Trial Outcomes & Findings for Evaluating the Safety and Immunogenicity of EnvSeq-1 and CH505 M5 gp120 Envs Adjuvanted With GLA-SE in Healthy, HIV-Uninfected Adults (NCT NCT03220724)
NCT ID: NCT03220724
Last Updated: 2026-05-04
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
117 participants
Primary outcome timeframe
Measured through Month Measured through 7 days after the vaccination at Month 0, 2, 4, 8, 12
Results posted on
2026-05-04
Participant Flow
Participant milestones
| Measure |
Group 6: Vaccine
400mcg CH505TF(m0), 400mcg CH505TF +
|
Group 7: Vaccine
400mcg CH505 M5(m0,2,4,8)
|
Group 8: Placebo
Placebo(m0,2,4,8)
|
Group 9: Vaccine
400mcg CH505TF(m0), 400mcg CH505w53(
|
Group 1: Vaccine
20 mcg CH505TF mo(0,2,4,8,12)
|
Group 2: Vaccine
100 mcg CH505TF mo(0,2,4,8,12)
|
Group 3: Vaccine
400 mcg CH505TF mo(0,2,4,8,12)
|
Group 4: Placebo
Placebo for CH505TF mo(0,2,4,8,12)
|
Group 5: Vaccine
400mcg CH505TF(m0), 400mcg CH505w53(
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
5
|
10
|
12
|
12
|
12
|
6
|
20
|
|
Overall Study
Month 4.5 Immunogenicity Cohort
|
20
|
19
|
4
|
9
|
11
|
12
|
12
|
3
|
19
|
|
Overall Study
COMPLETED
|
20
|
18
|
4
|
10
|
9
|
10
|
11
|
3
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
1
|
0
|
3
|
2
|
1
|
3
|
1
|
Reasons for withdrawal
| Measure |
Group 6: Vaccine
400mcg CH505TF(m0), 400mcg CH505TF +
|
Group 7: Vaccine
400mcg CH505 M5(m0,2,4,8)
|
Group 8: Placebo
Placebo(m0,2,4,8)
|
Group 9: Vaccine
400mcg CH505TF(m0), 400mcg CH505w53(
|
Group 1: Vaccine
20 mcg CH505TF mo(0,2,4,8,12)
|
Group 2: Vaccine
100 mcg CH505TF mo(0,2,4,8,12)
|
Group 3: Vaccine
400 mcg CH505TF mo(0,2,4,8,12)
|
Group 4: Placebo
Placebo for CH505TF mo(0,2,4,8,12)
|
Group 5: Vaccine
400mcg CH505TF(m0), 400mcg CH505w53(
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
1
|
0
|
2
|
2
|
0
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Evaluating the Safety and Immunogenicity of EnvSeq-1 and CH505 M5 gp120 Envs Adjuvanted With GLA-SE in Healthy, HIV-Uninfected Adults
Baseline characteristics by cohort
| Measure |
Group 1: Vaccine
n=12 Participants
20 mcg CH505TF mo(0,2,4,8,12)
|
Group 2: Vaccine
n=12 Participants
100 mcg CH505TF mo(0,2,4,8,12)
|
Group 3: Vaccine
n=12 Participants
400 mcg CH505TF mo(0,2,4,8,12)
|
Group 4: Placebo
n=6 Participants
Placebo for CH505TF mo(0,2,4,8,12)
|
Group 5: Vaccine
n=20 Participants
400mcg CH505TF(m0), 400mcg CH505w53(
|
Group 6: Vaccine
n=20 Participants
400mcg CH505TF(m0), 400mcg CH505TF +
|
Group 7: Vaccine
n=20 Participants
400mcg CH505 M5(m0,2,4,8)
|
Group 8: Placebo
n=5 Participants
Placebo(m0,2,4,8)
|
Group 9: Vaccine
n=10 Participants
400mcg CH505TF(m0), 400mcg CH505w53(
|
Total
n=117 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
32 years
n=54 Participants
|
31 years
n=60 Participants
|
27 years
n=114 Participants
|
28 years
n=1 Participants
|
29 years
n=9 Participants
|
28 years
n=71 Participants
|
28 years
n=504 Participants
|
23 years
n=6 Participants
|
30 years
n=15 Participants
|
28 years
n=55 Participants
|
|
Age, Customized
Less than 18 years
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=55 Participants
|
|
Age, Customized
18 - 20 years
|
1 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
1 Participants
n=1 Participants
|
0 Participants
n=9 Participants
|
2 Participants
n=71 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=15 Participants
|
8 Participants
n=55 Participants
|
|
Age, Customized
21 - 30 years
|
4 Participants
n=54 Participants
|
5 Participants
n=60 Participants
|
7 Participants
n=114 Participants
|
4 Participants
n=1 Participants
|
12 Participants
n=9 Participants
|
11 Participants
n=71 Participants
|
11 Participants
n=504 Participants
|
4 Participants
n=6 Participants
|
4 Participants
n=15 Participants
|
62 Participants
n=55 Participants
|
|
Age, Customized
31 - 40 years
|
5 Participants
n=54 Participants
|
4 Participants
n=60 Participants
|
2 Participants
n=114 Participants
|
0 Participants
n=1 Participants
|
6 Participants
n=9 Participants
|
5 Participants
n=71 Participants
|
7 Participants
n=504 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=15 Participants
|
33 Participants
n=55 Participants
|
|
Age, Customized
41 - 50 years
|
2 Participants
n=54 Participants
|
2 Participants
n=60 Participants
|
2 Participants
n=114 Participants
|
1 Participants
n=1 Participants
|
2 Participants
n=9 Participants
|
2 Participants
n=71 Participants
|
2 Participants
n=504 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=15 Participants
|
14 Participants
n=55 Participants
|
|
Age, Customized
Above 50 years
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=55 Participants
|
|
Age, Customized
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=55 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=54 Participants
|
5 Participants
n=60 Participants
|
4 Participants
n=114 Participants
|
3 Participants
n=1 Participants
|
7 Participants
n=9 Participants
|
9 Participants
n=71 Participants
|
8 Participants
n=504 Participants
|
2 Participants
n=6 Participants
|
5 Participants
n=15 Participants
|
48 Participants
n=55 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=54 Participants
|
7 Participants
n=60 Participants
|
8 Participants
n=114 Participants
|
3 Participants
n=1 Participants
|
13 Participants
n=9 Participants
|
11 Participants
n=71 Participants
|
12 Participants
n=504 Participants
|
3 Participants
n=6 Participants
|
5 Participants
n=15 Participants
|
69 Participants
n=55 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=1 Participants
|
3 Participants
n=9 Participants
|
3 Participants
n=71 Participants
|
5 Participants
n=504 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=15 Participants
|
16 Participants
n=55 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=54 Participants
|
11 Participants
n=60 Participants
|
12 Participants
n=114 Participants
|
6 Participants
n=1 Participants
|
17 Participants
n=9 Participants
|
17 Participants
n=71 Participants
|
15 Participants
n=504 Participants
|
3 Participants
n=6 Participants
|
8 Participants
n=15 Participants
|
101 Participants
n=55 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=55 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=55 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
3 Participants
n=114 Participants
|
0 Participants
n=1 Participants
|
2 Participants
n=9 Participants
|
0 Participants
n=71 Participants
|
2 Participants
n=504 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=15 Participants
|
10 Participants
n=55 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=55 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
3 Participants
n=114 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=71 Participants
|
3 Participants
n=504 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=15 Participants
|
13 Participants
n=55 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=54 Participants
|
8 Participants
n=60 Participants
|
6 Participants
n=114 Participants
|
4 Participants
n=1 Participants
|
17 Participants
n=9 Participants
|
16 Participants
n=71 Participants
|
14 Participants
n=504 Participants
|
4 Participants
n=6 Participants
|
7 Participants
n=15 Participants
|
84 Participants
n=55 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=54 Participants
|
2 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
1 Participants
n=1 Participants
|
0 Participants
n=9 Participants
|
3 Participants
n=71 Participants
|
1 Participants
n=504 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=15 Participants
|
10 Participants
n=55 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=55 Participants
|
|
Region of Enrollment
USA
|
12 Participants
n=54 Participants
|
12 Participants
n=60 Participants
|
12 Participants
n=114 Participants
|
6 Participants
n=1 Participants
|
20 Participants
n=9 Participants
|
20 Participants
n=71 Participants
|
20 Participants
n=504 Participants
|
5 Participants
n=6 Participants
|
10 Participants
n=15 Participants
|
117 Participants
n=55 Participants
|
PRIMARY outcome
Timeframe: Measured through Month Measured through 7 days after the vaccination at Month 0, 2, 4, 8, 12Graded 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 6: Vaccine
n=12 Participants
400mcg CH505TF(m0), 400mcg CH505TF + CH505W53(m2), 400mcg CH505TF + CH505w53 + CH505w78(m4), 400mcg CH505w53 + CH505w78(m8)
|
Group 7: Vaccine
n=12 Participants
400mcg CH505 M5(m0,2,4,8)
|
Group 8: Placebo
n=6 Participants
Placebo(m0,2,4,8)
|
Group 9: Vaccine
n=12 Participants
400mcg CH505TF(m0), 400mcg CH505w53(m2), 400mcg CH505w78(m4)
|
|---|---|---|---|---|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime
Pain · Moderate
|
4 Participants
|
4 Participants
|
0 Participants
|
3 Participants
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime
Pain · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime
Pain · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime
Tenderness · None
|
3 Participants
|
0 Participants
|
6 Participants
|
1 Participants
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime
Tenderness · Mild
|
5 Participants
|
7 Participants
|
0 Participants
|
6 Participants
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime
Tenderness · Moderate
|
4 Participants
|
5 Participants
|
0 Participants
|
5 Participants
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime
Tenderness · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime
Tenderness · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime
Pain and/or Tenderness · None
|
0 Participants
|
0 Participants
|
5 Participants
|
1 Participants
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime
Pain and/or Tenderness · Mild
|
7 Participants
|
7 Participants
|
1 Participants
|
6 Participants
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime
Pain and/or Tenderness · Moderate
|
5 Participants
|
5 Participants
|
0 Participants
|
4 Participants
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime
Pain and/or Tenderness · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime
Pain and/or Tenderness · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime
Erythema/Redness · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime
Erythema/Redness · None
|
9 Participants
|
10 Participants
|
5 Participants
|
10 Participants
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime
Erythema/Redness · Mild
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime
Erythema/Redness · Severe
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime
Erythema/Redness · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime
Induration/Swelling · None
|
9 Participants
|
11 Participants
|
6 Participants
|
11 Participants
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime
Induration/Swelling · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime
Induration/Swelling · Moderate
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime
Induration/Swelling · Severe
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime
Induration/Swelling · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime
Erythema and/or Induration · None
|
8 Participants
|
10 Participants
|
5 Participants
|
10 Participants
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime
Erythema and/or Induration · Mild
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime
Erythema and/or Induration · Moderate
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime
Erythema and/or Induration · Severe
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime
Erythema and/or Induration · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime
Pain · None
|
0 Participants
|
2 Participants
|
5 Participants
|
1 Participants
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime
Pain · Mild
|
8 Participants
|
6 Participants
|
1 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Measured through Month Measured through 7 days after the vaccination at Month 0, 2, 4, 8, 12Graded 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 6: Vaccine
n=12 Participants
400mcg CH505TF(m0), 400mcg CH505TF + CH505W53(m2), 400mcg CH505TF + CH505w53 + CH505w78(m4), 400mcg CH505w53 + CH505w78(m8)
|
Group 7: Vaccine
n=12 Participants
400mcg CH505 M5(m0,2,4,8)
|
Group 8: Placebo
n=6 Participants
Placebo(m0,2,4,8)
|
Group 9: Vaccine
n=12 Participants
400mcg CH505TF(m0), 400mcg CH505w53(m2), 400mcg CH505w78(m4)
|
|---|---|---|---|---|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Malaise and/or fatigue · Moderate
|
4 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Malaise and/or fatigue · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Headache · Mild
|
4 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Malaise and/or fatigue · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Myalgia · None
|
7 Participants
|
9 Participants
|
6 Participants
|
6 Participants
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Myalgia · Mild
|
4 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Myalgia · Moderate
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Myalgia · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Myalgia · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Headache · None
|
7 Participants
|
6 Participants
|
5 Participants
|
8 Participants
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Malaise and/or fatigue · None
|
4 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Malaise and/or fatigue · Mild
|
4 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Vomiting · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Chills · None
|
11 Participants
|
11 Participants
|
5 Participants
|
10 Participants
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Chills · Mild
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Chills · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Headache · Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Headache · Severe
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Headache · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Nausea · None
|
10 Participants
|
11 Participants
|
5 Participants
|
9 Participants
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Nausea · Mild
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Nausea · Moderate
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Nausea · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Nausea · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Vomiting · None
|
12 Participants
|
12 Participants
|
5 Participants
|
12 Participants
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Vomiting · Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Vomiting · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Vomiting · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Max. Systemic Symptoms · Mild
|
5 Participants
|
5 Participants
|
2 Participants
|
4 Participants
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Max. Systemic Symptoms · Moderate
|
4 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Max. Systemic Symptoms · Severe
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Max. Systemic Symptoms · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Temperature · None
|
10 Participants
|
11 Participants
|
6 Participants
|
12 Participants
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Temperature · Mild
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Temperature · Moderate
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Temperature · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Temperature · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Chills · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Chills · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Arthralgia · None
|
8 Participants
|
10 Participants
|
5 Participants
|
7 Participants
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Arthralgia · Mild
|
3 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Arthralgia · Moderate
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Arthralgia · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Arthralgia · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Max. Systemic Symptoms · None
|
2 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Measured through Month 24From the study termination form, early termination reasons associated with an AE or reactogenicity are tabulated by treatment arm
Outcome measures
| Measure |
Group 6: Vaccine
n=12 Participants
400mcg CH505TF(m0), 400mcg CH505TF + CH505W53(m2), 400mcg CH505TF + CH505w53 + CH505w78(m4), 400mcg CH505w53 + CH505w78(m8)
|
Group 7: Vaccine
n=12 Participants
400mcg CH505 M5(m0,2,4,8)
|
Group 8: Placebo
n=6 Participants
Placebo(m0,2,4,8)
|
Group 9: Vaccine
n=12 Participants
400mcg CH505TF(m0), 400mcg CH505w53(m2), 400mcg CH505w78(m4)
|
|---|---|---|---|---|
|
Part A: Number of Participants With Early Study Termination Associated With an Adverse Event (AE) or Reactogenicity During the Vaccine Regime
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through the Month 12 boostFrom the study product discontinuation form, study product administration reasons are tabulated by treatment arm
Outcome measures
| Measure |
Group 6: Vaccine
n=12 Participants
400mcg CH505TF(m0), 400mcg CH505TF + CH505W53(m2), 400mcg CH505TF + CH505w53 + CH505w78(m4), 400mcg CH505w53 + CH505w78(m8)
|
Group 7: Vaccine
n=12 Participants
400mcg CH505 M5(m0,2,4,8)
|
Group 8: Placebo
n=6 Participants
Placebo(m0,2,4,8)
|
Group 9: Vaccine
n=12 Participants
400mcg CH505TF(m0), 400mcg CH505w53(m2), 400mcg CH505w78(m4)
|
|---|---|---|---|---|
|
Part A: Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
Clinical Event
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part A: Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
Reactogenicity
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
Other reason
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Part A: Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
No discontinuation
|
9 Participants
|
11 Participants
|
4 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: Measured during screening, and 2 weeks after each vaccination at Month 0, 2, 4, 8, 12, and at Month 15Population: The "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, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit.
Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown.
