Trial Outcomes & Findings for Evaluating the Safety and Immunogenicity of ALVAC-HIV and MF59®- or AS01B-adjuvanted Bivalent Subtype C gp120 in Healthy, HIV-uninfected Adult Participants (NCT NCT03122223)
NCT ID: NCT03122223
Last Updated: 2023-03-14
Results Overview
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017. The maximum grade observed for each symptom over the time frame is presented;
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
160 participants
Primary outcome timeframe
Measured through 7 days after participants' last vaccination at Month 0,1,3, and 6
Results posted on
2023-03-14
Participant Flow
Participant milestones
| Measure |
Vaccine w/ MF59
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/MF59 at Months 3 and 6
|
Vaccine w/ AS01B - High Dose
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/AS01B at Months 3 and 6
|
Vaccine w/ AS01B - Low Dose
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 20mcg Protein/AS01B at Months 3 and 6
|
Placebo
Placebo at Months 0, 1, 3, and 6
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
50
|
10
|
|
Overall Study
Month 6.5 Immunogenicity Cohort
|
49
|
48
|
47
|
8
|
|
Overall Study
Month 12 Immunogenicity Cohort
|
47
|
45
|
46
|
10
|
|
Overall Study
COMPLETED
|
47
|
45
|
46
|
10
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
4
|
0
|
Reasons for withdrawal
| Measure |
Vaccine w/ MF59
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/MF59 at Months 3 and 6
|
Vaccine w/ AS01B - High Dose
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/AS01B at Months 3 and 6
|
Vaccine w/ AS01B - Low Dose
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 20mcg Protein/AS01B at Months 3 and 6
|
Placebo
Placebo at Months 0, 1, 3, and 6
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
2
|
0
|
|
Overall Study
Participant unable to adhere
|
1
|
1
|
1
|
0
|
Baseline Characteristics
Evaluating the Safety and Immunogenicity of ALVAC-HIV and MF59®- or AS01B-adjuvanted Bivalent Subtype C gp120 in Healthy, HIV-uninfected Adult Participants
Baseline characteristics by cohort
| Measure |
Vaccine w/ MF59
n=50 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/MF59 at Months 3 and 6
|
Vaccine w/ AS01B - High Dose
n=50 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/AS01B at Months 3 and 6
|
Vaccine w/ AS01B - Low Dose
n=50 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 20mcg Protein/AS01B at Months 3 and 6
|
Placebo
n=10 Participants
Placebo at Months 0, 1, 3, and 6
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
24 years
n=5 Participants
|
23.5 years
n=7 Participants
|
25.5 years
n=5 Participants
|
24 years
n=4 Participants
|
24 years
n=21 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
|
|
Age, Customized
18 - 20 years
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Age, Customized
21 - 30 years
|
30 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
100 Participants
n=21 Participants
|
|
Age, Customized
31 - 40 years
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
34 Participants
n=21 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
|
|
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
|
|
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
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
88 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
72 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
155 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
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
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 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
|
|
Race (NIH/OMB)
Black or African American
|
30 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
99 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 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
|
|
Region of Enrollment
USA
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
64 Participants
n=21 Participants
|
|
Region of Enrollment
Tanzania
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
|
Region of Enrollment
Zambia
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Region of Enrollment
Zimbabwe
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Measured through 7 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, Corrected Version 2.1, July 2017. The maximum grade observed for each symptom over the time frame is presented;
Outcome measures
| Measure |
Vaccine w/ MF59
n=50 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/MF59 at Months 3 and 6
|
Vaccine w/ AS01B - High Dose
n=50 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/AS01B at Months 3 and 6
|
Vaccine w/ AS01B - Low Dose
n=50 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 20mcg Protein/AS01B at Months 3 and 6
|
Placebo
n=10 Participants
Placebo at Months 0, 1, 3, and 6
|
|---|---|---|---|---|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen
Pain · Mild
|
27 Participants
|
17 Participants
|
20 Participants
|
3 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen
Pain · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen
Tenderness · None
|
21 Participants
|
20 Participants
|
15 Participants
|
8 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen
Tenderness · Severe
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen
Pain and/or Tenderness · None
|
15 Participants
|
15 Participants
|
12 Participants
|
7 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen
Pain and/or Tenderness · Mild
|
26 Participants
|
17 Participants
|
19 Participants
|
3 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen
Pain and/or Tenderness · Moderate
|
8 Participants
|
16 Participants
|
19 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen
Erythema and/or Induration · Mild
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen
Erythema and/or Induration · Moderate
|
3 Participants
|
2 Participants
|
8 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen
Erythema and/or Induration · Severe
|
0 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen
Erythema and/or Induration · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen
Pain · None
|
16 Participants
|
18 Participants
|
16 Participants
|
7 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen
Pain · Moderate
|
6 Participants
|
13 Participants
|
14 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen
Pain · Severe
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen
Tenderness · Mild
|
22 Participants
|
12 Participants
|
18 Participants
|
2 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen
Tenderness · Moderate
|
