visit schedule
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Unsolicited adverse event
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
PSRT decision
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 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
|
7 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: Measured through Month 16The number (percentage) of participants with early study termination and reason for early study termination was summarized by arm
Outcome measures
| Measure |
Group 1: Vaccine
n=3 Participants
PGT121.414.LS 3 mg/kg IV mo(0)
|
Group 2: Vaccine
n=3 Participants
PGT121.414.LS 10 mg/kg IV mo(0)
|
Group 3: Vaccine
n=3 Participants
PGT121.414.LS 30 mg/kg IV mo(0)
|
Group 4: Vaccine
n=3 Participants
PGT121.414.LS 5 mg/kg SC mo(0)
|
Group 5: Vaccine
n=10 Participants
PGT121.414.LS 20 mg/kg and VRC07-523LS 20 mg/kg IV sequentially at Mo(0, 4, 8)
|
Group 6: Vaccine
n=10 Participants
PGT121.414.LS 5 mg/kg and VRC07-523LS 5 mg/kg SC sequentially at Mo(0, 4, 8)
|
|---|---|---|---|---|---|---|
|
Number of Participants With Early Study Termination and Reason for Early Study Termination
Participant unable to adhere to visit schedule
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Early Study Termination and Reason for Early Study Termination
Unable to contact participant
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Early Study Termination and Reason for Early Study Termination
Scheduled exit visit/end of study
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
8 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: Days 0, 0.0417, 1, 2, 3, 6, 14, 28, 56, 84, 112, 112.0417, 140, 168, 196, 224, 224.0417, 252, 280, 336, 392, 448Population: 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 and VRC07-523LS at prespecified timepoints among participants who received all scheduled product administrations
Outcome measures
| Measure |
Group 1: Vaccine
n=3 Participants
PGT121.414.LS 3 mg/kg IV mo(0)
|
Group 2: Vaccine
n=4 Participants
PGT121.414.LS 10 mg/kg IV mo(0)
|
Group 3: Vaccine
n=3 Participants
PGT121.414.LS 30 mg/kg IV mo(0)
|
Group 4: Vaccine
n=3 Participants
PGT121.414.LS 5 mg/kg SC mo(0)
|
Group 5: Vaccine
n=10 Participants
PGT121.414.LS 20 mg/kg and VRC07-523LS 20 mg/kg IV sequentially at Mo(0, 4, 8)
|
Group 6: Vaccine
n=10 Participants
PGT121.414.LS 5 mg/kg and VRC07-523LS 5 mg/kg SC sequentially at Mo(0, 4, 8)
|
|---|---|---|---|---|---|---|
|
PGT121.414.LS and VRC07523LS Serum Concentrations
PGT121.414.LS-D392
|
—
|
—
|
—
|
—
|
69.69947 ug/ml
Interval 43.2393 to 95.21436
|
14.40051 ug/ml
Interval 10.43843 to 15.51276
|
|
PGT121.414.LS and VRC07523LS Serum Concentrations
PGT121.414.LS-D448
|
—
|
—
|
—
|
—
|
53.10780 ug/ml
Interval 31.55871 to 59.34636
|
—
|
|
PGT121.414.LS and VRC07523LS Serum Concentrations
PGT121.414.LS-D56
|
20.04609 ug/ml
Interval 19.38634 to 20.85822
|
59.34368 ug/ml
Interval 55.10586 to 63.75242
|
185.9332 ug/ml
Interval 178.5389 to 213.6618
|
19.82906 ug/ml
Interval 16.27034 to 21.76373
|
152.5493 ug/ml
Interval 117.002 to 162.5077
|
29.33043 ug/ml
Interval 27.8952 to 31.90966
|
|
PGT121.414.LS and VRC07523LS Serum Concentrations
PGT121.414.LS-D6
|
34.93493 ug/ml
Interval 33.47656 to 39.49249
|
126.4765 ug/ml
Interval 114.6745 to 128.2823
|
404.6015 ug/ml
Interval 353.2055 to 418.2706
|
24.72877 ug/ml
Interval 20.74606 to 31.10015
|
308.2920 ug/ml
Interval 246.9457 to 361.4559
|
44.67182 ug/ml
Interval 43.62332 to 59.62018
|
|
PGT121.414.LS and VRC07523LS Serum Concentrations
PGT121.414.LS-D84
|
—
|
—
|
—
|
—
|
118.2193 ug/ml
Interval 107.5665 to 127.2504
|
22.61336 ug/ml
Interval 18.97154 to 24.21829
|
|
PGT121.414.LS and VRC07523LS Serum Concentrations
VRC07-523LS-D0
|
—
|
—
|
—
|
—
|
0.02285 ug/ml
Interval 0.02285 to 0.061811
|
0.02285 ug/ml
Interval 0.02285 to 0.042424
|
|