Outcome measures
| Measure |
Group 6: Vaccine
n=12 Participants
400mcg CH505TF(m0), 400mcg CH505TF + CH505W53(m2), 400mcg CH505TF + CH505w53 + CH505w78(m4), 400mcg CH505w53 + CH505w78(m8)
|
Group 7: Vaccine
n=12 Participants
400mcg CH505 M5(m0,2,4,8)
|
Group 8: Placebo
n=6 Participants
Placebo(m0,2,4,8)
|
Group 9: Vaccine
n=12 Participants
400mcg CH505TF(m0), 400mcg CH505w53(m2), 400mcg CH505w78(m4)
|
|---|---|---|---|---|
|
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) in U/L
Alkaline Phosphatase (U/L)- Screening
|
62.5 U/L
Interval 55.5 to 81.0
|
63 U/L
Interval 51.0 to 67.0
|
66.5 U/L
Interval 55.0 to 81.0
|
64.5 U/L
Interval 52.0 to 71.5
|
|
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) in U/L
Alkaline Phosphatase (U/L)- Day 14
|
58.5 U/L
Interval 55.5 to 79.0
|
68.5 U/L
Interval 52.0 to 75.0
|
58 U/L
Interval 55.0 to 66.0
|
61.5 U/L
Interval 51.5 to 68.0
|
|
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) in U/L
ALT (SGPT) (U/L)- Screening
|
20.5 U/L
Interval 18.0 to 24.5
|
22 U/L
Interval 17.0 to 27.5
|
19 U/L
Interval 15.0 to 21.0
|
18.5 U/L
Interval 13.0 to 24.5
|
|
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) in U/L
ALT (SGPT) (U/L)- Day 14
|
18 U/L
Interval 12.5 to 23.5
|
19.5 U/L
Interval 17.0 to 21.5
|
15 U/L
Interval 14.0 to 24.0
|
19 U/L
Interval 13.0 to 25.5
|
|
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) in U/L
ALT (SGPT) (U/L)- Day 70
|
18 U/L
Interval 13.5 to 24.5
|
16.5 U/L
Interval 15.5 to 27.5
|
18 U/L
Interval 9.0 to 18.0
|
19 U/L
Interval 13.0 to 26.0
|
|
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) in U/L
ALT (SGPT) (U/L)- Day 126
|
16 U/L
Interval 11.0 to 25.0
|
18.5 U/L
Interval 14.5 to 23.0
|
15 U/L
Interval 14.0 to 24.0
|
18 U/L
Interval 15.0 to 23.0
|
|
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) in U/L
ALT (SGPT) (U/L)- Day 238
|
14 U/L
Interval 11.0 to 25.0
|
18 U/L
Interval 16.0 to 21.0
|
16.5 U/L
Interval 13.5 to 23.5
|
16 U/L
Interval 13.0 to 23.0
|
|
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) in U/L
AST (U/L)- Day 378
|
20 U/L
Interval 16.0 to 26.0
|
23 U/L
Interval 16.0 to 28.0
|
22 U/L
Interval 17.5 to 45.0
|
22 U/L
Interval 17.0 to 27.0
|
|
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) in U/L
AST (U/L)- Day 455
|
26 U/L
Interval 22.0 to 35.0
|
20 U/L
Interval 16.0 to 24.0
|
24 U/L
Interval 18.5 to 32.0
|
20 U/L
Interval 17.0 to 33.0
|
|
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) in U/L
Alkaline Phosphatase (U/L)- Day 238
|
61 U/L
Interval 55.0 to 77.0
|
67 U/L
Interval 57.0 to 78.0
|
57 U/L
Interval 47.5 to 68.0
|
66 U/L
Interval 50.0 to 79.0
|
|
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) in U/L
Alkaline Phosphatase (U/L)- Day 455
|
67 U/L
Interval 59.0 to 75.0
|
63 U/L
Interval 56.0 to 73.0
|
62 U/L
Interval 53.5 to 75.5
|
61.5 U/L
Interval 59.0 to 82.0
|
|
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) in U/L
Alkaline Phosphatase (U/L)- Day 70
|
61.5 U/L
Interval 52.0 to 79.0
|
64.5 U/L
Interval 56.0 to 73.5
|
67 U/L
Interval 54.0 to 112.0
|
60 U/L
Interval 48.0 to 70.0
|
|
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) in U/L
Alkaline Phosphatase (U/L)- Day 126
|
65 U/L
Interval 52.5 to 77.5
|
64.5 U/L
Interval 55.5 to 77.0
|
69 U/L
Interval 45.0 to 71.0
|
65 U/L
Interval 49.0 to 74.0
|
|
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) in U/L
ALT (SGPT) (U/L)- Day 378
|
15 U/L
Interval 13.0 to 30.0
|
18 U/L
Interval 16.0 to 41.0
|
21.5 U/L
Interval 16.0 to 43.0
|
16 U/L
Interval 15.0 to 19.0
|
|
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) in U/L
ALT (SGPT) (U/L)- Day 455
|
27 U/L
Interval 15.0 to 36.0
|
14 U/L
Interval 13.0 to 24.0
|
22.5 U/L
Interval 14.0 to 38.0
|
20.5 U/L
Interval 12.0 to 30.0
|
|
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) in U/L
AST (U/L)- Screening
|
22.5 U/L
Interval 19.0 to 27.5
|
22.5 U/L
Interval 18.5 to 27.5
|
20 U/L
Interval 16.0 to 27.0
|
24.5 U/L
Interval 18.5 to 35.5
|
|
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) in U/L
AST (U/L)- Day 14
|
22 U/L
Interval 18.5 to 24.5
|
22 U/L
Interval 19.0 to 23.5
|
22 U/L
Interval 14.0 to 24.0
|
23.5 U/L
Interval 19.0 to 27.0
|
|
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) in U/L
AST (U/L)- Day 70
|
21.5 U/L
Interval 18.0 to 24.0
|
20.5 U/L
Interval 18.5 to 25.0
|
17 U/L
Interval 15.0 to 27.0
|
22 U/L
Interval 19.0 to 27.0
|
|
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) in U/L
AST (U/L)- Day 126
|
20.5 U/L
Interval 15.5 to 24.0
|
19 U/L
Interval 15.0 to 23.5
|
23 U/L
Interval 15.0 to 30.0
|
20 U/L
Interval 19.0 to 25.0
|
|
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) in U/L
AST (U/L)- Day 238
|
20 U/L
Interval 16.0 to 26.0
|
20 U/L
Interval 19.0 to 24.0
|
21 U/L
Interval 18.5 to 27.0
|
22 U/L
Interval 19.0 to 25.0
|
|
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) in U/L
Alkaline Phosphatase (U/L)- Day 378
|
74 U/L
Interval 56.0 to 89.0
|
66 U/L
Interval 63.0 to 75.0
|
61.5 U/L
Interval 55.5 to 68.0
|
69 U/L
Interval 61.0 to 71.0
|
PRIMARY outcome
Timeframe: Measured during screening, and 2 weeks after each vaccination at Month 0, 2, 4, 8, 12, and at Month 15Population: The "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, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit.
Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown.
Outcome measures
| Measure |
Group 6: Vaccine
n=12 Participants
400mcg CH505TF(m0), 400mcg CH505TF + CH505W53(m2), 400mcg CH505TF + CH505w53 + CH505w78(m4), 400mcg CH505w53 + CH505w78(m8)
|
Group 7: Vaccine
n=12 Participants
400mcg CH505 M5(m0,2,4,8)
|
Group 8: Placebo
n=6 Participants
Placebo(m0,2,4,8)
|
Group 9: Vaccine
n=12 Participants
400mcg CH505TF(m0), 400mcg CH505w53(m2), 400mcg CH505w78(m4)
|
|---|---|---|---|---|
|
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Hemoglobin (g/dL)- Screening
|
14.5 g/dL
Interval 13.75 to 15.3
|
14.6 g/dL
Interval 13.3 to 15.8
|
13.75 g/dL
Interval 12.6 to 15.4
|
14 g/dL
Interval 13.55 to 14.9
|
|
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Hemoglobin (g/dL)- Day 14
|
13.6 g/dL
Interval 12.8 to 14.95
|
14.15 g/dL
Interval 13.0 to 15.4
|
12.3 g/dL
Interval 11.8 to 15.1
|
13.6 g/dL
Interval 13.0 to 14.7
|
|
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Hemoglobin (g/dL)- Day 70
|
14.35 g/dL
Interval 12.45 to 14.8
|
14.65 g/dL
Interval 12.95 to 15.7
|
12.7 g/dL
Interval 11.0 to 15.6
|
14 g/dL
Interval 13.4 to 15.3
|
|
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Hemoglobin (g/dL)- Day 126
|
14.25 g/dL
Interval 12.55 to 14.95
|
14.7 g/dL
Interval 12.5 to 15.25
|
12.7 g/dL
Interval 11.6 to 13.1
|
13.7 g/dL
Interval 13.4 to 15.4
|
|
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Hemoglobin (g/dL)- Day 238
|
14.2 g/dL
Interval 13.2 to 14.9
|
14.9 g/dL
Interval 14.2 to 15.3
|
11.75 g/dL
Interval 11.1 to 13.75
|
13.8 g/dL
Interval 13.3 to 14.6
|
|
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Hemoglobin (g/dL)- Day 378
|
14.3 g/dL
Interval 12.3 to 14.8
|
14.4 g/dL
Interval 13.9 to 15.6
|
12.2 g/dL
Interval 11.1 to 14.4
|
13.8 g/dL
Interval 13.7 to 15.0
|
|
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Hemoglobin (g/dL)- Day 455
|
13.8 g/dL
Interval 12.9 to 15.1
|
14.5 g/dL
Interval 13.4 to 15.4
|
12.45 g/dL
Interval 12.0 to 13.45
|
13.8 g/dL
Interval 13.6 to 15.0
|
|
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Creatinine (g/dL)- Screening
|
0.00094 g/dL
Interval 0.000725 to 0.001075
|
0.000905 g/dL
Interval 0.000785 to 0.000985
|
0.00082 g/dL
Interval 0.00069 to 0.0011
|
0.000885 g/dL
Interval 0.000775 to 0.00102
|
|
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Creatinine (g/dL)- Day 14
|
0.000935 g/dL
Interval 0.00078 to 0.001145
|
0.0009 g/dL
Interval 0.000845 to 0.00101
|
0.00072 g/dL
Interval 0.00066 to 0.00092
|
0.00081 g/dL
Interval 0.0008 to 0.001
|
|
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Creatinine (g/dL)- Day 70
|
0.00087 g/dL
Interval 0.0008 to 0.00111
|
0.000905 g/dL
Interval 0.0008 to 0.000965
|
0.00083 g/dL
Interval 0.00054 to 0.0011
|
0.0009 g/dL
Interval 0.00078 to 0.00097
|
|
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Creatinine (g/dL)- Day 126
|
0.00102 g/dL
Interval 0.0008 to 0.00109
|
0.0009 g/dL
Interval 0.00087 to 0.001
|
0.00081 g/dL
Interval 0.00061 to 0.00086
|
0.00088 g/dL
Interval 0.0008 to 0.00102
|
|
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Creatinine (g/dL)- Day 238
|
0.00089 g/dL
Interval 0.00076 to 0.00109
|
0.00084 g/dL
Interval 0.00082 to 0.0009
|
0.00072 g/dL
Interval 0.00067 to 0.00084
|
0.00084 g/dL
Interval 0.00072 to 0.00104
|
|
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Creatinine (g/dL)- Day 378
|
0.0009 g/dL
Interval 0.0008 to 0.00109
|
0.0009 g/dL
Interval 0.00077 to 0.001
|
0.000695 g/dL
Interval 0.000615 to 0.00086
|
0.00085 g/dL
Interval 0.0008 to 0.00094
|
|
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Creatinine (g/dL)- Day 455
|
0.00101 g/dL
Interval 0.00076 to 0.00105
|
0.0009 g/dL
Interval 0.0008 to 0.00098
|
0.000675 g/dL
Interval 0.00064 to 0.000795
|
0.0008 g/dL
Interval 0.00076 to 0.00094
|
PRIMARY outcome
Timeframe: Measured during screening, and 2 weeks after each vaccination at Month 0, 2, 4, 8, 12, and at Month 15Population: The "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, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit.
Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown.
Outcome measures
| Measure |
Group 6: Vaccine
n=12 Participants
400mcg CH505TF(m0), 400mcg CH505TF + CH505W53(m2), 400mcg CH505TF + CH505w53 + CH505w78(m4), 400mcg CH505w53 + CH505w78(m8)
|
Group 7: Vaccine
n=12 Participants
400mcg CH505 M5(m0,2,4,8)
|
Group 8: Placebo
n=6 Participants
Placebo(m0,2,4,8)
|
Group 9: Vaccine
n=12 Participants
400mcg CH505TF(m0), 400mcg CH505w53(m2), 400mcg CH505w78(m4)
|
|---|---|---|---|---|
|
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: White Blood Cell (WBC), Platelets, Lymphocytes, Neutrophils
Platelets (1000 cells per mm^3)- Day 14
|
232.85 1000 cells per mm^3
Interval 218.5 to 269.65
|
264.5 1000 cells per mm^3
Interval 245.5 to 302.9
|
289 1000 cells per mm^3
Interval 273.0 to 292.0
|
243 1000 cells per mm^3
Interval 192.0 to 265.75
|
|
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: White Blood Cell (WBC), Platelets, Lymphocytes, Neutrophils
Platelets (1000 cells per mm^3)- Screening
|
229.95 1000 cells per mm^3
Interval 206.7 to 258.0
|
249.35 1000 cells per mm^3
Interval 229.5 to 282.0
|
262.8 1000 cells per mm^3
Interval 230.5 to 300.0
|
226.5 1000 cells per mm^3
Interval 196.0 to 270.0
|
|
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: White Blood Cell (WBC), Platelets, Lymphocytes, Neutrophils
Platelets (1000 cells per mm^3)- Day 70
|
222 1000 cells per mm^3
Interval 210.5 to 251.0
|
265.5 1000 cells per mm^3
Interval 241.05 to 294.0
|
336 1000 cells per mm^3
Interval 235.6 to 351.0
|
231 1000 cells per mm^3
Interval 215.4 to 263.2
|
|
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: White Blood Cell (WBC), Platelets, Lymphocytes, Neutrophils
Platelets (1000 cells per mm^3)- Day 126
|
218 1000 cells per mm^3
Interval 208.95 to 276.0
|
252.5 1000 cells per mm^3
Interval 235.5 to 275.35
|
326.5 1000 cells per mm^3
Interval 296.0 to 357.0
|
251 1000 cells per mm^3
Interval 214.0 to 273.0
|
|
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: White Blood Cell (WBC), Platelets, Lymphocytes, Neutrophils
Platelets (1000 cells per mm^3)- Day 238
|
224.5 1000 cells per mm^3
Interval 217.0 to 287.0
|
252.5 1000 cells per mm^3
Interval 239.6 to 270.0
|
295.5 1000 cells per mm^3
Interval 223.5 to 329.5
|
250 1000 cells per mm^3
Interval 199.0 to 262.0
|
|
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: White Blood Cell (WBC), Platelets, Lymphocytes, Neutrophils
Platelets (1000 cells per mm^3)- Day 378
|
230 1000 cells per mm^3
Interval 203.0 to 273.0
|
247 1000 cells per mm^3
Interval 213.0 to 278.9
|
293.5 1000 cells per mm^3
Interval 224.5 to 314.5
|
252 1000 cells per mm^3
Interval 215.1 to 266.0
|
|
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: White Blood Cell (WBC), Platelets, Lymphocytes, Neutrophils
Platelets (1000 cells per mm^3)- Day 455
|
219 1000 cells per mm^3
Interval 204.0 to 247.0
|
245.4 1000 cells per mm^3
Interval 225.0 to 301.0
|
294 1000 cells per mm^3
Interval 231.0 to 327.0
|
236 1000 cells per mm^3
Interval 222.0 to 248.0
|
PRIMARY outcome
Timeframe: Measured at Month 4.5Population: "Overall Number of Participants Analyzed" includes the HIV uninfected participants with samples collected at the month 4.5 immunogenicity timepoint. "Number Analyzed" shows the number of participants with available data after filtering for assay-specific quality control criteria.
Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation.
Outcome measures
| Measure |
Group 6: Vaccine
n=12 Participants
400mcg CH505TF(m0), 400mcg CH505TF + CH505W53(m2), 400mcg CH505TF + CH505w53 + CH505w78(m4), 400mcg CH505w53 + CH505w78(m8)
|
Group 7: Vaccine
n=12 Participants
400mcg CH505 M5(m0,2,4,8)
|
Group 8: Placebo
n=6 Participants
Placebo(m0,2,4,8)
|
Group 9: Vaccine
n=12 Participants
400mcg CH505TF(m0), 400mcg CH505w53(m2), 400mcg CH505w78(m4)
|
|---|---|---|---|---|
|
Part A: Occurrence of HIV-specific Immunoglobulin G (IgG) Responses 2 Weeks After the Third Vaccination With CH505TF gp120
CH0505_CON D7gp120_avi/293F/Mon at Month 4.5
|
8 Participants
|
9 Participants
|
0 Participants
|
8 Participants
|
|
Part A: Occurrence of HIV-specific Immunoglobulin G (IgG) Responses 2 Weeks After the Third Vaccination With CH505TF gp120
CH505TF D7gp120d371_avi/293F/Mon at Month 4.5
|
8 Participants
|
9 Participants
|
0 Participants
|
8 Participants
|
|
Part A: Occurrence of HIV-specific Immunoglobulin G (IgG) Responses 2 Weeks After the Third Vaccination With CH505TF gp120
CH505TFD8N156KN160K_avi/293i Mon at Month 4.5
|
8 Participants
|
9 Participants
|
0 Participants
|
8 Participants
|
|
Part A: Occurrence of HIV-specific Immunoglobulin G (IgG) Responses 2 Weeks After the Third Vaccination With CH505TF gp120
Con 6 gp120/B at Month 4.5
|
8 Participants
|
9 Participants
|
0 Participants
|
8 Participants
|
|
Part A: Occurrence of HIV-specific Immunoglobulin G (IgG) Responses 2 Weeks After the Third Vaccination With CH505TF gp120
gp41 at Month 4.5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Occurrence of HIV-specific Immunoglobulin G (IgG) Responses 2 Weeks After the Third Vaccination With CH505TF gp120
1086C_D7gp120.avi/293F at Month 4.5
|
8 Participants
|
9 Participants
|
0 Participants
|
8 Participants
|
|
Part A: Occurrence of HIV-specific Immunoglobulin G (IgG) Responses 2 Weeks After the Third Vaccination With CH505TF gp120
CH0505_CON D7gp120_D368R_avi/293F/Mon at Month 4.5
|
8 Participants
|
9 Participants
|
0 Participants
|
8 Participants
|
|
Part A: Occurrence of HIV-specific Immunoglobulin G (IgG) Responses 2 Weeks After the Third Vaccination With CH505TF gp120
Con S gp140 CFI at Month 4.5
|
8 Participants
|
8 Participants
|
0 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: Measured at Month 4.5Population: "Overall Number of Participants Analyzed" includes the HIV uninfected participants with samples collected at the month 4.5 immunogenicity timepoint. "Number Analyzed" shows the number of participants with available data after filtering for assay-specific quality control criteria.
Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation.
Outcome measures
| Measure |
Group 6: Vaccine
n=12 Participants
400mcg CH505TF(m0), 400mcg CH505TF + CH505W53(m2), 400mcg CH505TF + CH505w53 + CH505w78(m4), 400mcg CH505w53 + CH505w78(m8)
|
Group 7: Vaccine
n=12 Participants
400mcg CH505 M5(m0,2,4,8)
|
Group 8: Placebo
n=6 Participants
Placebo(m0,2,4,8)
|
Group 9: Vaccine
n=12 Participants
400mcg CH505TF(m0), 400mcg CH505w53(m2), 400mcg CH505w78(m4)
|
|---|---|---|---|---|
|
Part A: Level of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120
1086C_D7gp120.avi/293F at Month 4.5
|
27854.25 relative fluorescence units
Interval 22628.0 to 28870.5
|
28419.25 relative fluorescence units
Interval 28098.25 to 29462.25
|
1 relative fluorescence units
Interval 1.0 to 4.25
|
27266.375 relative fluorescence units
Interval 24133.25 to 29136.875
|
|
Part A: Level of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120
Con S gp140 CFI at Month 4.5
|
12523.25 relative fluorescence units
Interval 400.5 to 19679.75
|
15397 relative fluorescence units
Interval 6772.25 to 24537.25
|
1 relative fluorescence units
Interval 1.0 to 1.0
|
5229.75 relative fluorescence units
Interval 1455.375 to 26839.375
|
|
Part A: Level of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120
gp41 at Month 4.5
|
1 relative fluorescence units
Interval 1.0 to 20.25
|
72.5 relative fluorescence units
Interval 1.0 to 208.0
|
92.5 relative fluorescence units
Interval 1.0 to 2345.75
|
1 relative fluorescence units
Interval 1.0 to 2.375
|
|
Part A: Level of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120
CH0505_CON D7gp120_D368R_avi/293F/Mon at Month 4.5
|
26439.75 relative fluorescence units
Interval 7317.75 to 27026.25
|
26973 relative fluorescence units
Interval 25791.25 to 27904.5
|
1 relative fluorescence units
Interval 1.0 to 23.25
|
24789.25 relative fluorescence units
Interval 18116.75 to 27759.25
|
|
Part A: Level of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120
CH0505_CON D7gp120_avi/293F/Mon at Month 4.5
|
17409.5 relative fluorescence units
Interval 1869.5 to 22388.75
|
22807.5 relative fluorescence units
Interval 17251.0 to 24569.5
|
1 relative fluorescence units
Interval 1.0 to 15.0
|
15775.25 relative fluorescence units
Interval 6227.25 to 26555.0
|
|
Part A: Level of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120
CH505TF D7gp120d371_avi/293F/Mon at Month 4.5
|
7335.75 relative fluorescence units
Interval 336.25 to 8839.0
|
10491.75 relative fluorescence units
Interval 6053.5 to 18757.25
|
1 relative fluorescence units
Interval 1.0 to 19.0
|
10859.875 relative fluorescence units
Interval 1526.375 to 24698.625
|
|
Part A: Level of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120
CH505TFD8N156KN160K_avi/293i Mon at Month 4.5
|
24931 relative fluorescence units
Interval 4200.75 to 26381.75
|
25146 relative fluorescence units
Interval 24498.0 to 27011.0
|
1 relative fluorescence units
Interval 1.0 to 11.5
|
21460.5 relative fluorescence units
Interval 13024.375 to 27776.375
|
|
Part A: Level of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120
Con 6 gp120/B at Month 4.5
|
3169.25 relative fluorescence units
Interval 297.0 to 15782.0
|
14748.5 relative fluorescence units
Interval 4326.0 to 21312.25
|
1 relative fluorescence units
Interval 1.0 to 1.0
|
11897.375 relative fluorescence units
Interval 782.875 to 25171.625
|
PRIMARY outcome
Timeframe: Measured at Month 4.5Population: "Overall Number of Participants Analyzed" includes the HIV uninfected participants with samples collected at the month 4.5 immunogenicity timepoint. "Number Analyzed" shows the number of participants with available data after filtering for assay-specific quality control criteria.