6 Participants
|
17 Participants
|
17 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen
Tenderness · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen
Pain and/or Tenderness · Severe
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen
Pain and/or Tenderness · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen
Erythema · None
|
46 Participants
|
42 Participants
|
43 Participants
|
9 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen
Erythema · Mild
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen
Erythema · Moderate
|
2 Participants
|
2 Participants
|
6 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen
Erythema · Severe
|
0 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen
Erythema · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen
Induration · None
|
49 Participants
|
45 Participants
|
43 Participants
|
10 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen
Induration · Mild
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen
Induration · Moderate
|
1 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen
Induration · Severe
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen
Induration · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen
Erythema and/or Induration · None
|
45 Participants
|
42 Participants
|
39 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: Measured through 7 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, Corrected Version 2.1,July 2017. The maximum grade observed for each symptom over the time frame is presented;
Outcome measures
| Measure |
Vaccine w/ MF59
n=50 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/MF59 at Months 3 and 6
|
Vaccine w/ AS01B - High Dose
n=50 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/AS01B at Months 3 and 6
|
Vaccine w/ AS01B - Low Dose
n=50 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 20mcg Protein/AS01B at Months 3 and 6
|
Placebo
n=10 Participants
Placebo at Months 0, 1, 3, and 6
|
|---|---|---|---|---|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Malaise and/or fatigue · None
|
26 Participants
|
27 Participants
|
22 Participants
|
6 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Malaise and/or fatigue · Mild
|
17 Participants
|
7 Participants
|
12 Participants
|
3 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Malaise and/or fatigue · Moderate
|
6 Participants
|
13 Participants
|
12 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Malaise and/or fatigue · Severe
|
1 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
|
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
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Myalgia · None
|
38 Participants
|
32 Participants
|
29 Participants
|
7 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Myalgia · Mild
|
11 Participants
|
7 Participants
|
9 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Myalgia · Moderate
|
1 Participants
|
9 Participants
|
8 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Myalgia · Severe
|
0 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Myalgia · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Headache · None
|
30 Participants
|
26 Participants
|
25 Participants
|
7 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Headache · Mild
|
15 Participants
|
13 Participants
|
15 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Headache · Moderate
|
5 Participants
|
11 Participants
|
7 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Headache · Severe
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Headache · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Nausea · None
|
42 Participants
|
39 Participants
|
38 Participants
|
7 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Nausea · Mild
|
6 Participants
|
10 Participants
|
7 Participants
|
3 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Nausea · Moderate
|
2 Participants
|
1 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Nausea · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Nausea · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Vomiting · None
|
48 Participants
|
48 Participants
|
49 Participants
|
9 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Vomiting · Mild
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Vomiting · Moderate
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Vomiting · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Vomiting · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Chills · None
|
42 Participants
|
33 Participants
|
30 Participants
|
10 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Chills · Mild
|
7 Participants
|
10 Participants
|
8 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Chills · Moderate
|
1 Participants
|
6 Participants
|
10 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Chills · Severe
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Chills · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Arthralgia · None
|
40 Participants
|
39 Participants
|
35 Participants
|
7 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Arthralgia · Mild
|
7 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Arthralgia · Severe
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Arthralgia · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Max. Systemic Symptoms · None
|
20 Participants
|
21 Participants
|
18 Participants
|
4 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Max. Systemic Symptoms · Mild
|
18 Participants
|
10 Participants
|
13 Participants
|
4 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Max. Systemic Symptoms · Moderate
|
11 Participants
|
16 Participants
|
14 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Max. Systemic Symptoms · Severe
|
1 Participants
|
3 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Temperature · Mild
|
2 Participants
|
2 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Arthralgia · Moderate
|
3 Participants
|
7 Participants
|
10 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Max. Systemic Symptoms · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Temperature · None
|
47 Participants
|
46 Participants
|
45 Participants
|
10 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Temperature · Moderate
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Temperature · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Temperature · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through 30 days after each vaccination at Month 0, 1, 3 and 6.For participants reporting multiple AEs over the time frame, the maximum relationship is counted.