PGT121.414.LS and VRC07523LS Serum Concentrations
VRC07-523LS-D0.0417
|
—
|
—
|
—
|
—
|
630.4643 ug/ml
Interval 585.8051 to 696.6382
|
0.198904 ug/ml
Interval 0.131714 to 0.335898
|
|
PGT121.414.LS and VRC07523LS Serum Concentrations
VRC07-523LS-D1
|
—
|
—
|
—
|
—
|
407.5692 ug/ml
Interval 365.1608 to 430.2688
|
—
|
|
PGT121.414.LS and VRC07523LS Serum Concentrations
VRC07-523LS-D112
|
—
|
—
|
—
|
—
|
35.65999 ug/ml
Interval 27.3697 to 46.33242
|
4.320423 ug/ml
Interval 3.675603 to 4.831495
|
|
PGT121.414.LS and VRC07523LS Serum Concentrations
VRC07-523LS-D112.0417
|
—
|
—
|
—
|
—
|
686.4594 ug/ml
Interval 640.2608 to 810.3886
|
4.605856 ug/ml
Interval 3.662888 to 5.491889
|
|
PGT121.414.LS and VRC07523LS Serum Concentrations
VRC07-523LS-D14
|
—
|
—
|
—
|
—
|
143.4822 ug/ml
Interval 129.0377 to 157.1381
|
18.69117 ug/ml
Interval 16.73262 to 24.82308
|
|
PGT121.414.LS and VRC07523LS Serum Concentrations
VRC07-523LS-D140
|
—
|
—
|
—
|
—
|
122.3509 ug/ml
Interval 112.0779 to 164.9094
|
21.86040 ug/ml
Interval 19.27535 to 30.60428
|
|
PGT121.414.LS and VRC07523LS Serum Concentrations
VRC07-523LS-D168
|
—
|
—
|
—
|
—
|
85.35126 ug/ml
Interval 77.5001 to 86.09826
|
16.51087 ug/ml
Interval 12.71702 to 18.51192
|
|
PGT121.414.LS and VRC07523LS Serum Concentrations
VRC07-523LS-D196
|
—
|
—
|
—
|
—
|
57.95509 ug/ml
Interval 42.46899 to 61.70629
|
11.16378 ug/ml
Interval 9.542171 to 12.68419
|
|
PGT121.414.LS and VRC07523LS Serum Concentrations
VRC07-523LS-D224
|
—
|
—
|
—
|
—
|
37.81075 ug/ml
Interval 26.11575 to 52.92875
|
6.780613 ug/ml
Interval 6.075665 to 7.060921
|
|
PGT121.414.LS and VRC07523LS Serum Concentrations
VRC07-523LS-D224.0417
|
—
|
—
|
—
|
—
|
743.0381 ug/ml
Interval 705.2543 to 786.3079
|
6.425585 ug/ml
Interval 5.544769 to 8.361913
|
|
PGT121.414.LS and VRC07523LS Serum Concentrations
VRC07-523LS-D252
|
—
|
—
|
—
|
—
|
144.2619 ug/ml
Interval 34.29301 to 152.7458
|
21.76401 ug/ml
Interval 19.25854 to 26.41406
|
|
PGT121.414.LS and VRC07523LS Serum Concentrations
VRC07-523LS-D28
|
—
|
—
|
—
|
—
|
102.0101 ug/ml
Interval 89.62093 to 104.4785
|
15.30037 ug/ml
Interval 13.04739 to 17.84672
|
|
PGT121.414.LS and VRC07523LS Serum Concentrations
VRC07-523LS-D280
|
—
|
—
|
—
|
—
|
78.68985 ug/ml
Interval 36.8379 to 92.49679
|
13.66478 ug/ml
Interval 9.885758 to 17.35632
|
|
PGT121.414.LS and VRC07523LS Serum Concentrations
VRC07-523LS-D3
|
—
|
—
|
—
|
—
|
206.2347 ug/ml
Interval 203.5824 to 243.3737
|
21.27877 ug/ml
Interval 18.46351 to 28.62675
|
|
PGT121.414.LS and VRC07523LS Serum Concentrations
VRC07-523LS-D336
|
—
|
—
|
—
|
—
|
36.82022 ug/ml
Interval 23.08635 to 59.66363
|
8.174529 ug/ml
Interval 5.21033 to 11.59268
|
|
PGT121.414.LS and VRC07523LS Serum Concentrations
VRC07-523LS-D392
|
—
|
—
|
—
|
—
|
18.29589 ug/ml
Interval 9.388055 to 27.69066
|
4.050364 ug/ml
Interval 1.956771 to 4.755294
|
|
PGT121.414.LS and VRC07523LS Serum Concentrations
VRC07-523LS-D448
|
—
|
—
|
—
|
—
|
7.518283 ug/ml
Interval 6.004015 to 15.08485
|
—
|
|
PGT121.414.LS and VRC07523LS Serum Concentrations
VRC07-523LS-D56
|
—
|
—
|
—
|
—
|
68.61530 ug/ml
Interval 61.43403 to 78.12051
|
11.10549 ug/ml
Interval 8.461712 to 11.92588
|
|
PGT121.414.LS and VRC07523LS Serum Concentrations
VRC07-523LS-D6
|
—
|
—
|
—
|
—
|
168.2826 ug/ml
Interval 142.7699 to 193.8876
|
21.24964 ug/ml
Interval 19.59201 to 28.91344
|
|
PGT121.414.LS and VRC07523LS Serum Concentrations
VRC07-523LS-D84
|
—
|
—
|
—
|
—
|
49.01481 ug/ml
Interval 42.62506 to 52.68755
|
7.679106 ug/ml
Interval 6.178084 to 8.08973
|
|
PGT121.414.LS and VRC07523LS Serum Concentrations
PGT121.414.LS-D0
|
0.32666 ug/ml
Interval 0.212155 to 0.408441
|
0.09765 ug/ml
Interval 0.09765 to 0.09765
|
0.09765 ug/ml
Interval 0.09765 to 0.09765
|
0.09765 ug/ml
Interval 0.09765 to 0.09765
|
0.09765 ug/ml
Interval 0.09765 to 0.09765
|
0.09765 ug/ml
