Trial Outcomes & Findings for A Safety and Immune Response Study of 2 Experimental HIV Vaccines (NCT NCT02404311)
NCT ID: NCT02404311
Last Updated: 2021-11-05
Results Overview
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\] The maximum grade observed for each symptom over the time frame is presented.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
252 participants
Primary outcome timeframe
Measured through 3 days after participants' last vaccination at Month 0,1,3, and 6
Results posted on
2021-11-05
Participant Flow
Participants who received all vaccinations in Part A and completed Part A as scheduled were eligible for the Part B extension study. N=63 vaccination recipients in Part A (Group 1) were re-randomized to Part B Group 1a or 1b with a 1:1 ratio, while N=7 placebo recipients from Part A (Group 2) re-enrolled to receive placebo injections in Part B.
Participant milestones
| Measure |
Part A, Group 1: Vaccine
Participants receive ALVAC-HIV (vCP2438) injections at months 0 and 1, and ALVAC-HIV (vCP2438) + bivalent subtype C gp120/MF59® injections at months 3, 6, and 12.
|
Part A, Group 2: Placebo
Participants receive placebo for ALVAC-HIV (vCP2438) at months 0 and 1, and placebo for ALVAC-HIV (vCP2438) + placebo for bivalent subtype C gp120/MF59® injections at months 3, 6, and 12.
|
Part B, Group 1a: Vaccine
Participants originally in Part A Group 1 receive ALVAC-HIV (vCP2438) + bivalent subtype C gp120/MF59® (vCP2438) injections at month 30.
|
Part B, Group 1b: Vaccine + Placebo
Participants originally in Part A Group 1 receive placebo for ALVAC-HIV (vCP2438) + active bivalent subtype C gp120/MF59® at month 30.
|
Part B, Group 2: Placebo
Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV (vCP2438) + placebo for bivalent subtype C gp120/MF59® at month 30.
|
|---|---|---|---|---|---|
|
Part A: Month 0-18
STARTED
|
210
|
42
|
0
|
0
|
0
|
|
Part A: Month 0-18
Per Protocol
|
185
|
37
|
0
|
0
|
0
|
|
Part A: Month 0-18
Month 6.5 Immunogenicity Timepoint
|
194
|
37
|
0
|
0
|
0
|
|
Part A: Month 0-18
Month 12.5 Immunogenicity Timepoint
|
186
|
33
|
0
|
0
|
0
|
|
Part A: Month 0-18
COMPLETED
|
184
|
36
|
0
|
0
|
0
|
|
Part A: Month 0-18
NOT COMPLETED
|
26
|
6
|
0
|
0
|
0
|
|
Part B: Month 30-36
STARTED
|
0
|
0
|
32
|
31
|
7
|
|
Part B: Month 30-36
Month 30.5 Immunogenicity Timepoint
|
0
|
0
|
28
|
30
|
6
|
|
Part B: Month 30-36
COMPLETED
|
0
|
0
|
32
|
31
|
7
|
|
Part B: Month 30-36
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part A, Group 1: Vaccine
Participants receive ALVAC-HIV (vCP2438) injections at months 0 and 1, and ALVAC-HIV (vCP2438) + bivalent subtype C gp120/MF59® injections at months 3, 6, and 12.
|
Part A, Group 2: Placebo
Participants receive placebo for ALVAC-HIV (vCP2438) at months 0 and 1, and placebo for ALVAC-HIV (vCP2438) + placebo for bivalent subtype C gp120/MF59® injections at months 3, 6, and 12.
|
Part B, Group 1a: Vaccine
Participants originally in Part A Group 1 receive ALVAC-HIV (vCP2438) + bivalent subtype C gp120/MF59® (vCP2438) injections at month 30.
|
Part B, Group 1b: Vaccine + Placebo
Participants originally in Part A Group 1 receive placebo for ALVAC-HIV (vCP2438) + active bivalent subtype C gp120/MF59® at month 30.
|
Part B, Group 2: Placebo
Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV (vCP2438) + placebo for bivalent subtype C gp120/MF59® at month 30.
|
|---|---|---|---|---|---|
|
Part A: Month 0-18
Death
|
2
|
0
|
0
|
0
|
0
|
|
Part A: Month 0-18
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
|
Part A: Month 0-18
Lost to Follow-up
|
4
|
2
|
0
|
0
|
0
|
|
Part A: Month 0-18
Withdrawal by Subject
|
6
|
2
|
0
|
0
|
0
|
|
Part A: Month 0-18
HIV Infection
|
6
|
2
|
0
|
0
|
0
|
|
Part A: Month 0-18
Participant unable to adhere
|
7
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Safety and Immune Response Study of 2 Experimental HIV Vaccines
Baseline characteristics by cohort
| Measure |
Part A Only: Group 1 (Vaccine)
n=147 Participants
Participants did not go on to Part B. In Part A, participants received ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part A Only: Group 2 (Placebo)
n=35 Participants
Participants did not go on to Part B. In Part A, participants received Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part A, Group 1 (Vaccine) + Part B, Group 1a (Vaccine)
n=32 Participants
Participants completed Part A in Group 1 (Vaccine), joined Part B and were randomized to Group 1a (Vaccine): ALVAC-HIV + bivalent subtype C gp120/MF59 at month 30
|
Part A, Group 1 (Vaccine) + Part B, Group 1b: Vaccine/Placeb
n=31 Participants
Participants completed Part A in Group 1 (Vaccine), joined Part B and were randomized to Group 1b (Vaccine/Placebo ): placebo for ALVAC-HIV + bivalent subtype C gp120/MF59 at month 30
|
Part A, Group 2 (Placebo) + Part B, Group 2 (Placebo)
n=7 Participants
Participants completed Part A in Group 2 (Placebo), joined Part B and received placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30
|
Total
n=252 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
23 years
n=5 Participants
|
23 years
n=7 Participants
|
25 years
n=5 Participants
|
23 years
n=4 Participants
|
24 years
n=21 Participants
|
23 years
n=8 Participants
|
|
Age, Customized
Less than 18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Customized
18 - 20 years
|
38 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
56 Participants
n=8 Participants
|
|
Age, Customized
21 - 30 years
|
95 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
167 Participants
n=8 Participants
|
|
Age, Customized
31 - 40 years
|
14 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
29 Participants
n=8 Participants
|
|
Age, Customized
41 - 50 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Customized
Above 50 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
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
|
|
Sex: Female, Male
Female
|
64 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
109 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
83 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
143 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
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
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
147 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
252 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
143 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
246 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
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
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
South Africa
|
147 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
252 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Measured through 3 days after participants' last vaccination at Month 0,1,3, and 6Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\] The maximum grade observed for each symptom over the time frame is presented.
Outcome measures
| Measure |
Part A, Group 1: Vaccine
n=210 Participants
ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part A, Group 2: Placebo
n=42 Participants
Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part B, Group 2: Placebo
Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30
|
|---|---|---|---|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Pain · None
|
42 Participants
|
26 Participants
|
—
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Pain · Mild
|
126 Participants
|
16 Participants
|
—
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Pain · Moderate
|
40 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Pain · Severe
|
2 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Pain · Life Threatening
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Tenderness · None
|
69 Participants
|
34 Participants
|
—
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Tenderness · Mild
|
114 Participants
|
8 Participants
|
—
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Tenderness · Moderate
|
26 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Tenderness · Severe
|
1 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Tenderness · Life Threatening
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Pain and/or Tenderness · None
|
35 Participants
|
26 Participants
|
—
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Pain and/or Tenderness · Mild
|
131 Participants
|
16 Participants
|
—
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Pain and/or Tenderness · Moderate
|
42 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Pain and/or Tenderness · Severe
|
2 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Pain and/or Tenderness · Life Threatening
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Erythema · None
|
201 Participants
|
42 Participants
|
—
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Erythema · Mild
|
6 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Erythema · Moderate
|
2 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Erythema · Severe
|
1 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Erythema · Life Threatening
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Induration · None
|
187 Participants
|
42 Participants
|
—
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Induration · Mild
|
13 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Induration · Moderate
|
9 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Induration · Severe
|
1 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Induration · Life Threatening
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Erythema and/or Induration · None
|
185 Participants
|
42 Participants
|
—
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Erythema and/or Induration · Mild
|
14 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Erythema and/or Induration · Moderate
|
10 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Erythema and/or Induration · Severe
|
1 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Erythema and/or Induration · Life Threatening
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Measured through 3 days after each vaccination at Month 0, 1, 3, and 6Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\]
Outcome measures
| Measure |
Part A, Group 1: Vaccine
n=210 Participants
ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part A, Group 2: Placebo
n=42 Participants
Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part B, Group 2: Placebo
Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30
|
|---|---|---|---|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Myalgia · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Headache · None
|
139 Participants
|
21 Participants
|
—
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Headache · Mild
|
56 Participants
|
15 Participants
|
—
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Headache · Moderate
|
15 Participants
|
6 Participants
|
—
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Headache · Severe
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Headache · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Vomiting · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Chills · None
|
195 Participants
|
40 Participants
|
—
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Arthralgia · None
|
151 Participants
|
33 Participants
|
—
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Arthralgia · Mild
|
53 Participants
|
8 Participants
|
—
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Max. Systemic Symptoms · Mild
|
109 Participants
|
18 Participants
|
—
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Max. Systemic Symptoms · Moderate
|
31 Participants
|
8 Participants
|
—
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Max. Systemic Symptoms · Severe
|
2 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Vomiting · None
|
200 Participants
|
41 Participants
|
—
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Vomiting · Mild
|
9 Participants
|
1 Participants
|
—
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Vomiting · Moderate
|
1 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Vomiting · Severe
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Chills · Mild
|
14 Participants
|
2 Participants
|
—
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Malaise and/or fatigue · None
|
125 Participants
|
28 Participants
|
—
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Malaise and/or fatigue · Mild
|
76 Participants
|
13 Participants
|
—
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Malaise and/or fatigue · Moderate
|
9 Participants
|
1 Participants
|
—
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Malaise and/or fatigue · Severe
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Malaise and/or fatigue · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Myalgia · None
|
132 Participants
|
34 Participants
|
—
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Myalgia · Mild
|
60 Participants
|
7 Participants
|
—
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Myalgia · Moderate
|
18 Participants
|
1 Participants
|
—
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Myalgia · Severe
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Nausea · None
|
179 Participants
|
39 Participants
|
—
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Nausea · Mild
|
29 Participants
|
3 Participants
|
—
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Nausea · Moderate
|
2 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Nausea · Severe
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Nausea · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Chills · Moderate
|
1 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Chills · Severe
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Chills · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Arthralgia · Moderate
|
4 Participants
|
1 Participants
|
—
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Arthralgia · Severe
|
2 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Arthralgia · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Max. Systemic Symptoms · None
|
68 Participants
|
16 Participants
|
—
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Max. Systemic Symptoms · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Temperature · None
|
195 Participants
|
41 Participants
|
—
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Temperature · Mild
|
8 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Temperature · Moderate
|
7 Participants
|
1 Participants
|
—
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Temperature · Severe
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Temperature · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Measured through Month 18From the study termination form, early termination reasons associated with an AE or reactogenicity are tabulated by treatment arm
Outcome measures
| Measure |
Part A, Group 1: Vaccine
n=210 Participants
ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part A, Group 2: Placebo
n=42 Participants
Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part B, Group 2: Placebo
Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30
|
|---|---|---|---|
|
Part A: Number of Participants With Early Study Termination Associated With an AE or Reactogenicity
Termination due to AE/Reactogenicity
|
4 Participants
|
2 Participants
|
—
|
|
Part A: Number of Participants With Early Study Termination Associated With an AE or Reactogenicity
Other Reasons
|
206 Participants
|
40 Participants
|
—
|
PRIMARY outcome
Timeframe: Measured through the Month 12 vaccinationFrom the study product discontinuation form, study product administration reasons are tabulated by treatment arm
Outcome measures
| Measure |
Part A, Group 1: Vaccine
n=210 Participants
ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part A, Group 2: Placebo
n=42 Participants
Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part B, Group 2: Placebo
Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30
|
|---|---|---|---|
|
Part A: Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
Clinical Event
|
1 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
Reactogenicity
|
1 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
Other Reasons
|
19 Participants
|
3 Participants
|
—
|
|
Part A: Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
No Discontinuation
|
189 Participants
|
39 Participants
|
—
|
PRIMARY outcome
Timeframe: Measured during screening for part A, and 2 weeks after each vaccination at Month 0, 1, 3, 6, and 12Population: The "overall number of participants analyzed" represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit.
Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown.
