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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: 2024-05-21

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

2024-05-21

Participant Flow

Participant milestones

Participant milestones
Measure
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(
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(
Overall Study
STARTED
12
12
12
6
20
20
20
5
10
Overall Study
Month 4.5 Immunogenicity Cohort
11
12
12
3
19
20
19
4
9
Overall Study
COMPLETED
9
10
11
3
19
20
18
4
10
Overall Study
NOT COMPLETED
3
2
1
3
1
0
2
1
0

Reasons for withdrawal

Reasons for withdrawal
Measure
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(
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(
Overall Study
Lost to Follow-up
2
2
0
3
1
0
2
1
0
Overall Study
Withdrawal by Subject
1
0
1
0
0
0
0
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

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=5 Participants
31 years
n=7 Participants
27 years
n=5 Participants
28 years
n=4 Participants
29 years
n=21 Participants
28 years
n=8 Participants
28 years
n=8 Participants
23 years
n=24 Participants
30 years
n=42 Participants
28 years
n=42 Participants
Age, Customized
Less than 18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
Age, Customized
18 - 20 years
1 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
1 Participants
n=4 Participants
0 Participants
n=21 Participants
2 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
2 Participants
n=42 Participants
8 Participants
n=42 Participants
Age, Customized
21 - 30 years
4 Participants
n=5 Participants
5 Participants
n=7 Participants
7 Participants
n=5 Participants
4 Participants
n=4 Participants
12 Participants
n=21 Participants
11 Participants
n=8 Participants
11 Participants
n=8 Participants
4 Participants
n=24 Participants
4 Participants
n=42 Participants
62 Participants
n=42 Participants
Age, Customized
31 - 40 years
5 Participants
n=5 Participants
4 Participants
n=7 Participants
2 Participants
n=5 Participants
0 Participants
n=4 Participants
6 Participants
n=21 Participants
5 Participants
n=8 Participants
7 Participants
n=8 Participants
1 Participants
n=24 Participants
3 Participants
n=42 Participants
33 Participants
n=42 Participants
Age, Customized
41 - 50 years
2 Participants
n=5 Participants
2 Participants
n=7 Participants
2 Participants
n=5 Participants
1 Participants
n=4 Participants
2 Participants
n=21 Participants
2 Participants
n=8 Participants
2 Participants
n=8 Participants
0 Participants
n=24 Participants
1 Participants
n=42 Participants
14 Participants
n=42 Participants
Age, Customized
Above 50 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
Age, Customized
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
Sex: Female, Male
Female
5 Participants
n=5 Participants
5 Participants
n=7 Participants
4 Participants
n=5 Participants
3 Participants
n=4 Participants
7 Participants
n=21 Participants
9 Participants
n=8 Participants
8 Participants
n=8 Participants
2 Participants
n=24 Participants
5 Participants
n=42 Participants
48 Participants
n=42 Participants
Sex: Female, Male
Male
7 Participants
n=5 Participants
7 Participants
n=7 Participants
8 Participants
n=5 Participants
3 Participants
n=4 Participants
13 Participants
n=21 Participants
11 Participants
n=8 Participants
12 Participants
n=8 Participants
3 Participants
n=24 Participants
5 Participants
n=42 Participants
69 Participants
n=42 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
1 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
3 Participants
n=21 Participants
3 Participants
n=8 Participants
5 Participants
n=8 Participants
2 Participants
n=24 Participants
2 Participants
n=42 Participants
16 Participants
n=42 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
12 Participants
n=5 Participants
11 Participants
n=7 Participants
12 Participants
n=5 Participants
6 Participants
n=4 Participants
17 Participants
n=21 Participants
17 Participants
n=8 Participants
15 Participants
n=8 Participants
3 Participants
n=24 Participants
8 Participants
n=42 Participants
101 Participants
n=42 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
1 Participants
n=7 Participants
3 Participants
n=5 Participants
0 Participants
n=4 Participants
2 Participants
n=21 Participants
0 Participants
n=8 Participants
2 Participants
n=8 Participants
1 Participants
n=24 Participants
1 Participants
n=42 Participants
10 Participants
n=42 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
Race (NIH/OMB)
Black or African American
3 Participants
n=5 Participants
1 Participants
n=7 Participants
3 Participants
n=5 Participants
1 Participants
n=4 Participants
1 Participants
n=21 Participants
1 Participants
n=8 Participants
3 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
13 Participants
n=42 Participants
Race (NIH/OMB)
White
8 Participants
n=5 Participants
8 Participants
n=7 Participants
6 Participants
n=5 Participants
4 Participants
n=4 Participants
17 Participants
n=21 Participants
16 Participants
n=8 Participants
14 Participants
n=8 Participants
4 Participants
n=24 Participants
7 Participants
n=42 Participants
84 Participants
n=42 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=5 Participants
2 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
0 Participants
n=21 Participants
3 Participants
n=8 Participants
1 Participants
n=8 Participants
0 Participants
n=24 Participants
2 Participants
n=42 Participants
10 Participants
n=42 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
Region of Enrollment
USA
12 Participants
n=5 Participants
12 Participants
n=7 Participants
12 Participants
n=5 Participants
6 Participants
n=4 Participants
20 Participants
n=21 Participants
20 Participants
n=8 Participants
20 Participants
n=8 Participants
5 Participants
n=24 Participants
10 Participants
n=42 Participants
117 Participants
n=42 Participants

PRIMARY outcome

Timeframe: Measured through Month Measured through 7 days after the vaccination at Month 0, 2, 4, 8, 12

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.

Outcome measures

Outcome measures
Measure
Part A, Group 1: Vaccine
n=12 Participants
20 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 2: Vaccine
n=12 Participants
100 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 3: Vaccine
n=12 Participants
400 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 4: Placebo
n=6 Participants
Placebo for CH505TF mo(0,2,4,8,12)
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
11 Participants
9 Participants
11 Participants
6 Participants
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime
Erythema and/or Induration · Moderate
1 Participants
2 Participants
0 Participants
0 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
Erythema and/or Induration · Severe
0 Participants
1 Participants
1 Participants
0 Participants
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime
Induration/Swelling · Moderate
1 Participants
2 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
1 Participants
0 Participants
2 Participants
5 Participants
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime
Pain · Mild
7 Participants
8 Participants
6 Participants
1 Participants
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime
Pain · Moderate
3 Participants
4 Participants
4 Participants
0 Participants
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime
Pain · Severe
1 Participants
0 Participants
0 Participants
0 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
1 Participants
3 Participants
0 Participants
6 Participants
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime
Tenderness · Mild
6 Participants
5 Participants
7 Participants
0 Participants
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime
Tenderness · Moderate
5 Participants
4 Participants
5 Participants
0 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
1 Participants
0 Participants
0 Participants
5 Participants
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime
Pain and/or Tenderness · Mild
6 Participants
7 Participants
7 Participants
1 Participants
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime
Pain and/or Tenderness · Moderate
4 Participants
5 Participants
5 Participants
0 Participants
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime
Pain and/or Tenderness · Severe
1 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 · 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 · None
10 Participants
9 Participants
10 Participants
5 Participants
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime
Erythema/Redness · Mild
1 Participants
2 Participants
1 Participants
1 Participants
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime
Erythema/Redness · Moderate
1 Participants
0 Participants
0 Participants
0 Participants
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime
Erythema/Redness · Severe
0 Participants
1 Participants
1 Participants
0 Participants
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime
Induration/Swelling · Severe
0 Participants
1 Participants
1 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
10 Participants
8 Participants
10 Participants
5 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

PRIMARY outcome

Timeframe: Measured through Month Measured through 7 days after the vaccination at Month 0, 2, 4, 8, 12

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.