Outcome measures
| Measure |
Vaccine w/ MF59
n=50 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/MF59 at Months 3 and 6
|
Vaccine w/ AS01B - High Dose
n=50 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/AS01B at Months 3 and 6
|
Vaccine w/ AS01B - Low Dose
n=50 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 20mcg Protein/AS01B at Months 3 and 6
|
Placebo
n=10 Participants
Placebo at Months 0, 1, 3, and 6
|
|---|---|---|---|---|
|
Frequency of Adverse Events by Relationship to the Study Product
Not Related
|
30 Participants
|
21 Participants
|
24 Participants
|
6 Participants
|
|
Frequency of Adverse Events by Relationship to the Study Product
No AE Reported
|
18 Participants
|
22 Participants
|
24 Participants
|
4 Participants
|
|
Frequency of Adverse Events by Relationship to the Study Product
Related
|
2 Participants
|
7 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through Month 18.No SAEs, AESIs, or new chronic conditions were reported over the course of the study
Outcome measures
| Measure |
Vaccine w/ MF59
n=50 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/MF59 at Months 3 and 6
|
Vaccine w/ AS01B - High Dose
n=50 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/AS01B at Months 3 and 6
|
Vaccine w/ AS01B - Low Dose
n=50 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 20mcg Protein/AS01B at Months 3 and 6
|
Placebo
n=10 Participants
Placebo at Months 0, 1, 3, and 6
|
|---|---|---|---|---|
|
Frequency of SAEs, AESIs, and New Chronic Conditions
SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of SAEs, AESIs, and New Chronic Conditions
AESI or new Chronic Condiiton
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of SAEs, AESIs, and New Chronic Conditions
No SAE or AESI or New Chronic condition
|
50 Participants
|
50 Participants
|
50 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: Measured at Month 0 (Screening) ,0.5(Day 14), 1.5 (Day 42) , 3.5 (Day 98) and 6.5 (Day 182)Population: The "overall number of participants analyzed" represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit.
Laboratory results are summarized by analyte and timepoint.
Outcome measures
| Measure |
Vaccine w/ MF59
n=50 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/MF59 at Months 3 and 6
|
Vaccine w/ AS01B - High Dose
n=50 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/AS01B at Months 3 and 6
|
Vaccine w/ AS01B - Low Dose
n=50 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 20mcg Protein/AS01B at Months 3 and 6
|
Placebo
n=10 Participants
Placebo at Months 0, 1, 3, and 6
|
|---|---|---|---|---|
|
Alkaline Phosphatase, AST, ALT in U/L
ALT (SGPT) (U/L)- Day182
|
16 U/L
Interval 13.0 to 21.0
|
17.5 U/L