Interval 0.09765 to 0.09765
|
|
PGT121.414.LS and VRC07523LS Serum Concentrations
PGT121.414.LS-D0.0417
|
63.83584 ug/ml
Interval 63.05451 to 69.8895
|
221.7834 ug/ml
Interval 213.0117 to 240.7665
|
554.8116 ug/ml
Interval 521.6919 to 676.4573
|
0.09765 ug/ml
Interval 0.09765 to 0.206709
|
714.2483 ug/ml
Interval 675.8913 to 842.2093
|
0.868341 ug/ml
Interval 0.501508 to 1.069614
|
|
PGT121.414.LS and VRC07523LS Serum Concentrations
PGT121.414.LS-D1
|
57.19892 ug/ml
Interval 53.425 to 64.15473
|
164.7475 ug/ml
Interval 152.5291 to 186.0908
|
525.8889 ug/ml
Interval 490.3319 to 624.0825
|
15.57179 ug/ml
Interval 10.89182 to 17.40282
|
540.5799 ug/ml
Interval 493.956 to 597.8813
|
—
|
|
PGT121.414.LS and VRC07523LS Serum Concentrations
PGT121.414.LS-D112
|
12.18623 ug/ml
Interval 11.62024 to 12.7322
|
31.38540 ug/ml
Interval 28.27068 to 36.24888
|
113.6597 ug/ml
Interval 96.48752 to 120.9419
|
10.28579 ug/ml
Interval 9.944198 to 12.06092
|
91.12431 ug/ml
Interval 74.69536 to 104.4369
|
14.53687 ug/ml
Interval 13.39469 to 16.86138
|
|
PGT121.414.LS and VRC07523LS Serum Concentrations
PGT121.414.LS-D112.0417
|
—
|
—
|
—
|
—
|
866.2283 ug/ml
Interval 793.2392 to 922.8176
|
13.15082 ug/ml
Interval 12.43524 to 15.52181
|
|
PGT121.414.LS and VRC07523LS Serum Concentrations
PGT121.414.LS-D14
|
33.50825 ug/ml
Interval 30.85342 to 36.28367
|
93.52175 ug/ml
Interval 89.45039 to 98.44224
|
287.3416 ug/ml
Interval 266.9812 to 302.3751
|
27.97899 ug/ml
Interval 22.78709 to 34.31463
|
250.1545 ug/ml
Interval 217.2386 to 279.6561
|
45.60168 ug/ml
Interval 40.84005 to 55.71133
|
|
PGT121.414.LS and VRC07523LS Serum Concentrations
PGT121.414.LS-D140
|
—
|
—
|
—
|
—
|
274.8957 ug/ml
Interval 218.4848 to 327.57
|
53.56555 ug/ml
Interval 52.04341 to 56.40598
|
|
PGT121.414.LS and VRC07523LS Serum Concentrations
PGT121.414.LS-D168
|
6.985977 ug/ml
Interval 6.696763 to 7.061191
|
17.03774 ug/ml
Interval 13.97447 to 21.98945
|
70.64411 ug/ml
Interval 58.9599 to 72.42533
|
6.447051 ug/ml
Interval 6.015901 to 7.8547
|
196.5922 ug/ml
Interval 165.2391 to 242.2765
|
40.64268 ug/ml
Interval 36.83466 to 43.96372
|
|
PGT121.414.LS and VRC07523LS Serum Concentrations
PGT121.414.LS-D196
|
—
|
—
|
—
|
—
|
131.9651 ug/ml
Interval 109.7402 to 155.0229
|
30.01136 ug/ml
Interval 26.97888 to 35.25343
|
|
PGT121.414.LS and VRC07523LS Serum Concentrations
PGT121.414.LS-D2
|
47.33316 ug/ml
Interval 46.00456 to 54.7376
|
146.6062 ug/ml
Interval 134.8796 to 160.8884
|
501.1791 ug/ml
Interval 437.2141 to 553.0405
|
19.73051 ug/ml
Interval 15.06059 to 26.21644
|
—
|
—
|
|
PGT121.414.LS and VRC07523LS Serum Concentrations
PGT121.414.LS-D224
|
4.546627 ug/ml
Interval 4.249129 to 4.606805
|
11.50982 ug/ml
Interval 8.860303 to 15.35904
|
51.03267 ug/ml
Interval 39.45568 to 54.68444
|
—
|
100.3895 ug/ml
Interval 83.59215 to 134.0949
|
20.24181 ug/ml
Interval 18.06964 to 22.66155
|
|
PGT121.414.LS and VRC07523LS Serum Concentrations
PGT121.414.LS-D224.0417
|
—
|
—
|
—
|
—
|
858.8545 ug/ml
Interval 767.1668 to 937.6442
|
19.81756 ug/ml
Interval 14.01395 to 22.69359
|
|
PGT121.414.LS and VRC07523LS Serum Concentrations
PGT121.414.LS-D252
|
—
|
—
|
—
|
—
|
300.5559 ug/ml
Interval 101.1321 to 355.2648
|
49.82065 ug/ml
Interval 47.13868 to 61.15881
|
|
PGT121.414.LS and VRC07523LS Serum Concentrations
PGT121.414.LS-D28
|
24.41258 ug/ml
Interval 23.89791 to 27.52718
|
86.60540 ug/ml
Interval 82.8672 to 91.74298
|
250.3132 ug/ml
Interval 240.6387 to 279.1332
|
22.88940 ug/ml
Interval 20.97324 to 26.82628
|
218.4120 ug/ml
Interval 175.2238 to 233.6124
|
38.72047 ug/ml
Interval 36.35462 to 48.21425
|
|
PGT121.414.LS and VRC07523LS Serum Concentrations
PGT121.414.LS-D280
|
—
|
—
|
—
|
—
|
190.1484 ug/ml
Interval 106.4923 to 211.1041
|
39.22639 ug/ml
Interval 32.07971 to 49.07706
|
|
PGT121.414.LS and VRC07523LS Serum Concentrations