Serum HIV-1-specific IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation.
Outcome measures
| Measure |
Group 6: Vaccine
n=12 Participants
400mcg CH505TF(m0), 400mcg CH505TF + CH505W53(m2), 400mcg CH505TF + CH505w53 + CH505w78(m4), 400mcg CH505w53 + CH505w78(m8)
|
Group 7: Vaccine
n=12 Participants
400mcg CH505 M5(m0,2,4,8)
|
Group 8: Placebo
n=6 Participants
Placebo(m0,2,4,8)
|
Group 9: Vaccine
n=12 Participants
400mcg CH505TF(m0), 400mcg CH505w53(m2), 400mcg CH505w78(m4)
|
|---|---|---|---|---|
|
Part A: Occurrence of HIV-specific Immunoglobulin A (IgA) Responses 2 Weeks After the Third Vaccination With CH505TF gp120
1086C_D7gp120.avi/293F at Month 4.5
|
6 Participants
|
11 Participants
|
0 Participants
|
8 Participants
|
|
Part A: Occurrence of HIV-specific Immunoglobulin A (IgA) Responses 2 Weeks After the Third Vaccination With CH505TF gp120
CH505TFD8N156KN160K_avi/293i Mon at Month 4.5
|
6 Participants
|
9 Participants
|
0 Participants
|
8 Participants
|
|
Part A: Occurrence of HIV-specific Immunoglobulin A (IgA) Responses 2 Weeks After the Third Vaccination With CH505TF gp120
Con 6 gp120/B at Month 4.5
|
2 Participants
|
4 Participants
|
0 Participants
|
3 Participants
|
|
Part A: Occurrence of HIV-specific Immunoglobulin A (IgA) Responses 2 Weeks After the Third Vaccination With CH505TF gp120
CH0505_CON D7gp120_D368R_avi/293F/Mon at Month 4.5
|
6 Participants
|
9 Participants
|
0 Participants
|
8 Participants
|
|
Part A: Occurrence of HIV-specific Immunoglobulin A (IgA) Responses 2 Weeks After the Third Vaccination With CH505TF gp120
CH0505_CON D7gp120_avi/293F/Mon at Month 4.5
|
4 Participants
|
8 Participants
|
0 Participants
|
8 Participants
|
|
Part A: Occurrence of HIV-specific Immunoglobulin A (IgA) Responses 2 Weeks After the Third Vaccination With CH505TF gp120
CH505TF D7gp120d371_avi/293F/Mon at Month 4.5
|
3 Participants
|
5 Participants
|
0 Participants
|
5 Participants
|
|
Part A: Occurrence of HIV-specific Immunoglobulin A (IgA) Responses 2 Weeks After the Third Vaccination With CH505TF gp120
Con S gp140 CFI at Month 4.5
|
3 Participants
|
4 Participants
|
0 Participants
|
4 Participants
|
|
Part A: Occurrence of HIV-specific Immunoglobulin A (IgA) Responses 2 Weeks After the Third Vaccination With CH505TF gp120
gp41 at Month 4.5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured at Month 4.5Population: "Overall Number of Participants Analyzed" includes the HIV uninfected participants with samples collected at the month 4.5 immunogenicity timepoint. "Number Analyzed" shows the number of participants with available data after filtering for assay-specific quality control criteria.
Serum HIV-1-specific IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation.
Outcome measures
| Measure |
Group 6: Vaccine
n=12 Participants
400mcg CH505TF(m0), 400mcg CH505TF + CH505W53(m2), 400mcg CH505TF + CH505w53 + CH505w78(m4), 400mcg CH505w53 + CH505w78(m8)
|
Group 7: Vaccine
n=12 Participants
400mcg CH505 M5(m0,2,4,8)
|
Group 8: Placebo
n=6 Participants
Placebo(m0,2,4,8)
|
Group 9: Vaccine
n=12 Participants
400mcg CH505TF(m0), 400mcg CH505w53(m2), 400mcg CH505w78(m4)
|
|---|---|---|---|---|
|
Part A: Level of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120
Con S gp140 CFI at Month 4.5
|
28.875 relative fluorescence units
Interval 1.0 to 1597.875
|
3 relative fluorescence units
Interval 1.0 to 347.75
|
1 relative fluorescence units
Interval 1.0 to 1.0
|
14.25 relative fluorescence units
Interval 1.0 to 347.75
|
|
Part A: Level of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120
gp41 at Month 4.5
|
1 relative fluorescence units
Interval 1.0 to 26.375
|
1 relative fluorescence units
Interval 1.0 to 21.25
|
1 relative fluorescence units
Interval 1.0 to 264.75
|
1 relative fluorescence units
Interval 1.0 to 8.75
|
|
Part A: Level of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120
1086C_D7gp120.avi/293F at Month 4.5
|
3116.125 relative fluorescence units
Interval 528.75 to 8968.125
|
3498 relative fluorescence units
Interval 2746.25 to 4777.0
|
1 relative fluorescence units
Interval 1.0 to 1.0
|
1379.5 relative fluorescence units
Interval 114.25 to 7947.5
|
|
Part A: Level of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120
CH0505_CON D7gp120_D368R_avi/293F/Mon at Month 4.5
|
1718.5 relative fluorescence units
Interval 135.875 to 3705.375
|
2684.5 relative fluorescence units
Interval 1163.75 to 5112.25
|
1 relative fluorescence units
Interval 1.0 to 100.5
|
1812 relative fluorescence units
Interval 315.0 to 4170.25
|
|
Part A: Level of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120
CH0505_CON D7gp120_avi/293F/Mon at Month 4.5
|
658.625 relative fluorescence units
Interval 47.0 to 1495.5
|
985 relative fluorescence units
Interval 384.5 to 1225.75
|
1 relative fluorescence units
Interval 1.0 to 196.5
|
684.375 relative fluorescence units
Interval 162.25 to 1813.0
|
|
Part A: Level of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120
CH505TF D7gp120d371_avi/293F/Mon at Month 4.5
|
89.125 relative fluorescence units
Interval 10.875 to 858.0
|
109.25 relative fluorescence units
Interval 1.0 to 503.5
|
1 relative fluorescence units
Interval 1.0 to 261.75
|
174.625 relative fluorescence units
Interval 1.0 to 490.25
|
|
Part A: Level of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120
CH505TFD8N156KN160K_avi/293i Mon at Month 4.5
|
1065.875 relative fluorescence units
Interval 78.375 to 2239.25
|
1594 relative fluorescence units
Interval 689.75 to 1869.25
|
1 relative fluorescence units
Interval 1.0 to 182.0
|
1142.5 relative fluorescence units
Interval 256.25 to 2757.0
|
|
Part A: Level of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120
Con 6 gp120/B at Month 4.5
|
26.25 relative fluorescence units
Interval 1.0 to 196.125
|
75.25 relative fluorescence units
Interval 1.0 to 621.75
|
1 relative fluorescence units
Interval 1.0 to 16.75
|
18.25 relative fluorescence units
Interval 1.0 to 164.75
|
PRIMARY outcome
Timeframe: Measured through Month Measured through Month Measured through 7 days after the vaccination at Month 0, 2, 4, 8Graded 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 6: Vaccine
n=20 Participants
400mcg CH505TF(m0), 400mcg CH505TF + CH505W53(m2), 400mcg CH505TF + CH505w53 + CH505w78(m4), 400mcg CH505w53 + CH505w78(m8)
|
Group 7: Vaccine
n=20 Participants
400mcg CH505 M5(m0,2,4,8)
|
Group 8: Placebo
n=5 Participants
Placebo(m0,2,4,8)
|
Group 9: Vaccine
n=20 Participants
400mcg CH505TF(m0), 400mcg CH505w53(m2), 400mcg CH505w78(m4)
|
|---|---|---|---|---|
|
Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms
Pain · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms
Tenderness · None
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms
Tenderness · Mild
|
17 Participants
|
14 Participants
|
2 Participants
|
11 Participants
|
|
Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms
Tenderness · Moderate
|
2 Participants
|
5 Participants
|
0 Participants
|
6 Participants
|
|
Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms
Tenderness · Severe
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms
Tenderness · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms
Pain and/or Tenderness · None
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms
Pain and/or Tenderness · Mild
|
13 Participants
|
13 Participants
|
2 Participants
|
10 Participants
|
|
Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms
Pain and/or Tenderness · Moderate
|
6 Participants
|
5 Participants
|
0 Participants
|
6 Participants
|
|
Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms
Pain and/or Tenderness · Severe
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms
Induration/Swelling · Moderate
|
2 Participants
|
3 Participants
|
0 Participants
|
4 Participants
|
|
Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms
Induration/Swelling · Severe
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms
Pain and/or Tenderness · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema/Redness · None
|
16 Participants
|
13 Participants
|
5 Participants
|
15 Participants
|
|
Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema/Redness · Mild
|
3 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema/Redness · Moderate
|
1 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
|
Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema/Redness · Severe
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema/Redness · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms
Induration/Swelling · None
|
15 Participants
|
14 Participants
|
5 Participants
|
14 Participants
|
|
Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms
Induration/Swelling · Mild
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema and/or Induration · Moderate
|
2 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms
Induration/Swelling · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema and/or Induration · Severe
|
1 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
|
Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema and/or Induration · None
|
15 Participants
|
12 Participants
|
5 Participants
|
14 Participants
|
|
Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema and/or Induration · Mild
|
2 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema and/or Induration · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms
Pain · Severe
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms
Pain · None
|
3 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
|
Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms
Pain · Mild
|
12 Participants
|
14 Participants
|
1 Participants
|
9 Participants
|
|
Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms
Pain · Moderate
|
5 Participants
|
4 Participants
|
0 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Measured through Month Measured through Month Measured through 7 days after the vaccination at Month 0, 2, 4, 8Graded 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 6: Vaccine
n=20 Participants
400mcg CH505TF(m0), 400mcg CH505TF + CH505W53(m2), 400mcg CH505TF + CH505w53 + CH505w78(m4), 400mcg CH505w53 + CH505w78(m8)
|
Group 7: Vaccine
n=20 Participants
400mcg CH505 M5(m0,2,4,8)
|
Group 8: Placebo
n=5 Participants
Placebo(m0,2,4,8)
|
Group 9: Vaccine
n=20 Participants
400mcg CH505TF(m0), 400mcg CH505w53(m2), 400mcg CH505w78(m4)
|
|---|---|---|---|---|
|
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · None
|
5 Participants
|
3 Participants
|
3 Participants
|
7 Participants
|
|
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Mild
|
9 Participants
|
12 Participants
|
2 Participants
|
4 Participants
|
|
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Moderate
|
5 Participants
|
4 Participants
|
0 Participants
|
6 Participants
|
|
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Severe
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Vomiting · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Vomiting · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · None
|
14 Participants
|
12 Participants
|
5 Participants
|
12 Participants
|
|
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Mild
|
6 Participants
|
6 Participants
|
0 Participants
|
5 Participants
|
|
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Moderate
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · None
|
17 Participants
|
15 Participants
|
5 Participants
|
12 Participants
|
|
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Mild
|
3 Participants
|
4 Participants
|
0 Participants
|
5 Participants
|
|
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · None
|
8 Participants
|
6 Participants
|
4 Participants
|
11 Participants
|
|
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Mild
|
8 Participants
|
9 Participants
|
0 Participants
|
1 Participants
|
|
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Moderate
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Vomiting · None
|
20 Participants
|
20 Participants
|
5 Participants
|
19 Participants
|
|
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Vomiting · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Vomiting · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · None
|
1 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
|
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Mild
|
11 Participants
|
11 Participants
|
3 Participants
|
4 Participants
|
|
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · None
|
9 Participants
|
6 Participants
|
2 Participants
|
8 Participants
|
|
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Mild
|
9 Participants
|
8 Participants
|
3 Participants
|
8 Participants
|
|
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Moderate
|
2 Participants
|
6 Participants
|
0 Participants
|
3 Participants
|
|
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · None
|
19 Participants
|
18 Participants
|
5 Participants
|
17 Participants
|
|
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Mild
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Moderate
|
4 Participants
|
5 Participants
|
1 Participants
|
7 Participants
|
|
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Mild
|
4 Participants
|
5 Participants
|
1 Participants
|
7 Participants
|
|
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · None
|
15 Participants
|
14 Participants
|
4 Participants
|
12 Participants
|
|
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Moderate
|
7 Participants
|
7 Participants
|
1 Participants
|
8 Participants
|
|
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Severe
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Measured through Month 20From the study termination form, early termination reasons associated with an AE or reactogenicity are tabulated by treatment arm
Outcome measures
| Measure |
Group 6: Vaccine
n=20 Participants
400mcg CH505TF(m0), 400mcg CH505TF + CH505W53(m2), 400mcg CH505TF + CH505w53 + CH505w78(m4), 400mcg CH505w53 + CH505w78(m8)
|
Group 7: Vaccine
n=20 Participants
400mcg CH505 M5(m0,2,4,8)
|
Group 8: Placebo
n=5 Participants
Placebo(m0,2,4,8)
|
Group 9: Vaccine
n=20 Participants
400mcg CH505TF(m0), 400mcg CH505w53(m2), 400mcg CH505w78(m4)
|
|---|---|---|---|---|
|
Part B: Number of Participants With Early Study Termination Associated With an AE or Reactogenicity During the Vaccine Regime
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through the Month 8 boostPopulation: Safety population
From the study product discontinuation form, study product administration reasons are tabulated by treatment arm
Outcome measures
| Measure |
Group 6: Vaccine
n=20 Participants
400mcg CH505TF(m0), 400mcg CH505TF + CH505W53(m2), 400mcg CH505TF + CH505w53 + CH505w78(m4), 400mcg CH505w53 + CH505w78(m8)
|
Group 7: Vaccine
n=20 Participants
400mcg CH505 M5(m0,2,4,8)
|
Group 8: Placebo
n=5 Participants
Placebo(m0,2,4,8)
|
Group 9: Vaccine
n=20 Participants
400mcg CH505TF(m0), 400mcg CH505w53(m2), 400mcg CH505w78(m4)
|
|---|---|---|---|---|
|
Number of Part B Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
Did not discontinue SPA
|
20 Participants
|
20 Participants
|
4 Participants
|
17 Participants
|
|
Number of Part B Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
Reactogenicity symptoms
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Part B Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
Withdrawal by Subject
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Part B Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
Investigator reason
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Part B Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
Lost to Follow-Up
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Measured during screening, and 2 weeks after each vaccination at Month 0, 2, 4, 8, and at Month 11Population: T5-T8 All enrolled
Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown.