Outcome measures
| Measure |
Part A, Group 1: Vaccine
n=210 Participants
ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part A, Group 2: Placebo
n=42 Participants
Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part B, Group 2: Placebo
Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30
|
|---|---|---|---|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
Neutrophils (1000/cubic mm)-Screening
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
Neutrophils (1000/cubic mm)-Day 14
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
Neutrophils (1000/cubic mm)-Day 42
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
Neutrophils (1000/cubic mm)-Day 98
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
Platelets (1000/cubic mm)-Day 42
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
Platelets (1000/cubic mm)-Day 98
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
Platelets (1000/cubic mm)-Day 182
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
WBC (1000/cubic mm)-Screening
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
WBC (1000/cubic mm)-Day 14
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
WBC (1000/cubic mm)-Day 42
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
WBC (1000/cubic mm)-Day 98
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
WBC (1000/cubic mm)-Day 182
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
WBC (1000/cubic mm)-Day 378
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
Neutrophils (1000/cubic mm)-Day 182
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
Neutrophils (1000/cubic mm)-Day 378
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
Hemoglobin (g/dL)-Screening
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
Hemoglobin (g/dL)-Day 14
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
Hemoglobin (g/dL)-Day 42
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
Hemoglobin (g/dL)-Day 98
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
Hemoglobin (g/dL)-Day 182
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
Hemoglobin (g/dL)-Day 378
|
1 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
Lymphocytes (1000/cubic mm)-Screening
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
Lymphocytes (1000/cubic mm)-Day 14
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
Lymphocytes (1000/cubic mm)-Day 42
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
Lymphocytes (1000/cubic mm)-Day 98
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
Lymphocytes (1000/cubic mm)-Day 182
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
Lymphocytes (1000/cubic mm)-Day 378
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
Platelets (1000/cubic mm)-Screening
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
Platelets (1000/cubic mm)-Day 14
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
Platelets (1000/cubic mm)-Day 378
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
ALT (SGPT) (U/L)-Screening
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
ALT (SGPT) (U/L)-Day 14
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
ALT (SGPT) (U/L)-Day 42
|
1 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
ALT (SGPT) (U/L)-Day 98
|
1 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
ALT (SGPT) (U/L)-Day 182
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
ALT (SGPT) (U/L)-Day 378
|
1 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
AST (U/L)-Screening
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
AST (U/L)-Day 14
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
AST (U/L)-Day 42
|
2 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
AST (U/L)-Day 98
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
AST (U/L)-Day 182
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
AST (U/L)-Day 378
|
1 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
Alkaline Phosphatase (U/L)-Screening
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
Alkaline Phosphatase (U/L)-Day 14
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
Alkaline Phosphatase (U/L)-Day 42
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
Alkaline Phosphatase (U/L)-Day 98
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
Alkaline Phosphatase (U/L)-Day 182
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
Alkaline Phosphatase (U/L)-Day 378
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
Creatinine (g/dL)-Screening
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
Creatinine (g/dL)-Day 14
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
Creatinine (g/dL)-Day 42
|
1 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
Creatinine (g/dL)-Day 98
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
Creatinine (g/dL)-Day 182
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
Creatinine (g/dL)-Day 378
|
3 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Time Frame: Measured during screening for part A, and 2 weeks after each vaccination at Month 0, 1, 3, 6, and 12Population: 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.
For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population.
Outcome measures
| Measure |
Part A, Group 1: Vaccine
n=210 Participants
ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part A, Group 2: Placebo
n=42 Participants
Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part B, Group 2: Placebo
Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30
|
|---|---|---|---|
|
Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT
ALT (SGPT) (U/L)-Day 14
|
17 U/L
Interval 13.0 to 22.0
|
19 U/L
Interval 14.0 to 22.0
|
—
|
|
Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT
ALT (SGPT) (U/L)-Day 42
|
19 U/L
Interval 14.0 to 28.0
|
21 U/L
Interval 14.5 to 27.0
|
—
|
|
Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT
ALT (SGPT) (U/L)-Day 98
|
18.5 U/L
Interval 13.0 to 26.0
|
18 U/L
Interval 14.0 to 22.0
|
—
|
|
Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT
ALT (SGPT) (U/L)-Screening
|
17 U/L
Interval 13.0 to 24.0
|
19 U/L
Interval 13.0 to 24.0
|
—
|
|
Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT
ALT (SGPT) (U/L)-Day 182
|
19 U/L
Interval 13.0 to 25.0
|
19 U/L
Interval 15.0 to 23.0
|
—
|
|
Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT
ALT (SGPT) (U/L)-Day 378
|
20 U/L
Interval 15.0 to 30.0
|
21 U/L
Interval 17.0 to 27.0
|
—
|
|
Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT
AST (U/L)-Screening
|
22 U/L
Interval 19.0 to 26.0
|
22 U/L
Interval 19.0 to 26.0
|
—
|
|
Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT
AST (U/L)-Day 14
|
22 U/L
Interval 19.0 to 25.0
|
21 U/L
Interval 18.0 to 24.0
|
—
|
|
Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT
AST (U/L)-Day 42
|
23 U/L
Interval 19.0 to 29.0
|
23 U/L
Interval 19.0 to 27.5
|
—
|
|
Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT
AST (U/L)-Day 98
|
23 U/L
Interval 20.0 to 28.0
|
23 U/L
Interval 21.0 to 27.0
|
—
|
|
Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT
AST (U/L)-Day 182
|
24 U/L
Interval 21.0 to 29.0
|
25 U/L
Interval 21.0 to 28.0
|
—
|
|
Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT
AST (U/L)-Day 378
|
24 U/L
Interval 20.0 to 28.5
|
22.5 U/L
Interval 20.0 to 26.0
|
—
|
|
Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT
Alkaline Phosphatase (U/L)-Screening
|
71.5 U/L
Interval 56.0 to 85.0
|
72.5 U/L
Interval 57.0 to 87.0
|
—
|
|
Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT
Alkaline Phosphatase (U/L)-Day 14
|
69 U/L
Interval 57.0 to 83.0
|
71 U/L
Interval 56.0 to 81.0
|
—
|
|
Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT
Alkaline Phosphatase (U/L)-Day 42
|
70 U/L
Interval 59.0 to 86.0
|
71 U/L
Interval 58.0 to 87.5
|
—
|
|
Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT
Alkaline Phosphatase (U/L)-Day 98
|
73 U/L
Interval 60.0 to 87.0
|
74 U/L
Interval 62.0 to 85.0
|
—
|
|
Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT
Alkaline Phosphatase (U/L)-Day 182
|
69 U/L
Interval 59.0 to 83.0
|
70 U/L
Interval 59.0 to 85.0
|
—
|
|
Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT
Alkaline Phosphatase (U/L)-Day 378
|
72 U/L
Interval 60.5 to 87.0
|
74.5 U/L
Interval 61.5 to 86.5
|
—
|
PRIMARY outcome
Timeframe: Time Frame: Measured during screening for part A, and 2 weeks after each vaccination at Month 0, 1, 3, 6, and 12Population: 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.
For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population.
Outcome measures
| Measure |
Part A, Group 1: Vaccine
n=210 Participants
ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part A, Group 2: Placebo
n=42 Participants
Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part B, Group 2: Placebo
Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30
|
|---|---|---|---|
|
Part A Chemistry Laboratory Measures: Hemoglobin, Creatinine
Hemoglobin (g/dL)-Screening
|
14.7 g/dL
Interval 13.6 to 15.7
|
14.4 g/dL
Interval 13.1 to 15.9
|
—
|
|
Part A Chemistry Laboratory Measures: Hemoglobin, Creatinine
Hemoglobin (g/dL)-Day 14
|
14.1 g/dL
Interval 12.9 to 15.2
|
13.4 g/dL
Interval 12.3 to 15.0
|
—
|
|
Part A Chemistry Laboratory Measures: Hemoglobin, Creatinine
Hemoglobin (g/dL)-Day 42
|
14.4 g/dL
Interval 13.3 to 15.6
|
13.75 g/dL
Interval 12.45 to 15.2
|
—
|
|
Part A Chemistry Laboratory Measures: Hemoglobin, Creatinine
Hemoglobin (g/dL)-Day 98
|
14.3 g/dL
Interval 13.3 to 15.5
|
13.5 g/dL
Interval 12.7 to 15.5
|
—
|
|
Part A Chemistry Laboratory Measures: Hemoglobin, Creatinine
Hemoglobin (g/dL)-Day 182
|
14.1 g/dL
Interval 12.9 to 15.2
|
13.9 g/dL
Interval 12.8 to 14.9
|
—
|
|
Part A Chemistry Laboratory Measures: Hemoglobin, Creatinine
Hemoglobin (g/dL)-Day 378
|
13.9 g/dL
Interval 12.7 to 14.7
|
13.4 g/dL
Interval 12.35 to 15.35
|
—
|
|
Part A Chemistry Laboratory Measures: Hemoglobin, Creatinine
Creatinine (g/dL)-Screening
|
0.0007 g/dL
Interval 0.00063 to 0.00081
|
0.0007 g/dL
Interval 0.0006 to 0.0008
|
—
|
|
Part A Chemistry Laboratory Measures: Hemoglobin, Creatinine
Creatinine (g/dL)-Day 14
|
0.00077 g/dL
Interval 0.00063 to 0.0009
|
0.0007 g/dL
Interval 0.00063 to 0.0008
|
—
|
|
Part A Chemistry Laboratory Measures: Hemoglobin, Creatinine
Creatinine (g/dL)-Day 42
|
0.0007 g/dL
Interval 0.00068 to 0.00081
|
0.0007 g/dL
Interval 0.000605 to 0.000855
|
—
|
|
Part A Chemistry Laboratory Measures: Hemoglobin, Creatinine
Creatinine (g/dL)-Day 98
|
0.00073 g/dL
Interval 0.00066 to 0.00081
|
0.00077 g/dL
Interval 0.0006 to 0.0009
|
—
|
|
Part A Chemistry Laboratory Measures: Hemoglobin, Creatinine
Creatinine (g/dL)-Day 182
|
0.0008 g/dL
Interval 0.00069 to 0.0009
|
0.0007 g/dL
Interval 0.00062 to 0.0008
|
—
|
|
Part A Chemistry Laboratory Measures: Hemoglobin, Creatinine
Creatinine (g/dL)-Day 378
|
0.0008 g/dL
Interval 0.0007 to 0.0009
|
0.0007 g/dL
Interval 0.000635 to 0.0008
|
—
|
PRIMARY outcome
Timeframe: Measured during screening for part A, and 2 weeks after each vaccination at Month 0, 1, 3, 6, and 12Population: 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.
For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population.