PGT121.414.LS-D3
|
42.63419 ug/ml
Interval 41.91706 to 48.18462
|
135.5188 ug/ml
Interval 120.8723 to 153.3014
|
496.2948 ug/ml
Interval 402.0094 to 543.2997
|
21.51805 ug/ml
Interval 17.73029 to 30.87779
|
328.0125 ug/ml
Interval 290.1827 to 413.4903
|
43.11783 ug/ml
Interval 40.49056 to 56.40417
|
|
PGT121.414.LS and VRC07523LS Serum Concentrations
PGT121.414.LS-D336
|
—
|
—
|
—
|
—
|
122.0257 ug/ml
Interval 82.5951 to 146.5593
|
25.60772 ug/ml
Interval 20.73072 to 28.07847
|
PRIMARY outcome
Timeframe: Day 3, Months 1, 2, 4, 6, 8, 10, 12Population: Overall Number of Participants Analyzed- represents the number of sampled participants. Number Analyzed shows the number of participants with available nAb data after filtering for assay specific quality control criteria at each timepoint.
Level of ID50 and ID80 titer data from the TZMbl neutralizing antibody assays against 1 bnAb-specific virus (CH505TF.N334S.N160A.N280D.1, sensitive to PGT121, resistant to VRC07) for all Part A participants (IV or SC administration of PGT121.414.LS alone), and 1 bnAb-specific virus (CNE55.N160K, sensitive to VRC07, resistant to PGT121) for all Part B participants (IV or SC administration of PGT121.414.LS in combination with VRC07523LS) at all expected timepoints.
Outcome measures
| Measure |
Group 1: Vaccine
n=3 Participants
PGT121.414.LS 3 mg/kg IV mo(0)
|
Group 2: Vaccine
n=4 Participants
PGT121.414.LS 10 mg/kg IV mo(0)
|
Group 3: Vaccine
n=3 Participants
PGT121.414.LS 30 mg/kg IV mo(0)
|
Group 4: Vaccine
n=3 Participants
PGT121.414.LS 5 mg/kg SC mo(0)
|
Group 5: Vaccine
n=10 Participants
PGT121.414.LS 20 mg/kg and VRC07-523LS 20 mg/kg IV sequentially at Mo(0, 4, 8)
|
Group 6: Vaccine
n=10 Participants
PGT121.414.LS 5 mg/kg and VRC07-523LS 5 mg/kg SC sequentially at Mo(0, 4, 8)
|
|---|---|---|---|---|---|---|
|
Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells
CH505TF.N334S.N160A.N280D.1-ID50-D3
|
6832.5 Titers
Interval 6821.2 to 7003.2
|
25726 Titers
Interval 23363.6 to 28600.8
|
116600.9 Titers
Interval 108979.7 to 133926.6
|
3427.7 Titers
Interval 2941.7 to 4943.3
|
—
|
—
|
|
Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells
CH505TF.N334S.N160A.N280D.1-ID50-M1
|
—
|
—
|
—
|
—
|
53020.9 Titers
Interval 28536.0 to 65545.7
|
5686.5 Titers
Interval 4465.5 to 6864.9
|
|
Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells
CH505TF.N334S.N160A.N280D.1-ID50-M10
|
—
|
—
|
—
|
—
|
32718.2 Titers
Interval 24975.9 to 48877.2
|
5772.9 Titers
Interval 3981.2 to 7243.8
|
|
Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells
CH505TF.N334S.N160A.N280D.1-ID50-M12
|
—
|
—
|
—
|
—
|
39662.8 Titers
Interval 29982.6 to 51363.2
|
6546.9 Titers
Interval 4098.0 to 7237.8
|
|
Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells
CH505TF.N334S.N160A.N280D.1-ID50-M2
|
3890.8 Titers
Interval 3794.0 to 4199.2
|
13658 Titers
Interval 11356.2 to 16332.7
|
36244.6 Titers
Interval 32857.4 to 70743.2
|
3448.4 Titers
Interval 2996.3 to 5706.9
|
26629.7 Titers
Interval 22590.0 to 35325.9
|
3259.5 Titers
Interval 2769.9 to 4454.8
|
|
Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells
CH505TF.N334S.N160A.N280D.1-ID50-M4
|
2538.5 Titers
Interval 2455.2 to 2687.3
|
5465.7 Titers
Interval 4628.4 to 6854.7
|
18205.1 Titers
Interval 17918.8 to 26675.0
|
1809 Titers
Interval 1577.0 to 2057.1
|
15379 Titers
Interval 12071.4 to 24537.5
|
2129.6 Titers
Interval 1557.8 to 2876.5
|
|
Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells
CH505TF.N334S.N160A.N280D.1-ID50-M6
|
—
|
—
|
—
|
—
|
46634.1 Titers
Interval 42560.6 to 74955.6
|
7168.7 Titers
Interval 5793.5 to 9319.8
|
|
Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells
CH505TF.N334S.N160A.N280D.1-ID50-M8
|
—
|
—
|
—
|
—
|
26951.7 Titers
Interval 15555.0 to 42057.0
|
3378.6 Titers
Interval 2734.6 to 3734.2