Outcome measures
| Measure |
Group 6: Vaccine
n=20 Participants
400mcg CH505TF(m0), 400mcg CH505TF + CH505W53(m2), 400mcg CH505TF + CH505w53 + CH505w78(m4), 400mcg CH505w53 + CH505w78(m8)
|
Group 7: Vaccine
n=20 Participants
400mcg CH505 M5(m0,2,4,8)
|
Group 8: Placebo
n=5 Participants
Placebo(m0,2,4,8)
|
Group 9: Vaccine
n=20 Participants
400mcg CH505TF(m0), 400mcg CH505w53(m2), 400mcg CH505w78(m4)
|
|---|---|---|---|---|
|
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
ALT (SGPT) (U/L)- Day 70
|
18 U/L
Interval 11.0 to 24.0
|
15 U/L
Interval 12.0 to 23.0
|
18.5 U/L
Interval 10.5 to 28.0
|
13 U/L
Interval 12.0 to 22.0
|
|
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
ALT (SGPT) (U/L)- Day 126
|
18.5 U/L
Interval 13.5 to 28.5
|
17 U/L
Interval 13.0 to 24.0
|
22 U/L
Interval 12.0 to 30.5
|
14 U/L
Interval 13.0 to 17.0
|
|
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
ALT (SGPT) (U/L)- Day 238
|
18.5 U/L
Interval 10.0 to 28.0
|
14.5 U/L
Interval 12.0 to 30.0
|
15 U/L
Interval 11.0 to 34.0
|
16 U/L
Interval 12.0 to 22.0
|
|
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
ALT (SGPT) (U/L)- Day 308
|
20 U/L
Interval 13.5 to 26.0
|
19 U/L
Interval 15.0 to 30.0
|
14.5 U/L
Interval 11.0 to 31.5
|
14.5 U/L
Interval 12.0 to 18.0
|
|
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
AST (U/L)- Screening
|
22 U/L
Interval 20.0 to 23.5
|
18 U/L
Interval 16.5 to 29.0
|
20 U/L
Interval 17.0 to 23.0
|
19 U/L
Interval 17.5 to 23.0
|
|
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
ALT (SGPT) (U/L)- Screening
|
18.5 U/L
Interval 13.5 to 28.0
|
16.5 U/L
Interval 12.0 to 28.0
|
16 U/L
Interval 14.0 to 23.0
|
16 U/L
Interval 12.5 to 19.5
|
|
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
ALT (SGPT) (U/L)- Day 14
|
18 U/L
Interval 13.0 to 21.5
|
17 U/L
Interval 12.0 to 31.0
|
15 U/L
Interval 15.0 to 17.0
|
14.5 U/L
Interval 12.0 to 19.0
|
|
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
AST (U/L)- Day 70
|
19 U/L
Interval 17.0 to 24.0
|
18 U/L
Interval 16.0 to 22.0
|
19 U/L
Interval 14.5 to 20.0
|
20 U/L
Interval 16.0 to 22.0
|
|
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
AST (U/L)- Day 126
|
20.5 U/L
Interval 18.5 to 27.0
|
19 U/L
Interval 16.0 to 24.0
|
18.5 U/L
Interval 14.0 to 23.5
|
18 U/L
Interval 16.0 to 23.0
|
|
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
AST (U/L)- Day 238
|
23.5 U/L
Interval 18.0 to 34.0
|
18 U/L
Interval 15.0 to 24.0
|
16.5 U/L
Interval 13.5 to 27.5
|
18 U/L
Interval 15.0 to 30.0
|
|
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
AST (U/L)- Day 308
|
21 U/L
Interval 18.0 to 27.0
|
18 U/L
Interval 18.0 to 26.0
|
18 U/L
Interval 14.5 to 21.0
|
17 U/L
Interval 16.0 to 19.0
|
|
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
Alkaline Phosphatase (U/L)- Screening
|
61 U/L
Interval 53.0 to 74.0
|
64 U/L
Interval 54.5 to 76.0
|
79 U/L
Interval 64.0 to 81.0
|
57.5 U/L
Interval 48.5 to 89.5
|
|
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
Alkaline Phosphatase (U/L)- Day 14
|
60 U/L
Interval 53.0 to 69.5
|
62 U/L
Interval 51.0 to 79.0
|
76 U/L
Interval 59.0 to 77.0
|
53.5 U/L
Interval 44.0 to 83.5
|
|
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
Alkaline Phosphatase (U/L)- Day 70
|
62 U/L
Interval 49.0 to 70.0
|
63 U/L
Interval 52.0 to 77.0
|
60.5 U/L
Interval 44.0 to 74.5
|
63 U/L
Interval 42.0 to 82.0
|
|
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
Alkaline Phosphatase (U/L)- Day 126
|
60.5 U/L
Interval 52.0 to 77.0
|
64 U/L
Interval 53.0 to 79.0
|
64 U/L
Interval 50.0 to 73.0
|
59 U/L
Interval 46.0 to 85.0
|
|
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
Alkaline Phosphatase (U/L)- Day 238
|
58 U/L
Interval 52.0 to 66.0
|
67.5 U/L
Interval 46.0 to 76.0
|
59 U/L
Interval 48.5 to 80.0
|
65 U/L
Interval 44.0 to 78.0
|
|
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
Alkaline Phosphatase (U/L)- Day 308
|
59 U/L
Interval 51.5 to 70.0
|
60 U/L
Interval 52.0 to 77.0
|
66.5 U/L
Interval 51.0 to 87.0
|
60 U/L
Interval 40.0 to 77.0
|
|
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
AST (U/L)- Day 14
|
21 U/L
Interval 17.5 to 23.0
|
18 U/L
Interval 15.0 to 25.0
|
18 U/L
Interval 17.0 to 21.0
|
18 U/L
Interval 15.5 to 24.5
|
PRIMARY outcome
Timeframe: Measured during screening, and 2 weeks after each vaccination at Month 0, 2, 4, 8, and at Month 11Population: T5-T8 All enrolled
Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown.
Outcome measures
| Measure |
Group 6: Vaccine
n=20 Participants
400mcg CH505TF(m0), 400mcg CH505TF + CH505W53(m2), 400mcg CH505TF + CH505w53 + CH505w78(m4), 400mcg CH505w53 + CH505w78(m8)
|
Group 7: Vaccine
n=20 Participants
400mcg CH505 M5(m0,2,4,8)
|
Group 8: Placebo
n=5 Participants
Placebo(m0,2,4,8)
|
Group 9: Vaccine
n=20 Participants
400mcg CH505TF(m0), 400mcg CH505w53(m2), 400mcg CH505w78(m4)
|
|---|---|---|---|---|
|
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Hemoglobin (g/dL)- Day 238
|
14.1 g/dL
Interval 12.1 to 14.9
|
13.8 g/dL
Interval 12.4 to 14.5
|
13.8 g/dL
Interval 12.1 to 15.05
|
13.55 g/dL
Interval 12.8 to 13.9
|
|
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Hemoglobin (g/dL)- Day 308
|
14.55 g/dL
Interval 13.1 to 15.3
|
14.1 g/dL
Interval 12.7 to 14.6
|
14.1 g/dL
Interval 12.8 to 15.05
|
13.45 g/dL
Interval 12.6 to 14.6
|
|
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Creatinine (g/dL)- Screening
|
0.00088 g/dL
Interval 0.00079 to 0.00094
|
0.00087 g/dL
Interval 0.000775 to 0.000985
|
0.00081 g/dL
Interval 0.0007 to 0.00084
|
0.00086 g/dL
Interval 0.00075 to 0.00093
|
|
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Creatinine (g/dL)- Day 126
|
0.000895 g/dL
Interval 0.00079 to 0.001005
|
0.00093 g/dL
Interval 0.00081 to 0.00098
|
0.000765 g/dL
Interval 0.00064 to 0.000995
|
0.0009 g/dL
Interval 0.00072 to 0.001
|
|
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Creatinine (g/dL)- Day 238
|
0.000885 g/dL
Interval 0.00076 to 0.00098
|
0.00087 g/dL
Interval 0.0008 to 0.00097
|
0.00082 g/dL
Interval 0.0007 to 0.000955
|
0.0009 g/dL
Interval 0.00076 to 0.00101
|
|
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Hemoglobin (g/dL)- Screening
|
14.65 g/dL
Interval 13.7 to 15.25
|
14.35 g/dL
Interval 13.05 to 15.05
|
14.2 g/dL
Interval 13.3 to 15.3
|
13.7 g/dL
Interval 13.25 to 15.05
|
|
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Hemoglobin (g/dL)- Day 126
|
14.45 g/dL
Interval 13.0 to 15.5
|
13.9 g/dL
Interval 13.2 to 14.5
|
13.75 g/dL
Interval 12.55 to 14.95
|
14 g/dL
Interval 13.4 to 15.0
|
|
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Creatinine (g/dL)- Day 14
|
0.000875 g/dL
Interval 0.00077 to 0.000945
|
0.00085 g/dL
Interval 0.0008 to 0.00101
|
0.00095 g/dL
Interval 0.00073 to 0.00098
|
0.00093 g/dL
Interval 0.00077 to 0.00101
|
|
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Creatinine (g/dL)- Day 70
|
0.0009 g/dL
Interval 0.00074 to 0.00095
|
0.0009 g/dL
Interval 0.00082 to 0.00102
|
0.000765 g/dL
Interval 0.00068 to 0.0009
|
0.00089 g/dL
Interval 0.00082 to 0.00103
|
|
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Creatinine (g/dL)- Day 308
|
0.00082 g/dL
Interval 0.00079 to 0.001015
|
0.0009 g/dL
Interval 0.0008 to 0.00096
|
0.00087 g/dL
Interval 0.00073 to 0.000995
|
0.0009 g/dL
Interval 0.00073 to 0.00101
|
|
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Hemoglobin (g/dL)- Day 70
|
13.9 g/dL
Interval 12.5 to 15.2
|
14 g/dL
Interval 12.1 to 15.0
|
13.65 g/dL
Interval 11.55 to 14.7
|
13.9 g/dL
Interval 13.2 to 14.8
|
|
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Hemoglobin (g/dL)- Day 14
|
14.05 g/dL
Interval 13.1 to 14.95
|
13.4 g/dL
Interval 12.1 to 14.5
|
13.8 g/dL
Interval 13.6 to 14.6
|
13.7 g/dL
Interval 12.9 to 14.5
|
PRIMARY outcome
Timeframe: Measured during screening, and 2 weeks after each vaccination at Month 0, 2, 4, 8, and at Month 11Population: T5-T8 All enrolled
Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown.
Outcome measures
| Measure |
Group 6: Vaccine
n=20 Participants
400mcg CH505TF(m0), 400mcg CH505TF + CH505W53(m2), 400mcg CH505TF + CH505w53 + CH505w78(m4), 400mcg CH505w53 + CH505w78(m8)
|
Group 7: Vaccine
n=20 Participants
400mcg CH505 M5(m0,2,4,8)
|
Group 8: Placebo
n=5 Participants
Placebo(m0,2,4,8)
|
Group 9: Vaccine
n=20 Participants
400mcg CH505TF(m0), 400mcg CH505w53(m2), 400mcg CH505w78(m4)
|
|---|---|---|---|---|
|
Part B Chemistry and Hematology Laboratory Measures
WBC (1000 cells per mm^3)- Screening
|
6.15 1000 cells per mm^3
Interval 5.15 to 7.1
|
6.12 1000 cells per mm^3
Interval 5.1 to 7.55
|
6.9 1000 cells per mm^3
Interval 6.17 to 8.0
|
5.63 1000 cells per mm^3
Interval 4.66 to 7.05
|
|
Part B Chemistry and Hematology Laboratory Measures
WBC (1000 cells per mm^3)- Day 14
|
5.95 1000 cells per mm^3
Interval 4.75 to 6.75
|
6.1 1000 cells per mm^3
Interval 4.9 to 7.17
|
5.27 1000 cells per mm^3
Interval 5.04 to 5.8
|
5.695 1000 cells per mm^3
Interval 4.825 to 7.49
|
|
Part B Chemistry and Hematology Laboratory Measures
WBC (1000 cells per mm^3)- Day 238
|
5.75 1000 cells per mm^3
Interval 4.69 to 6.5
|
5.98 1000 cells per mm^3
Interval 5.3 to 6.5
|
5.615 1000 cells per mm^3
Interval 5.1 to 6.715
|
5.935 1000 cells per mm^3
Interval 4.8 to 7.38
|
|
Part B Chemistry and Hematology Laboratory Measures
WBC (1000 cells per mm^3)- Day 308
|
5.95 1000 cells per mm^3
Interval 5.11 to 6.845
|
5.6 1000 cells per mm^3
Interval 5.12 to 7.19
|
7.33 1000 cells per mm^3
Interval 5.8 to 8.68
|
5.39 1000 cells per mm^3
Interval 4.7 to 7.06
|
|
Part B Chemistry and Hematology Laboratory Measures
Neutrophils (1000 cells per mm^3)- Screening
|
3.718 1000 cells per mm^3
Interval 2.676 to 4.5425
|
3.805 1000 cells per mm^3
Interval 2.946 to 4.803
|
4.361 1000 cells per mm^3
Interval 3.625 to 5.232
|
3.0445 1000 cells per mm^3
Interval 2.7 to 4.272
|
|
Part B Chemistry and Hematology Laboratory Measures
Neutrophils (1000 cells per mm^3)- Day 14
|
3.375 1000 cells per mm^3
Interval 2.255 to 4.1685
|
3.44 1000 cells per mm^3
Interval 2.72 to 4.55
|
3.029 1000 cells per mm^3
Interval 2.53 to 3.631
|
3.1395 1000 cells per mm^3
Interval 2.455 to 4.45
|
|
Part B Chemistry and Hematology Laboratory Measures
Neutrophils (1000 cells per mm^3)- Day 70
|
3.09 1000 cells per mm^3
Interval 2.46 to 4.8
|
3.49 1000 cells per mm^3
Interval 3.02 to 5.039
|
2.9985 1000 cells per mm^3
Interval 2.6275 to 3.265
|
2.97 1000 cells per mm^3
Interval 2.48 to 4.25
|
|
Part B Chemistry and Hematology Laboratory Measures
Neutrophils (1000 cells per mm^3)- Day 126
|
3.61 1000 cells per mm^3
Interval 3.006 to 4.9155
|
3.7 1000 cells per mm^3
Interval 3.375 to 4.32
|
3.3835 1000 cells per mm^3
Interval 2.9735 to 3.867
|
2.76 1000 cells per mm^3
Interval 2.49 to 4.11
|
|
Part B Chemistry and Hematology Laboratory Measures
Neutrophils (1000 cells per mm^3)- Day 238
|
3.2765 1000 cells per mm^3
Interval 2.537 to 4.019
|
3.245 1000 cells per mm^3
Interval 2.9 to 4.1
|
3.0805 1000 cells per mm^3
Interval 2.9585 to 3.9365
|
3.16 1000 cells per mm^3
Interval 2.29 to 4.25
|
|
Part B Chemistry and Hematology Laboratory Measures
Neutrophils (1000 cells per mm^3)- Day 308
|
3.663 1000 cells per mm^3
Interval 2.655 to 4.341
|
3.416 1000 cells per mm^3
Interval 2.81 to 4.488
|
4.225 1000 cells per mm^3
Interval 3.5265 to 5.681
|
3.133 1000 cells per mm^3
Interval 2.24 to 3.48
|
|
Part B Chemistry and Hematology Laboratory Measures
Platelets (1000 cells per mm^3)- Day 14
|
269 1000 cells per mm^3
Interval 240.0 to 300.5
|
274 1000 cells per mm^3
Interval 242.5 to 320.0
|
281 1000 cells per mm^3
Interval 277.0 to 297.1
|
258.5 1000 cells per mm^3
Interval 213.5 to 285.5
|
|
Part B Chemistry and Hematology Laboratory Measures
Platelets (1000 cells per mm^3)- Day 70
|
272 1000 cells per mm^3
Interval 213.0 to 308.0
|
277.3 1000 cells per mm^3
Interval 244.0 to 311.0
|
229.05 1000 cells per mm^3
Interval 189.55 to 272.0
|
253 1000 cells per mm^3
Interval 217.0 to 269.0
|
|
Part B Chemistry and Hematology Laboratory Measures
Platelets (1000 cells per mm^3)- Day 126
|
286.5 1000 cells per mm^3
Interval 236.5 to 310.0
|
265 1000 cells per mm^3
Interval 247.0 to 346.0
|
244.85 1000 cells per mm^3
Interval 193.85 to 287.5
|
241 1000 cells per mm^3
Interval 219.0 to 298.0
|
|
Part B Chemistry and Hematology Laboratory Measures
Platelets (1000 cells per mm^3)- Day 308
|
282 1000 cells per mm^3
Interval 217.5 to 306.5
|
274.9 1000 cells per mm^3
Interval 228.0 to 303.0
|
262.9 1000 cells per mm^3
Interval 202.4 to 297.0
|
229.5 1000 cells per mm^3
Interval 211.0 to 264.0
|
|
Part B Chemistry and Hematology Laboratory Measures
Lymphocytes (1000 cells per mm^3)- Screening
|
2.0365 1000 cells per mm^3
Interval 1.575 to 2.1045
|
1.8095 1000 cells per mm^3
Interval 1.463 to 2.245
|
1.918 1000 cells per mm^3
Interval 1.42 to 2.072
|
1.805 1000 cells per mm^3
Interval 1.72 to 2.145
|
|
Part B Chemistry and Hematology Laboratory Measures
Lymphocytes (1000 cells per mm^3)- Day 14
|
1.94 1000 cells per mm^3
Interval 1.6 to 2.11
|
1.89 1000 cells per mm^3
Interval 1.458 to 2.13
|
1.72 1000 cells per mm^3
Interval 1.618 to 1.936
|
1.9705 1000 cells per mm^3
Interval 1.585 to 2.2425
|
|
Part B Chemistry and Hematology Laboratory Measures
Lymphocytes (1000 cells per mm^3)- Day 70
|
1.986 1000 cells per mm^3
Interval 1.68 to 2.32
|
1.76 1000 cells per mm^3
Interval 1.344 to 2.451
|
1.619 1000 cells per mm^3
Interval 1.1685 to 2.0525
|
1.99 1000 cells per mm^3
Interval 1.54 to 2.37
|
|
Part B Chemistry and Hematology Laboratory Measures
Lymphocytes (1000 cells per mm^3)- Day 126
|
2.025 1000 cells per mm^3
Interval 1.84 to 2.199
|
1.99 1000 cells per mm^3
Interval 1.265 to 2.36
|
1.553 1000 cells per mm^3
Interval 1.3175 to 1.729
|
1.8 1000 cells per mm^3
Interval 1.58 to 2.33
|
|
Part B Chemistry and Hematology Laboratory Measures
WBC (1000 cells per mm^3)- Day 70
|
5.7 1000 cells per mm^3
Interval 5.1 to 7.5
|
6 1000 cells per mm^3
Interval 5.3 to 7.62
|
5.13 1000 cells per mm^3
Interval 4.43 to 5.9
|
5.5 1000 cells per mm^3
Interval 4.9 to 7.46
|
|
Part B Chemistry and Hematology Laboratory Measures
WBC (1000 cells per mm^3)- Day 126
|
6.33 1000 cells per mm^3
Interval 5.55 to 8.0
|
6.67 1000 cells per mm^3
Interval 5.35 to 7.06
|
5.49 1000 cells per mm^3
Interval 4.8 to 6.34
|
6 1000 cells per mm^3
Interval 4.53 to 6.74
|
|
Part B Chemistry and Hematology Laboratory Measures
Lymphocytes (1000 cells per mm^3)- Day 238
|
1.78 1000 cells per mm^3
Interval 1.64 to 2.022
|
1.885 1000 cells per mm^3
Interval 1.65 to 2.242
|
1.836 1000 cells per mm^3
Interval 1.534 to 2.1425
|
1.85 1000 cells per mm^3
Interval 1.6 to 2.04
|
|
Part B Chemistry and Hematology Laboratory Measures
Lymphocytes (1000 cells per mm^3)- Day 308
|
1.816 1000 cells per mm^3
Interval 1.4885 to 2.229
|
1.72 1000 cells per mm^3
Interval 1.377 to 2.06
|
2.0175 1000 cells per mm^3
Interval 1.6075 to 2.2275
|
1.805 1000 cells per mm^3
Interval 1.71 to 1.989
|
|
Part B Chemistry and Hematology Laboratory Measures
Platelets (1000 cells per mm^3)- Screening
|
284.5 1000 cells per mm^3
Interval 240.5 to 314.0
|
274 1000 cells per mm^3
Interval 237.0 to 327.0
|
269 1000 cells per mm^3
Interval 223.6 to 280.0
|
246.5 1000 cells per mm^3
Interval 214.5 to 268.5
|
|
Part B Chemistry and Hematology Laboratory Measures
Platelets (1000 cells per mm^3)- Day 238
|
262.5 1000 cells per mm^3
Interval 232.0 to 298.0
|
272.3 1000 cells per mm^3
Interval 258.0 to 332.0
|
242.3 1000 cells per mm^3
Interval 208.3 to 313.5
|
248 1000 cells per mm^3
Interval 227.0 to 270.0
|
PRIMARY outcome
Timeframe: Measured at Month 8.5Magnitude-breadth characterize the magnitude (ID50) 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 proportion of isolates among the virus panel with magnitudes greater than this threshold. The area under the magnitude-breadth curve (AUC-MB) integrates magnitude and breadth information and provides effective tools to display, summarize, and compare multi-viral immunological data in the context of HIV-1 vaccine trials.