Outcome measures

Outcome measures
Measure
Part A, Group 1: Vaccine
n=12 Participants
20 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 2: Vaccine
n=12 Participants
100 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 3: Vaccine
n=12 Participants
400 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 4: Placebo
n=6 Participants
Placebo for CH505TF mo(0,2,4,8,12)
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
Malaise and/or fatigue · None
5 Participants
4 Participants
5 Participants
4 Participants
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Malaise and/or fatigue · Mild
3 Participants
4 Participants
5 Participants
2 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
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
12 Participants
10 Participants
11 Participants
6 Participants
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Temperature · Mild
0 Participants
1 Participants
1 Participants
0 Participants
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Temperature · Moderate
0 Participants
1 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
Chills · None
10 Participants
11 Participants
11 Participants
5 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
1 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
7 Participants
8 Participants
10 Participants
5 Participants
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Arthralgia · Mild
4 Participants
3 Participants
1 Participants
1 Participants
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Arthralgia · Moderate
1 Participants
1 Participants
1 Participants
0 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
4 Participants
2 Participants
3 Participants
3 Participants
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Max. Systemic Symptoms · Mild
4 Participants
5 Participants
5 Participants
2 Participants
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Max. Systemic Symptoms · Moderate
4 Participants
4 Participants
3 Participants
1 Participants
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Max. Systemic Symptoms · Severe
0 Participants
1 Participants
1 Participants
0 Participants
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Malaise and/or fatigue · Moderate
4 Participants
4 Participants
2 Participants
0 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
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
6 Participants
7 Participants
9 Participants
6 Participants
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Myalgia · Mild
4 Participants
4 Participants
2 Participants
0 Participants
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Myalgia · Moderate
2 Participants
1 Participants
1 Participants
0 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
8 Participants
7 Participants
6 Participants
5 Participants
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Headache · Mild
2 Participants
4 Participants
4 Participants
1 Participants
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Headache · Moderate
2 Participants
0 Participants
1 Participants
0 Participants
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Headache · Severe
0 Participants
1 Participants
1 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
9 Participants
10 Participants
11 Participants
5 Participants
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Nausea · Mild
2 Participants
2 Participants
0 Participants
0 Participants
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Nausea · Moderate
1 Participants
0 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
12 Participants
5 Participants
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime
Vomiting · Mild
0 Participants
0 Participants
0 Participants
1 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
Vomiting · Potentially Life-threatening
0 Participants
0 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: Measured through Month 24

From the study termination form, early termination reasons associated with an AE or reactogenicity are tabulated by treatment arm

Outcome measures

Outcome measures
Measure
Part A, Group 1: Vaccine
n=12 Participants
20 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 2: Vaccine
n=12 Participants
100 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 3: Vaccine
n=12 Participants
400 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 4: Placebo
n=6 Participants
Placebo for CH505TF mo(0,2,4,8,12)
Part A: 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 12 boost

From the study product discontinuation form, study product administration reasons are tabulated by treatment arm

Outcome measures

Outcome measures
Measure
Part A, Group 1: Vaccine
n=12 Participants
20 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 2: Vaccine
n=12 Participants
100 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 3: Vaccine
n=12 Participants
400 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 4: Placebo
n=6 Participants
Placebo for CH505TF mo(0,2,4,8,12)
Part A: Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
Clinical Event
1 Participants
1 Participants
0 Participants
0 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
2 Participants
1 Participants
2 Participants
Part A: Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
No discontinuation
9 Participants
9 Participants
11 Participants
4 Participants

PRIMARY outcome

Timeframe: Measured during screening, and 2 weeks after each vaccination at Month 0, 2, 4, 8, 12, and at Month 15

Population: 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

Outcome measures
Measure
Part A, Group 1: Vaccine
n=12 Participants
20 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 2: Vaccine
n=12 Participants
100 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 3: Vaccine
n=12 Participants
400 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 4: Placebo
n=6 Participants
Placebo for CH505TF mo(0,2,4,8,12)
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
AST (U/L)- Day 126
20 U/L
Interval 19.0 to 25.0
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
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
AST (U/L)- Day 14
23.5 U/L
Interval 19.0 to 27.0
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
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
AST (U/L)- Day 70
22 U/L
Interval 19.0 to 27.0
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
Part A: 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 13.0 to 24.5
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
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
ALT (SGPT) (U/L)- Day 14
19 U/L
Interval 13.0 to 25.5
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
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
ALT (SGPT) (U/L)- Day 70
19 U/L
Interval 13.0 to 26.0
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
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
ALT (SGPT) (U/L)- Day 126
18 U/L
Interval 15.0 to 23.0
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
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
ALT (SGPT) (U/L)- Day 238
16 U/L
Interval 13.0 to 23.0
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
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
ALT (SGPT) (U/L)- Day 378
16 U/L
Interval 15.0 to 19.0
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
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
ALT (SGPT) (U/L)- Day 455
20.5 U/L
Interval 12.0 to 30.0
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
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
AST (U/L)- Screening
24.5 U/L
Interval 18.5 to 35.5
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
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
AST (U/L)- Day 238
22 U/L
Interval 19.0 to 25.0
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
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
AST (U/L)- Day 378
22 U/L
Interval 17.0 to 27.0
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
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
AST (U/L)- Day 455
20 U/L
Interval 17.0 to 33.0
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
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
Alkaline Phosphatase (U/L)- Screening
64.5 U/L
Interval 52.0 to 71.5
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
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
Alkaline Phosphatase (U/L)- Day 14
61.5 U/L
Interval 51.5 to 68.0
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
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
Alkaline Phosphatase (U/L)- Day 70
60 U/L
Interval 48.0 to 70.0
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
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
Alkaline Phosphatase (U/L)- Day 126
65 U/L
Interval 49.0 to 74.0
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
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
Alkaline Phosphatase (U/L)- Day 238
66 U/L
Interval 50.0 to 79.0
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
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
Alkaline Phosphatase (U/L)- Day 378
69 U/L
Interval 61.0 to 71.0
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
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
Alkaline Phosphatase (U/L)- Day 455
61.5 U/L
Interval 59.0 to 82.0
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

PRIMARY outcome

Timeframe: Measured during screening, and 2 weeks after each vaccination at Month 0, 2, 4, 8, 12, and at Month 15