|
|
Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells
CH505TF.N334S.N160A.N280D.1-ID80-D3
|
2916.3 Titers
Interval 2721.2 to 3082.5
|
9300.8 Titers
Interval 9063.8 to 10409.4
|
45841.5 Titers
Interval 38158.8 to 48483.0
|
1138 Titers
Interval 1027.3 to 1665.6
|
—
|
—
|
|
Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells
CH505TF.N334S.N160A.N280D.1-ID80-M1
|
—
|
—
|
—
|
—
|
17845.1 Titers
Interval 10766.7 to 23337.0
|
1905.1 Titers
Interval 1624.7 to 2328.0
|
|
Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells
CH505TF.N334S.N160A.N280D.1-ID80-M10
|
—
|
—
|
—
|
—
|
13884.8 Titers
Interval 7506.2 to 15979.8
|
1658.2 Titers
Interval 1217.5 to 2494.5
|
|
Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells
CH505TF.N334S.N160A.N280D.1-ID80-M12
|
—
|
—
|
—
|
—
|
12040.2 Titers
Interval 7037.7 to 14895.8
|
1366.9 Titers
Interval 958.9 to 1765.3
|
|
Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells
CH505TF.N334S.N160A.N280D.1-ID80-M2
|
1320.9 Titers
Interval 1313.7 to 1402.3
|
4458.1 Titers
Interval 3360.6 to 5606.9
|
12014.8 Titers
Interval 11496.4 to 23690.5
|
1238.9 Titers
Interval 1220.0 to 1736.6
|
9708.8 Titers
Interval 7510.3 to 13896.2
|
1150.6 Titers
Interval 962.4 to 1620.9
|
|
Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells
CH505TF.N334S.N160A.N280D.1-ID80-M4
|
712.2 Titers
Interval 688.9 to 739.0
|
2144.3 Titers
Interval 1727.6 to 2608.7
|
6949.7 Titers
Interval 6162.4 to 8432.2
|
573.6 Titers
Interval 561.5 to 727.9
|
4439.9 Titers
Interval 3907.5 to 6936.3
|
555.2 Titers
Interval 506.1 to 675.3
|
|
Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells
CH505TF.N334S.N160A.N280D.1-ID80-M6
|
—
|
—
|
—
|
—
|
17924.3 Titers
Interval 16013.6 to 18093.5
|
1803.7 Titers
Interval 1688.6 to 2319.2
|
|
Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells
CH505TF.N334S.N160A.N280D.1-ID80-M8
|
—
|
—
|
—
|
—
|
6137.5 Titers
Interval 5157.2 to 12462.7
|
1074.3 Titers
Interval 936.0 to 1347.5
|
|
Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells
CNE55.N160K-ID50-M1
|
—
|
—
|
—
|
—
|
1644.8 Titers
Interval 889.9 to 2377.7
|
50.4 Titers
Interval 34.1 to 80.9
|
|
Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells
CNE55.N160K-ID50-M10
|
—
|
—
|
—
|
—
|
881.4 Titers
Interval 296.7 to 2596.9
|
67 Titers
Interval 35.0 to 103.7
|
|
Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells
CNE55.N160K-ID50-M12
|
—
|
—
|
—
|
—
|
394.1 Titers
Interval 139.0 to 730.3
|
57.5 Titers
Interval 23.1 to 82.4
|
|
Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells
CNE55.N160K-ID50-M2
|
—
|
—
|
—
|
—
|
1197.6 Titers
Interval 564.5 to 2642.1
|
45.9 Titers
Interval 33.2 to 56.7
|
|
Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells
CNE55.N160K-ID50-M4
|
—
|
—
|
—
|
—
|
183.5 Titers
Interval 110.7 to 669.0
|
5 Titers
Interval 5.0 to 5.0
|
|
Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells
CNE55.N160K-ID50-M6
|
—
|
—
|
—
|
—
|
1088 Titers
Interval 508.5 to 3589.4
|
66.2 Titers
Interval 39.2 to 69.0
|
|
Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells
CNE55.N160K-ID50-M8
|
—
|
—
|
—
|
—
|
318.2 Titers
Interval 118.9 to 765.2
|
15.8 Titers
Interval 5.0 to 28.9
|
|
Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells
CNE55.N160K-ID80-M1
|
—
|
—
|
—
|
—
|
258.6 Titers
Interval 135.5 to 312.8
|
5 Titers
Interval 5.0 to 5.0
|
|
Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells
CNE55.N160K-ID80-M10
|
—
|
—
|
—
|
—
|
151.9 Titers
Interval 32.1 to 183.7
|
5 Titers
Interval 5.0 to 5.0
|
|
Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells
CNE55.N160K-ID80-M12
|
—
|
—
|
—
|
—
|
34.9 Titers
Interval 26.9 to 73.4
|
5 Titers
Interval 5.0 to 5.0
|
|
Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells
CNE55.N160K-ID80-M2
|
—
|
—
|
—
|
—
|
111.9 Titers
Interval 65.9 to 201.6
|