Outcome measures
| Measure |
Group 6: Vaccine
n=20 Participants
400mcg CH505TF(m0), 400mcg CH505TF + CH505W53(m2), 400mcg CH505TF + CH505w53 + CH505w78(m4), 400mcg CH505w53 + CH505w78(m8)
|
Group 7: Vaccine
n=20 Participants
400mcg CH505 M5(m0,2,4,8)
|
Group 8: Placebo
n=5 Participants
Placebo(m0,2,4,8)
|
Group 9: Vaccine
n=20 Participants
400mcg CH505TF(m0), 400mcg CH505w53(m2), 400mcg CH505w78(m4)
|
|---|---|---|---|---|
|
Part B Magnitude and Breadth of Neutralizing Antibody Response Against Autologous Viral Isolates and Related CH103 and CH235 Precursor Detection Isolates 2 Weeks After the Fourth Vaccinations
|
1.1849438379 log10 titer*percentage of isolates
Interval 1.1769724686 to 1.219004435
|
1.1194766117 log10 titer*percentage of isolates
Interval 1.050817124 to 1.1611045902
|
0.6989700043 log10 titer*percentage of isolates
Interval 0.6989700043 to 0.6989700043
|
1.1384246921 log10 titer*percentage of isolates
Interval 1.0811824148 to 1.1585691555
|
PRIMARY outcome
Timeframe: Measured at Month 8.5Magnitude-breadth characterize the magnitude (ID50) 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 proportion of isolates among the virus panel with magnitudes greater than this threshold. The area under the magnitude-breadth curve (AUC-MB) integrates magnitude and breadth information and provides effective tools to display, summarize, and compare multi-viral immunological data in the context of HIV-1 vaccine trials.
Outcome measures
| Measure |
Group 6: Vaccine
n=20 Participants
400mcg CH505TF(m0), 400mcg CH505TF + CH505W53(m2), 400mcg CH505TF + CH505w53 + CH505w78(m4), 400mcg CH505w53 + CH505w78(m8)
|
Group 7: Vaccine
n=20 Participants
400mcg CH505 M5(m0,2,4,8)
|
Group 8: Placebo
n=5 Participants
Placebo(m0,2,4,8)
|
Group 9: Vaccine
n=20 Participants
400mcg CH505TF(m0), 400mcg CH505w53(m2), 400mcg CH505w78(m4)
|
|---|---|---|---|---|
|
Part B Magnitude and Breadth of Neutralizing Antibody Responses Against a Panel of Heterologous Tier 2 Isolates Induced 2 Weeks After the Fourth Vaccinations
|
0.7500872649 log10 titer*percentage of isolates
Interval 0.6989700043 to 0.8869830068
|
0.6989700043 log10 titer*percentage of isolates
Interval 0.6989700043 to 0.7983235391
|
0.6989700043 log10 titer*percentage of isolates
Interval 0.6989700043 to 0.7487297683
|
0.6989700043 log10 titer*percentage of isolates
Interval 0.6989700043 to 0.6989700043
|
PRIMARY outcome
Timeframe: Measured through Month Measured through Month Measured through 7 days after the vaccination at Month 0, 2, 4Graded 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 6: Vaccine
400mcg CH505TF(m0), 400mcg CH505TF + CH505W53(m2), 400mcg CH505TF + CH505w53 + CH505w78(m4), 400mcg CH505w53 + CH505w78(m8)
|
Group 7: Vaccine
400mcg CH505 M5(m0,2,4,8)
|
Group 8: Placebo
Placebo(m0,2,4,8)
|
Group 9: Vaccine
n=10 Participants
400mcg CH505TF(m0), 400mcg CH505w53(m2), 400mcg CH505w78(m4)
|
|---|---|---|---|---|
|
Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms
Pain and/or Tenderness · Severe
|
—
|
—
|
—
|
0 Participants
|
|
Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms
Pain and/or Tenderness · Potentially Life-threatening
|
—
|
—
|
—
|
0 Participants
|
|
Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema/Redness · None
|
—
|
—
|
—
|
7 Participants
|
|
Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema/Redness · Mild
|
—
|
—
|
—
|
1 Participants
|
|
Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema/Redness · Moderate
|
—
|
—
|
—
|
2 Participants
|
|
Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema/Redness · Severe
|
—
|
—
|
—
|
0 Participants
|
|
Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema and/or Induration · Potentially Life-threatening
|
—
|
—
|
—
|
0 Participants
|
|
Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema and/or Induration · None
|
—
|
—
|
—
|
5 Participants
|
|
Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema and/or Induration · Mild
|
—
|
—
|
—
|
2 Participants
|
|
Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema and/or Induration · Moderate
|
—
|
—
|
—
|
3 Participants
|
|
Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema and/or Induration · Severe
|
—
|
—
|
—
|
0 Participants
|
|
Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms
Pain · None
|
—
|
—
|
—
|
1 Participants
|
|
Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms
Pain · Mild
|
—
|
—
|
—
|
6 Participants
|
|
Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms
Pain · Moderate
|
—
|
—
|
—
|
3 Participants
|
|
Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms
Pain · Severe
|
—
|
—
|
—
|
0 Participants
|
|
Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms
Pain · Potentially Life-threatening
|
—
|
—
|
—
|
0 Participants
|
|
Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms
Tenderness · None
|
—
|
—
|
—
|
1 Participants
|
|
Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms
Tenderness · Mild
|
—
|
—
|
—
|
6 Participants
|
|
Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms
Tenderness · Moderate
|
—
|
—
|
—
|
3 Participants
|
|
Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms
Tenderness · Severe
|
—
|
—
|
—
|
0 Participants
|
|
Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms
Tenderness · Potentially Life-threatening
|
—
|
—
|
—
|
0 Participants
|
|
Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms
Pain and/or Tenderness · None
|
—
|
—
|
—
|
1 Participants
|
|
Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms
Pain and/or Tenderness · Mild
|
—
|
—
|
—
|
5 Participants
|
|
Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms
Pain and/or Tenderness · Moderate
|
—
|
—
|
—
|
4 Participants
|
|
Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema/Redness · Potentially Life-threatening
|
—
|
—
|
—
|
0 Participants
|
|
Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms
Induration/Swelling · None
|
—
|
—
|
—
|
5 Participants
|
|
Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms
Induration/Swelling · Mild
|
—
|
—
|
—
|
2 Participants
|
|
Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms
Induration/Swelling · Moderate
|
—
|
—
|
—
|
3 Participants
|
|
Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms
Induration/Swelling · Severe
|
—
|
—
|
—
|
0 Participants
|
|
Number of Part C Participants Reporting Local Reactogenicity Signs and Symptoms
Induration/Swelling · Potentially Life-threatening
|
—
|
—
|
—
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through Month Measured through Month Measured through 7 days after the vaccination at Month 0, 2, 4Graded 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 6: Vaccine
400mcg CH505TF(m0), 400mcg CH505TF + CH505W53(m2), 400mcg CH505TF + CH505w53 + CH505w78(m4), 400mcg CH505w53 + CH505w78(m8)
|
Group 7: Vaccine
400mcg CH505 M5(m0,2,4,8)
|
Group 8: Placebo
Placebo(m0,2,4,8)
|
Group 9: Vaccine
n=10 Participants
400mcg CH505TF(m0), 400mcg CH505w53(m2), 400mcg CH505w78(m4)
|
|---|---|---|---|---|
|
Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Mild
|
—
|
—
|
—
|
4 Participants
|
|
Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Moderate
|
—
|
—
|
—
|
4 Participants
|
|
Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Severe
|
—
|
—
|
—
|
0 Participants
|
|
Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Potentially Life-threatening
|
—
|
—
|
—
|
0 Participants
|
|
Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · None
|
—
|
—
|
—
|
5 Participants
|
|
Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Severe
|
—
|
—
|
—
|
0 Participants
|
|
Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Potentially Life-threatening
|
—
|
—
|
—
|
0 Participants
|
|
Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · None
|
—
|
—
|
—
|
9 Participants
|
|
Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Severe
|
—
|
—
|
—
|
0 Participants
|
|
Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · None
|
—
|
—
|
—
|
2 Participants
|
|
Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Mild
|
—
|
—
|
—
|
3 Participants
|
|
Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Moderate
|
—
|
—
|
—
|
2 Participants
|
|
Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Severe
|
—
|
—
|
—
|
0 Participants
|
|
Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Potentially Life-threatening
|
—
|
—
|
—
|
0 Participants
|
|
Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · None
|
—
|
—
|
—
|
4 Participants
|
|
Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Mild
|
—
|
—
|
—
|
5 Participants
|
|
Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Moderate
|
—
|
—
|
—
|
1 Participants
|
|
Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Severe
|
—
|
—
|
—
|
0 Participants
|
|
Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Potentially Life-threatening
|
—
|
—
|
—
|
0 Participants
|
|
Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · None
|
—
|
—
|
—
|
4 Participants
|
|
Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Mild
|
—
|
—
|
—
|
4 Participants
|
|
Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Moderate
|
—
|
—
|
—
|
2 Participants
|
|
Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · None
|
—
|
—
|
—
|
7 Participants
|
|
Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Mild
|
—
|
—
|
—
|
0 Participants
|
|
Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Moderate
|
—
|
—
|
—
|
3 Participants
|
|
Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Severe
|
—
|
—
|
—
|
0 Participants
|
|
Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Potentially Life-threatening
|
—
|
—
|
—
|
0 Participants
|
|
Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · None
|
—
|
—
|
—
|
2 Participants
|
|
Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Mild
|
—
|
—
|
—
|
4 Participants
|
|
Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Moderate
|
—
|
—
|
—
|
4 Participants
|
|
Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Mild
|
—
|
—
|
—
|
1 Participants
|
|
Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Moderate
|
—
|
—
|
—
|
0 Participants
|
|
Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Severe
|
—
|
—
|
—
|
0 Participants
|
|
Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Potentially Life-threatening
|
—
|
—
|
—
|
0 Participants
|
|
Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Potentially Life-threatening
|
—
|
—
|
—
|
0 Participants
|
|
Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms
Vomiting · None
|
—
|
—
|
—
|
10 Participants
|
|
Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms
Vomiting · Mild
|
—
|
—
|
—
|
0 Participants
|
|
Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms
Vomiting · Moderate
|
—
|
—
|
—
|
0 Participants
|
|
Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms
Vomiting · Severe
|
—
|
—
|
—
|
0 Participants
|
|
Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms
Vomiting · Potentially Life-threatening
|
—
|
—
|
—
|
0 Participants
|
|
Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · None
|
—
|
—
|
—
|
9 Participants
|
|
Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Mild
|
—
|
—
|
—
|
1 Participants
|
|
Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Moderate
|
—
|
—
|
—
|
0 Participants
|
|
Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Severe
|
—
|
—
|
—
|
0 Participants
|
|
Number of Part C Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Potentially Life-threatening
|
—
|
—
|
—
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through Month 16From the study termination form, early termination reasons associated with an AE or reactogenicity are tabulated by treatment arm
Outcome measures
| Measure |
Group 6: Vaccine
400mcg CH505TF(m0), 400mcg CH505TF + CH505W53(m2), 400mcg CH505TF + CH505w53 + CH505w78(m4), 400mcg CH505w53 + CH505w78(m8)
|
Group 7: Vaccine
400mcg CH505 M5(m0,2,4,8)
|
Group 8: Placebo
Placebo(m0,2,4,8)
|
Group 9: Vaccine
n=10 Participants
400mcg CH505TF(m0), 400mcg CH505w53(m2), 400mcg CH505w78(m4)
|
|---|---|---|---|---|
|
Part C: Number of Participants With Early Study Termination Associated With an AE or Reactogenicity During the Vaccine Regime
|
—
|
—
|
—
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through the Month 4 administrationPopulation: Safety population
From the study product discontinuation form, study product administration reasons are tabulated by treatment arm
Outcome measures
| Measure |
Group 6: Vaccine
400mcg CH505TF(m0), 400mcg CH505TF + CH505W53(m2), 400mcg CH505TF + CH505w53 + CH505w78(m4), 400mcg CH505w53 + CH505w78(m8)
|
Group 7: Vaccine
400mcg CH505 M5(m0,2,4,8)
|
Group 8: Placebo
Placebo(m0,2,4,8)
|
Group 9: Vaccine
n=10 Participants
400mcg CH505TF(m0), 400mcg CH505w53(m2), 400mcg CH505w78(m4)
|
|---|---|---|---|---|
|
Number of Part C Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
Reactogenicity symptoms
|
—
|
—
|
—
|
0 Participants
|
|
Number of Part C Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
Withdrawal by Subject
|
—
|
—
|
—
|
1 Participants
|
|
Number of Part C Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
Investigator reason
|
—
|
—
|
—
|
0 Participants
|
|
Number of Part C Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
Lost to Follow-Up
|
—
|
—
|
—
|
0 Participants
|
|
Number of Part C Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
Did not discontinue SPA
|
—
|
—
|
—
|
9 Participants
|
PRIMARY outcome
Timeframe: Measured during screening, and 2 weeks after each vaccination at Month 0, 2, 4, and at Month 10Population: T9 All enrolled
Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown.
Outcome measures
| Measure |
Group 6: Vaccine
400mcg CH505TF(m0), 400mcg CH505TF + CH505W53(m2), 400mcg CH505TF + CH505w53 + CH505w78(m4), 400mcg CH505w53 + CH505w78(m8)
|
Group 7: Vaccine
400mcg CH505 M5(m0,2,4,8)
|
Group 8: Placebo
Placebo(m0,2,4,8)
|
Group 9: Vaccine
n=10 Participants
400mcg CH505TF(m0), 400mcg CH505w53(m2), 400mcg CH505w78(m4)
|
|---|---|---|---|---|
|
Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
ALT (SGPT) (U/L)- Screening
|
—
|
—
|
—
|
13 U/L
Interval 12.0 to 15.0
|
|
Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
ALT (SGPT) (U/L)- Day 14
|
—
|
—
|
—
|
13 U/L
Interval 12.0 to 15.0
|
|
Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
ALT (SGPT) (U/L)- Day 70
|
—
|
—
|
—
|
14 U/L
Interval 13.0 to 14.0
|
|
Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
ALT (SGPT) (U/L)- Day 126
|
—
|
—
|
—
|
13 U/L
Interval 11.0 to 15.0
|
|
Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
ALT (SGPT) (U/L)- Day 303
|
—
|
—
|
—
|
14 U/L
Interval 11.0 to 15.0
|
|
Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
AST (U/L)- Screening
|
—
|
—
|
—
|
17.5 U/L
Interval 16.0 to 21.0
|
|
Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
AST (U/L)- Day 14
|
—
|
—
|
—
|
16 U/L
Interval 14.0 to 18.0
|
|
Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
AST (U/L)- Day 70
|
—
|
—
|
—
|
16 U/L
Interval 15.0 to 20.0
|
|
Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
AST (U/L)- Day 126
|
—
|
—
|
—
|
14 U/L
Interval 13.0 to 16.0
|
|
Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
AST (U/L)- Day 303
|
—
|
—
|
—
|
16 U/L
Interval 15.0 to 17.0
|
|
Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
Alkaline Phosphatase (U/L)- Screening
|
—
|
—
|
—
|
73.5 U/L
Interval 50.0 to 85.0
|
|
Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
Alkaline Phosphatase (U/L)- Day 14
|
—
|
—
|
—
|
60 U/L
Interval 54.0 to 66.0
|
|
Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
Alkaline Phosphatase (U/L)- Day 70
|
—
|
—
|
—
|
63 U/L
Interval 57.0 to 72.0
|
|
Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
Alkaline Phosphatase (U/L)- Day 126
|
—
|
—
|
—
|
61 U/L
Interval 56.0 to 76.0
|
|
Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
Alkaline Phosphatase (U/L)- Day 303
|
—
|
—
|
—
|
63 U/L
Interval 53.0 to 71.0
|
PRIMARY outcome
Timeframe: Measured during screening, and 2 weeks after each vaccination at Month 0, 2, 4, and at Month 10Population: T9 All enrolled
Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown.
Outcome measures
| Measure |
Group 6: Vaccine
400mcg CH505TF(m0), 400mcg CH505TF + CH505W53(m2), 400mcg CH505TF + CH505w53 + CH505w78(m4), 400mcg CH505w53 + CH505w78(m8)
|
Group 7: Vaccine
400mcg CH505 M5(m0,2,4,8)
|
Group 8: Placebo
Placebo(m0,2,4,8)
|
Group 9: Vaccine
n=10 Participants
400mcg CH505TF(m0), 400mcg CH505w53(m2), 400mcg CH505w78(m4)
|
|---|---|---|---|---|
|
Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Hemoglobin (g/dL)- Screening
|
—
|
—
|
—
|
14.45 g/dL
Interval 13.3 to 15.1
|
|
Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Hemoglobin (g/dL)- Day 14
|
—
|
—
|
—
|
13.85 g/dL
Interval 13.0 to 15.1
|
|
Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Hemoglobin (g/dL)- Day 70
|
—
|
—
|
—
|
14.3 g/dL
Interval 13.6 to 14.6
|
|
Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Hemoglobin (g/dL)- Day 126
|
—
|
—
|
—
|
13.9 g/dL
Interval 13.2 to 14.2
|
|
Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Hemoglobin (g/dL)- Day 303
|
—
|
—
|
—
|
13.6 g/dL
Interval 13.2 to 14.6
|
|
Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Creatinine (g/dL)- Screening
|
—
|
—
|
—
|
0.000815 g/dL
Interval 0.00078 to 0.00089
|
|
Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Creatinine (g/dL)- Day 14
|
—
|
—
|
—
|
0.00082 g/dL
Interval 0.00077 to 0.00088
|
|
Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Creatinine (g/dL)- Day 70
|
—
|
—
|
—
|
0.0008 g/dL
Interval 0.00076 to 0.0009
|
|
Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Creatinine (g/dL)- Day 126
|
—
|
—
|
—
|
0.00083 g/dL
Interval 0.00077 to 0.00091
|
|
Part C Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Creatinine (g/dL)- Day 303
|
—
|
—
|
—
|
0.00084 g/dL
Interval 0.00074 to 0.00089
|
PRIMARY outcome
Timeframe: Measured during screening, and 2 weeks after each vaccination at Month 0, 2, 4, and at Month 10Population: T9 All enrolled
Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown.