Outcome measures
| Measure |
Part A, Group 1: Vaccine
n=210 Participants
ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part A, Group 2: Placebo
n=42 Participants
Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part B, Group 2: Placebo
Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30
|
|---|---|---|---|
|
Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils
Neutrophils (1000/cubic mm)-Day 14
|
3.18 thousand cells/cubic mm
Interval 2.233 to 4.217
|
3.08 thousand cells/cubic mm
Interval 1.987 to 4.107
|
—
|
|
Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils
Neutrophils (1000/cubic mm)-Day 42
|
3.057 thousand cells/cubic mm
Interval 2.159 to 4.02
|
2.9015 thousand cells/cubic mm
Interval 1.7805 to 4.18
|
—
|
|
Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils
Neutrophils (1000/cubic mm)-Day 98
|
3.284 thousand cells/cubic mm
Interval 2.251 to 4.627
|
3.25 thousand cells/cubic mm
Interval 2.302 to 3.99
|
—
|
|
Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils
Platelets (1000/cubic mm)-Day 378
|
273 thousand cells/cubic mm
Interval 233.0 to 318.0
|
264.5 thousand cells/cubic mm
Interval 244.0 to 307.5
|
—
|
|
Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils
WBC (1000/cubic mm)-Screening
|
6.135 thousand cells/cubic mm
Interval 5.06 to 7.6
|
6.3 thousand cells/cubic mm
Interval 5.5 to 7.7
|
—
|
|
Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils
WBC (1000/cubic mm)-Day 14
|
6 thousand cells/cubic mm
Interval 4.84 to 7.29
|
5.9 thousand cells/cubic mm
Interval 4.54 to 7.02
|
—
|
|
Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils
WBC (1000/cubic mm)-Day 42
|
5.87 thousand cells/cubic mm
Interval 4.6 to 6.9
|
5.425 thousand cells/cubic mm
Interval 4.395 to 7.1
|
—
|
|
Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils
WBC (1000/cubic mm)-Day 98
|
6.055 thousand cells/cubic mm
Interval 4.76 to 7.32
|
5.9 thousand cells/cubic mm
Interval 4.44 to 7.2
|
—
|
|
Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils
WBC (1000/cubic mm)-Day 182
|
5.67 thousand cells/cubic mm
Interval 4.7 to 6.9
|
5.63 thousand cells/cubic mm
Interval 4.1 to 6.71
|
—
|
|
Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils
WBC (1000/cubic mm)-Day 378
|
5.69 thousand cells/cubic mm
Interval 4.72 to 7.0
|
5.815 thousand cells/cubic mm
Interval 4.5 to 7.18
|
—
|
|
Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils
Neutrophils (1000/cubic mm)-Screening
|
3.23 thousand cells/cubic mm
Interval 2.38 to 4.419
|
3.265 thousand cells/cubic mm
Interval 2.41 to 4.16
|
—
|
|
Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils
Neutrophils (1000/cubic mm)-Day 182
|
2.927 thousand cells/cubic mm
Interval 2.219 to 4.09
|
2.629 thousand cells/cubic mm
Interval 1.796 to 4.02
|
—
|
|
Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils
Neutrophils (1000/cubic mm)-Day 378
|
3.08 thousand cells/cubic mm
Interval 2.22 to 3.99
|
3.089 thousand cells/cubic mm
Interval 1.802 to 4.1015
|
—
|
|
Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils
Lymphocytes (1000/cubic mm)-Screening
|
2.182 thousand cells/cubic mm
Interval 1.84 to 2.546
|
2.299 thousand cells/cubic mm
Interval 1.947 to 2.66
|
—
|
|
Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils
Lymphocytes (1000/cubic mm)-Day 14
|
2.102 thousand cells/cubic mm
Interval 1.731 to 2.434
|
2.064 thousand cells/cubic mm
Interval 1.84 to 2.31
|
—
|
|
Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils
Lymphocytes (1000/cubic mm)-Day 42
|
2.0545 thousand cells/cubic mm
Interval 1.663 to 2.39
|
2.031 thousand cells/cubic mm
Interval 1.72 to 2.375
|
—
|
|
Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils
Lymphocytes (1000/cubic mm)-Day 98
|
1.9435 thousand cells/cubic mm
Interval 1.657 to 2.35
|
2.02 thousand cells/cubic mm
Interval 1.777 to 2.58
|
—
|
|
Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils
Lymphocytes (1000/cubic mm)-Day 182
|
2.004 thousand cells/cubic mm
Interval 1.675 to 2.41
|
1.96 thousand cells/cubic mm
Interval 1.77 to 2.25
|
—
|
|
Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils
Lymphocytes (1000/cubic mm)-Day 378
|
2 thousand cells/cubic mm
Interval 1.62 to 2.38
|
1.975 thousand cells/cubic mm
Interval 1.6885 to 2.315
|
—
|
|
Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils
Platelets (1000/cubic mm)-Screening
|
250.5 thousand cells/cubic mm
Interval 213.0 to 295.0
|
275 thousand cells/cubic mm
Interval 233.0 to 308.0
|
—
|
|
Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils
Platelets (1000/cubic mm)-Day 14
|
265 thousand cells/cubic mm
Interval 222.0 to 313.0
|
272 thousand cells/cubic mm
Interval 227.0 to 311.0
|
—
|
|
Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils
Platelets (1000/cubic mm)-Day 42
|
267 thousand cells/cubic mm
Interval 223.0 to 313.0
|
270 thousand cells/cubic mm
Interval 229.5 to 300.0
|
—
|
|
Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils
Platelets (1000/cubic mm)-Day 98
|
267 thousand cells/cubic mm
Interval 224.0 to 309.0
|
276 thousand cells/cubic mm
Interval 234.0 to 321.0
|
—
|
|
Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils
Platelets (1000/cubic mm)-Day 182
|
259.5 thousand cells/cubic mm
Interval 220.0 to 303.0
|
267 thousand cells/cubic mm
Interval 237.0 to 294.0
|
—
|
PRIMARY outcome
Timeframe: Measured at Month 6.5Population: "Overall Number of Participants Analyzed" includes those with samples collected at the month 6.5 immunogenicity timepoint, who were HIV-uninfected and received the first 4 vaccinations. "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. Samples from post-enrollment visits have positive responses if they meet three conditions: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of pre-vaccination net MFI), (2) net MFI values are greater than 3 times pre-vaccination net MFI, and (3) experimental antigen MFI values are greater than 3 times pre-vaccination MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI.
Outcome measures
| Measure |
Part A, Group 1: Vaccine
n=185 Participants
ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part A, Group 2: Placebo
n=37 Participants
Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part B, Group 2: Placebo
Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30
|
|---|---|---|---|
|
Part A: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Primary Vaccine Regimen, Measured by HIV-1 Multiplex Antibody Assay
96ZM651.D11gp120.avi
|
185 Participants
|
0 Participants
|
—
|
|
Part A: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Primary Vaccine Regimen, Measured by HIV-1 Multiplex Antibody Assay
1086C_D7gp120.avi/293F
|
185 Participants
|
0 Participants
|
—
|
|
Part A: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Primary Vaccine Regimen, Measured by HIV-1 Multiplex Antibody Assay
TV1c8_D11gp120.avi/293F
|
185 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Measured at Month 6.5Population: "Overall Number of Participants Analyzed" includes those with samples collected at the month 6.5 immunogenicity timepoint, who were HIV-uninfected and received the first 4 vaccinations. "Number Analyzed" shows the number of participants with available data after filtering for assay-specific quality control criteria.
Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation.
Outcome measures
| Measure |
Part A, Group 1: Vaccine
n=185 Participants
ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part A, Group 2: Placebo
n=37 Participants
Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part B, Group 2: Placebo
Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30
|
|---|---|---|---|
|
Part A: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Primary Vaccine Regimen, Measured by HIV-1 Multiplex Antibody Assay
96ZM651.D11gp120.avi
|
2650 fluorescence unit relative to background
Interval 1536.0 to 4868.5
|
1 fluorescence unit relative to background
Interval 1.0 to 1.0
|
—
|
|
Part A: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Primary Vaccine Regimen, Measured by HIV-1 Multiplex Antibody Assay
1086C_D7gp120.avi/293F
|
28359.5 fluorescence unit relative to background
Interval 25888.0 to 30784.25
|
1 fluorescence unit relative to background
Interval 1.0 to 1.0
|
—
|
|
Part A: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Primary Vaccine Regimen, Measured by HIV-1 Multiplex Antibody Assay
TV1c8_D11gp120.avi/293F
|
12883.5 fluorescence unit relative to background
Interval 6023.5 to 22540.75
|
1 fluorescence unit relative to background
Interval 1.0 to 1.0
|
—
|
PRIMARY outcome
Timeframe: Measured at Month 6.5Population: "Overall Number of Participants Analyzed" includes those with samples collected at the month 6.5 immunogenicity timepoint, who were HIV-uninfected and received the first 4 vaccinations. "Number Analyzed" shows the number of participants with available data after filtering for assay-specific quality control criteria.
Measured by HIV-1 multiplex Ab assay: refer to earlier description for assay methods and analysis variable derivation. The number and percentage of participants with positive responses are summarized by antigen.
Outcome measures
| Measure |
Part A, Group 1: Vaccine
n=185 Participants
ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part A, Group 2: Placebo
n=37 Participants
Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part B, Group 2: Placebo
Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30
|
|---|---|---|---|
|
Part A: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Primary Vaccine Regimen
gp70-TV1.21 V1V2
|
113 Participants
|
0 Participants
|
—
|
|
Part A: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Primary Vaccine Regimen
C.1086C_V1_V2 Tags
|
129 Participants
|
0 Participants
|
—
|
|
Part A: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Primary Vaccine Regimen
gp70-96ZM651.02 V1v2
|
88 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Measured at Month 6.5Population: "Overall Number of Participants Analyzed" includes those with samples collected at the month 6.5 immunogenicity timepoint, who were HIV-uninfected and received the first 4 vaccinations. "Number Analyzed" shows the number of participants with available data after filtering for assay-specific quality control criteria.
Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation.
Outcome measures
| Measure |
Part A, Group 1: Vaccine
n=185 Participants
ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part A, Group 2: Placebo
n=37 Participants
Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part B, Group 2: Placebo
Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30
|
|---|---|---|---|
|
Part A: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Primary Vaccine Regimen
gp70-TV1.21 V1V2
|
338.25 fluorescence unit relative to background
Interval 37.25 to 1188.3
|
1 fluorescence unit relative to background
Interval 1.0 to 1.0
|
—
|
|
Part A: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Primary Vaccine Regimen
C.1086C_V1_V2 Tags
|
562 fluorescence unit relative to background
Interval 98.5 to 2085.75
|
1 fluorescence unit relative to background
Interval 1.0 to 2.5
|
—
|
|
Part A: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Primary Vaccine Regimen
gp70-96ZM651.02 V1v2
|
392.5 fluorescence unit relative to background
Interval 48.0 to 1008.0
|
1 fluorescence unit relative to background
Interval 1.0 to 138.0
|
—
|
PRIMARY outcome
Timeframe: Measured at Month 6.5Population: "Overall Number of Participants Analyzed" includes those with samples collected at the month 6.5 immunogenicity timepoint, who were HIV-uninfected and received the first 4 vaccinations. "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. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p\<=0.00001. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.
Outcome measures
| Measure |
Part A, Group 1: Vaccine
n=185 Participants
ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part A, Group 2: Placebo
n=37 Participants
Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part B, Group 2: Placebo
Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30
|
|---|---|---|---|
|
Part A: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Primary Vaccine Regimen. Measured by Flow Cytometry.
Any gp120
|
120 Participants
|
1 Participants
|
—
|
|
Part A: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Primary Vaccine Regimen. Measured by Flow Cytometry.
1086 gp120
|
82 Participants
|
1 Participants
|
—
|
|
Part A: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Primary Vaccine Regimen. Measured by Flow Cytometry.
TV1 gp120
|
112 Participants
|
1 Participants
|
—
|
|
Part A: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Primary Vaccine Regimen. Measured by Flow Cytometry.
ZM96 gp120
|
102 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Measured at Month 6.5Population: "Overall Number of Participants Analyzed" includes those with samples collected at the month 6.5 immunogenicity timepoint, who were HIV-uninfected and received the first 4 vaccinations. "Number Analyzed" shows the number of participants with available data after filtering for assay-specific quality control criteria.
Measured by flow cytometry ICS assay: refer to earlier description for assay methods and analysis variable derivation. Percentage of T-cells expressing cytokines are summarized for positive responders only.
Outcome measures
| Measure |
Part A, Group 1: Vaccine
n=185 Participants
ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part A, Group 2: Placebo
n=37 Participants
Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part B, Group 2: Placebo
Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30
|
|---|---|---|---|
|
Part A: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Primary Vaccine Regimen.
Any gp120
|
0.11501130 % CD4+ T-cells
Interval 0.06637581 to 0.196508
|
0.003579320 % CD4+ T-cells
Interval -0.0031696 to 0.02699403
|
—
|
|
Part A: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Primary Vaccine Regimen.
1086 gp120
|
0.06613413 % CD4+ T-cells
Interval 0.03475199 to 0.1374808
|
-0.00296204 % CD4+ T-cells
Interval -0.01473795 to 0.00669736
|
—
|
|
Part A: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Primary Vaccine Regimen.
TV1 gp120
|
0.09629575 % CD4+ T-cells
Interval 0.052697 to 0.1701793
|
-0.002244635 % CD4+ T-cells
Interval -0.01399708 to 0.00818973
|
—
|
|
Part A: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Primary Vaccine Regimen.
ZM96 gp120
|
0.0889934 % CD4+ T-cells
Interval 0.0443736 to 0.1742616
|
-0.002505630 % CD4+ T-cells
Interval -0.00943639 to 0.00967744
|
—
|
PRIMARY outcome
Timeframe: Measured through 3 days after the Month 30 vaccinationGraded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\]. For each participant, the maximum grade observed for each symptom over the time frame is presented.