7.6 Titers
Interval 5.0 to 12.1
|
|
Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells
CNE55.N160K-ID80-M4
|
—
|
—
|
—
|
—
|
37.4 Titers
Interval 32.2 to 68.6
|
5 Titers
Interval 5.0 to 5.0
|
|
Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells
CNE55.N160K-ID80-M6
|
—
|
—
|
—
|
—
|
130.5 Titers
Interval 105.1 to 198.4
|
5 Titers
Interval 5.0 to 14.0
|
|
Magnitude of Serum Neutralizing Activity Measured With mAb-specific Env-pseudotyped Viruses in TZM-bl Cells
CNE55.N160K-ID80-M8
|
—
|
—
|
—
|
—
|
29 Titers
Interval 20.6 to 41.5
|
5 Titers
Interval 5.0 to 5.0
|
SECONDARY outcome
Timeframe: Day 0, 112, 196, 224, 336, 392, 448Population: Overall Number of Participants Analyzed presents the number of enrolled participants in each treatment arm. Number Analyzed shows the number of samples available and tested in a certain tier and timepoint.
Antidrug antibodies (ADA) are most typically detected and characterized using a tiered testing strategy. In Tier I, a sensitive binding assay is used to determine if samples may have ADA present. In Tier II, the response is confirmed, typically by establishing the specificity of the response by competition with free drug. In Tier III, the response is characterized, typically with a neutralization reduction assay and/or a titering assay.
Outcome measures
| Measure |
Group 1: Vaccine
n=3 Participants
PGT121.414.LS 3 mg/kg IV mo(0)
|
Group 2: Vaccine
n=4 Participants
PGT121.414.LS 10 mg/kg IV mo(0)
|
Group 3: Vaccine
n=3 Participants
PGT121.414.LS 30 mg/kg IV mo(0)
|
Group 4: Vaccine
n=3 Participants
PGT121.414.LS 5 mg/kg SC mo(0)
|
Group 5: Vaccine
n=10 Participants
PGT121.414.LS 20 mg/kg and VRC07-523LS 20 mg/kg IV sequentially at Mo(0, 4, 8)
|
Group 6: Vaccine
n=10 Participants
PGT121.414.LS 5 mg/kg and VRC07-523LS 5 mg/kg SC sequentially at Mo(0, 4, 8)
|
|---|---|---|---|---|---|---|
|
Occurrence of Antidrug Antibodies (ADA)
PGT121.414.LS-Tier I-D0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Antidrug Antibodies (ADA)
PGT121.414.LS-Tier I-D112
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Antidrug Antibodies (ADA)
PGT121.414.LS-Tier I-D196
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Occurrence of Antidrug Antibodies (ADA)
PGT121.414.LS-Tier I-D224
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Occurrence of Antidrug Antibodies (ADA)
PGT121.414.LS-Tier I-D336
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Occurrence of Antidrug Antibodies (ADA)
PGT121.414.LS-Tier I-D392
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Occurrence of Antidrug Antibodies (ADA)
PGT121.414.LS-Tier I-D448
|
—
|
—
|
—
|
—
|
0 Participants
|
—
|
|
Occurrence of Antidrug Antibodies (ADA)
VRC07-523LS-Tier I-D0
|
—
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
|
Occurrence of Antidrug Antibodies (ADA)
VRC07-523LS-Tier I-D112
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Occurrence of Antidrug Antibodies (ADA)
VRC07-523LS-Tier I-D196
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Occurrence of Antidrug Antibodies (ADA)
VRC07-523LS-Tier I-D224
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Occurrence of Antidrug Antibodies (ADA)
VRC07-523LS-Tier I-D336
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Occurrence of Antidrug Antibodies (ADA)
VRC07-523LS-Tier I-D392
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Occurrence of Antidrug Antibodies (ADA)
VRC07-523LS-Tier I-D448
|
—
|
—
|
—
|
—
|
0 Participants
|
—
|
|
Occurrence of Antidrug Antibodies (ADA)
VRC07-523LS-Tier II-D0
|
—
|
—
|
—
|
—
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Months 1, 4, and 9Population: Overall Number of Participants Analyzed presents the number of enrolled participants in each treatment arm. Number Analyzed shows the number of samples available and tested in a certain tier and timepoint.