Population: 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

Outcome measures
Measure
Part A, Group 1: Vaccine
n=12 Participants
20 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 2: Vaccine
n=12 Participants
100 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 3: Vaccine
n=12 Participants
400 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 4: Placebo
n=6 Participants
Placebo for CH505TF mo(0,2,4,8,12)
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Hemoglobin (g/dL)- Screening
14 g/dL
Interval 13.55 to 14.9
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
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 13.0 to 14.7
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
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Hemoglobin (g/dL)- Day 70
14 g/dL
Interval 13.4 to 15.3
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
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Hemoglobin (g/dL)- Day 126
13.7 g/dL
Interval 13.4 to 15.4
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
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Hemoglobin (g/dL)- Day 238
13.8 g/dL
Interval 13.3 to 14.6
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
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Hemoglobin (g/dL)- Day 378
13.8 g/dL
Interval 13.7 to 15.0
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
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 13.6 to 15.0
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
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Creatinine (g/dL)- Screening
0.000885 g/dL
Interval 0.000775 to 0.00102
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
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Creatinine (g/dL)- Day 14
0.00081 g/dL
Interval 0.0008 to 0.001
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
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Creatinine (g/dL)- Day 70
0.0009 g/dL
Interval 0.00078 to 0.00097
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
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Creatinine (g/dL)- Day 126
0.00088 g/dL
Interval 0.0008 to 0.00102
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
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Creatinine (g/dL)- Day 238
0.00084 g/dL
Interval 0.00072 to 0.00104
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
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Creatinine (g/dL)- Day 378
0.00085 g/dL
Interval 0.0008 to 0.00094
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
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Creatinine (g/dL)- Day 455
0.0008 g/dL
Interval 0.00076 to 0.00094
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

PRIMARY outcome

Timeframe: Measured during screening, and 2 weeks after each vaccination at Month 0, 2, 4, 8, 12, and at Month 15

Population: 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

Outcome measures
Measure
Part A, Group 1: Vaccine
n=12 Participants
20 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 2: Vaccine
n=12 Participants
100 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 3: Vaccine
n=12 Participants
400 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 4: Placebo
n=6 Participants
Placebo for CH505TF mo(0,2,4,8,12)
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils
Platelets (1000 cells per mm^3)- Day 70
231 1000 cells per mm^3
Interval 215.4 to 263.2
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
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils
Platelets (1000 cells per mm^3)- Day 126
251 1000 cells per mm^3
Interval 214.0 to 273.0
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
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils
Platelets (1000 cells per mm^3)- Screening
226.5 1000 cells per mm^3
Interval 196.0 to 270.0
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
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils
Platelets (1000 cells per mm^3)- Day 14
243 1000 cells per mm^3
Interval 192.0 to 265.75
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
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils
Platelets (1000 cells per mm^3)- Day 238
250 1000 cells per mm^3
Interval 199.0 to 262.0
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
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils
Platelets (1000 cells per mm^3)- Day 378
252 1000 cells per mm^3
Interval 215.1 to 266.0
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
Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils
Platelets (1000 cells per mm^3)- Day 455
236 1000 cells per mm^3
Interval 222.0 to 248.0
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

PRIMARY outcome

Timeframe: Measured at Month 4.5

Population: "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

Outcome measures
Measure
Part A, Group 1: Vaccine
n=12 Participants
20 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 2: Vaccine
n=12 Participants
100 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 3: Vaccine
n=12 Participants
400 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 4: Placebo
n=6 Participants
Placebo for CH505TF mo(0,2,4,8,12)
Part A: Occurrence of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120
CH505TFD8N156KN160K_avi/293i Mon at Month 4.5
8 Participants
8 Participants
9 Participants
0 Participants
Part A: Occurrence of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120
Con 6 gp120/B at Month 4.5
8 Participants
8 Participants
9 Participants
0 Participants
Part A: Occurrence of HIV-specific 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 IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120
CH0505_CON D7gp120_avi/293F/Mon at Month 4.5
8 Participants
8 Participants
9 Participants
0 Participants
Part A: Occurrence of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120
1086C_D7gp120.avi/293F at Month 4.5
8 Participants
8 Participants
9 Participants
0 Participants
Part A: Occurrence 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
8 Participants
8 Participants
9 Participants
0 Participants
Part A: Occurrence of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120
CH505TF D7gp120d371_avi/293F/Mon at Month 4.5
8 Participants
8 Participants
9 Participants
0 Participants
Part A: Occurrence of HIV-specific IgG Responses 2 Weeks After the Third Vaccination With CH505TF gp120
Con S gp140 CFI at Month 4.5
8 Participants
8 Participants
8 Participants
0 Participants

PRIMARY outcome

Timeframe: Measured at Month 4.5

Population: "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

Outcome measures
Measure
Part A, Group 1: Vaccine
n=12 Participants
20 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 2: Vaccine
n=12 Participants
100 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 3: Vaccine
n=12 Participants
400 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 4: Placebo
n=6 Participants
Placebo for CH505TF mo(0,2,4,8,12)
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
27266.375 relative fluorescence units
Interval 24133.25 to 29136.875
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
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
24789.25 relative fluorescence units
Interval 18116.75 to 27759.25
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
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
21460.5 relative fluorescence units
Interval 13024.375 to 27776.375
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
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
11897.375 relative fluorescence units
Interval 782.875 to 25171.625
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
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
5229.75 relative fluorescence units
Interval 1455.375 to 26839.375
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
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 2.375
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
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
15775.25 relative fluorescence units
Interval 6227.25 to 26555.0
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
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
10859.875 relative fluorescence units
Interval 1526.375 to 24698.625
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

PRIMARY outcome

Timeframe: Measured at Month 4.5

Population: "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

Outcome measures
Measure
Part A, Group 1: Vaccine
n=12 Participants
20 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 2: Vaccine
n=12 Participants
100 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 3: Vaccine
n=12 Participants
400 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 4: Placebo
n=6 Participants
Placebo for CH505TF mo(0,2,4,8,12)
Part A: Occurrence of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120
Con 6 gp120/B at Month 4.5
3 Participants
2 Participants
4 Participants
0 Participants
Part A: Occurrence of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120
CH505TFD8N156KN160K_avi/293i Mon at Month 4.5
8 Participants
6 Participants
9 Participants
0 Participants
Part A: Occurrence 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
8 Participants
6 Participants
9 Participants
0 Participants
Part A: Occurrence of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120
1086C_D7gp120.avi/293F at Month 4.5
8 Participants
6 Participants
11 Participants
0 Participants
Part A: Occurrence of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120
Con S gp140 CFI at Month 4.5
4 Participants
3 Participants
4 Participants
0 Participants
Part A: Occurrence of HIV-specific IgA 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 IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120
CH0505_CON D7gp120_avi/293F/Mon at Month 4.5
8 Participants
4 Participants
8 Participants
0 Participants
Part A: Occurrence of HIV-specific IgA Responses 2 Weeks After the Third Vaccination With CH505TF gp120
CH505TF D7gp120d371_avi/293F/Mon at Month 4.5
5 Participants
3 Participants
5 Participants
0 Participants

PRIMARY outcome

Timeframe: Measured at Month 4.5

Population: "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

Outcome measures
Measure
Part A, Group 1: Vaccine
n=12 Participants
20 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 2: Vaccine
n=12 Participants
100 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 3: Vaccine
n=12 Participants
400 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 4: Placebo
n=6 Participants
Placebo for CH505TF mo(0,2,4,8,12)
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
1812 relative fluorescence units
Interval 315.0 to 4170.25
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
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
684.375 relative fluorescence units
Interval 162.25 to 1813.0
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
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
174.625 relative fluorescence units
Interval 1.0 to 490.25
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
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
1142.5 relative fluorescence units
Interval 256.25 to 2757.0
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
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
18.25 relative fluorescence units
Interval 1.0 to 164.75
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
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
14.25 relative fluorescence units
Interval 1.0 to 347.75
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
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 8.75
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
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
1379.5 relative fluorescence units
Interval 114.25 to 7947.5
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

PRIMARY outcome

Timeframe: Measured through Month Measured through Month Measured through 7 days after the vaccination at Month 0, 2, 4, 8

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.