Outcome measures
| Measure |
Part A, Group 1: Vaccine
n=32 Participants
ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part A, Group 2: Placebo
n=31 Participants
Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part B, Group 2: Placebo
n=7 Participants
Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30
|
|---|---|---|---|
|
Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study
Pain · Life Threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study
Tenderness · None
|
21 Participants
|
25 Participants
|
7 Participants
|
|
Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study
Tenderness · Moderate
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study
Induration · Severe
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study
Induration · Life Threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study
Erythema and/or Induration · Mild
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study
Pain · None
|
16 Participants
|
18 Participants
|
7 Participants
|
|
Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study
Pain · Mild
|
12 Participants
|
11 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study
Pain · Moderate
|
4 Participants
|
2 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study
Pain · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study
Tenderness · Mild
|
7 Participants
|
5 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study
Tenderness · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study
Tenderness · Life Threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study
Pain and/or Tenderness · None
|
14 Participants
|
17 Participants
|
7 Participants
|
|
Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study
Pain and/or Tenderness · Mild
|
11 Participants
|
12 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study
Pain and/or Tenderness · Moderate
|
7 Participants
|
2 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study
Pain and/or Tenderness · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study
Pain and/or Tenderness · Life Threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study
Erythema · None
|
28 Participants
|
27 Participants
|
7 Participants
|
|
Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study
Erythema · Mild
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study
Erythema · Moderate
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study
Erythema · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study
Erythema · Life Threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study
Induration · None
|
28 Participants
|
25 Participants
|
7 Participants
|
|
Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study
Induration · Mild
|
1 Participants
|
4 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study
Induration · Moderate
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study
Erythema and/or Induration · None
|
28 Participants
|
24 Participants
|
7 Participants
|
|
Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study
Erythema and/or Induration · Moderate
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study
Erythema and/or Induration · Severe
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study
Erythema and/or Induration · Life Threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through 3 days after the Month 30 vaccinationGraded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\]. For each participant, the maximum grade observed for each symptom over the time frame is presented.
Outcome measures
| Measure |
Part A, Group 1: Vaccine
n=32 Participants
ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part A, Group 2: Placebo
n=31 Participants
Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part B, Group 2: Placebo
n=7 Participants
Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30
|
|---|---|---|---|
|
Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study
Myalgia · Moderate
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study
Myalgia · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study
Myalgia · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study
Headache · None
|
26 Participants
|
29 Participants
|
6 Participants
|
|
Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study
Headache · Mild
|
6 Participants
|
2 Participants
|
1 Participants
|
|
Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study
Headache · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study
Malaise and/or fatigue · None
|
21 Participants
|
24 Participants
|
7 Participants
|
|
Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study
Malaise and/or fatigue · Mild
|
9 Participants
|
7 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study
Malaise and/or fatigue · Moderate
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study
Headache · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study
Headache · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study
Nausea · None
|
31 Participants
|
30 Participants
|
7 Participants
|
|
Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study
Nausea · Mild
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study
Nausea · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study
Nausea · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study
Nausea · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study
Vomiting · None
|
32 Participants
|
30 Participants
|
7 Participants
|
|
Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study
Vomiting · Mild
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study
Vomiting · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study
Vomiting · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study
Vomiting · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study
Chills · None
|
28 Participants
|
29 Participants
|
7 Participants
|
|
Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study
Chills · Mild
|
4 Participants
|
2 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study
Chills · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study
Chills · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study
Malaise and/or fatigue · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study
Malaise and/or fatigue · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study
Myalgia · None
|
21 Participants
|
24 Participants
|
7 Participants
|
|
Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study
Chills · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study
Arthralgia · None
|
25 Participants
|
28 Participants
|
7 Participants
|
|
Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study
Arthralgia · Mild
|
6 Participants
|
3 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study
Arthralgia · Moderate
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study
Myalgia · Mild
|
7 Participants
|
7 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study
Arthralgia · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study
Arthralgia · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study
Max. Systemic Symptoms · None
|
16 Participants
|
21 Participants
|
6 Participants
|
|
Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study
Max. Systemic Symptoms · Mild
|
11 Participants
|
10 Participants
|
1 Participants
|
|
Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study
Max. Systemic Symptoms · Moderate
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study
Max. Systemic Symptoms · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study
Max. Systemic Symptoms · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study
Temperature · None
|
32 Participants
|
31 Participants
|
7 Participants
|
|
Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study
Temperature · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study
Temperature · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study
Temperature · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study
Temperature · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through Month 36From the study termination form, early termination reasons associated with an AE are tabulated by treatment arm
Outcome measures
| Measure |
Part A, Group 1: Vaccine
n=32 Participants
ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part A, Group 2: Placebo
n=31 Participants
Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part B, Group 2: Placebo
n=7 Participants
Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30
|
|---|---|---|---|
|
Part B: Number of Participants With Early Study Termination Associated With an AE or Reactogenicity
Termination not due to AE/Reactogenicity
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With Early Study Termination Associated With an AE or Reactogenicity
Other reason
|
32 Participants
|
31 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Time Frame: Measured during screening for part B, and 2 weeks after vaccination at Month 30Population: The "overall number of participants analyzed" represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit.
Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown.
Outcome measures
| Measure |
Part A, Group 1: Vaccine
n=32 Participants
ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part A, Group 2: Placebo
n=31 Participants
Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part B, Group 2: Placebo
n=7 Participants
Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30
|
|---|---|---|---|
|
Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher
Hemoglobin (g/dL)-Day 924
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher
Lymphocytes (1000/cubic mm)-Part B Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher
Lymphocytes (1000/cubic mm)-Day 924
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher
Neutrophils (1000/cubic mm)-Day 924
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher
Hemoglobin (g/dL)-Part B Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher
WBC (1000/cubic mm)-Part B Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher
WBC (1000/cubic mm)-Day 924
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher
Neutrophils (1000/cubic mm)-Part B Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher
Platelets (1000/cubic mm)-Part B Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher
Platelets (1000/cubic mm)-Day 924
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher
ALT (SGPT) (U/L)-Part B Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher
ALT (SGPT) (U/L)-Day 924
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher
AST (U/L)-Part B Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher
AST (U/L)-Day 924
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher
Alkaline Phosphatase (U/L)-Part B Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher
Alkaline Phosphatase (U/L)-Day 924
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher
Creatinine (g/dL)-Part B Screening
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher
Creatinine (g/dL)-Day 924
|
1 Participants
|
6 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Measured during screening for part B, and 2 weeks after vaccination at Month 30Population: 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.
For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population.
Outcome measures
| Measure |
Part A, Group 1: Vaccine
n=32 Participants
ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part A, Group 2: Placebo
n=31 Participants
Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part B, Group 2: Placebo
n=7 Participants
Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30
|
|---|---|---|---|
|
Part B Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT
ALT (SGPT) (U/L)-Part B Screening
|
17 U/L
Interval 12.0 to 23.0
|
18 U/L
Interval 16.0 to 21.0
|
20 U/L
Interval 12.0 to 23.0
|
|
Part B Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT
ALT (SGPT) (U/L)-Day 924
|
16 U/L
Interval 13.0 to 22.0
|
15 U/L
Interval 12.0 to 22.0
|
16.5 U/L
Interval 14.0 to 29.0
|
|
Part B Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT
AST (U/L)-Part B Screening
|
22.5 U/L
Interval 18.5 to 26.0
|
23 U/L
Interval 19.0 to 26.0
|
20 U/L
Interval 19.0 to 22.0
|
|
Part B Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT
AST (U/L)-Day 924
|
20.5 U/L
Interval 19.0 to 26.0
|
21 U/L
Interval 19.0 to 23.0
|
22 U/L
Interval 16.0 to 24.0
|
|
Part B Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT
Alkaline Phosphatase (U/L)-Part B Screening
|
73 U/L
Interval 59.0 to 88.0
|
74 U/L
Interval 64.0 to 90.0
|
68 U/L
Interval 62.0 to 86.0
|
|
Part B Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT
Alkaline Phosphatase (U/L)-Day 924
|
76.5 U/L
Interval 64.5 to 92.0
|
69 U/L
Interval 56.0 to 79.0
|
59.5 U/L
Interval 58.0 to 79.0
|
PRIMARY outcome
Timeframe: Measured during screening for part B, and 2 weeks after vaccination at Month 30Population: 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.
For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population.
Outcome measures
| Measure |
Part A, Group 1: Vaccine
n=32 Participants
ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part A, Group 2: Placebo
n=31 Participants
Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part B, Group 2: Placebo
n=7 Participants
Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30
|
|---|---|---|---|
|
Part B Chemistry Laboratory Measures: Hemoglobin, Creatinine
Creatinine (g/dL)-Part B Screening
|
0.00085 g/dL
Interval 0.0007 to 0.001
|
0.0007 g/dL
Interval 0.0007 to 0.0008
|
0.0007 g/dL
Interval 0.0006 to 0.0008
|
|
Part B Chemistry Laboratory Measures: Hemoglobin, Creatinine
Hemoglobin (g/dL)-Part B Screening
|
14.85 g/dL
Interval 13.75 to 15.7
|
14.6 g/dL
Interval 12.9 to 15.6
|
13.8 g/dL
Interval 11.9 to 15.3
|
|
Part B Chemistry Laboratory Measures: Hemoglobin, Creatinine
Hemoglobin (g/dL)-Day 924
|
14.65 g/dL
Interval 13.45 to 15.1
|
13.965 g/dL
Interval 12.1 to 15.2
|
13.7 g/dL
Interval 11.7 to 14.9
|
|
Part B Chemistry Laboratory Measures: Hemoglobin, Creatinine
Creatinine (g/dL)-Day 924
|
0.0009 g/dL
Interval 0.00072 to 0.00095
|
0.0008 g/dL
Interval 0.00061 to 0.0009
|
0.00075 g/dL
Interval 0.00069 to 0.0008
|
PRIMARY outcome
Timeframe: Measured during screening for part B, and 2 weeks after vaccination at Month 30Population: 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.
For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population.
Outcome measures
| Measure |
Part A, Group 1: Vaccine
n=32 Participants
ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part A, Group 2: Placebo
n=31 Participants
Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part B, Group 2: Placebo
n=7 Participants
Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30
|
|---|---|---|---|
|
Part B Chemistry Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils
WBC (1000/cubic mm)-Day 924
|
6.28 thousand cells/cubic mm
Interval 5.285 to 8.295
|
6.355 thousand cells/cubic mm
Interval 4.67 to 6.93
|
6.505 thousand cells/cubic mm
Interval 5.76 to 7.73
|
|
Part B Chemistry Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils
Platelets (1000/cubic mm)-Day 924
|
279 thousand cells/cubic mm
Interval 240.0 to 317.0
|
248.5 thousand cells/cubic mm
Interval 211.0 to 297.0
|
281.5 thousand cells/cubic mm
Interval 277.0 to 297.0
|
|
Part B Chemistry Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils
WBC (1000/cubic mm)-Part B Screening
|
6.4 thousand cells/cubic mm
Interval 5.45 to 7.79
|
6.59 thousand cells/cubic mm
Interval 4.66 to 8.03
|
7.1 thousand cells/cubic mm
Interval 5.0 to 8.03
|
|
Part B Chemistry Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils
Neutrophils (1000/cubic mm)-Part B Screening
|
3.499 thousand cells/cubic mm
Interval 2.847 to 4.741
|
3.41 thousand cells/cubic mm
Interval 2.54 to 4.959
|
3.38 thousand cells/cubic mm
Interval 2.331 to 4.826
|
|
Part B Chemistry Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils
Neutrophils (1000/cubic mm)-Day 924
|
3.577 thousand cells/cubic mm
Interval 2.7545 to 5.1055
|
3.7825 thousand cells/cubic mm
Interval 2.309 to 4.133
|
3.031 thousand cells/cubic mm
Interval 2.92 to 4.352
|
|
Part B Chemistry Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils
Lymphocytes (1000/cubic mm)-Part B Screening
|
2.2295 thousand cells/cubic mm
Interval 1.859 to 2.5305
|
1.941 thousand cells/cubic mm
Interval 1.682 to 2.583
|
2.559 thousand cells/cubic mm
Interval 2.425 to 3.01
|
|
Part B Chemistry Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils
Lymphocytes (1000/cubic mm)-Day 924
|
2.031 thousand cells/cubic mm
Interval 1.742 to 2.3985
|
1.9295 thousand cells/cubic mm
Interval 1.666 to 2.093
|
2.541 thousand cells/cubic mm
Interval 2.334 to 2.72
|
|
Part B Chemistry Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils
Platelets (1000/cubic mm)-Part B Screening
|
264 thousand cells/cubic mm
Interval 225.0 to 291.0
|
256 thousand cells/cubic mm
Interval 213.0 to 294.0
|
311 thousand cells/cubic mm
Interval 265.0 to 343.0
|
PRIMARY outcome
Timeframe: Measured at Month 30.5Population: "Overall Number of Participants Analyzed" includes those with samples collected at month 30.5, who were HIV-uninfected and received the all vaccinations. "Number Analyzed" counts participants with available data after filtering for assay-specific quality control criteria.