Magnitude-breadth characterize the magnitude (ID50 or ID80 titers) and breadth (number of virus isolates) of each individual serum sample assayed against a panel of virus isolates. MB curves show, for each possible magnitude threshold, the fraction of assays with magnitudes greater than this threshold. The area under the magnitude-breadth curve (AUC-MB) is calculated as the average of the log10-based ID50 or ID80 titers over the panel of isolates. Isolates includes: 0330.v4.c3, 3426.v5.c17, 377.v4.c09, AC10.0.29, Ce1176\_A3, DU156.12, DU172.17, PVO.4, RHPA4259.7, SC422661.8, T2638, andTRO.11.
Outcome measures
| Measure |
Group 1: Vaccine
n=3 Participants
PGT121.414.LS 3 mg/kg IV mo(0)
|
Group 2: Vaccine
n=4 Participants
PGT121.414.LS 10 mg/kg IV mo(0)
|
Group 3: Vaccine
n=3 Participants
PGT121.414.LS 30 mg/kg IV mo(0)
|
Group 4: Vaccine
n=3 Participants
PGT121.414.LS 5 mg/kg SC mo(0)
|
Group 5: Vaccine
n=10 Participants
PGT121.414.LS 20 mg/kg and VRC07-523LS 20 mg/kg IV sequentially at Mo(0, 4, 8)
|
Group 6: Vaccine
n=10 Participants
PGT121.414.LS 5 mg/kg and VRC07-523LS 5 mg/kg SC sequentially at Mo(0, 4, 8)
|
|---|---|---|---|---|---|---|
|
Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves at Months 1, 4, and 9
ID80-M1
|
2.28 log10(titer)
Interval 2.28 to 2.36
|
2.84 log10(titer)
Interval 2.83 to 2.84
|
3.36 log10(titer)
Interval 3.29 to 3.48
|
2.23 log10(titer)
Interval 2.15 to 2.29
|
3.46 log10(titer)
Interval 3.4 to 3.49
|
2.47 log10(titer)
Interval 2.44 to 2.51
|
|
Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves at Months 1, 4, and 9
ID80-M4
|
1.89 log10(titer)
Interval 1.85 to 1.91
|
2.36 log10(titer)
Interval 2.24 to 2.49
|
2.88 log10(titer)
Interval 2.82 to 2.97
|
1.81 log10(titer)
Interval 1.79 to 1.92
|
—
|
—
|
|
Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves at Months 1, 4, and 9
ID80-M9
|
—
|
—
|
—
|
—
|
3.62 log10(titer)
Interval 3.06 to 3.71
|
2.66 log10(titer)
Interval 2.65 to 2.71
|
|
Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves at Months 1, 4, and 9
ID50-M1
|
2.87 log10(titer)
Interval 2.86 to 2.99
|
3.39 log10(titer)
Interval 3.38 to 3.42
|
4 log10(titer)
Interval 3.91 to 4.14
|
2.79 log10(titer)
Interval 2.78 to 2.89
|
3.97 log10(titer)
Interval 3.92 to 4.01
|
3.02 log10(titer)
Interval 2.97 to 3.07
|
|
Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves at Months 1, 4, and 9
ID50-M4
|
2.54 log10(titer)
Interval 2.5 to 2.57
|
3.08 log10(titer)
Interval 2.99 to 3.15
|
3.55 log10(titer)
Interval 3.44 to 3.58
|
2.42 log10(titer)
Interval 2.39 to 2.61
|
—
|
—
|
|
Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves at Months 1, 4, and 9
ID50-M9
|
—
|
—
|
—
|
—
|
4.12 log10(titer)
Interval 3.65 to 4.22
|
3.2 log10(titer)
Interval 3.17 to 3.27
|
Adverse Events
Group 1: Vaccine
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 2: Vaccine
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 3: Vaccine
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 4: Vaccine
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group 5: Vaccine
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Group 6: Vaccine
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1: Vaccine
n=3 participants at risk
PGT121.414.LS 3 mg/kg IV mo(0)
|
Group 2: Vaccine
n=3 participants at risk
PGT121.414.LS 10 mg/kg IV mo(0)
|
Group 3: Vaccine
n=3 participants at risk
PGT121.414.LS 30 mg/kg IV mo(0)
|
Group 4: Vaccine
n=3 participants at risk
PGT121.414.LS 5 mg/kg SC mo(0)
|
Group 5: Vaccine
n=10 participants at risk
PGT121.414.LS 20 mg/kg and VRC07-523LS 20 mg/kg IV sequentially at Mo(0, 4, 8)
|
Group 6: Vaccine
n=10 participants at risk
PGT121.414.LS 5 mg/kg and VRC07-523LS 5 mg/kg SC sequentially at Mo(0, 4, 8)
|
|---|---|---|---|---|---|---|
|
Investigations
Haemoglobin decreased
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
33.3%
1/3 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
33.3%
1/3 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
10.0%
1/10 • Number of events 3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
33.3%
1/3 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (Solicited)
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
20.0%
2/10 • Number of events 2 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
33.3%
1/3 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Musculoskeletal and connective tissue disorders
Myalgia (Solicited)
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
33.3%
1/3 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
20.0%
2/10 • Number of events 2 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
10.0%
1/10 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
10.0%
1/10 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
10.0%
1/10 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
20.0%
2/10 • Number of events 3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
20.0%
2/10 • Number of events 2 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Nervous system disorders
Headache (Solicited)
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
33.3%
1/3 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
66.7%
2/3 • Number of events 2 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
70.0%
7/10 • Number of events 7 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
20.0%
2/10 • Number of events 2 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
10.0%
1/10 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
10.0%
1/10 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
10.0%
1/10 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
10.0%
1/10 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
10.0%
1/10 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
10.0%
1/10 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
20.0%
2/10 • Number of events 2 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
10.0%
1/10 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
10.0%
1/10 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
20.0%
2/10 • Number of events 2 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Reproductive system and breast disorders
Premenstrual dysphoric disorder
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
10.0%
1/10 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
10.0%
1/10 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
10.0%