Outcome measures

Outcome measures
Measure
Part A, Group 1: Vaccine
n=20 Participants
20 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 2: Vaccine
n=20 Participants
100 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 3: Vaccine
n=20 Participants
400 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 4: Placebo
n=5 Participants
Placebo for CH505TF mo(0,2,4,8,12)
Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms
Pain · None
4 Participants
3 Participants
0 Participants
4 Participants
Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms
Pain · Mild
9 Participants
12 Participants
14 Participants
1 Participants
Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms
Pain · Moderate
5 Participants
5 Participants
4 Participants
0 Participants
Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms
Pain · Severe
2 Participants
0 Participants
2 Participants
0 Participants
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
2 Participants
0 Participants
0 Participants
3 Participants
Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms
Tenderness · Mild
11 Participants
17 Participants
14 Participants
2 Participants
Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms
Tenderness · Moderate
6 Participants
2 Participants
5 Participants
0 Participants
Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms
Tenderness · Severe
1 Participants
1 Participants
1 Participants
0 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
2 Participants
0 Participants
0 Participants
3 Participants
Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms
Pain and/or Tenderness · Moderate
6 Participants
6 Participants
5 Participants
0 Participants
Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms
Pain and/or Tenderness · Severe
2 Participants
1 Participants
2 Participants
0 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
15 Participants
16 Participants
13 Participants
5 Participants
Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema/Redness · Severe
2 Participants
0 Participants
2 Participants
0 Participants
Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms
Induration/Swelling · Mild
1 Participants
2 Participants
1 Participants
0 Participants
Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms
Induration/Swelling · Moderate
4 Participants
2 Participants
3 Participants
0 Participants
Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms
Induration/Swelling · Severe
1 Participants
1 Participants
2 Participants
0 Participants
Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema and/or Induration · Severe
2 Participants
1 Participants
3 Participants
0 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 and/or Tenderness · Mild
10 Participants
13 Participants
13 Participants
2 Participants
Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema/Redness · Mild
1 Participants
3 Participants
2 Participants
0 Participants
Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema/Redness · Moderate
2 Participants
1 Participants
3 Participants
0 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
14 Participants
15 Participants
14 Participants
5 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 · None
14 Participants
15 Participants
12 Participants
5 Participants
Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema and/or Induration · Mild
1 Participants
2 Participants
3 Participants
0 Participants
Number of Part B Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema and/or Induration · Moderate
3 Participants
2 Participants
2 Participants
0 Participants

PRIMARY outcome

Timeframe: Measured through Month Measured through Month Measured through 7 days after the vaccination at Month 0, 2, 4, 8

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.

Outcome measures

Outcome measures
Measure
Part A, Group 1: Vaccine
n=20 Participants
20 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 2: Vaccine
n=20 Participants
100 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 3: Vaccine
n=20 Participants
400 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 4: Placebo
n=5 Participants
Placebo for CH505TF mo(0,2,4,8,12)
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Mild
8 Participants
9 Participants
8 Participants
3 Participants
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Moderate
6 Participants
5 Participants
4 Participants
0 Participants
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Severe
3 Participants
1 Participants
1 Participants
0 Participants
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · None
11 Participants
8 Participants
6 Participants
4 Participants
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Mild
1 Participants
8 Participants
9 Participants
0 Participants
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Moderate
7 Participants
4 Participants
5 Participants
1 Participants
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · None
8 Participants
9 Participants
6 Participants
2 Participants
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Severe
1 Participants
0 Participants
0 Participants
0 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
12 Participants
15 Participants
14 Participants
4 Participants
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Mild
7 Participants
4 Participants
5 Participants
1 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 · 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
Chills · None
12 Participants
14 Participants
12 Participants
5 Participants
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Mild
5 Participants
6 Participants
6 Participants
0 Participants
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Severe
1 Participants
0 Participants
0 Participants
0 Participants
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · None
12 Participants
17 Participants
15 Participants
5 Participants
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Mild
5 Participants
3 Participants
4 Participants
0 Participants
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Moderate
2 Participants
0 Participants
1 Participants
0 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 · None
5 Participants
1 Participants
1 Participants
1 Participants
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Mild
4 Participants
11 Participants
11 Participants
3 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
17 Participants
19 Participants
18 Participants
5 Participants
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Mild
2 Participants
1 Participants
2 Participants
0 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
Malaise and/or fatigue · None
7 Participants
5 Participants
3 Participants
3 Participants
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Mild
4 Participants
9 Participants
12 Participants
2 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
Myalgia · Severe
1 Participants
0 Participants
0 Participants
0 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 · Moderate
3 Participants
2 Participants
6 Participants
0 Participants
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Moderate
1 Participants
1 Participants
1 Participants
0 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
19 Participants
20 Participants
20 Participants
5 Participants
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Vomiting · Moderate
1 Participants
0 Participants
0 Participants
0 Participants
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Moderate
2 Participants
0 Participants
2 Participants
0 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
1 Participants
0 Participants
0 Participants
0 Participants
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Moderate
8 Participants
7 Participants
7 Participants
1 Participants
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Severe
3 Participants
1 Participants
1 Participants
0 Participants
Number of Part B Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Moderate
1 Participants
0 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: Measured through Month 20

From the study termination form, early termination reasons associated with an AE or reactogenicity are tabulated by treatment arm

Outcome measures

Outcome measures
Measure
Part A, Group 1: Vaccine
n=20 Participants
20 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 2: Vaccine
n=20 Participants
100 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 3: Vaccine
n=20 Participants
400 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 4: Placebo
n=5 Participants
Placebo for CH505TF mo(0,2,4,8,12)
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 boost

Population: Safety population

From the study product discontinuation form, study product administration reasons are tabulated by treatment arm

Outcome measures

Outcome measures
Measure
Part A, Group 1: Vaccine
n=20 Participants
20 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 2: Vaccine
n=20 Participants
100 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 3: Vaccine
n=20 Participants
400 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 4: Placebo
n=5 Participants
Placebo for CH505TF mo(0,2,4,8,12)
Number of Part B Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
Reactogenicity symptoms
1 Participants
0 Participants
0 Participants
0 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
1 Participants
0 Participants
0 Participants
0 Participants
Number of Part B Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
Lost to Follow-Up
1 Participants
0 Participants
0 Participants
1 Participants
Number of Part B Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
Did not discontinue SPA
17 Participants
20 Participants
20 Participants
4 Participants

PRIMARY outcome

Timeframe: Measured during screening, and 2 weeks after each vaccination at Month 0, 2, 4, 8, and at Month 11