Outcome measures
| Measure |
Group 6: Vaccine
400mcg CH505TF(m0), 400mcg CH505TF + CH505W53(m2), 400mcg CH505TF + CH505w53 + CH505w78(m4), 400mcg CH505w53 + CH505w78(m8)
|
Group 7: Vaccine
400mcg CH505 M5(m0,2,4,8)
|
Group 8: Placebo
Placebo(m0,2,4,8)
|
Group 9: Vaccine
n=10 Participants
400mcg CH505TF(m0), 400mcg CH505w53(m2), 400mcg CH505w78(m4)
|
|---|---|---|---|---|
|
Part C Chemistry and Hematology Laboratory Measures
Platelets (1000 cells per mm^3)- Day 70
|
—
|
—
|
—
|
288 1000 cells per mm^3
Interval 260.0 to 319.0
|
|
Part C Chemistry and Hematology Laboratory Measures
Platelets (1000 cells per mm^3)- Day 126
|
—
|
—
|
—
|
275 1000 cells per mm^3
Interval 233.0 to 316.0
|
|
Part C Chemistry and Hematology Laboratory Measures
Platelets (1000 cells per mm^3)- Day 303
|
—
|
—
|
—
|
280 1000 cells per mm^3
Interval 233.0 to 295.0
|
|
Part C Chemistry and Hematology Laboratory Measures
WBC (1000 cells per mm^3)- Screening
|
—
|
—
|
—
|
5.95 1000 cells per mm^3
Interval 4.94 to 8.03
|
|
Part C Chemistry and Hematology Laboratory Measures
WBC (1000 cells per mm^3)- Day 14
|
—
|
—
|
—
|
6.08 1000 cells per mm^3
Interval 4.56 to 7.2
|
|
Part C Chemistry and Hematology Laboratory Measures
WBC (1000 cells per mm^3)- Day 70
|
—
|
—
|
—
|
6.67 1000 cells per mm^3
Interval 4.53 to 9.08
|
|
Part C Chemistry and Hematology Laboratory Measures
WBC (1000 cells per mm^3)- Day 126
|
—
|
—
|
—
|
6.2 1000 cells per mm^3
Interval 4.31 to 7.17
|
|
Part C Chemistry and Hematology Laboratory Measures
WBC (1000 cells per mm^3)- Day 303
|
—
|
—
|
—
|
7.62 1000 cells per mm^3
Interval 4.36 to 8.4
|
|
Part C Chemistry and Hematology Laboratory Measures
Neutrophils (1000 cells per mm^3)- Screening
|
—
|
—
|
—
|
3.783 1000 cells per mm^3
Interval 2.97 to 4.79
|
|
Part C Chemistry and Hematology Laboratory Measures
Neutrophils (1000 cells per mm^3)- Day 14
|
—
|
—
|
—
|
3.47 1000 cells per mm^3
Interval 2.83 to 4.33
|
|
Part C Chemistry and Hematology Laboratory Measures
Neutrophils (1000 cells per mm^3)- Day 70
|
—
|
—
|
—
|
3.5 1000 cells per mm^3
Interval 2.71 to 5.88
|
|
Part C Chemistry and Hematology Laboratory Measures
Neutrophils (1000 cells per mm^3)- Day 126
|
—
|
—
|
—
|
3.639 1000 cells per mm^3
Interval 2.55 to 3.98
|
|
Part C Chemistry and Hematology Laboratory Measures
Neutrophils (1000 cells per mm^3)- Day 303
|
—
|
—
|
—
|
4.58 1000 cells per mm^3
Interval 2.53 to 5.8
|
|
Part C Chemistry and Hematology Laboratory Measures
Lymphocytes (1000 cells per mm^3)- Screening
|
—
|
—
|
—
|
1.6835 1000 cells per mm^3
Interval 1.4 to 2.4
|
|
Part C Chemistry and Hematology Laboratory Measures
Lymphocytes (1000 cells per mm^3)- Day 14
|
—
|
—
|
—
|
1.629 1000 cells per mm^3
Interval 1.25 to 2.11
|
|
Part C Chemistry and Hematology Laboratory Measures
Lymphocytes (1000 cells per mm^3)- Day 70
|
—
|
—
|
—
|
1.73 1000 cells per mm^3
Interval 1.28 to 2.33
|
|
Part C Chemistry and Hematology Laboratory Measures
Lymphocytes (1000 cells per mm^3)- Day 126
|
—
|
—
|
—
|
1.562 1000 cells per mm^3
Interval 1.41 to 2.2
|
|
Part C Chemistry and Hematology Laboratory Measures
Lymphocytes (1000 cells per mm^3)- Day 303
|
—
|
—
|
—
|
1.806 1000 cells per mm^3
Interval 1.295 to 2.1
|
|
Part C Chemistry and Hematology Laboratory Measures
Platelets (1000 cells per mm^3)- Screening
|
—
|
—
|
—
|
276.5 1000 cells per mm^3
Interval 220.0 to 334.0
|
|
Part C Chemistry and Hematology Laboratory Measures
Platelets (1000 cells per mm^3)- Day 14
|
—
|
—
|
—
|
299 1000 cells per mm^3
Interval 240.0 to 320.0
|
SECONDARY outcome
Timeframe: Measured at Month 4.5Magnitude-breadth characterize the magnitude (ID50) 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 proportion of isolates among the virus panel with magnitudes greater than this threshold. The area under the magnitude-breadth curve (AUC-MB) integrates magnitude and breadth information and provides effective tools to display, summarize, and compare multi-viral immunological data in the context of HIV-1 vaccine trials. Six autologous isolates were assayed and included for the AUC-MB calculation: CH0505.w4.3, CH0505.w53.16, CH0505.w78.e33, CH0505.w100.B6, CH0505s, and CH0505TF.M5.
Outcome measures
| Measure |
Group 6: Vaccine
400mcg CH505TF(m0), 400mcg CH505TF + CH505W53(m2), 400mcg CH505TF + CH505w53 + CH505w78(m4), 400mcg CH505w53 + CH505w78(m8)
|
Group 7: Vaccine
400mcg CH505 M5(m0,2,4,8)
|
Group 8: Placebo
Placebo(m0,2,4,8)
|
Group 9: Vaccine
n=10 Participants
400mcg CH505TF(m0), 400mcg CH505w53(m2), 400mcg CH505w78(m4)
|
|---|---|---|---|---|
|
Part C Magnitude and Breadth of Neutralizing Antibody Response Against Autologous Viral Isolates and Related CH103 and CH235 Precursor Detection Isolates 2 Weeks After the Third (Final) Vaccination
|
—
|
—
|
—
|
0.9919921716 log10 titer*percentage of isolates
Interval 0.9551699712 to 1.0164352642
|
SECONDARY outcome
Timeframe: Measured at Month 4.5Magnitude-breadth characterize the magnitude (ID50) 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 proportion of isolates among the virus panel with magnitudes greater than this threshold. The area under the magnitude-breadth curve (AUC-MB) integrates magnitude and breadth information and provides effective tools to display, summarize, and compare multi-viral immunological data in the context of HIV-1 vaccine trials. Six autologous isolates were assayed and included for the AUC-MB calculation: CH0505.w4.3, CH0505.w53.16, CH0505.w78.e33, CH0505.w100.B6, CH0505s, and CH0505TF.M5.
Outcome measures
| Measure |
Group 6: Vaccine
400mcg CH505TF(m0), 400mcg CH505TF + CH505W53(m2), 400mcg CH505TF + CH505w53 + CH505w78(m4), 400mcg CH505w53 + CH505w78(m8)
|
Group 7: Vaccine
400mcg CH505 M5(m0,2,4,8)
|
Group 8: Placebo
Placebo(m0,2,4,8)
|
Group 9: Vaccine
n=10 Participants
400mcg CH505TF(m0), 400mcg CH505w53(m2), 400mcg CH505w78(m4)
|
|---|---|---|---|---|
|
Part C Magnitude and Breadth of Neutralizing Antibody Responses Against a Panel of Heterologous Tier 2 Isolates Induced 2 Weeks After the Third (Final) Vaccination
|
—
|
—
|
—
|
0.8284675826 log10 titer*percentage of isolates
Interval 0.6989700043 to 0.8446388582
|
SECONDARY outcome
Timeframe: Measured at Month 4.5Population: "Overall Number of Participants Analyzed" includes the HIV uninfected participants with samples collected at the month 4.5 immunogenicity timepoint. "Number Analyzed" shows the number of participants with available data after filtering for assay-specific quality control criteria.
The CD4 binding-site (CD4bs) and Env-specific B cells were quantified using biotinylated CH505TF gp120 protein probes and the CD4bs-mutant in the context of a flow cytometry panel to identify and characterize those B cells. Post-vaccine samples are defined as positive responders if the frequency of Env-specific B cells for the post-vaccine data was statistically greater than that for the data from baseline, compared by one-sided Fisher's exact test. The Fisher's exact test is not applied to compare between endpoints.
Outcome measures
| Measure |
Group 6: Vaccine
n=12 Participants
400mcg CH505TF(m0), 400mcg CH505TF + CH505W53(m2), 400mcg CH505TF + CH505w53 + CH505w78(m4), 400mcg CH505w53 + CH505w78(m8)
|
Group 7: Vaccine
n=12 Participants
400mcg CH505 M5(m0,2,4,8)
|
Group 8: Placebo
n=6 Participants
Placebo(m0,2,4,8)
|
Group 9: Vaccine
n=12 Participants
400mcg CH505TF(m0), 400mcg CH505w53(m2), 400mcg CH505w78(m4)
|
|---|---|---|---|---|
|
Part A: Occurence of Memory B Cells Differentially Binding to the CH505 Wildtype gp120 TF Env vs the Mutant CH505 Env I Delta 371 gp120 2 Weeks After the Third Vaccination With CH505TF gp120
CD4bs+ CH505+ B cells
|
9 Participants
|
11 Participants
|
0 Participants
|
9 Participants
|
|
Part A: Occurence of Memory B Cells Differentially Binding to the CH505 Wildtype gp120 TF Env vs the Mutant CH505 Env I Delta 371 gp120 2 Weeks After the Third Vaccination With CH505TF gp120
CD4bs+ CH505+ IgG+ B cells
|
9 Participants
|
11 Participants
|
0 Participants
|
10 Participants
|
|
Part A: Occurence of Memory B Cells Differentially Binding to the CH505 Wildtype gp120 TF Env vs the Mutant CH505 Env I Delta 371 gp120 2 Weeks After the Third Vaccination With CH505TF gp120
CH505+ B cells
|
11 Participants
|
12 Participants
|
0 Participants
|
11 Participants
|
|
Part A: Occurence of Memory B Cells Differentially Binding to the CH505 Wildtype gp120 TF Env vs the Mutant CH505 Env I Delta 371 gp120 2 Weeks After the Third Vaccination With CH505TF gp120
CH505+ IgG+ B cells
|
11 Participants
|
12 Participants
|
0 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Measured at Month 4.5Population: "Overall Number of Participants Analyzed" includes the HIV uninfected participants with samples collected at the month 4.5 immunogenicity timepoint. "Number Analyzed" shows the number of participants with available data after filtering for assay-specific quality control criteria.
The CD4 binding-site (CD4bs) and Env-specific B cells were quantified using biotinylated CH505TF gp120 protein probes and the CD4bs-mutant in the context of a flow cytometry panel to identify and characterize those B cells. The reported frequencies are: The % CH505+ of total B cells equals the frequency of double-positive CH505 gp120+ B cells out of total B cells; the % CD4bs CH505+ of total B cells equals the frequency of double-positive CH505 gp120+ B cells that are negative for the CD4bs mutant (CH505 I delta 371) out of total B cells; the % CH505+ of IgG+ B cells equals the frequency of double-positive CH505 gp120+ IgG+ B cells out of IgG+ B cells; and the % CD4bs CH505+ of IgG+ B cells equals the frequency of double-positive CH505 gp120+ IgG+ B cells that are negative for the CD4bs mutant (CH505 I delta 371) out of IgG+ B cells.
Outcome measures
| Measure |
Group 6: Vaccine
n=12 Participants
400mcg CH505TF(m0), 400mcg CH505TF + CH505W53(m2), 400mcg CH505TF + CH505w53 + CH505w78(m4), 400mcg CH505w53 + CH505w78(m8)
|
Group 7: Vaccine
n=12 Participants
400mcg CH505 M5(m0,2,4,8)
|
Group 8: Placebo
n=6 Participants
Placebo(m0,2,4,8)
|
Group 9: Vaccine
n=12 Participants
400mcg CH505TF(m0), 400mcg CH505w53(m2), 400mcg CH505w78(m4)
|
|---|---|---|---|---|
|
Part A: Level of Memory B Cells Differentially Binding to the CH505 Wildtype gp120 TF Env vs the Mutant CH505 Env I Delta 371 gp120 2 Weeks After the Third Vaccination With CH505TF gp120
CD4bs+ CH505+ IgG+ B cells
|
0.2227163176 % B-cells
Interval 0.0869480928 to 0.3467235194
|
0.2295544376 % B-cells
Interval 0.1114627336 to 0.5010063155
|
0.001277025 % B-cells
Interval 0.0 to 0.0061192021
|
0.3432494279 % B-cells
Interval 0.0737350136 to 0.6560563723
|
|
Part A: Level of Memory B Cells Differentially Binding to the CH505 Wildtype gp120 TF Env vs the Mutant CH505 Env I Delta 371 gp120 2 Weeks After the Third Vaccination With CH505TF gp120
CH505+ IgG+ B cells
|
3.4168305845 % B-cells
Interval 1.2972281912 to 5.4550889701
|
4.0027261874 % B-cells
Interval 3.0877152432 to 6.7554425115
|
0.0051081002 % B-cells
Interval 0.0 to 0.0122384041
|
3.9065053939 % B-cells
Interval 2.8087107152 to 5.6719558166
|
|
Part A: Level of Memory B Cells Differentially Binding to the CH505 Wildtype gp120 TF Env vs the Mutant CH505 Env I Delta 371 gp120 2 Weeks After the Third Vaccination With CH505TF gp120
CD4bs+ CH505+ B cells
|
0.0383802953 % B-cells
Interval 0.0260133882 to 0.0607006346
|
0.033951166 % B-cells
Interval 0.0243709361 to 0.0960959665
|
0.0052190432 % B-cells
Interval 0.001061008 to 0.0127753304
|
0.0336336336 % B-cells
Interval 0.015625 to 0.0450757377
|
|
Part A: Level of Memory B Cells Differentially Binding to the CH505 Wildtype gp120 TF Env vs the Mutant CH505 Env I Delta 371 gp120 2 Weeks After the Third Vaccination With CH505TF gp120
CH505+ B cells
|
0.5019394658 % B-cells
Interval 0.186793809 to 0.895629002
|
0.6492676935 % B-cells
Interval 0.3473426094 to 1.1017202497
|
0.0062628519 % B-cells
Interval 0.0018567639 to 0.013876652
|
0.3928819444 % B-cells
Interval 0.248440694 to 0.7179063361
|
SECONDARY outcome
Timeframe: Measured at Month 4.5Population: Only participants with data available for all six isolates are included.
Magnitude-breadth characterize the magnitude (ID50) 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 proportion of isolates among the virus panel with magnitudes greater than this threshold. The area under the magnitude-breadth curve (AUC-MB) integrates magnitude and breadth information and provides effective tools to display, summarize, and compare multi-viral immunological data in the context of HIV-1 vaccine trials. Six autologous isolates were assayed and included for the AUC-MB calculation: CH0505.w4.3, CH0505.w53.16, CH0505.w78.e33, CH0505.w100.B6, CH0505s, and CH0505TF.M5.
Outcome measures
| Measure |
Group 6: Vaccine
n=12 Participants
400mcg CH505TF(m0), 400mcg CH505TF + CH505W53(m2), 400mcg CH505TF + CH505w53 + CH505w78(m4), 400mcg CH505w53 + CH505w78(m8)
|
Group 7: Vaccine
n=12 Participants
400mcg CH505 M5(m0,2,4,8)
|
Group 8: Placebo
n=6 Participants
Placebo(m0,2,4,8)
|
Group 9: Vaccine
n=12 Participants
400mcg CH505TF(m0), 400mcg CH505w53(m2), 400mcg CH505w78(m4)
|
|---|---|---|---|---|
|
Part A: Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 2 Weeks After the Third Vaccination With CH505TF gp120
|
0.93 log10 titer*percentage of isolates
Interval 0.85 to 0.97
|
0.97 log10 titer*percentage of isolates
Interval 0.95 to 1.01
|
0.70 log10 titer*percentage of isolates
Interval 0.7 to 0.7
|
0.94 log10 titer*percentage of isolates
Interval 0.88 to 0.97
|
SECONDARY outcome
Timeframe: Measured at Months 4.5 and 12.5Population: "Overall Number of Participants Analyzed" includes the HIV uninfected participants with samples collected at the months 4.5 and 12.5 immunogenicity timepoint. "Number Analyzed" shows the number of participants with available data after filtering for assay-specific quality control criteria.
PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. Response positivity is derived by testing if the number of cells expressing the marker is equal in the stimulated vs. unstimulated cells. Response is positive if the one-sided Fisher's exact test (discrete Bonferroni adjustment over the peptide pools) p greater than or equal to 0.00001. The Fisher's exact test is not applied to compare between endpoints. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.
Outcome measures
| Measure |
Group 6: Vaccine
n=12 Participants
400mcg CH505TF(m0), 400mcg CH505TF + CH505W53(m2), 400mcg CH505TF + CH505w53 + CH505w78(m4), 400mcg CH505w53 + CH505w78(m8)
|
Group 7: Vaccine
n=12 Participants
400mcg CH505 M5(m0,2,4,8)
|
Group 8: Placebo
n=6 Participants
Placebo(m0,2,4,8)
|
Group 9: Vaccine
n=12 Participants
400mcg CH505TF(m0), 400mcg CH505w53(m2), 400mcg CH505w78(m4)
|
|---|---|---|---|---|
|
Part A: Occurrence of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF
Any Env at Month 4.5
|
6 Participants
|
5 Participants
|
0 Participants
|
4 Participants
|
|
Part A: Occurrence of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF
Any Env at Month 12.5
|
2 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
|
Part A: Occurrence of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF
Env-1-PTEg-SEQ at Month 4.5
|
6 Participants
|
5 Participants
|
0 Participants
|
4 Participants
|
|
Part A: Occurrence of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF
Env-1-PTEg-SEQ at Month 12.5
|
2 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
|
Part A: Occurrence of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF
Env-2-PTEg-SEQ at Month 4.5
|
6 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Part A: Occurrence of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF
Env-2-PTEg-SEQ at Month 12.5
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Measured at Months 4.5 and 12.5Population: "Overall Number of Participants Analyzed" includes the HIV uninfected participants with samples collected at the months 4.5 and 12.5 immunogenicity timepoint. "Number Analyzed" shows the number of participants with available data after filtering for assay-specific quality control criteria.
PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. Response positivity is derived by testing if the number of cells expressing the marker is equal in the stimulated vs. unstimulated cells. Response is positive if the one-sided Fisher's exact test (discrete Bonferroni adjustment over the peptide pools) p greater than or equal to 0.00001. The Fisher's exact test is not applied to compare between endpoints. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.