Measured by HIV-1 multiplex Ab assay: refer to earlier description for assay methods and analysis variable derivation. The number and percentage of participants with positive responses are summarized by antigen.
Outcome measures
| Measure |
Part A, Group 1: Vaccine
n=28 Participants
ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part A, Group 2: Placebo
n=30 Participants
Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part B, Group 2: Placebo
n=6 Participants
Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30
|
|---|---|---|---|
|
Part B: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study
C.1086C_V1_V2 Tags
|
19 Participants
|
23 Participants
|
0 Participants
|
|
Part B: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study
gp70-96ZM651.02 V1v2
|
14 Participants
|
15 Participants
|
0 Participants
|
|
Part B: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study
gp70-TV1.GSKvacV1V2/293F
|
15 Participants
|
18 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured at Month 30.5Population: "Overall Number of Participants Analyzed" includes those with samples collected at month 30.5, who were HIV-uninfected and received the all vaccinations. "Number Analyzed" counts participants with available data after filtering for assay-specific quality control criteria.
Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation.
Outcome measures
| Measure |
Part A, Group 1: Vaccine
n=28 Participants
ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part A, Group 2: Placebo
n=30 Participants
Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part B, Group 2: Placebo
n=6 Participants
Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30
|
|---|---|---|---|
|
Part B: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study
gp70-96ZM651.02 V1v2
|
858.125 fluorescence unit relative to background
Interval 159.75 to 17625.5
|
1015.625 fluorescence unit relative to background
Interval 183.5 to 2618.5
|
1 fluorescence unit relative to background
Interval 1.0 to 133.5
|
|
Part B: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study
gp70-TV1.GSKvacV1V2/293F
|
924.75 fluorescence unit relative to background
Interval 304.0 to 6457.5
|
1537 fluorescence unit relative to background
Interval 154.75 to 11308.0
|
1 fluorescence unit relative to background
Interval 1.0 to 4.75
|
|
Part B: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study
C.1086C_V1_V2 Tags
|
527.375 fluorescence unit relative to background
Interval 156.25 to 1506.5
|
562.25 fluorescence unit relative to background
Interval 171.25 to 2866.75
|
1 fluorescence unit relative to background
Interval 1.0 to 1.0
|
PRIMARY outcome
Timeframe: Measured at Month 30.5Population: "Overall Number of Participants Analyzed" includes those with samples collected at month 30.5, who were HIV-uninfected and received the all vaccinations. "Number Analyzed" counts participants with available data after filtering for assay-specific quality control criteria.
Measured by HIV-1 multiplex Ab assay: refer to earlier description for assay methods and analysis variable derivation. The number and percentage of participants with positive responses are summarized by antigen.
Outcome measures
| Measure |
Part A, Group 1: Vaccine
n=28 Participants
ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part A, Group 2: Placebo
n=30 Participants
Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part B, Group 2: Placebo
n=6 Participants
Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30
|
|---|---|---|---|
|
Part B: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study
1086C_D7gp120.avi/293F
|
26 Participants
|
30 Participants
|
0 Participants
|
|
Part B: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study
96ZM651.D11gp120.avi
|
25 Participants
|
29 Participants
|
0 Participants
|
|
Part B: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study
TV1c8_D11gp120.avi/293F
|
26 Participants
|
30 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured at Month 30.5Population: "Overall Number of Participants Analyzed" includes those with samples collected at month 30.5, who were HIV-uninfected and received the all vaccinations. "Number Analyzed" counts participants with available data after filtering for assay-specific quality control criteria.
Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation.
Outcome measures
| Measure |
Part A, Group 1: Vaccine
n=28 Participants
ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part A, Group 2: Placebo
n=30 Participants
Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part B, Group 2: Placebo
n=6 Participants
Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30
|
|---|---|---|---|
|
Part B: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study
1086C_D7gp120.avi/293F
|
31063.875 fluorescence unit relative to background
Interval 30695.25 to 31272.0
|
30887.75 fluorescence unit relative to background
Interval 30415.0 to 31428.75
|
1 fluorescence unit relative to background
Interval 1.0 to 1.0
|
|
Part B: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study
96ZM651.D11gp120.avi
|
30006.875 fluorescence unit relative to background
Interval 29070.75 to 30465.25
|
30137.5 fluorescence unit relative to background
Interval 28980.0 to 30938.25
|
1 fluorescence unit relative to background
Interval 1.0 to 12.25
|
|
Part B: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study
TV1c8_D11gp120.avi/293F
|
30864.875 fluorescence unit relative to background
Interval 30308.0 to 31304.75
|
30674.125 fluorescence unit relative to background
Interval 30076.5 to 31240.25
|
1 fluorescence unit relative to background
Interval 1.0 to 5.75
|
PRIMARY outcome
Timeframe: Measured at Month 30.5Population: "Overall Number of Participants Analyzed" includes those with samples collected at month 30.5, who were HIV-uninfected and received the all vaccinations. "Number Analyzed" counts participants with available data after filtering for assay-specific quality control criteria.
Measured by flow cytometry ICS assay: refer to earlier description for assay methods and analysis variable derivation. The number and percentage of participants with positive responses are summarized by peptide pool.
Outcome measures
| Measure |
Part A, Group 1: Vaccine
n=28 Participants
ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part A, Group 2: Placebo
n=30 Participants
Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part B, Group 2: Placebo
n=6 Participants
Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30
|
|---|---|---|---|
|
Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study
Any gp120
|
25 Participants
|
26 Participants
|
0 Participants
|
|
Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study
1086 gp120
|
22 Participants
|
23 Participants
|
0 Participants
|
|
Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study
TV1 gp120
|
24 Participants
|
25 Participants
|
0 Participants
|
|
Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study
ZM96 gp120
|
23 Participants
|
22 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured at Month 30.5Population: "Overall Number of Participants Analyzed" includes those with samples collected at month 30.5, who were HIV-uninfected and received the all vaccinations. "Number Analyzed" counts participants with available data after filtering for assay-specific quality control criteria.
Measured by flow cytometry ICS assay: refer to earlier description for assay methods and analysis variable derivation. Percentage of T-cells expressing cytokines are summarized for positive responders only.
Outcome measures
| Measure |
Part A, Group 1: Vaccine
n=28 Participants
ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part A, Group 2: Placebo
n=30 Participants
Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part B, Group 2: Placebo
n=6 Participants
Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30
|
|---|---|---|---|
|
Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study
Any gp120
|
0.284956245 % of CD4+ T-cells
Interval 0.11146075 to 0.38500129
|
0.18676016 % of CD4+ T-cells
Interval 0.121813505 to 0.261912375
|
0.00889506 % of CD4+ T-cells
Interval 0.0 to 0.0335174
|
|
Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study
1086 gp120
|
0.1299094 % of CD4+ T-cells
Interval 0.06802766 to 0.27495601
|
0.11812899 % of CD4+ T-cells
Interval 0.076206435 to 0.17014021
|
-0.00507644 % of CD4+ T-cells
Interval -0.00912041 to -0.00408307
|
|
Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study
TV1 gp120
|
0.23924445 % of CD4+ T-cells
Interval 0.10696857 to 0.35719109
|
0.180244495 % of CD4+ T-cells
Interval 0.086940765 to 0.242827475
|
0.00889506 % of CD4+ T-cells
Interval -0.01525722 to 0.00990069
|
|
Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study
ZM96 gp120
|
0.25434725 % of CD4+ T-cells
Interval 0.10973632 to 0.33505092
|
0.13517637 % of CD4+ T-cells
Interval 0.068628665 to 0.18483264
|
-0.00325229 % of CD4+ T-cells
Interval -0.00701159 to -0.00203876
|
SECONDARY outcome
Timeframe: Measured through 3 days after each vaccination at Month 0, 1, 3, 6, and 12Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\]. The maximum grade observed for each symptom over the time frame is presented.
Outcome measures
| Measure |
Part A, Group 1: Vaccine
n=210 Participants
ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part A, Group 2: Placebo
n=42 Participants
Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part B, Group 2: Placebo
Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30
|
|---|---|---|---|
|
Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Pain · None
|
37 Participants
|
24 Participants
|
—
|
|
Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Pain · Mild
|
120 Participants
|
17 Participants
|
—
|
|
Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Pain · Moderate
|
50 Participants
|
1 Participants
|
—
|
|
Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Pain · Severe
|
3 Participants
|
0 Participants
|
—
|
|
Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Pain · Life Threatening
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Tenderness · None
|
60 Participants
|
33 Participants
|
—
|
|
Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Tenderness · Mild
|
114 Participants
|
8 Participants
|
—
|
|
Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Tenderness · Moderate
|
35 Participants
|
1 Participants
|
—
|
|
Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Tenderness · Severe
|
1 Participants
|
0 Participants
|
—
|
|
Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Tenderness · Life Threatening
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Pain and/or Tenderness · None
|
30 Participants
|
24 Participants
|
—
|
|
Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Pain and/or Tenderness · Mild
|
123 Participants
|
17 Participants
|
—
|
|
Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Pain and/or Tenderness · Moderate
|
54 Participants
|
1 Participants
|
—
|
|
Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Pain and/or Tenderness · Severe
|
3 Participants
|
0 Participants
|
—
|
|
Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Pain and/or Tenderness · Life Threatening
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Erythema · None
|
196 Participants
|
42 Participants
|
—
|
|
Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Erythema · Mild
|
8 Participants
|
0 Participants
|
—
|
|
Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Erythema · Moderate
|
3 Participants
|
0 Participants
|
—
|
|
Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Erythema · Severe
|
3 Participants
|
0 Participants
|
—
|
|
Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Erythema · Life Threatening
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Induration · None
|
178 Participants
|
42 Participants
|
—
|
|
Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Induration · Mild
|
17 Participants
|
0 Participants
|
—
|
|
Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Induration · Moderate
|
12 Participants
|
0 Participants
|
—
|
|
Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Induration · Severe
|
3 Participants
|
0 Participants
|
—
|
|
Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Induration · Life Threatening
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Erythema and/or Induration · None
|
176 Participants
|
42 Participants
|
—
|
|
Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Erythema and/or Induration · Mild
|
17 Participants
|
0 Participants
|
—
|
|
Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Erythema and/or Induration · Moderate
|
14 Participants
|
0 Participants
|
—
|
|
Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Erythema and/or Induration · Severe
|
3 Participants
|
0 Participants
|
—
|
|
Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Erythema and/or Induration · Life Threatening
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Measured through 3 days after each vaccination at Month 0, 1, 3, 6, and 12Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\]. The maximum grade observed for each symptom over the time frame is presented.
Outcome measures
| Measure |
Part A, Group 1: Vaccine
n=210 Participants
ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part A, Group 2: Placebo
n=42 Participants
Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part B, Group 2: Placebo
Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30
|
|---|---|---|---|
|
Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Myalgia · Mild
|
64 Participants
|
7 Participants
|
—
|
|
Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Myalgia · Severe
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Myalgia · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Headache · None
|
130 Participants
|
19 Participants
|
—
|
|
Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Headache · Mild
|
62 Participants
|
17 Participants
|
—
|
|
Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Headache · Moderate
|
17 Participants
|
6 Participants
|
—
|
|
Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Headache · Severe
|
1 Participants
|
0 Participants
|
—
|
|
Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Headache · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Nausea · None
|
174 Participants
|
38 Participants
|
—
|
|
Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Nausea · Mild
|
34 Participants
|
4 Participants
|
—
|
|
Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Nausea · Moderate
|
2 Participants
|
0 Participants
|
—
|
|
Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Nausea · Severe
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Nausea · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Vomiting · None
|
200 Participants
|
41 Participants
|
—
|
|
Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Vomiting · Mild
|
9 Participants
|
1 Participants
|
—
|
|
Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Vomiting · Moderate
|
1 Participants
|
0 Participants
|
—
|
|
Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Vomiting · Severe
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Vomiting · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Chills · None
|
187 Participants
|
40 Participants
|
—
|
|
Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Chills · Mild
|
21 Participants
|
2 Participants
|
—
|
|
Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Chills · Moderate
|
2 Participants
|
0 Participants
|
—
|
|
Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Chills · Severe
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Chills · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Arthralgia · None
|
143 Participants
|
33 Participants
|
—
|
|
Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Arthralgia · Mild
|
57 Participants
|
8 Participants
|
—
|
|
Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Arthralgia · Moderate
|
8 Participants
|
1 Participants
|
—
|
|
Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Arthralgia · Severe
|
2 Participants
|
0 Participants
|
—
|
|
Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Arthralgia · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Max. Systemic Symptoms · None
|
63 Participants
|
14 Participants
|
—
|
|
Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Max. Systemic Symptoms · Mild
|
104 Participants
|
19 Participants
|
—
|
|
Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Max. Systemic Symptoms · Moderate
|
40 Participants
|
8 Participants
|
—
|
|
Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Max. Systemic Symptoms · Severe
|
3 Participants
|
1 Participants
|
—
|
|
Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Max. Systemic Symptoms · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Temperature · None
|
192 Participants
|
41 Participants
|
—
|
|
Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Temperature · Mild
|
11 Participants
|
0 Participants
|
—
|
|
Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Temperature · Moderate
|
7 Participants
|
1 Participants
|
—
|
|
Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Temperature · Severe
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Temperature · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Myalgia · None
|
124 Participants
|
34 Participants
|
—
|
|
Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Malaise and/or fatigue · None
|
121 Participants
|
26 Participants
|
—
|
|
Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Malaise and/or fatigue · Mild
|
74 Participants
|
14 Participants
|
—
|
|
Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Malaise and/or fatigue · Moderate
|
15 Participants
|
1 Participants
|
—
|
|
Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Malaise and/or fatigue · Severe
|
0 Participants
|
1 Participants
|
—
|
|
Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Malaise and/or fatigue · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Myalgia · Moderate
|
22 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Measured at Month 6.5 and 12.5Population: The durability cohort was randomly selected from those in the month 6.5 cohort with samples collected at month 12.5. Selection was stratified by gender to match the overall protocol. "Overall Number of Participants Analyzed" represents the durability cohort. "Number Analyzed" counts participants with data meeting assay-specific quality 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. Samples from post-enrollment visits have positive responses if they meet three conditions: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of pre-vaccination net MFI), (2) net MFI values are greater than 3 times pre-vaccination net MFI, and (3) experimental antigen MFI values are greater than 3 times pre-vaccination MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI.