Population: 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

Outcome measures
Measure
Part A, Group 1: Vaccine
n=20 Participants
20 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 2: Vaccine
n=20 Participants
100 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 3: Vaccine
n=20 Participants
400 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 4: Placebo
n=5 Participants
Placebo for CH505TF mo(0,2,4,8,12)
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
ALT (SGPT) (U/L)- Screening
16 U/L
Interval 12.5 to 19.5
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
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
ALT (SGPT) (U/L)- Day 70
13 U/L
Interval 12.0 to 22.0
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
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
ALT (SGPT) (U/L)- Day 126
14 U/L
Interval 13.0 to 17.0
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
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
ALT (SGPT) (U/L)- Day 238
16 U/L
Interval 12.0 to 22.0
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
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
Alkaline Phosphatase (U/L)- Day 14
53.5 U/L
Interval 44.0 to 83.5
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
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
ALT (SGPT) (U/L)- Day 14
14.5 U/L
Interval 12.0 to 19.0
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
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
ALT (SGPT) (U/L)- Day 308
14.5 U/L
Interval 12.0 to 18.0
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
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
AST (U/L)- Screening
19 U/L
Interval 17.5 to 23.0
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
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
AST (U/L)- Day 14
18 U/L
Interval 15.5 to 24.5
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
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
AST (U/L)- Day 70
20 U/L
Interval 16.0 to 22.0
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
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
AST (U/L)- Day 126
18 U/L
Interval 16.0 to 23.0
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
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
AST (U/L)- Day 238
18 U/L
Interval 15.0 to 30.0
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
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
AST (U/L)- Day 308
17 U/L
Interval 16.0 to 19.0
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
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
Alkaline Phosphatase (U/L)- Screening
57.5 U/L
Interval 48.5 to 89.5
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
Part B 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 42.0 to 82.0
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
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
Alkaline Phosphatase (U/L)- Day 126
59 U/L
Interval 46.0 to 85.0
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
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
Alkaline Phosphatase (U/L)- Day 238
65 U/L
Interval 44.0 to 78.0
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
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
Alkaline Phosphatase (U/L)- Day 308
60 U/L
Interval 40.0 to 77.0
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

PRIMARY outcome

Timeframe: Measured during screening, and 2 weeks after each vaccination at Month 0, 2, 4, 8, and at Month 11

Population: 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

Outcome measures
Measure
Part A, Group 1: Vaccine
n=20 Participants
20 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 2: Vaccine
n=20 Participants
100 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 3: Vaccine
n=20 Participants
400 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 4: Placebo
n=5 Participants
Placebo for CH505TF mo(0,2,4,8,12)
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Creatinine (g/dL)- Screening
0.00086 g/dL
Interval 0.00075 to 0.00093
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
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Creatinine (g/dL)- Day 70
0.00089 g/dL
Interval 0.00082 to 0.00103
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
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Creatinine (g/dL)- Day 126
0.0009 g/dL
Interval 0.00072 to 0.001
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
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Hemoglobin (g/dL)- Screening
13.7 g/dL
Interval 13.25 to 15.05
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
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Hemoglobin (g/dL)- Day 14
13.7 g/dL
Interval 12.9 to 14.5
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
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 13.2 to 14.8
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
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Hemoglobin (g/dL)- Day 126
14 g/dL
Interval 13.4 to 15.0
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
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Hemoglobin (g/dL)- Day 238
13.55 g/dL
Interval 12.8 to 13.9
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
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Hemoglobin (g/dL)- Day 308
13.45 g/dL
Interval 12.6 to 14.6
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
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Creatinine (g/dL)- Day 14
0.00093 g/dL
Interval 0.00077 to 0.00101
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
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Creatinine (g/dL)- Day 238
0.0009 g/dL
Interval 0.00076 to 0.00101
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
Part B Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Creatinine (g/dL)- Day 308
0.0009 g/dL
Interval 0.00073 to 0.00101
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

PRIMARY outcome

Timeframe: Measured during screening, and 2 weeks after each vaccination at Month 0, 2, 4, 8, and at Month 11

Population: 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

Outcome measures
Measure
Part A, Group 1: Vaccine
n=20 Participants
20 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 2: Vaccine
n=20 Participants
100 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 3: Vaccine
n=20 Participants
400 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 4: Placebo
n=5 Participants
Placebo for CH505TF mo(0,2,4,8,12)
Part B Chemistry and Hematology Laboratory Measures
Lymphocytes (1000 cells per mm^3)- Day 308
1.805 1000 cells per mm^3
Interval 1.71 to 1.989
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
Part B Chemistry and Hematology Laboratory Measures
Platelets (1000 cells per mm^3)- Screening
246.5 1000 cells per mm^3
Interval 214.5 to 268.5
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
Part B Chemistry and Hematology Laboratory Measures
Platelets (1000 cells per mm^3)- Day 70
253 1000 cells per mm^3
Interval 217.0 to 269.0
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
Part B Chemistry and Hematology Laboratory Measures
Platelets (1000 cells per mm^3)- Day 14
258.5 1000 cells per mm^3
Interval 213.5 to 285.5
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
Part B Chemistry and Hematology Laboratory Measures
Platelets (1000 cells per mm^3)- Day 126
241 1000 cells per mm^3
Interval 219.0 to 298.0
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
Part B Chemistry and Hematology Laboratory Measures
Platelets (1000 cells per mm^3)- Day 238
248 1000 cells per mm^3
Interval 227.0 to 270.0
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
Part B Chemistry and Hematology Laboratory Measures
Platelets (1000 cells per mm^3)- Day 308
229.5 1000 cells per mm^3
Interval 211.0 to 264.0
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
Part B Chemistry and Hematology Laboratory Measures
WBC (1000 cells per mm^3)- Screening
5.63 1000 cells per mm^3
Interval 4.66 to 7.05
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
Part B Chemistry and Hematology Laboratory Measures
WBC (1000 cells per mm^3)- Day 14
5.695 1000 cells per mm^3
Interval 4.825 to 7.49
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
Part B Chemistry and Hematology Laboratory Measures
WBC (1000 cells per mm^3)- Day 70
5.5 1000 cells per mm^3
Interval 4.9 to 7.46
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
Part B Chemistry and Hematology Laboratory Measures
WBC (1000 cells per mm^3)- Day 126
6 1000 cells per mm^3
Interval 4.53 to 6.74
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
Part B Chemistry and Hematology Laboratory Measures
WBC (1000 cells per mm^3)- Day 238
5.935 1000 cells per mm^3
Interval 4.8 to 7.38
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
Part B Chemistry and Hematology Laboratory Measures
WBC (1000 cells per mm^3)- Day 308
5.39 1000 cells per mm^3
Interval 4.7 to 7.06
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
Part B Chemistry and Hematology Laboratory Measures
Neutrophils (1000 cells per mm^3)- Screening
3.0445 1000 cells per mm^3
Interval 2.7 to 4.272
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
Part B Chemistry and Hematology Laboratory Measures
Neutrophils (1000 cells per mm^3)- Day 14
3.1395 1000 cells per mm^3
Interval 2.455 to 4.45
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
Part B Chemistry and Hematology Laboratory Measures
Neutrophils (1000 cells per mm^3)- Day 70
2.97 1000 cells per mm^3
Interval 2.48 to 4.25
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
Part B Chemistry and Hematology Laboratory Measures
Neutrophils (1000 cells per mm^3)- Day 126
2.76 1000 cells per mm^3
Interval 2.49 to 4.11
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
Part B Chemistry and Hematology Laboratory Measures
Neutrophils (1000 cells per mm^3)- Day 238
3.16 1000 cells per mm^3
Interval 2.29 to 4.25
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
Part B Chemistry and Hematology Laboratory Measures
Neutrophils (1000 cells per mm^3)- Day 308
3.133 1000 cells per mm^3
Interval 2.24 to 3.48
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
Part B Chemistry and Hematology Laboratory Measures
Lymphocytes (1000 cells per mm^3)- Screening
1.805 1000 cells per mm^3
Interval 1.72 to 2.145
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
Part B Chemistry and Hematology Laboratory Measures
Lymphocytes (1000 cells per mm^3)- Day 14
1.9705 1000 cells per mm^3
Interval 1.585 to 2.2425
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
Part B Chemistry and Hematology Laboratory Measures
Lymphocytes (1000 cells per mm^3)- Day 70
1.99 1000 cells per mm^3
Interval 1.54 to 2.37
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
Part B Chemistry and Hematology Laboratory Measures
Lymphocytes (1000 cells per mm^3)- Day 126
1.8 1000 cells per mm^3
Interval 1.58 to 2.33
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
Part B Chemistry and Hematology Laboratory Measures
Lymphocytes (1000 cells per mm^3)- Day 238
1.85 1000 cells per mm^3
Interval 1.6 to 2.04
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