Outcome measures
| Measure |
Group 6: Vaccine
n=12 Participants
400mcg CH505TF(m0), 400mcg CH505TF + CH505W53(m2), 400mcg CH505TF + CH505w53 + CH505w78(m4), 400mcg CH505w53 + CH505w78(m8)
|
Group 7: Vaccine
n=12 Participants
400mcg CH505 M5(m0,2,4,8)
|
Group 8: Placebo
n=6 Participants
Placebo(m0,2,4,8)
|
Group 9: Vaccine
n=12 Participants
400mcg CH505TF(m0), 400mcg CH505w53(m2), 400mcg CH505w78(m4)
|
|---|---|---|---|---|
|
Part A: Level of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF
Env-1-PTEg-SEQ at Month 12.5
|
0.02299821 % CD4+ T-cells
Interval 0.01601415 to 0.0551526
|
0.02889892 % CD4+ T-cells
Interval 0.00559549 to 0.05235601
|
0.00867745 % CD4+ T-cells
Interval 0.00277486 to 0.0127573
|
0.04420066 % CD4+ T-cells
Interval 0.03908209 to 0.06830406
|
|
Part A: Level of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF
Any Env at Month 4.5
|
0.132646355 % CD4+ T-cells
Interval 0.04007281 to 0.37230634
|
0.073603225 % CD4+ T-cells
Interval 0.031028225 to 0.158387505
|
0.00911761 % CD4+ T-cells
Interval -0.00401237 to 0.02455366
|
0.07193596 % CD4+ T-cells
Interval 0.0453187 to 0.11852354
|
|
Part A: Level of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF
Any Env at Month 12.5
|
0.04367241 % CD4+ T-cells
Interval 0.04052204 to 0.07384431
|
0.04605537 % CD4+ T-cells
Interval 0.02988448 to 0.07826411
|
-0.00279413 % CD4+ T-cells
Interval -0.00571998 to 0.01167789
|
0.07052576 % CD4+ T-cells
Interval 0.05099588 to 0.08964846
|
|
Part A: Level of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF
Env-1-PTEg-SEQ at Month 4.5
|
0.0783176 % CD4+ T-cells
Interval 0.02824605 to 0.1525245
|
0.04050064 % CD4+ T-cells
Interval 0.014047985 to 0.105562815
|
-0.00285989 % CD4+ T-cells
Interval -0.0052998 to 0.0234871
|
0.04602687 % CD4+ T-cells
Interval 0.02316902 to 0.08966309
|
|
Part A: Level of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF
Env-2-PTEg-SEQ at Month 4.5
|
0.048858555 % CD4+ T-cells
Interval 0.01152919 to 0.13757644
|
0.021711805 % CD4+ T-cells
Interval 0.00698941 to 0.06117293
|
0.00128743 % CD4+ T-cells
Interval 0.00106656 to 0.0119775
|
0.02507079 % CD4+ T-cells
Interval 0.01127097 to 0.03920034
|
|
Part A: Level of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS) 2 Weeks After the Third and Fifth Vaccination With CH505TF
Env-2-PTEg-SEQ at Month 12.5
|
0.02479532 % CD4+ T-cells
Interval 0.01261996 to 0.02788738
|
0.02428899 % CD4+ T-cells
Interval 0.0057976 to 0.04546687
|
-0.00849484 % CD4+ T-cells
Interval -0.01147158 to -0.00107941
|
0.0213444 % CD4+ T-cells
Interval 0.00876609 to 0.06531986
|
SECONDARY outcome
Timeframe: Measured at Month 4.5Population: "Overall Number of Participants Analyzed" includes the HIV uninfected participants with samples collected at the month 4.5 immunogenicity timepoint. "Number Analyzed" shows the number of participants with available data after filtering for assay-specific quality control criteria.
ELISA responses were measured at serial three-fold serum dilutions from 1:30 to 1:(30×3\^11 = 5,314,410) for each analyte. Positive responses are defined as (analyte optical density (OD)) \> 3×(background OD) in wells of dilutions 1:30 and 1:90.
Outcome measures
| Measure |
Group 6: Vaccine
n=12 Participants
400mcg CH505TF(m0), 400mcg CH505TF + CH505W53(m2), 400mcg CH505TF + CH505w53 + CH505w78(m4), 400mcg CH505w53 + CH505w78(m8)
|
Group 7: Vaccine
n=12 Participants
400mcg CH505 M5(m0,2,4,8)
|
Group 8: Placebo
n=6 Participants
Placebo(m0,2,4,8)
|
Group 9: Vaccine
n=12 Participants
400mcg CH505TF(m0), 400mcg CH505w53(m2), 400mcg CH505w78(m4)
|
|---|---|---|---|---|
|
Part A: Occurrence of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding
CH505TF_D7gp120d371_avi
|
11 Participants
|
12 Participants
|
0 Participants
|
11 Participants
|
|
Part A: Occurrence of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding
CH0505_CON D7gp120_D368R_avi/293F/Mon
|
11 Participants
|
12 Participants
|
0 Participants
|
11 Participants
|
|
Part A: Occurrence of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding
CH0505_CON D7 gp120_avi/293F/Mon
|
11 Participants
|
12 Participants
|
0 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Measured at Month 4.5Population: "Overall Number of Participants Analyzed" includes the HIV uninfected participants with samples collected at the month 4.5 immunogenicity timepoint. "Number Analyzed" shows the number of participants with available data after filtering for assay-specific quality control criteria.
ELISA responses were measured at serial three-fold serum dilutions from 1:30 to 1:(30×3\^11 = 5,314,410) for each analyte. The area under the dilution-magnitude curve (AUC) was calculated as the average untransformed optical density (OD) over the log10 dilutions using the trapezoidal rule.
Outcome measures
| Measure |
Group 6: Vaccine
n=12 Participants
400mcg CH505TF(m0), 400mcg CH505TF + CH505W53(m2), 400mcg CH505TF + CH505w53 + CH505w78(m4), 400mcg CH505w53 + CH505w78(m8)
|
Group 7: Vaccine
n=12 Participants
400mcg CH505 M5(m0,2,4,8)
|
Group 8: Placebo
n=6 Participants
Placebo(m0,2,4,8)
|
Group 9: Vaccine
n=12 Participants
400mcg CH505TF(m0), 400mcg CH505w53(m2), 400mcg CH505w78(m4)
|
|---|---|---|---|---|
|
Part A: Level of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding
CH0505_CON D7 gp120_avi/293F/Mon
|
6.8592025102 Optical density
Interval 5.1850198115 to 7.5037456131
|
7.5422612265 Optical density
Interval 7.2787233014 to 8.1849197005
|
0.229304475 Optical density
Interval 0.225129664 to 0.3374678635
|
6.6971124919 Optical density
Interval 5.4824094895 to 7.4119832678
|
|
Part A: Level of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding
CH0505_CON D7gp120_D368R_avi/293F/Mon
|
6.5292373784 Optical density
Interval 4.7412493324 to 7.2369990477
|
7.3797656551 Optical density
Interval 6.9723160316 to 7.907127778
|
0.2318809298 Optical density
Interval 0.230807407 to 0.3256591124
|
6.1512380643 Optical density
Interval 5.2453995062 to 7.2585410723
|
|
Part A: Level of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding
CH505TF_D7gp120d371_avi
|
6.1353499266 Optical density
Interval 4.3269053068 to 6.8560177258
|
6.7855111323 Optical density
Interval 6.4254992896 to 7.2542946932
|
0.2366759984 Optical density
Interval 0.2306881267 to 0.3305018931
|
5.6756913098 Optical density
Interval 4.905379044 to 7.1963244607
|
SECONDARY outcome
Timeframe: Measured at Month 2.5 and 8.5Population: T5-T8 pptflow. The number of participants analyzed varied across antigens because some participants missed visits and some assays were not performed.
Serum HIV-1-specific immunoglobulin G (IgG) responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation.
Outcome measures
| Measure |
Group 6: Vaccine
n=20 Participants
400mcg CH505TF(m0), 400mcg CH505TF + CH505W53(m2), 400mcg CH505TF + CH505w53 + CH505w78(m4), 400mcg CH505w53 + CH505w78(m8)
|
Group 7: Vaccine
n=20 Participants
400mcg CH505 M5(m0,2,4,8)
|
Group 8: Placebo
n=5 Participants
Placebo(m0,2,4,8)
|
Group 9: Vaccine
n=20 Participants
400mcg CH505TF(m0), 400mcg CH505w53(m2), 400mcg CH505w78(m4)
|
|---|---|---|---|---|
|
Part B: Occurrence of HIV-specific Binding Antibody (Ab) Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
CH505TF D7gp120d371 avi/293F/Mon-M8.5
|
18 Participants
|
18 Participants
|
0 Participants
|
14 Participants
|
|
Part B: Occurrence of HIV-specific Binding Antibody (Ab) Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
Con S gp140 CFI-M2.5
|
19 Participants
|
18 Participants
|
0 Participants
|
19 Participants
|
|
Part B: Occurrence of HIV-specific Binding Antibody (Ab) Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
gp41-M2.5
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part B: Occurrence of HIV-specific Binding Antibody (Ab) Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
gp70 CH505TF V1V2 N156KN160K avi/293F-M2.5
|
9 Participants
|
14 Participants
|
0 Participants
|
4 Participants
|
|
Part B: Occurrence of HIV-specific Binding Antibody (Ab) Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
gp70 CH505TF V1V2 avi/293F-M8.5
|
15 Participants
|
15 Participants
|
0 Participants
|
5 Participants
|
|
Part B: Occurrence of HIV-specific Binding Antibody (Ab) Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
1086C D7gp120.avi/293F-M2.5
|
19 Participants
|
18 Participants
|
0 Participants
|
19 Participants
|
|
Part B: Occurrence of HIV-specific Binding Antibody (Ab) Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
1086C D7gp120.avi/293F-M8.5
|
18 Participants
|
18 Participants
|
0 Participants
|
16 Participants
|
|
Part B: Occurrence of HIV-specific Binding Antibody (Ab) Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
CH0505 CON D7gp120 D368R avi/293F/Mon-M2.5
|
19 Participants
|
18 Participants
|
0 Participants
|
19 Participants
|
|
Part B: Occurrence of HIV-specific Binding Antibody (Ab) Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
CH0505 CON D7gp120 D368R avi/293F/Mon-M8.5
|
18 Participants
|
18 Participants
|
0 Participants
|
16 Participants
|
|
Part B: Occurrence of HIV-specific Binding Antibody (Ab) Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
CH0505 CON D7gp120 avi/293F/Mon-M2.5
|
18 Participants
|
18 Participants
|
0 Participants
|
19 Participants
|
|
Part B: Occurrence of HIV-specific Binding Antibody (Ab) Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
CH0505 CON D7gp120 avi/293F/Mon-M8.5
|
17 Participants
|
18 Participants
|
0 Participants
|
16 Participants
|
|
Part B: Occurrence of HIV-specific Binding Antibody (Ab) Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
CH0505.w53.e16.D8gp120/293F-M2.5
|
19 Participants
|
18 Participants
|
0 Participants
|
19 Participants
|
|
Part B: Occurrence of HIV-specific Binding Antibody (Ab) Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
CH0505.w53.e16.D8gp120/293F-M8.5
|
18 Participants
|
18 Participants
|
0 Participants
|
16 Participants
|
|
Part B: Occurrence of HIV-specific Binding Antibody (Ab) Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
CH0505.w78.env33.D8gp120/293F-M2.5
|
19 Participants
|
18 Participants
|
0 Participants
|
19 Participants
|
|
Part B: Occurrence of HIV-specific Binding Antibody (Ab) Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
CH0505.w78.env33.D8gp120/293F-M8.5
|
18 Participants
|
18 Participants
|
0 Participants
|
16 Participants
|
|
Part B: Occurrence of HIV-specific Binding Antibody (Ab) Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
CH505.M5D8gp120/293F-M2.5
|
19 Participants
|
18 Participants
|
0 Participants
|
19 Participants
|
|
Part B: Occurrence of HIV-specific Binding Antibody (Ab) Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
CH505.M5D8gp120/293F-M8.5
|
18 Participants
|
18 Participants
|
0 Participants
|
16 Participants
|
|
Part B: Occurrence of HIV-specific Binding Antibody (Ab) Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
CH505TF D7gp120d371 avi/293F/Mon-M2.5
|
17 Participants
|
17 Participants
|
0 Participants
|
17 Participants
|
|
Part B: Occurrence of HIV-specific Binding Antibody (Ab) Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
CH505TF D8gp120/293F-M2.5
|
19 Participants
|
18 Participants
|
0 Participants
|
19 Participants
|
|
Part B: Occurrence of HIV-specific Binding Antibody (Ab) Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
CH505TF D8gp120/293F-M8.5
|
18 Participants
|
18 Participants
|
0 Participants
|
16 Participants
|
|
Part B: Occurrence of HIV-specific Binding Antibody (Ab) Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
CH505TF.6R.SOSIP.664.v4.1 avi.2-Bio/293F-M2.5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Occurrence of HIV-specific Binding Antibody (Ab) Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
CH505TF.6R.SOSIP.664.v4.1 avi.2-Bio/293F-M8.5
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Part B: Occurrence of HIV-specific Binding Antibody (Ab) Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
CH505TFD8N156KN160K avi/293i Mon-M2.5
|
19 Participants
|
18 Participants
|
0 Participants
|
19 Participants
|
|
Part B: Occurrence of HIV-specific Binding Antibody (Ab) Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
CH505TFD8N156KN160K avi/293i Mon-M8.5
|
18 Participants
|
18 Participants
|
0 Participants
|
16 Participants
|
|
Part B: Occurrence of HIV-specific Binding Antibody (Ab) Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
Con 6 gp120/B-M2.5
|
19 Participants
|
18 Participants
|
0 Participants
|
19 Participants
|
|
Part B: Occurrence of HIV-specific Binding Antibody (Ab) Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
Con 6 gp120/B-M8.5
|
18 Participants
|
18 Participants
|
0 Participants
|
16 Participants
|
|
Part B: Occurrence of HIV-specific Binding Antibody (Ab) Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
Con S gp140 CFI-M8.5
|
18 Participants
|
18 Participants
|
0 Participants
|
16 Participants
|
|
Part B: Occurrence of HIV-specific Binding Antibody (Ab) Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
gp41-M8.5
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Part B: Occurrence of HIV-specific Binding Antibody (Ab) Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
gp70 CH505TF V1V2 N156KN160K avi/293F-M8.5
|
16 Participants
|
16 Participants
|
0 Participants
|
3 Participants
|
|
Part B: Occurrence of HIV-specific Binding Antibody (Ab) Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
gp70 CH505TF V1V2 avi/293F-M2.5
|
11 Participants
|
12 Participants
|
0 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Measured at Month 2.5 and 8.5Population: T5-T8 pptflow. The number of participants analyzed varied across antigens because some participants missed visits and some assays were not performed.
Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation.
Outcome measures
| Measure |
Group 6: Vaccine
n=20 Participants
400mcg CH505TF(m0), 400mcg CH505TF + CH505W53(m2), 400mcg CH505TF + CH505w53 + CH505w78(m4), 400mcg CH505w53 + CH505w78(m8)
|
Group 7: Vaccine
n=20 Participants
400mcg CH505 M5(m0,2,4,8)
|
Group 8: Placebo
n=5 Participants
Placebo(m0,2,4,8)
|
Group 9: Vaccine
n=20 Participants
400mcg CH505TF(m0), 400mcg CH505w53(m2), 400mcg CH505w78(m4)
|
|---|---|---|---|---|
|
Part B: Level of HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
1086C D7gp120.avi/293F-M8.5
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
5.5 relative fluorescence units
Interval 1.8 to 9.5
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
|
Part B: Level of HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
CH0505 CON D7gp120 D368R avi/293F/Mon-M2.5
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
1 relative fluorescence units
Interval 1.0 to 1.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
|
Part B: Level of HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
CH0505 CON D7gp120 avi/293F/Mon-M2.5
|
22000 relative fluorescence units
Interval 17333.8 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
1 relative fluorescence units
Interval 1.0 to 1.0
|
14504.8 relative fluorescence units
Interval 12837.0 to 21318.4
|
|
Part B: Level of HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
CH0505 CON D7gp120 avi/293F/Mon-M8.5
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
1 relative fluorescence units
Interval 1.0 to 1.3
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
|
Part B: Level of HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
CH0505.w53.e16.D8gp120/293F-M2.5
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
1 relative fluorescence units
Interval 1.0 to 3.9
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
|
Part B: Level of HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
CH505TF D7gp120d371 avi/293F/Mon-M2.5
|
11259 relative fluorescence units
Interval 4082.6 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
1 relative fluorescence units
Interval 1.0 to 1.0
|
2967.2 relative fluorescence units
Interval 2258.1 to 6400.6
|
|
Part B: Level of HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
CH505TF D7gp120d371 avi/293F/Mon-M8.5
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
1 relative fluorescence units
Interval 1.0 to 1.0
|
22000 relative fluorescence units
Interval 18546.8 to 22000.0
|
|
Part B: Level of HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
CH505TF D8gp120/293F-M2.5
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
1 relative fluorescence units
Interval 1.0 to 2.0
|
21080.2 relative fluorescence units
Interval 17646.4 to 22000.0
|
|
Part B: Level of HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
Con S gp140 CFI-M2.5
|
22000 relative fluorescence units
Interval 13347.6 to 22000.0
|
22000 relative fluorescence units
Interval 9029.2 to 22000.0
|
12.4 relative fluorescence units
Interval 10.1 to 21.2
|
18984.2 relative fluorescence units
Interval 10654.9 to 22000.0
|
|
Part B: Level of HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
1086C D7gp120.avi/293F-M2.5
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
1.3 relative fluorescence units
Interval 1.0 to 2.2
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
|
Part B: Level of HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
CH0505 CON D7gp120 D368R avi/293F/Mon-M8.5
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
1 relative fluorescence units
Interval 1.0 to 1.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
|
Part B: Level of HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
CH0505.w53.e16.D8gp120/293F-M8.5
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
1 relative fluorescence units
Interval 1.0 to 1.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
|
Part B: Level of HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
CH0505.w78.env33.D8gp120/293F-M2.5
|
22000 relative fluorescence units
Interval 19053.6 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
7.9 relative fluorescence units
Interval 1.0 to 15.0
|
18980.8 relative fluorescence units
Interval 14333.2 to 22000.0
|
|
Part B: Level of HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
CH0505.w78.env33.D8gp120/293F-M8.5
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
1 relative fluorescence units
Interval 1.0 to 1.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
|
Part B: Level of HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
CH505.M5D8gp120/293F-M2.5
|
18160.2 relative fluorescence units
Interval 10113.5 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
1 relative fluorescence units
Interval 1.0 to 1.2
|
7803.2 relative fluorescence units
Interval 7008.0 to 13949.0
|
|
Part B: Level of HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
CH505.M5D8gp120/293F-M8.5
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
3.1 relative fluorescence units
Interval 1.0 to 7.9
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
|
Part B: Level of HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
CH505TF D8gp120/293F-M8.5
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
1 relative fluorescence units
Interval 1.0 to 5.4
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
|
Part B: Level of HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
CH505TF.6R.SOSIP.664.v4.1 avi.2-Bio/293F-M
|
62.2 relative fluorescence units
Interval 39.1 to 145.1
|
102.8 relative fluorescence units
Interval 52.9 to 171.2
|
13.3 relative fluorescence units
Interval 1.0 to 31.4
|
66.2 relative fluorescence units
Interval 47.1 to 106.5
|
|
Part B: Level of HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
CH505TFD8N156KN160K avi/293i Mon-M2.5
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
1 relative fluorescence units
Interval 1.0 to 1.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
|
Part B: Level of HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
CH505TFD8N156KN160K avi/293i Mon-M8.5
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
1 relative fluorescence units
Interval 1.0 to 1.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
|
Part B: Level of HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
Con 6 gp120/B-M2.5
|
9282 relative fluorescence units
Interval 4606.2 to 14634.1
|
9561.8 relative fluorescence units
Interval 4371.1 to 18538.9
|
1.6 relative fluorescence units
Interval 1.0 to 2.7
|
4814 relative fluorescence units
Interval 2969.9 to 7146.2
|
|
Part B: Level of HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
Con 6 gp120/B-M8.5
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
1 relative fluorescence units
Interval 1.0 to 1.6
|
22000 relative fluorescence units
Interval 14436.5 to 22000.0
|
|
Part B: Level of HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
Con S gp140 CFI-M8.5
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
14.6 relative fluorescence units
Interval 11.2 to 28.6
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
|
Part B: Level of HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
gp41-M2.5
|
883.5 relative fluorescence units
Interval 693.0 to 1348.5
|
869.9 relative fluorescence units
Interval 461.2 to 2010.2
|
653.5 relative fluorescence units
Interval 401.6 to 925.6
|
954.1 relative fluorescence units
Interval 637.2 to 1111.2
|
|
Part B: Level of HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
gp41-M8.5
|
822.9 relative fluorescence units
Interval 590.3 to 1094.2
|
960.8 relative fluorescence units
Interval 586.8 to 1979.5
|
722.9 relative fluorescence units
Interval 343.9 to 1211.9
|
872 relative fluorescence units
Interval 652.4 to 2079.4
|
|
Part B: Level of HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
gp70 CH505TF V1V2 N156KN160K avi/293F-M2.5
|
2113.6 relative fluorescence units
Interval 287.2 to 13817.9
|
13829 relative fluorescence units
Interval 1567.1 to 22000.0
|
1 relative fluorescence units
Interval 1.0 to 1.0
|
58 relative fluorescence units
Interval 2.9 to 1037.1
|
|
Part B: Level of HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
gp70 CH505TF V1V2 N156KN160K avi/293F-M8.5
|
13846 relative fluorescence units
Interval 3859.2 to 22000.0
|
22000 relative fluorescence units
Interval 19210.5 to 22000.0
|
1 relative fluorescence units
Interval 1.0 to 1.0
|
71 relative fluorescence units
Interval 1.0 to 733.7
|
|
Part B: Level of HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
gp70 CH505TF V1V2 avi/293F-M2.5
|
3733.6 relative fluorescence units
Interval 512.8 to 13083.2
|
18632.4 relative fluorescence units
Interval 1933.6 to 22000.0
|
1 relative fluorescence units
Interval 1.0 to 1.0
|
170.6 relative fluorescence units
Interval 45.8 to 2765.7
|
|
Part B: Level of HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Second and After the Fourth Vaccinations
gp70 CH505TF V1V2 avi/293F-M8.5
|
22000 relative fluorescence units
Interval 9616.2 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
1 relative fluorescence units
Interval 1.0 to 1.0
|
238.4 relative fluorescence units
Interval 9.3 to 2103.3
|
SECONDARY outcome
Timeframe: No dataPopulation: No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future.