Outcome measures
| Measure |
Part A, Group 1: Vaccine
n=65 Participants
ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part A, Group 2: Placebo
Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part B, Group 2: Placebo
Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30
|
|---|---|---|---|
|
Part A: Compare the Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Fourth Versus the Fifth Vaccination
1086C_D7gp120.avi/293F (Month 6.5)
|
64 Participants
|
—
|
—
|
|
Part A: Compare the Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Fourth Versus the Fifth Vaccination
1086C_D7gp120.avi/293F (Month 12.5)
|
64 Participants
|
—
|
—
|
|
Part A: Compare the Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Fourth Versus the Fifth Vaccination
96ZM651.D11gp120.avi (Month 6.5)
|
59 Participants
|
—
|
—
|
|
Part A: Compare the Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Fourth Versus the Fifth Vaccination
96ZM651.D11gp120.avi (Month 12.5)
|
59 Participants
|
—
|
—
|
|
Part A: Compare the Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Fourth Versus the Fifth Vaccination
TV1c8_D11gp120.avi/293F (Month 6.5)
|
64 Participants
|
—
|
—
|
|
Part A: Compare the Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Fourth Versus the Fifth Vaccination
TV1c8_D11gp120.avi/293F (Month 12.5)
|
64 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured at Month 6.5 and 12.5Population: The durability cohort was randomly selected from those in the month 6.5 cohort with samples collected at month 12.5. Selection was stratified by gender to match the overall protocol. "Overall Number of Participants Analyzed" represents the durability cohort. "Number Analyzed" counts participants with data meeting assay-specific quality 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. Comparisons were performed among positive responders only (positivity criteria is described in Outcome 30).
Outcome measures
| Measure |
Part A, Group 1: Vaccine
n=65 Participants
ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part A, Group 2: Placebo
Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part B, Group 2: Placebo
Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30
|
|---|---|---|---|
|
Part A: Compare the Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Fourth Versus the Fifth Vaccination
1086C_D7gp120.avi/293F (Month 6.5)
|
29317.375 fluorescence unit relative to background
Interval 28375.25 to 29980.25
|
—
|
—
|
|
Part A: Compare the Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Fourth Versus the Fifth Vaccination
1086C_D7gp120.avi/293F (Month 12.5)
|
31407.349999 fluorescence unit relative to background
Interval 30676.474999 to 31978.475001
|
—
|
—
|
|
Part A: Compare the Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Fourth Versus the Fifth Vaccination
96ZM651.D11gp120.avi (Month 6.5)
|
26437.25 fluorescence unit relative to background
Interval 24669.0 to 28770.5
|
—
|
—
|
|
Part A: Compare the Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Fourth Versus the Fifth Vaccination
96ZM651.D11gp120.avi (Month 12.5)
|
31378.5 fluorescence unit relative to background
Interval 30576.5 to 31901.5
|
—
|
—
|
|
Part A: Compare the Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Fourth Versus the Fifth Vaccination
TV1c8_D11gp120.avi/293F (Month 6.5)
|
28365.625 fluorescence unit relative to background
Interval 27214.375 to 29583.25
|
—
|
—
|
|
Part A: Compare the Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Fourth Versus the Fifth Vaccination
TV1c8_D11gp120.avi/293F (Month 12.5)
|
31425.5 fluorescence unit relative to background
Interval 30760.475006 to 31893.375
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured at Month 6.5 and 12.5Population: The durability cohort was randomly selected from those in the month 6.5 cohort with samples collected at month 12.5. Selection was stratified by gender to match the overall protocol. "Overall Number of Participants Analyzed" represents the durability cohort. "Number Analyzed" counts participants with data meeting assay-specific quality 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. Samples from post-enrollment visits have positive responses if they meet three conditions: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of pre-vaccination net MFI), (2) net MFI values are greater than 3 times pre-vaccination net MFI, and (3) experimental antigen MFI values are greater than 3 times pre-vaccination MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI.
Outcome measures
| Measure |
Part A, Group 1: Vaccine
n=65 Participants
ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part A, Group 2: Placebo
Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part B, Group 2: Placebo
Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30
|
|---|---|---|---|
|
Part A: Compare the Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Fourth Versus the Fifth Vaccination
C.1086C_V1_V2 Tags (Month 6.5)
|
49 Participants
|
—
|
—
|
|
Part A: Compare the Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Fourth Versus the Fifth Vaccination
C.1086C_V1_V2 Tags (Month 12.5)
|
57 Participants
|
—
|
—
|
|
Part A: Compare the Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Fourth Versus the Fifth Vaccination
gp70-96ZM651.02 V1v2 (Month 6.5)
|
29 Participants
|
—
|
—
|
|
Part A: Compare the Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Fourth Versus the Fifth Vaccination
gp70-96ZM651.02 V1v2 (Month 12.5)
|
44 Participants
|
—
|
—
|
|
Part A: Compare the Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Fourth Versus the Fifth Vaccination
gp70-TV1.GSKvacV1V2/293F (Month 6.5)
|
36 Participants
|
—
|
—
|
|
Part A: Compare the Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Fourth Versus the Fifth Vaccination
gp70-TV1.GSKvacV1V2/293F (Month 12.5)
|
50 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured at Month 6.5 and 12.5Population: The durability cohort was randomly selected from those in the month 6.5 cohort with samples collected at month 12.5. Selection was stratified by gender to match the overall protocol. "Overall Number of Participants Analyzed" represents the durability cohort. "Number Analyzed" counts participants with data meeting assay-specific quality 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. Comparisons were performed among positive responders only (positivity criteria is described in Outcome 32).
Outcome measures
| Measure |
Part A, Group 1: Vaccine
n=65 Participants
ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part A, Group 2: Placebo
Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part B, Group 2: Placebo
Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30
|
|---|---|---|---|
|
Part A: Compare the Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Fourth Versus the Fifth Vaccination
C.1086C_V1_V2 Tags (Month 6.5)
|
1281.5 fluorescence unit relative to background
Interval 662.75 to 2252.0
|
—
|
—
|
|
Part A: Compare the Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Fourth Versus the Fifth Vaccination
C.1086C_V1_V2 Tags (Month 12.5)
|
2938.5 fluorescence unit relative to background
Interval 1141.699997 to 6677.999806
|
—
|
—
|
|
Part A: Compare the Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Fourth Versus the Fifth Vaccination
gp70-96ZM651.02 V1v2 (Month 6.5)
|
1747.5 fluorescence unit relative to background
Interval 871.75 to 3196.25
|
—
|
—
|
|
Part A: Compare the Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Fourth Versus the Fifth Vaccination
gp70-96ZM651.02 V1v2 (Month 12.5)
|
3821.75 fluorescence unit relative to background
Interval 1544.4000245 to 9955.8500005
|
—
|
—
|
|
Part A: Compare the Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Fourth Versus the Fifth Vaccination
gp70-TV1.GSKvacV1V2/293F (Month 6.5)
|
3082.625 fluorescence unit relative to background
Interval 1198.375 to 8855.0
|
—
|
—
|
|
Part A: Compare the Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Fourth Versus the Fifth Vaccination
gp70-TV1.GSKvacV1V2/293F (Month 12.5)
|
4207.8499015 fluorescence unit relative to background
Interval 1341.5 to 13130.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured at Month 6.5 and 12.5PBMC 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. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p\<=0.00001. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.
Outcome measures
| Measure |
Part A, Group 1: Vaccine
n=56 Participants
ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part A, Group 2: Placebo
Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part B, Group 2: Placebo
Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30
|
|---|---|---|---|
|
Part A: Compare the Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Fourth Versus the Fifth Vaccinations
TV1 gp120 (Month 6.5)
|
32 Participants
|
—
|
—
|
|
Part A: Compare the Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Fourth Versus the Fifth Vaccinations
TV1 gp120 (Month 12.5)
|
31 Participants
|
—
|
—
|
|
Part A: Compare the Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Fourth Versus the Fifth Vaccinations
1086 gp120 (Month 6.5)
|
24 Participants
|
—
|
—
|
|
Part A: Compare the Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Fourth Versus the Fifth Vaccinations
1086 gp120 (Month 12.5)
|
23 Participants
|
—
|
—
|
|
Part A: Compare the Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Fourth Versus the Fifth Vaccinations
ZM96 gp120 (Month 6.5)
|
30 Participants
|
—
|
—
|
|
Part A: Compare the Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Fourth Versus the Fifth Vaccinations
ZM96 gp120 (Month 12.5)
|
34 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured at Month 6.5 and 12.5PBMC 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. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p\<=0.00001. 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. Comparisons were performed among positive responders only.
Outcome measures
| Measure |
Part A, Group 1: Vaccine
n=56 Participants
ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part A, Group 2: Placebo
Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part B, Group 2: Placebo
Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30
|
|---|---|---|---|
|
Part A: Compare the Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Fourth Versus the Fifth Vaccinations
1086 gp120 (Month 12.5)
|
0.14932756 % CD4+ T-cells
Interval 0.11886426 to 0.34311697
|
—
|
—
|
|
Part A: Compare the Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Fourth Versus the Fifth Vaccinations
TV1 gp120 (Month 6.5)
|
0.158423055 % CD4+ T-cells
Interval 0.12192562 to 0.354710545
|
—
|
—
|
|
Part A: Compare the Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Fourth Versus the Fifth Vaccinations
TV1 gp120 (Month 12.5)
|
0.22183561 % CD4+ T-cells
Interval 0.13385739 to 0.33774746
|
—
|
—
|
|
Part A: Compare the Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Fourth Versus the Fifth Vaccinations
ZM96 gp120 (Month 6.5)
|
0.17436147 % CD4+ T-cells
Interval 0.1468941 to 0.36994411
|
—
|
—
|
|
Part A: Compare the Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Fourth Versus the Fifth Vaccinations
ZM96 gp120 (Month 12.5)
|
0.203201925 % CD4+ T-cells
Interval 0.14269436 to 0.4014336
|
—
|
—
|
|
Part A: Compare the Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Fourth Versus the Fifth Vaccinations
1086 gp120 (Month 6.5)
|
0.17577251 % CD4+ T-cells
Interval 0.116401835 to 0.27437614
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured at Month 30 and 36Population: "Overall Number of Participants Analyzed" represents Part B participants. "Number Analyzed" counts participants with data meeting assay-specific quality 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. Samples from post-enrollment visits have positive responses if they meet three conditions: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of pre-vaccination net MFI), (2) net MFI values are greater than 3 times pre-vaccination net MFI, and (3) experimental antigen MFI values are greater than 3 times pre-vaccination MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI.