PRIMARY outcome

Timeframe: Measured at Month 8.5

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.

Outcome measures

Outcome measures
Measure
Part A, Group 1: Vaccine
n=20 Participants
20 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 2: Vaccine
n=20 Participants
100 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 3: Vaccine
n=20 Participants
400 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 4: Placebo
n=5 Participants
Placebo for CH505TF mo(0,2,4,8,12)
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
1.1384246921 log10 titer*percentage of isolates
Interval 1.0811824148 to 1.1585691555
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

PRIMARY outcome

Timeframe: Measured at Month 8.5

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.

Outcome measures

Outcome measures
Measure
Part A, Group 1: Vaccine
n=20 Participants
20 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 2: Vaccine
n=20 Participants
100 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 3: Vaccine
n=20 Participants
400 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 4: Placebo
n=5 Participants
Placebo for CH505TF mo(0,2,4,8,12)
Part B Magnitude and Breadth of Neutralizing Antibody Responses Against a Panel of Heterologous Tier 2 Isolates Induced 2 Weeks After the Fourth Vaccinations
0.6989700043 log10 titer*percentage of isolates
Interval 0.6989700043 to 0.6989700043
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

PRIMARY outcome

Timeframe: Measured through Month Measured through Month Measured through 7 days after the vaccination at Month 0, 2, 4

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.

Outcome measures

Outcome measures
Measure
Part A, Group 1: Vaccine
n=10 Participants
20 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 2: Vaccine
100 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 3: Vaccine
400 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 4: Placebo
Placebo for CH505TF mo(0,2,4,8,12)
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 · 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
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
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 · Mild
6 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
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
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
—
—
—
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
Erythema and/or Induration · 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, 4

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.

Outcome measures

Outcome measures
Measure
Part A, Group 1: Vaccine
n=10 Participants
20 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 2: Vaccine
100 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 3: Vaccine
400 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 4: Placebo
Placebo for CH505TF mo(0,2,4,8,12)
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 · 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
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
Arthralgia · None
7 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
Malaise and/or fatigue · None
2 Participants
—
—
—
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
Myalgia · Mild
3 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
Nausea · Moderate
2 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
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
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
—
—
—
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
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
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 · Potentially Life-threatening
0 Participants
—
—
—

PRIMARY outcome

Timeframe: Measured through Month 16

From the study termination form, early termination reasons associated with an AE or reactogenicity are tabulated by treatment arm

Outcome measures

Outcome measures
Measure
Part A, Group 1: Vaccine
n=10 Participants
20 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 2: Vaccine
100 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 3: Vaccine
400 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 4: Placebo
Placebo for CH505TF mo(0,2,4,8,12)
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 administration

Population: Safety population

From the study product discontinuation form, study product administration reasons are tabulated by treatment arm

Outcome measures

Outcome measures
Measure
Part A, Group 1: Vaccine
n=10 Participants
20 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 2: Vaccine
100 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 3: Vaccine
400 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 4: Placebo
Placebo for CH505TF mo(0,2,4,8,12)
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
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
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 10

Population: 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

Outcome measures
Measure
Part A, Group 1: Vaccine
n=10 Participants
20 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 2: Vaccine
100 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 3: Vaccine
400 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 4: Placebo
Placebo for CH505TF mo(0,2,4,8,12)
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
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
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
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 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 10

Population: 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

Outcome measures
Measure
Part A, Group 1: Vaccine
n=10 Participants
20 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 2: Vaccine
100 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 3: Vaccine
400 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 4: Placebo
Placebo for CH505TF mo(0,2,4,8,12)
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
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)- 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 10

Population: 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

Outcome measures
Measure
Part A, Group 1: Vaccine
n=10 Participants
20 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 2: Vaccine
100 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 3: Vaccine
400 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 4: Placebo
Placebo for CH505TF mo(0,2,4,8,12)
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
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
Platelets (1000 cells per mm^3)- Day 14
299 1000 cells per mm^3
Interval 240.0 to 320.0
—
—
—
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
—
—
—

SECONDARY outcome

Timeframe: Measured at Month 4.5

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

Outcome measures
Measure
Part A, Group 1: Vaccine
n=10 Participants
20 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 2: Vaccine
100 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 3: Vaccine
400 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 4: Placebo
Placebo for CH505TF mo(0,2,4,8,12)
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 4.5

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

Outcome measures
Measure
Part A, Group 1: Vaccine
n=10 Participants
20 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 2: Vaccine
100 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 3: Vaccine
400 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 4: Placebo
Placebo for CH505TF mo(0,2,4,8,12)
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 4.5

Population: "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

Outcome measures
Measure
Part A, Group 1: Vaccine
n=12 Participants
20 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 2: Vaccine
n=12 Participants
100 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 3: Vaccine
n=12 Participants
400 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 4: Placebo
n=6 Participants
Placebo for CH505TF mo(0,2,4,8,12)
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
9 Participants
11 Participants
0 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
10 Participants
9 Participants
11 Participants
0 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
11 Participants
12 Participants
0 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
11 Participants
12 Participants
0 Participants

SECONDARY outcome

Timeframe: Measured at Month 4.5

Population: "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

Outcome measures
Measure
Part A, Group 1: Vaccine
n=12 Participants
20 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 2: Vaccine
n=12 Participants
100 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 3: Vaccine
n=12 Participants
400 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 4: Placebo
n=6 Participants
Placebo for CH505TF mo(0,2,4,8,12)
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
0.0336336336 % B-cells
Interval 0.015625 to 0.0450757377
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
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
0.3432494279 % B-cells
Interval 0.0737350136 to 0.6560563723
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
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
0.3928819444 % B-cells
Interval 0.248440694 to 0.7179063361
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
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
3.9065053939 % B-cells
Interval 2.8087107152 to 5.6719558166
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