No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: No dataPopulation: No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future.
No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: No dataPopulation: No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future.
No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: No dataPopulation: No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future.
No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: No dataPopulation: No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future.
No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: No dataPopulation: No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future.
No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: No dataPopulation: No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future.
No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at Month 4.5Population: T9 pptflow. The number of participants analyzed varied across antigens because some participants missed visits and some assays were not performed.
Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation.
Outcome measures
| Measure |
Group 6: Vaccine
400mcg CH505TF(m0), 400mcg CH505TF + CH505W53(m2), 400mcg CH505TF + CH505w53 + CH505w78(m4), 400mcg CH505w53 + CH505w78(m8)
|
Group 7: Vaccine
400mcg CH505 M5(m0,2,4,8)
|
Group 8: Placebo
Placebo(m0,2,4,8)
|
Group 9: Vaccine
n=10 Participants
400mcg CH505TF(m0), 400mcg CH505w53(m2), 400mcg CH505w78(m4)
|
|---|---|---|---|---|
|
Part C: Occurrence of HIV-specific IgG Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Final Vaccination
1086C D7gp120.avi/293F-
|
—
|
—
|
—
|
9 Participants
|
|
Part C: Occurrence of HIV-specific IgG Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Final Vaccination
CH0505 CON D7gp120 D368R avi/293F/Mon-
|
—
|
—
|
—
|
9 Participants
|
|
Part C: Occurrence of HIV-specific IgG Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Final Vaccination
CH0505 CON D7gp120 avi/293F/Mon-
|
—
|
—
|
—
|
9 Participants
|
|
Part C: Occurrence of HIV-specific IgG Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Final Vaccination
CH0505.w53.e16.D8gp120/293F-
|
—
|
—
|
—
|
9 Participants
|
|
Part C: Occurrence of HIV-specific IgG Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Final Vaccination
CH0505.w78.env33.D8gp120/293F-
|
—
|
—
|
—
|
9 Participants
|
|
Part C: Occurrence of HIV-specific IgG Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Final Vaccination
CH505.M5D8gp120/293F-
|
—
|
—
|
—
|
9 Participants
|
|
Part C: Occurrence of HIV-specific IgG Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Final Vaccination
CH505TF D7gp120d371 avi/293F/Mon-
|
—
|
—
|
—
|
9 Participants
|
|
Part C: Occurrence of HIV-specific IgG Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Final Vaccination
CH505TF D8gp120/293F-
|
—
|
—
|
—
|
9 Participants
|
|
Part C: Occurrence of HIV-specific IgG Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Final Vaccination
CH505TF.6R.SOSIP.664.v4.1 avi.2-Bio/293F-
|
—
|
—
|
—
|
0 Participants
|
|
Part C: Occurrence of HIV-specific IgG Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Final Vaccination
CH505TFD8N156KN160K avi/293i Mon-
|
—
|
—
|
—
|
9 Participants
|
|
Part C: Occurrence of HIV-specific IgG Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Final Vaccination
Con 6 gp120/B-
|
—
|
—
|
—
|
9 Participants
|
|
Part C: Occurrence of HIV-specific IgG Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Final Vaccination
Con S gp140 CFI-
|
—
|
—
|
—
|
9 Participants
|
|
Part C: Occurrence of HIV-specific IgG Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Final Vaccination
gp41-
|
—
|
—
|
—
|
0 Participants
|
|
Part C: Occurrence of HIV-specific IgG Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Final Vaccination
gp70 CH505TF V1V2 N156KN160K avi/293F-
|
—
|
—
|
—
|
2 Participants
|
|
Part C: Occurrence of HIV-specific IgG Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Final Vaccination
gp70 CH505TF V1V2 avi/293F-
|
—
|
—
|
—
|
4 Participants
|
SECONDARY outcome
Timeframe: Measured at Month 4.5Population: T9 pptflow. The number of participants analyzed varied across antigens because some participants missed visits and some assays were not performed.
Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation.
Outcome measures
| Measure |
Group 6: Vaccine
400mcg CH505TF(m0), 400mcg CH505TF + CH505W53(m2), 400mcg CH505TF + CH505w53 + CH505w78(m4), 400mcg CH505w53 + CH505w78(m8)
|
Group 7: Vaccine
400mcg CH505 M5(m0,2,4,8)
|
Group 8: Placebo
Placebo(m0,2,4,8)
|
Group 9: Vaccine
n=10 Participants
400mcg CH505TF(m0), 400mcg CH505w53(m2), 400mcg CH505w78(m4)
|
|---|---|---|---|---|
|
Part C: Level of HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Final Vaccination
1086C D7gp120.avi/293F-
|
—
|
—
|
—
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
|
Part C: Level of HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Final Vaccination
CH0505 CON D7gp120 D368R avi/293F/Mon-
|
—
|
—
|
—
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
|
Part C: Level of HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Final Vaccination
CH0505 CON D7gp120 avi/293F/Mon-
|
—
|
—
|
—
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
|
Part C: Level of HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Final Vaccination
CH0505.w53.e16.D8gp120/293F-
|
—
|
—
|
—
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
|
Part C: Level of HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Final Vaccination
CH0505.w78.env33.D8gp120/293F-
|
—
|
—
|
—
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
|
Part C: Level of HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Final Vaccination
CH505.M5D8gp120/293F-
|
—
|
—
|
—
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
|
Part C: Level of HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Final Vaccination
CH505TF D7gp120d371 avi/293F/Mon-
|
—
|
—
|
—
|
19028.8 relative fluorescence units
Interval 17237.5 to 22000.0
|
|
Part C: Level of HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Final Vaccination
CH505TF D8gp120/293F-
|
—
|
—
|
—
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
|
Part C: Level of HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Final Vaccination
CH505TF.6R.SOSIP.664.v4.1 avi.2-Bio/293F-
|
—
|
—
|
—
|
119 relative fluorescence units
Interval 82.5 to 172.8
|
|
Part C: Level of HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Final Vaccination
CH505TFD8N156KN160K avi/293i Mon-
|
—
|
—
|
—
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
|
Part C: Level of HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Final Vaccination
Con 6 gp120/B-
|
—
|
—
|
—
|
13534.2 relative fluorescence units
Interval 5899.5 to 21443.8
|
|
Part C: Level of HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Final Vaccination
Con S gp140 CFI-
|
—
|
—
|
—
|
22000 relative fluorescence units
Interval 15609.2 to 22000.0
|
|
Part C: Level of HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Final Vaccination
gp41-
|
—
|
—
|
—
|
546.5 relative fluorescence units
Interval 365.0 to 788.2
|
|
Part C: Level of HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Final Vaccination
gp70 CH505TF V1V2 N156KN160K avi/293F-
|
—
|
—
|
—
|
611.2 relative fluorescence units
Interval 95.8 to 989.5
|
|
Part C: Level of HIV-specific Binding Ab Responses as Assessed by Binding Ab Multiplex Assay 2 Weeks After the Final Vaccination
gp70 CH505TF V1V2 avi/293F-
|
—
|
—
|
—
|
1202.2 relative fluorescence units
Interval 204.5 to 1611.0
|
SECONDARY outcome
Timeframe: No dataPopulation: No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future.
No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: No dataPopulation: No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future.
No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: No dataPopulation: No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future.
No data are available. The protocol-specified assays required to generate these data were not performed due to insufficient remaining funds at the end of the study, unrelated to participant safety or study conduct issues. Prespecified measurement values were not obtained and they will not be collected in the future.
Outcome measures
Outcome data not reported
Adverse Events
Group 4: Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Group 5: Vaccine
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Group 6: Vaccine
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Group 7: Vaccine
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Group 8: Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 9: Vaccine
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Group 1: Vaccine
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Group 2: Vaccine
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Group 3: Vaccine
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 4: Placebo
n=6 participants at risk
Placebo for CH505TF mo(0,2,4,8,12)
|
Group 5: Vaccine
n=20 participants at risk
400mcg CH505TF(m0), 400mcg CH505w53(
|
Group 6: Vaccine
n=20 participants at risk
400mcg CH505TF(m0), 400mcg CH505TF +
|
Group 7: Vaccine
n=20 participants at risk
400mcg CH505 M5(m0,2,4,8)
|
Group 8: Placebo
n=5 participants at risk
Placebo(m0,2,4,8)
|
Group 9: Vaccine
n=10 participants at risk
400mcg CH505TF(m0), 400mcg CH505w53(
|
Group 1: Vaccine
n=12 participants at risk
20 mcg CH505TF mo(0,2,4,8,12)
|
Group 2: Vaccine
n=12 participants at risk
100 mcg CH505TF mo(0,2,4,8,12)
|
Group 3: Vaccine
n=12 participants at risk
400 mcg CH505TF mo(0,2,4,8,12)
|
|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Any Event in SOC
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Nervous system disorders
Seizure
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Psychiatric disorders
Any Event in SOC
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 3 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 3 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
Other adverse events
| Measure |
Group 4: Placebo
n=6 participants at risk
Placebo for CH505TF mo(0,2,4,8,12)
|
Group 5: Vaccine
n=20 participants at risk
400mcg CH505TF(m0), 400mcg CH505w53(
|
Group 6: Vaccine
n=20 participants at risk
400mcg CH505TF(m0), 400mcg CH505TF +
|
Group 7: Vaccine
n=20 participants at risk
400mcg CH505 M5(m0,2,4,8)
|
Group 8: Placebo
n=5 participants at risk
Placebo(m0,2,4,8)
|
Group 9: Vaccine
n=10 participants at risk
400mcg CH505TF(m0), 400mcg CH505w53(
|
Group 1: Vaccine
n=12 participants at risk
20 mcg CH505TF mo(0,2,4,8,12)
|
Group 2: Vaccine
n=12 participants at risk
100 mcg CH505TF mo(0,2,4,8,12)
|
Group 3: Vaccine
n=12 participants at risk
400 mcg CH505TF mo(0,2,4,8,12)
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Any Event in SOC
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
10.0%
2/20 • Number of events 5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 3 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Cardiac disorders
Any Event in SOC
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Cardiac disorders
Postural orthostatic tachycardia syndrome
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Congenital, familial and genetic disorders
Any Event in SOC
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Congenital, familial and genetic disorders
Dermoid cyst
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Ear and labyrinth disorders
Any Event in SOC
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Endocrine disorders
Any Event in SOC
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Endocrine disorders
Hypogonadism
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Gastrointestinal disorders
Any Event in SOC
|
16.7%
1/6 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
30.0%
6/20 • Number of events 6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
20.0%
4/20 • Number of events 5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
10.0%
2/20 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
10.0%
1/10 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
16.7%
1/6 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
10.0%
1/10 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
General disorders
Any Event in SOC
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
10.0%
2/20 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
20.0%
4/20 • Number of events 5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
20.0%
2/10 • Number of events 5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
General disorders
Fatigue
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
10.0%
1/10 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
General disorders
Injection site pruritus
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
10.0%
2/20 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
15.0%
3/20 • Number of events 4 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
20.0%
2/10 • Number of events 4 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Immune system disorders
Any Event in SOC
|
16.7%
1/6 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
16.7%
2/12 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Immune system disorders
Allergy to animal
|
16.7%
1/6 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
16.7%
2/12 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Infections and infestations
Any Event in SOC
|
50.0%
3/6 • Number of events 6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
60.0%
12/20 • Number of events 25 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
65.0%
13/20 • Number of events 21 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
45.0%
9/20 • Number of events 10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
40.0%
2/5 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
60.0%
6/10 • Number of events 7 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
25.0%
3/12 • Number of events 3 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
41.7%
5/12 • Number of events 8 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
25.0%
3/12 • Number of events 5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
10.0%
1/10 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Infections and infestations
COVID-19
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
25.0%
5/20 • Number of events 6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
30.0%
6/20 • Number of events 6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
15.0%
3/20 • Number of events 3 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
40.0%
2/5 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
30.0%
3/10 • Number of events 3 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Infections and infestations
Ear infection
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Infections and infestations
Epididymitis
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Infections and infestations
Fungal infection
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Infections and infestations
Genitourinary chlamydia infection
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Infections and infestations
Influenza
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
10.0%
2/20 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Infections and infestations
Injection site cellulitis
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Infections and infestations
Latent syphilis
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Infections and infestations
Oral herpes
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Infections and infestations
Otitis externa
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Infections and infestations
Paronychia
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
10.0%
1/10 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
10.0%
2/20 • Number of events 3 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Infections and infestations
Sinusitis
|
16.7%
1/6 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
10.0%
2/20 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Infections and infestations
Sinusitis bacterial
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Infections and infestations
Suspected COVID-19
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Infections and infestations
Tinea cruris
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
10.0%
1/10 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
1/6 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
20.0%
4/20 • Number of events 4 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
10.0%
2/20 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
10.0%
1/10 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
33.3%
4/12 • Number of events 4 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Infections and infestations
Urinary tract infection
|
16.7%
1/6 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Infections and infestations
Viral infection
|
33.3%
2/6 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
10.0%
2/20 • Number of events 3 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
10.0%
2/20 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Injury, poisoning and procedural complications
Any Event in SOC
|
33.3%
2/6 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
10.0%
2/20 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
15.0%
3/20 • Number of events 3 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
10.0%
1/10 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Injury, poisoning and procedural complications
Contusion
|
16.7%
1/6 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Investigations
Blood iron decreased
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
16.7%
1/6 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Nervous system disorders
Migraine
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
10.0%
1/10 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Investigations
Any Event in SOC
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
15.0%
3/20 • Number of events 4 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
25.0%
5/20 • Number of events 8 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
15.0%
3/20 • Number of events 4 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
20.0%
1/5 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
33.3%
4/12 • Number of events 8 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
16.7%
2/12 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
10.0%
2/20 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
10.0%
2/20 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
16.7%
2/12 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Investigations
Blood creatinine increased
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
20.0%
1/5 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
16.7%
2/12 • Number of events 4 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Investigations
Blood pressure increased
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
10.0%
2/20 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 3 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Investigations
Full blood count abnormal
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
20.0%
1/5 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Metabolism and nutrition disorders
Any Event in SOC
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Musculoskeletal and connective tissue disorders
Any Event in SOC
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
10.0%
2/20 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
20.0%
4/20 • Number of events 4 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
20.0%
1/5 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
20.0%
1/5 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Nervous system disorders
Any Event in SOC
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
10.0%
1/10 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
10.0%
1/10 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Psychiatric disorders
Any Event in SOC
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
10.0%
2/20 • Number of events 3 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Psychiatric disorders
Generalised anxiety disorder
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Renal and urinary disorders
Any Event in SOC
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
10.0%
2/20 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
10.0%
2/20 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Reproductive system and breast disorders
Any Event in SOC
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
20.0%
1/5 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
20.0%
1/5 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Respiratory, thoracic and mediastinal disorders
Any Event in SOC
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
10.0%
2/20 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Skin and subcutaneous tissue disorders
Any Event in SOC
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
16.7%
2/12 • Number of events 4 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Skin and subcutaneous tissue disorders
Keratosis pilaris
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
8.3%
1/12 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Social circumstances
Any Event in SOC
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
|
Social circumstances
Victim of sexual abuse
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
5.0%
1/20 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/20 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/5 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
|
Additional Information
Jessica Andriesen, PhD, Associate Director of HVTN SDMC Operations
Fred Hutchinson Cancer Research Center
Phone: 206-667-5812
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place