Outcome measures
| Measure |
Part A, Group 1: Vaccine
n=32 Participants
ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part A, Group 2: Placebo
n=31 Participants
Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part B, Group 2: Placebo
n=7 Participants
Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30
|
|---|---|---|---|
|
Part B: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination
1086C_D7gp120.avi/293F (Month 30)
|
31 Participants
|
30 Participants
|
0 Participants
|
|
Part B: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination
1086C_D7gp120.avi/293F (Month 36)
|
31 Participants
|
30 Participants
|
0 Participants
|
|
Part B: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination
96ZM651.D11gp120.avi (Month 30)
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Part B: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination
96ZM651.D11gp120.avi (Month 36)
|
24 Participants
|
25 Participants
|
0 Participants
|
|
Part B: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination
TV1c8_D11gp120.avi/293F (Month 30)
|
27 Participants
|
30 Participants
|
0 Participants
|
|
Part B: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination
TV1c8_D11gp120.avi/293F (Month 36)
|
31 Participants
|
30 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Measured at Month 30 and 36Population: "Overall Number of Participants Analyzed" represents Part B participants. "Number Analyzed" counts participants with data meeting assay-specific quality criteria.
Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation.
Outcome measures
| Measure |
Part A, Group 1: Vaccine
n=32 Participants
ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part A, Group 2: Placebo
n=31 Participants
Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part B, Group 2: Placebo
n=7 Participants
Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30
|
|---|---|---|---|
|
Part B: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination
1086C_D7gp120.avi/293F (Month 30)
|
6664 fluorescence unit relative to background
Interval 2265.25 to 10900.5
|
4415 fluorescence unit relative to background
Interval 2585.75 to 7880.0
|
1 fluorescence unit relative to background
Interval 1.0 to 1.0
|
|
Part B: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination
1086C_D7gp120.avi/293F (Month 36)
|
25399 fluorescence unit relative to background
Interval 21608.25 to 30932.25
|
24763.625 fluorescence unit relative to background
Interval 18642.25 to 27445.0
|
1 fluorescence unit relative to background
Interval 1.0 to 1.0
|
|
Part B: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination
96ZM651.D11gp120.avi (Month 30)
|
895.25 fluorescence unit relative to background
Interval 301.25 to 1278.5
|
706.5 fluorescence unit relative to background
Interval 424.25 to 1566.0
|
1 fluorescence unit relative to background
Interval 1.0 to 10.75
|
|
Part B: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination
96ZM651.D11gp120.avi (Month 36)
|
9750 fluorescence unit relative to background
Interval 2871.0 to 22625.0
|
7324.75 fluorescence unit relative to background
Interval 4300.5 to 16439.25
|
2.75 fluorescence unit relative to background
Interval 1.0 to 12.0
|
|
Part B: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination
TV1c8_D11gp120.avi/293F (Month 30)
|
937 fluorescence unit relative to background
Interval 328.75 to 2063.0
|
616.25 fluorescence unit relative to background
Interval 273.75 to 1288.5
|
1 fluorescence unit relative to background
Interval 1.0 to 73.5
|
|
Part B: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination
TV1c8_D11gp120.avi/293F (Month 36)
|
17175.5 fluorescence unit relative to background
Interval 5443.25 to 30353.75
|
17192.375 fluorescence unit relative to background
Interval 9493.0 to 23194.25
|
1 fluorescence unit relative to background
Interval 1.0 to 84.25
|
SECONDARY outcome
Timeframe: Measured at Month 30 and 36Population: "Overall Number of Participants Analyzed" represents Part B participants. "Number Analyzed" counts participants with data meeting assay-specific quality 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. Samples from post-enrollment visits have positive responses if they meet three conditions: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of pre-vaccination net MFI), (2) net MFI values are greater than 3 times pre-vaccination net MFI, and (3) experimental antigen MFI values are greater than 3 times pre-vaccination MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI.
Outcome measures
| Measure |
Part A, Group 1: Vaccine
n=32 Participants
ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part A, Group 2: Placebo
n=31 Participants
Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part B, Group 2: Placebo
n=7 Participants
Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30
|
|---|---|---|---|
|
Part B: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination
C.1086C_V1_V2 Tags (Month 30)
|
7 Participants
|
6 Participants
|
0 Participants
|
|
Part B: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination
C.1086C_V1_V2 Tags (Month 36)
|
9 Participants
|
12 Participants
|
1 Participants
|
|
Part B: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination
gp70-96ZM651.02 V1v2 (Month 30)
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Part B: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination
gp70-96ZM651.02 V1v2 (Month 36)
|
7 Participants
|
3 Participants
|
1 Participants
|
|
Part B: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination
gp70-TV1.GSKvacV1V2/293F (Month 30)
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Part B: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination
gp70-TV1.GSKvacV1V2/293F (Month 36)
|
4 Participants
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Measured at Month 30 and 36Population: "Overall Number of Participants Analyzed" represents Part B participants. "Number Analyzed" counts participants with data meeting assay-specific quality criteria.
Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation.
Outcome measures
| Measure |
Part A, Group 1: Vaccine
n=32 Participants
ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part A, Group 2: Placebo
n=31 Participants
Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part B, Group 2: Placebo
n=7 Participants
Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30
|
|---|---|---|---|
|
Part B: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination
C.1086C_V1_V2 Tags (Month 30)
|
13.5 fluorescence unit relative to background
Interval 8.25 to 89.5
|
23 fluorescence unit relative to background
Interval 4.75 to 92.0
|
2.75 fluorescence unit relative to background
Interval 1.0 to 61.75
|
|
Part B: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination
C.1086C_V1_V2 Tags (Month 36)
|
47.25 fluorescence unit relative to background
Interval 12.75 to 152.0
|
79.25 fluorescence unit relative to background
Interval 18.25 to 322.75
|
4.75 fluorescence unit relative to background
Interval 1.75 to 80.0
|
|
Part B: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination
gp70-96ZM651.02 V1v2 (Month 30)
|
1 fluorescence unit relative to background
Interval 1.0 to 246.0
|
1 fluorescence unit relative to background
Interval 1.0 to 51.25
|
1 fluorescence unit relative to background
Interval 1.0 to 333.5
|
|
Part B: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination
gp70-96ZM651.02 V1v2 (Month 36)
|
19.75 fluorescence unit relative to background
Interval 1.0 to 1438.0
|
35.375 fluorescence unit relative to background
Interval 1.0 to 166.0
|
1 fluorescence unit relative to background
Interval 1.0 to 654.75
|
|
Part B: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination
gp70-TV1.GSKvacV1V2/293F (Month 30)
|
1 fluorescence unit relative to background
Interval 1.0 to 46.5
|
1 fluorescence unit relative to background
Interval 1.0 to 1.0
|
1 fluorescence unit relative to background
Interval 1.0 to 1.0
|
|
Part B: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination
gp70-TV1.GSKvacV1V2/293F (Month 36)
|
1 fluorescence unit relative to background
Interval 1.0 to 130.5
|
7.625 fluorescence unit relative to background
Interval 1.0 to 93.25
|
1 fluorescence unit relative to background
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: Measured at Month 30 and 36Population: "Overall Number of Participants Analyzed" represents Part B participants. "Number Analyzed" counts participants with data meeting assay-specific quality 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. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p\<=0.00001. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.
Outcome measures
| Measure |
Part A, Group 1: Vaccine
n=32 Participants
ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part A, Group 2: Placebo
n=31 Participants
Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part B, Group 2: Placebo
n=7 Participants
Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30
|
|---|---|---|---|
|
Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination
Any gp120 (Month 30)
|
18 Participants
|
17 Participants
|
0 Participants
|
|
Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination
Any gp120 (Month 36)
|
18 Participants
|
16 Participants
|
0 Participants
|
|
Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination
1086 gp120 (Month 30)
|
12 Participants
|
8 Participants
|
0 Participants
|
|
Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination
1086 gp120 (Month 36)
|
11 Participants
|
12 Participants
|
0 Participants
|
|
Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination
TV1 gp120 (Month 30)
|
16 Participants
|
15 Participants
|
0 Participants
|
|
Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination
TV1 gp120 (Month 36)
|
17 Participants
|
12 Participants
|
0 Participants
|
|
Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination
ZM96 gp120 (Month 30)
|
15 Participants
|
14 Participants
|
0 Participants
|
|
Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination
ZM96 gp120 (Month 36)
|
15 Participants
|
13 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Measured at Month 30 and 36Population: "Overall Number of Participants Analyzed" represents Part B participants. "Number Analyzed" counts participants with data meeting assay-specific quality 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. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p\<=0.00001. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.
Outcome measures
| Measure |
Part A, Group 1: Vaccine
n=32 Participants
ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part A, Group 2: Placebo
n=31 Participants
Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part B, Group 2: Placebo
n=7 Participants
Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30
|
|---|---|---|---|
|
Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination
Any gp120 (Month 30)
|
0.128764915 % CD4+ T-cells
Interval 0.06016473 to 0.27276348
|
0.10384047 % CD4+ T-cells
Interval 0.066876795 to 0.13216669
|
0.00929931 % CD4+ T-cells
Interval 0.00092681 to 0.014916
|
|
Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination
Any gp120 (Month 36)
|
0.115994935 % CD4+ T-cells
Interval 0.05879524 to 0.23501344
|
0.09751639 % CD4+ T-cells
Interval 0.04296324 to 0.13914346
|
0.007663255 % CD4+ T-cells
Interval 0.00606286 to 0.01858776
|
|
Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination
1086 gp120 (Month 30)
|
0.07396858 % CD4+ T-cells
Interval 0.02441189 to 0.12233446
|
0.05696544 % CD4+ T-cells
Interval 0.03144404 to 0.07578682
|
0.00878693 % CD4+ T-cells
Interval -0.00320097 to 0.01448971
|
|
Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination
1086 gp120 (Month 36)
|
0.064916705 % CD4+ T-cells
Interval 0.0324317 to 0.13007222
|
0.06119621 % CD4+ T-cells
Interval 0.0304561 to 0.09814416
|
0.001323895 % CD4+ T-cells
Interval -0.00945559 to 0.01858776
|
|
Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination
TV1 gp120 (Month 30)
|
0.114625195 % CD4+ T-cells
Interval 0.05209329 to 0.20612288
|
0.077949675 % CD4+ T-cells
Interval 0.03458573 to 0.119078365
|
-0.00139331 % CD4+ T-cells
Interval -0.00836455 to 0.00929931
|
|
Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination
TV1 gp120 (Month 36)
|
0.106333215 % CD4+ T-cells
Interval 0.05700492 to 0.22142132
|
0.04974197 % CD4+ T-cells
Interval 0.03854645 to 0.11333829
|
-0.00506502 % CD4+ T-cells
Interval -0.01127566 to 0.00837665
|
|
Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination
ZM96 gp120 (Month 30)
|
0.09879441 % CD4+ T-cells
Interval 0.041524935 to 0.2188063
|
0.08841848 % CD4+ T-cells
Interval 0.04422036 to 0.13041836
|
-0.006057945 % CD4+ T-cells
Interval -0.01286774 to 0.0063703
|
|
Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination
ZM96 gp120 (Month 36)
|
0.104756745 % CD4+ T-cells
Interval 0.0461914 to 0.19649763
|
0.10113899 % CD4+ T-cells
Interval 0.01625771 to 0.1234859
|
-0.001777015 % CD4+ T-cells
Interval -0.01008356 to 0.00631053
|
Adverse Events
Part A, Group 1: Vaccine
Serious events: 7 serious events
Other events: 147 other events
Deaths: 2 deaths
Part A, Group 2: Placebo
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Part B, Group 1a: Vaccine
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Part B, Group 1b: Vaccine/Placebo
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Part B, Group 2: Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A, Group 1: Vaccine
n=210 participants at risk
ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part A, Group 2: Placebo
n=42 participants at risk
Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part B, Group 1a: Vaccine
n=32 participants at risk
Participants originally in Part A Group 1 (Vaccine) receive ALVAC-HIV + bivalent subtype C gp120/MF59 at month 30
|
Part B, Group 1b: Vaccine/Placebo
n=31 participants at risk
Participants originally in Part A Group 1 (Vaccine) receive placebo for ALVAC-HIV + bivalent subtype C gp120/MF59 at month 30
|
Part B, Group 2: Placebo
n=7 participants at risk
Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30
|
|---|---|---|---|---|---|
|
Infections and infestations
Any Event in SOC
|
0.95%
2/210 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Infections and infestations
Gastrointestinal infection
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Infections and infestations
Hepatitis C
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Injury, poisoning and procedural complications
Any Event in SOC
|
0.48%
1/210 • Number of events 3 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Musculoskeletal and connective tissue disorders
Any Event in SOC
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Musculoskeletal and connective tissue disorders
Rheumatic fever
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Nervous system disorders
Any Event in SOC
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Nervous system disorders
Transient ischaemic attack
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Psychiatric disorders
Any Event in SOC
|
0.95%
2/210 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Psychiatric disorders
Bipolar disorder
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Psychiatric disorders
Completed suicide
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
Other adverse events
| Measure |
Part A, Group 1: Vaccine
n=210 participants at risk
ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part A, Group 2: Placebo
n=42 participants at risk
Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12
|
Part B, Group 1a: Vaccine
n=32 participants at risk
Participants originally in Part A Group 1 (Vaccine) receive ALVAC-HIV + bivalent subtype C gp120/MF59 at month 30
|
Part B, Group 1b: Vaccine/Placebo
n=31 participants at risk
Participants originally in Part A Group 1 (Vaccine) receive placebo for ALVAC-HIV + bivalent subtype C gp120/MF59 at month 30
|
Part B, Group 2: Placebo
n=7 participants at risk
Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30
|
|---|---|---|---|---|---|
|
Infections and infestations
Urogenital trichomoniasis
|
0.00%
0/210 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
3.1%
1/32 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
3.2%
1/31 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Infections and infestations
Vaginal infection
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Infections and infestations
Varicella
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Infections and infestations
Viral infection
|
0.95%
2/210 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
2.4%
1/42 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Infections and infestations
Urinary tract infection
|
2.9%
6/210 • Number of events 7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
4.8%
2/42 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Blood and lymphatic system disorders
Any Event in SOC
|
2.4%
5/210 • Number of events 5 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
4.8%
2/42 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.95%
2/210 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
2.4%
1/42 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
2.4%
1/42 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Cardiac disorders
Any Event in SOC
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Cardiac disorders
Sinus bradycardia
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Ear and labyrinth disorders
Any Event in SOC
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
2.4%
1/42 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Ear and labyrinth disorders
Ear pain
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/210 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
2.4%
1/42 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Eye disorders
Any Event in SOC
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
2.4%
1/42 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Eye disorders
Conjunctivitis allergic
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Eye disorders
Eye pruritus
|
0.00%
0/210 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
2.4%
1/42 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Gastrointestinal disorders
Any Event in SOC
|
9.5%
20/210 • Number of events 23 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
16.7%
7/42 • Number of events 10 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
3.1%
1/32 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
3.2%
1/31 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
4.8%
2/42 • Number of events 3 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.95%
2/210 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/210 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
2.4%
1/42 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/210 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
2.4%
1/42 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
3.1%
1/32 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Gastrointestinal disorders
Diarrhoea
|
1.4%
3/210 • Number of events 3 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
4.8%
2/42 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
3.2%
1/31 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Gastrointestinal disorders