SECONDARY outcome

Timeframe: Measured at Month 4.5

Population: 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

Outcome measures
Measure
Part A, Group 1: Vaccine
n=12 Participants
20 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 2: Vaccine
n=12 Participants
100 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 3: Vaccine
n=12 Participants
400 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 4: Placebo
n=6 Participants
Placebo for CH505TF mo(0,2,4,8,12)
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
0.94 log10 titer*percentage of isolates
Interval 0.88 to 0.97
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

SECONDARY outcome

Timeframe: Measured at Months 4.5 and 12.5

Population: "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

Outcome measures
Measure
Part A, Group 1: Vaccine
n=12 Participants
20 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 2: Vaccine
n=12 Participants
100 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 3: Vaccine
n=12 Participants
400 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 4: Placebo
n=6 Participants
Placebo for CH505TF mo(0,2,4,8,12)
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
4 Participants
6 Participants
5 Participants
0 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
1 Participants
6 Participants
3 Participants
0 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
2 Participants
0 Participants
0 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
4 Participants
2 Participants
0 Participants
0 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
4 Participants
6 Participants
5 Participants
0 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
4 Participants
2 Participants
0 Participants
0 Participants

SECONDARY outcome

Timeframe: Measured at Months 4.5 and 12.5

Population: "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

Outcome measures
Measure
Part A, Group 1: Vaccine
n=12 Participants
20 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 2: Vaccine
n=12 Participants
100 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 3: Vaccine
n=12 Participants
400 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 4: Placebo
n=6 Participants
Placebo for CH505TF mo(0,2,4,8,12)
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
0.07193596 % CD4+ T-cells
Interval 0.0453187 to 0.11852354
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
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
0.07052576 % CD4+ T-cells
Interval 0.05099588 to 0.08964846
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
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
0.04602687 % CD4+ T-cells
Interval 0.02316902 to 0.08966309
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
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
0.04420066 % CD4+ T-cells
Interval 0.03908209 to 0.06830406
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
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
0.02507079 % CD4+ T-cells
Interval 0.01127097 to 0.03920034
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
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
0.0213444 % CD4+ T-cells
Interval 0.00876609 to 0.06531986
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

SECONDARY outcome

Timeframe: Measured at Month 4.5

Population: "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 OD) \> 3×(background OD) in wells of dilutions 1:30 and 1:90.

Outcome measures

Outcome measures
Measure
Part A, Group 1: Vaccine
n=12 Participants
20 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 2: Vaccine
n=12 Participants
100 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 3: Vaccine
n=12 Participants
400 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 4: Placebo
n=6 Participants
Placebo for CH505TF mo(0,2,4,8,12)
Part A: Occurrence of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding
CH505TF_D7gp120d371_avi
11 Participants
11 Participants
12 Participants
0 Participants
Part A: Occurrence of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding
CH0505_CON D7 gp120_avi/293F/Mon
11 Participants
11 Participants
12 Participants
0 Participants
Part A: Occurrence of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding
CH0505_CON D7gp120_D368R_avi/293F/Mon
11 Participants
11 Participants
12 Participants
0 Participants

SECONDARY outcome

Timeframe: Measured at Month 4.5

Population: "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

Outcome measures
Measure
Part A, Group 1: Vaccine
n=12 Participants
20 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 2: Vaccine
n=12 Participants
100 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 3: Vaccine
n=12 Participants
400 mcg CH505TF mo(0,2,4,8,12)
Part A, Group 4: Placebo
n=6 Participants
Placebo for CH505TF mo(0,2,4,8,12)
Part A: Level of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding
CH0505_CON D7 gp120_avi/293F/Mon
6.6971124919 Optical density
Interval 5.4824094895 to 7.4119832678
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
Part A: Level of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding
CH0505_CON D7gp120_D368R_avi/293F/Mon
6.1512380643 Optical density
Interval 5.2453995062 to 7.2585410723
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
Part A: Level of Monoclonal Antibodies Evaluated for CD4 Binding Site Loop Binding
CH505TF_D7gp120d371_avi
5.6756913098 Optical density
Interval 4.905379044 to 7.1963244607
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

SECONDARY outcome

Timeframe: Measured at Month 2.5 and Month 8.5

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

Outcome data not reported

SECONDARY outcome

Timeframe: Measured at Months 2.5 and 8.5

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

Outcome data not reported

SECONDARY outcome

Timeframe: Measured at Months 2.5 and 8.5

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

Outcome data not reported

SECONDARY outcome

Timeframe: Measured at Month 2.5

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 OD) \> 3×(background OD) in wells of dilutions 1:30 and 1:90.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Measured at Month 2.5

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

Outcome data not reported

SECONDARY outcome

Timeframe: Measured at Month 4.5

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

Outcome data not reported

SECONDARY outcome

Timeframe: Measured at Month 0 and at Month 4.5

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

Outcome data not reported

SECONDARY outcome

Timeframe: Measured at Month 4.5

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

Outcome data not reported

SECONDARY outcome

Timeframe: Measured at Month 4.5

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

Outcome data not reported

SECONDARY outcome

Timeframe: Measured at Month 0, Month 2.5 and Month 4.5

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

Outcome data not reported

SECONDARY outcome

Timeframe: Measured at Month 0, Month 2.5 and Month 4.5

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

Outcome data not reported

SECONDARY outcome

Timeframe: Measured at Month 4.5

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

Outcome data not reported

Adverse Events

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

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

Serious adverse events

Serious adverse events
Measure
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)
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(
Nervous system disorders
Any Event in SOC
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 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%
0/6 • 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).
Nervous system disorders
Seizure
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 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%
0/6 • 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).
Psychiatric disorders
Any Event in SOC
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Psychiatric disorders
Suicidal ideation
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).