1/10 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
33.3%
1/3 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
10.0%
1/10 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis (Solicited)
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
10.0%
1/10 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
10.0%
1/10 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
10.0%
1/10 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Skin and subcutaneous tissue disorders
Urticaria cholinergic
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
10.0%
1/10 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
10.0%
1/10 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
10.0%
1/10 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
10.0%
1/10 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
10.0%
1/10 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
10.0%
1/10 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Gastrointestinal disorders
Hiatus hernia
|
33.3%
1/3 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Gastrointestinal disorders
Nausea (Solicited)
|
33.3%
1/3 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
30.0%
3/10 • Number of events 3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
10.0%
1/10 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
10.0%
1/10 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
General disorders
Chest discomfort
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
10.0%
1/10 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
General disorders
Chills (Solicited)
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
20.0%
2/10 • Number of events 2 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
General disorders
Infusion site erythema
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
10.0%
1/10 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
General disorders
Infusion site erythema (Solicited)
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
60.0%
6/10 • Number of events 6 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
General disorders
Infusion site pain (Solicited)
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
60.0%
6/10 • Number of events 6 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
70.0%
7/10 • Number of events 7 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
General disorders
Infusion site pruritus
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
10.0%
1/10 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
General disorders
Infusion site swelling (Solicited)
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
60.0%
6/10 • Number of events 6 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
General disorders
Malaise (Solicited)
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
66.7%
2/3 • Number of events 2 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
33.3%
1/3 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
33.3%
1/3 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
60.0%
6/10 • Number of events 6 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
50.0%
5/10 • Number of events 5 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Infections and infestations
COVID-19
|
33.3%
1/3 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
30.0%
3/10 • Number of events 3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
30.0%
3/10 • Number of events 3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Infections and infestations
Dermatophytosis of nail
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
10.0%
1/10 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Infections and infestations
Oral herpes
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
10.0%
1/10 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
10.0%
1/10 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
10.0%
1/10 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
10.0%
1/10 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Infections and infestations
Urinary tract infection
|
33.3%
1/3 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
10.0%
1/10 • Number of events 4 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Infections and infestations
Viral infection
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
10.0%
1/10 • Number of events 2 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
33.3%
1/3 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
10.0%
1/10 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
33.3%
1/3 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Injury, poisoning and procedural complications
Concussion
|
33.3%
1/3 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
10.0%
1/10 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
30.0%
3/10 • Number of events 6 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
10.0%
1/10 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
10.0%
1/10 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
20.0%
2/10 • Number of events 2 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
10.0%
1/10 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
10.0%
1/10 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Investigations
Blood bicarbonate decreased
|
33.3%
1/3 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
33.3%
1/3 • Number of events 2 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
10.0%
1/10 • Number of events 2 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
10.0%
1/10 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Investigations
Blood sodium decreased
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
10.0%
1/10 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
|
Investigations
Body temperature increased (Solicited)
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/3 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
0.00%
0/10 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
10.0%
1/10 • Number of events 1 • Measured through Month 24 for Unsolicited AEs and Measured through 3 days after each vaccine dose at T1-T4: Day 0; T5-T6: Days 0, 112, 224 for Solicited AEs
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events ware summarized by arm
|
Additional Information
Jessica Andriesen, PhD, Associate Director of HVTN SDMC Operations
Fred Hutchinson Cancer Center
Phone: 206-667-5812
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place