Enteritis
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Gastrointestinal disorders
Gastritis
|
0.95%
2/210 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
2.4%
1/42 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.95%
2/210 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Gastrointestinal disorders
Nausea
|
0.95%
2/210 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/210 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
2.4%
1/42 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Gastrointestinal disorders
Toothache
|
1.9%
4/210 • Number of events 4 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
2.4%
1/42 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Gastrointestinal disorders
Vomiting
|
0.95%
2/210 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
General disorders
Any Event in SOC
|
10.5%
22/210 • Number of events 29 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
16.7%
7/42 • Number of events 8 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
General disorders
Chest pain
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
General disorders
Influenza like illness
|
8.6%
18/210 • Number of events 21 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
11.9%
5/42 • Number of events 5 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
General disorders
Injection site nodule
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
General disorders
Injection site pruritus
|
0.95%
2/210 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
4.8%
2/42 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
General disorders
Pain
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
General disorders
Suprapubic pain
|
0.00%
0/210 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
2.4%
1/42 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
General disorders
Vessel puncture site bruise
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
General disorders
Vessel puncture site pain
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
General disorders
Vessel puncture site swelling
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Infections and infestations
Any Event in SOC
|
38.6%
81/210 • Number of events 112 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
57.1%
24/42 • Number of events 27 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
31.2%
10/32 • Number of events 12 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
32.3%
10/31 • Number of events 10 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Infections and infestations
Abscess limb
|
0.95%
2/210 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Infections and infestations
Acarodermatitis
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Infections and infestations
Anal abscess
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Infections and infestations
Bacterial vaginosis
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Infections and infestations
Blister infected
|
0.00%
0/210 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
2.4%
1/42 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Infections and infestations
Body tinea
|
1.9%
4/210 • Number of events 4 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
3.1%
1/32 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Infections and infestations
Chlamydial infection
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
3.1%
1/32 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Infections and infestations
Conjunctivitis
|
0.95%
2/210 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
7.1%
3/42 • Number of events 3 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Infections and infestations
Cystitis
|
0.95%
2/210 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Infections and infestations
Dysentery
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/210 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
2.4%
1/42 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Infections and infestations
Folliculitis
|
0.95%
2/210 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Infections and infestations
Fungal skin infection
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Infections and infestations
Furuncle
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Infections and infestations
Gastroenteritis
|
2.9%
6/210 • Number of events 6 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
2.4%
1/42 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
6.5%
2/31 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Infections and infestations
Genitourinary chlamydia infection
|
0.00%
0/210 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
9.4%
3/32 • Number of events 3 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
12.9%
4/31 • Number of events 4 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Infections and infestations
Genitourinary tract gonococcal infection
|
0.00%
0/210 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
3.1%
1/32 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Infections and infestations
Gingivitis
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Infections and infestations
Hepatitis C
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Infections and infestations
Influenza
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Infections and infestations
Nasal herpes
|
0.00%
0/210 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
2.4%
1/42 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Infections and infestations
Nasopharyngitis
|
0.48%
1/210 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
2.4%
1/42 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Infections and infestations
Oral herpes
|
0.95%
2/210 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
2.4%
1/42 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Infections and infestations
Otitis media
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.00%
0/210 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
2.4%
1/42 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Infections and infestations
Pharyngitis
|
2.4%
5/210 • Number of events 5 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
3.1%
1/32 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/210 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
2.4%
1/42 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/210 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
2.4%
1/42 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Infections and infestations
Respiratory tract infection bacterial
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Infections and infestations
Rhinitis
|
3.8%
8/210 • Number of events 9 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
2.4%
1/42 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
3.1%
1/32 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Infections and infestations
Sinusitis
|
1.4%
3/210 • Number of events 3 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Infections and infestations
Subcutaneous abscess
|
1.4%
3/210 • Number of events 3 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
3.1%
1/32 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
3.2%
1/31 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Infections and infestations
Tinea versicolour
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
4.8%
2/42 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/210 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
3.1%
1/32 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Infections and infestations
Upper respiratory tract infection
|
15.2%
32/210 • Number of events 35 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
9.5%
4/42 • Number of events 5 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
3.1%
1/32 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
3.2%
1/31 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Infections and infestations
Urethritis
|
0.95%
2/210 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/210 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
3.2%
1/31 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
2.4%
5/210 • Number of events 5 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
7.1%
3/42 • Number of events 4 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Infections and infestations
Vulvovaginitis trichomonal
|
0.95%
2/210 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Infections and infestations
Wound infection
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Injury, poisoning and procedural complications
Any Event in SOC
|
11.0%
23/210 • Number of events 26 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
7.1%
3/42 • Number of events 3 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.95%
2/210 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Injury, poisoning and procedural complications
Buttock injury
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Injury, poisoning and procedural complications
Ear canal abrasion
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Injury, poisoning and procedural complications
Face injury
|
1.4%
3/210 • Number of events 4 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Injury, poisoning and procedural complications
Injury
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.95%
2/210 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Injury, poisoning and procedural complications
Post procedural contusion
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
0.95%
2/210 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
2.4%
1/42 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
4.8%
2/42 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Injury, poisoning and procedural complications
Skin laceration
|
1.9%
4/210 • Number of events 4 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.95%
2/210 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Investigations
Any Event in SOC
|
22.9%
48/210 • Number of events 75 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
19.0%
8/42 • Number of events 11 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
3.1%
1/32 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
22.6%
7/31 • Number of events 7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
14.3%
1/7 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Investigations
Alanine aminotransferase increased
|
9.0%
19/210 • Number of events 22 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Investigations
Aspartate aminotransferase increased
|
10.5%
22/210 • Number of events 26 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
4.8%
2/42 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Investigations
Blood alkaline phosphatase increased
|
0.95%
2/210 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Investigations
Blood creatinine increased
|
3.3%
7/210 • Number of events 9 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
3.1%
1/32 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
19.4%
6/31 • Number of events 6 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
14.3%
1/7 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Investigations
Blood pressure increased
|
1.9%
4/210 • Number of events 5 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
2.4%
1/42 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Investigations
Haemoglobin decreased
|
0.95%
2/210 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
9.5%
4/42 • Number of events 5 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
3.2%
1/31 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Investigations
Neutrophil count decreased
|
2.4%
5/210 • Number of events 5 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
2.4%
1/42 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Investigations
Platelet count decreased
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Investigations
Urobilinogen urine increased
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Investigations
Weight decreased
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Investigations
White blood cell count decreased
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
2.4%
1/42 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Musculoskeletal and connective tissue disorders
Any Event in SOC
|
6.7%
14/210 • Number of events 15 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
3.1%
1/32 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.95%
2/210 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.95%
2/210 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
3.1%
1/32 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.95%
2/210 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.4%
3/210 • Number of events 3 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.9%
4/210 • Number of events 4 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Nervous system disorders
Any Event in SOC
|
8.6%
18/210 • Number of events 21 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
9.5%
4/42 • Number of events 4 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Nervous system disorders
Dizziness
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Nervous system disorders
Headache
|
6.7%
14/210 • Number of events 15 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
9.5%
4/42 • Number of events 4 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Nervous system disorders
Presyncope
|
0.95%
2/210 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Nervous system disorders
Somnolence
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Nervous system disorders
Tension headache
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Nervous system disorders
Tremor
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Psychiatric disorders
Any Event in SOC
|
1.9%
4/210 • Number of events 4 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
4.8%
2/42 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/210 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
2.4%
1/42 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Psychiatric disorders
Depression
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Psychiatric disorders
Premature ejaculation
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Psychiatric disorders
Stress
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Psychiatric disorders
Substance abuse
|
0.00%
0/210 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
2.4%
1/42 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Psychiatric disorders
Substance-induced psychotic disorder
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Renal and urinary disorders
Any Event in SOC
|
9.0%
19/210 • Number of events 23 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
7.1%
3/42 • Number of events 4 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
6.2%
2/32 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
6.5%
2/31 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Renal and urinary disorders
Dysuria
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Renal and urinary disorders
Glycosuria
|
1.9%
4/210 • Number of events 4 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
2.4%
1/42 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Renal and urinary disorders
Haematuria
|
1.4%
3/210 • Number of events 4 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
2.4%
1/42 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
3.2%
1/31 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Renal and urinary disorders
Proteinuria
|
6.2%
13/210 • Number of events 14 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
4.8%
2/42 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
6.2%
2/32 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
3.2%
1/31 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Reproductive system and breast disorders
Any Event in SOC
|
6.7%
14/210 • Number of events 16 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
7.1%
3/42 • Number of events 4 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Reproductive system and breast disorders
Abnormal withdrawal bleeding
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Reproductive system and breast disorders
Amenorrhoea
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Reproductive system and breast disorders
Dyspareunia
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Reproductive system and breast disorders
Menorrhagia
|
1.4%
3/210 • Number of events 3 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Reproductive system and breast disorders
Metrorrhagia
|
3.8%
8/210 • Number of events 8 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
2.4%
1/42 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
4.8%
2/42 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/210 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
2.4%
1/42 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Respiratory, thoracic and mediastinal disorders
Any Event in SOC
|
3.3%
7/210 • Number of events 7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
2.4%
1/42 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
3.1%
1/32 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
2.4%
1/42 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum ulceration
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/210 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
3.1%
1/32 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.95%
2/210 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Skin and subcutaneous tissue disorders
Any Event in SOC
|
6.2%
13/210 • Number of events 19 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
2.4%
1/42 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
6.2%
2/32 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
3.2%
1/31 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.95%
2/210 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.95%
2/210 • Number of events 3 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.48%
1/210 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
1.4%
3/210 • Number of events 4 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
3.1%
1/32 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.95%
2/210 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.48%
1/210 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.95%
2/210 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
1.4%
3/210 • Number of events 3 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
2.4%
1/42 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
3.2%
1/31 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/210 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
3.1%
1/32 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Vascular disorders
Any Event in SOC
|
0.48%
1/210 • Number of events 3 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
|
Vascular disorders
Hypertension
|
0.48%
1/210 • Number of events 3 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/42 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/32 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/31 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
|
Additional Information
Jessica Andriesen, PhD, Associate Director of HVTN SDMC Operations
Fred Hutchinson Cancer Research Center
Phone: 206-667-5812
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place