Other adverse events

Other adverse events
Measure
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)
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(
Gastrointestinal disorders
Any Event in SOC
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 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).
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).
Blood and lymphatic system disorders
Any Event in SOC
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Blood and lymphatic system disorders
Lymph node pain
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Blood and lymphatic system disorders
Lymphadenopathy
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Blood and lymphatic system disorders
Microcytic anaemia
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Cardiac disorders
Any Event in SOC
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Cardiac disorders
Postural orthostatic tachycardia syndrome
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Congenital, familial and genetic disorders
Any Event in SOC
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 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%
0/6 • 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).
Congenital, familial and genetic disorders
Dermoid cyst
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 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%
0/6 • 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).
Ear and labyrinth disorders
Any Event in SOC
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Ear and labyrinth disorders
Tinnitus
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Endocrine disorders
Any Event in SOC
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 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%
0/6 • 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).
Endocrine disorders
Hypogonadism
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 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%
0/6 • 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).
Gastrointestinal disorders
Abdominal discomfort
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 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%
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).
Gastrointestinal disorders
Abdominal pain
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Gastrointestinal disorders
Abdominal pain upper
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Gastrointestinal disorders
Dental caries
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Gastrointestinal disorders
Diarrhoea
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Gastrointestinal disorders
Flatulence
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 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%
0/6 • 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).
Gastrointestinal disorders
Food poisoning
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Gastrointestinal disorders
Gastritis
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Gastrointestinal disorders
Gastrointestinal disorder
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Gastrointestinal disorders
Gastrooesophageal reflux disease
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 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%
0/6 • 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).
Gastrointestinal disorders
Haemorrhoids
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Gastrointestinal disorders
Mouth ulceration
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Gastrointestinal disorders
Nausea
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Gastrointestinal disorders
Tooth impacted
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Gastrointestinal disorders
Toothache
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
General disorders
Any Event in SOC
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).
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).
General disorders
Fatigue
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).
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).
General disorders
Influenza like illness
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 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%
0/6 • 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).
General disorders
Injection site pruritus
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
General disorders
Pyrexia
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Immune system disorders
Any Event in SOC
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).
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).
Immune system disorders
Allergy to animal
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 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%
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).
Immune system disorders
Drug hypersensitivity
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Immune system disorders
Seasonal allergy
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).
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).
Infections and infestations
Any Event in SOC
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).
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).
Infections and infestations
Bacterial vaginosis
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Infections and infestations
Bronchitis
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Infections and infestations
COVID-19
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Infections and infestations
Diarrhoea infectious
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 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%
0/6 • 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).
Infections and infestations
Ear infection
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Infections and infestations
Epididymitis
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Infections and infestations
Fungal infection
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Infections and infestations
Gastroenteritis
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Infections and infestations
Gastroenteritis viral
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 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%
0/6 • 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).
Infections and infestations
Genitourinary chlamydia infection
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Infections and infestations
Infectious mononucleosis
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Infections and infestations
Influenza
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Infections and infestations
Injection site cellulitis
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 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%
0/6 • 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).
Infections and infestations
Latent syphilis
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Infections and infestations
Onychomycosis
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Infections and infestations
Oral herpes
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 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%
0/6 • 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).
Infections and infestations
Otitis externa
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Infections and infestations
Paronychia
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Infections and infestations
Pharyngitis
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Infections and infestations
Pharyngitis streptococcal
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 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%
0/6 • 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).
Infections and infestations
Pneumonia
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 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%
0/6 • 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).
Infections and infestations
Sinusitis
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 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%
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).
Infections and infestations
Sinusitis bacterial
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Infections and infestations
Suspected COVID-19
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Infections and infestations
Tinea cruris
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Infections and infestations
Tinea versicolour
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).
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).
Infections and infestations
Tonsillitis
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Infections and infestations
Upper respiratory tract infection
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).
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).
Infections and infestations
Urinary tract infection
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).
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).
Infections and infestations
Viral infection
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 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%
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).
Infections and infestations
Viral upper respiratory tract infection
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Infections and infestations
Vulvovaginal mycotic infection
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Injury, poisoning and procedural complications
Any Event in SOC
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 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).
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).
Injury, poisoning and procedural complications
Burns second degree
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Injury, poisoning and procedural complications
Contusion
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 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%
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).
Injury, poisoning and procedural complications
Eye injury
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Injury, poisoning and procedural complications
Ligament rupture
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Injury, poisoning and procedural complications
Ligament sprain
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 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%
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).
Injury, poisoning and procedural complications
Muscle strain
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Injury, poisoning and procedural complications
Overdose
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 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%
0/6 • 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).
Injury, poisoning and procedural complications
Skin laceration
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Injury, poisoning and procedural complications
Subdural haematoma
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 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%
0/6 • 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).
Reproductive system and breast disorders
Vaginal haemorrhage
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Investigations
Any Event in SOC
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).
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).
Investigations
Alanine aminotransferase increased
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 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).
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).
Investigations
Aspartate aminotransferase increased
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 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).
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).
Investigations
Blood creatinine increased
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).
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).
Investigations
Blood iron decreased
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Investigations
Blood pressure increased
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Investigations
Full blood count abnormal
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Investigations
Haemoglobin decreased
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Investigations
Lymphocyte count decreased
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Metabolism and nutrition disorders
Any Event in SOC
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Metabolism and nutrition disorders
Decreased appetite
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Musculoskeletal and connective tissue disorders
Any Event in SOC
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).
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).
Musculoskeletal and connective tissue disorders
Arthralgia
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Musculoskeletal and connective tissue disorders
Back pain
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).
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).
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Musculoskeletal and connective tissue disorders
Muscle spasms
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Musculoskeletal and connective tissue disorders
Myalgia
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Nervous system disorders
Any Event in SOC
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 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%
0/6 • 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).
Nervous system disorders
Headache
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Nervous system disorders
Hypoaesthesia
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Nervous system disorders
Migraine
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 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%
0/6 • 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).
Psychiatric disorders
Any Event in SOC
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 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%
0/6 • 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).
Psychiatric disorders
Adjustment disorder with depressed mood
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 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%
0/6 • 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).
Psychiatric disorders
Anxiety
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Psychiatric disorders
Depression
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Psychiatric disorders
Generalised anxiety disorder
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Psychiatric disorders
Insomnia
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Renal and urinary disorders
Any Event in SOC
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).
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).
Renal and urinary disorders
Glycosuria
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Renal and urinary disorders
Haematuria
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).
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).
Renal and urinary disorders
Proteinuria
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Reproductive system and breast disorders
Any Event in SOC
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 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%
0/6 • 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).
Reproductive system and breast disorders
Breast pain
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 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%
0/6 • 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).
Reproductive system and breast disorders
Cervical dysplasia
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Reproductive system and breast disorders
Testicular pain
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Respiratory, thoracic and mediastinal disorders
Any Event in SOC
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).
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).
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 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%
0/6 • 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).
Respiratory, thoracic and mediastinal disorders
Nasal congestion
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Respiratory, thoracic and mediastinal disorders
Sinus congestion
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Respiratory, thoracic and mediastinal disorders
Throat irritation
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).
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).
Skin and subcutaneous tissue disorders
Any Event in SOC
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).
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).
Skin and subcutaneous tissue disorders
Acne
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 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%
0/6 • 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).
Skin and subcutaneous tissue disorders
Blister
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 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%
0/6 • 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).
Skin and subcutaneous tissue disorders
Dermal cyst
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Skin and subcutaneous tissue disorders
Dermatitis contact
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 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%
0/6 • 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).
Skin and subcutaneous tissue disorders
Keratosis pilaris
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 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%
0/6 • 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).
Skin and subcutaneous tissue disorders
Rash
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).
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).
Skin and subcutaneous tissue disorders
Rash maculo-papular
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Social circumstances
Any Event in SOC
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).
Social circumstances
Victim of sexual abuse
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
0.00%
0/12 • Serious Adverse events are collected throughout the study (months 0-18 for Part A, months 0-14 for Part B and months 0-10 for Part C). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 2, 4, 8, 12 for Part A, at months 0, 2, 4, 8 for Part B and months 0, 2, 4 for Part C).
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).

Additional Information

Jessica Andriesen, PhD, Associate Director of HVTN SDMC Operations

Fred Hutchinson Cancer Research Center

Phone: 206-667-5812

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place