Interval 12.0 to 24.0
|
17 U/L
Interval 13.0 to 21.0
|
22.5 U/L
Interval 17.0 to 28.5
|
|
Alkaline Phosphatase, AST, ALT in U/L
Alkaline Phosphatase (U/L)- Screening
|
75 U/L
Interval 60.0 to 101.0
|
69 U/L
Interval 55.0 to 94.0
|
72 U/L
Interval 63.0 to 92.0
|
78 U/L
Interval 63.0 to 103.0
|
|
Alkaline Phosphatase, AST, ALT in U/L
Alkaline Phosphatase (U/L)- Day14
|
74.5 U/L
Interval 55.0 to 94.0
|
67 U/L
Interval 55.0 to 85.0
|
70 U/L
Interval 56.5 to 87.5
|
78 U/L
Interval 55.0 to 88.0
|
|
Alkaline Phosphatase, AST, ALT in U/L
Alkaline Phosphatase (U/L)- Day42
|
70 U/L
Interval 57.5 to 93.0
|
65 U/L
Interval 52.0 to 87.0
|
67 U/L
Interval 60.0 to 88.0
|
77 U/L
Interval 61.0 to 88.0
|
|
Alkaline Phosphatase, AST, ALT in U/L
Alkaline Phosphatase (U/L)- Day98
|
70.5 U/L
Interval 58.0 to 90.0
|
67 U/L
Interval 51.0 to 90.0
|
69.5 U/L
Interval 60.0 to 84.0
|
81.5 U/L
Interval 60.5 to 93.5
|
|
Alkaline Phosphatase, AST, ALT in U/L
Alkaline Phosphatase (U/L)- Day182
|
72 U/L
Interval 58.0 to 88.0
|
66.5 U/L
Interval 50.0 to 82.5
|
68 U/L
Interval 55.0 to 82.0
|
74.5 U/L
Interval 54.0 to 90.0
|
|
Alkaline Phosphatase, AST, ALT in U/L
ALT (SGPT) (U/L)- Day98
|
16.5 U/L
Interval 12.0 to 22.0
|
18 U/L
Interval 13.0 to 23.0
|
16.5 U/L
Interval 12.0 to 21.0
|
24 U/L
Interval 15.0 to 32.0
|
|
Alkaline Phosphatase, AST, ALT in U/L
AST (U/L)- Screening
|
20.5 U/L
Interval 16.0 to 24.0
|
20 U/L
Interval 16.0 to 24.0
|
22 U/L
Interval 17.0 to 26.0
|
22.5 U/L
Interval 18.0 to 26.0
|
|
Alkaline Phosphatase, AST, ALT in U/L
AST (U/L)- Day14
|
20 U/L
Interval 16.0 to 24.0
|
20 U/L
Interval 17.0 to 23.0
|
21 U/L
Interval 17.0 to 24.0
|
21.5 U/L
Interval 19.0 to 24.0
|
|
Alkaline Phosphatase, AST, ALT in U/L
AST (U/L)- Day42
|
22 U/L
Interval 16.0 to 25.5
|
21 U/L
Interval 18.0 to 24.0
|
20 U/L
Interval 16.0 to 26.0
|
21 U/L
Interval 19.0 to 22.0
|
|
Alkaline Phosphatase, AST, ALT in U/L
AST (U/L)- Day98
|
21 U/L
Interval 16.0 to 25.5
|
20 U/L
Interval 17.5 to 23.0
|
20 U/L
Interval 18.0 to 24.0
|
25.5 U/L
Interval 18.0 to 28.0
|
|
Alkaline Phosphatase, AST, ALT in U/L
AST (U/L)- Day182
|
22 U/L
Interval 17.0 to 26.0
|
19 U/L
Interval 17.0 to 23.5
|
20 U/L
Interval 16.0 to 25.0
|
25.5 U/L
Interval 18.5 to 30.5
|
|
Alkaline Phosphatase, AST, ALT in U/L
ALT (SGPT) (U/L)- Screening
|
17.5 U/L
Interval 14.0 to 22.0
|
16.5 U/L
Interval 13.0 to 24.0
|
16.5 U/L
Interval 12.0 to 22.0
|
18.5 U/L
Interval 16.0 to 26.0
|
|
Alkaline Phosphatase, AST, ALT in U/L
ALT (SGPT) (U/L)- Day14
|
17 U/L
Interval 13.0 to 21.0
|
16 U/L
Interval 13.0 to 21.0
|
16.5 U/L
Interval 12.0 to 21.0
|
20.5 U/L
Interval 17.0 to 22.0
|
|
Alkaline Phosphatase, AST, ALT in U/L
ALT (SGPT) (U/L)- Day42
|
17 U/L
Interval 13.0 to 22.0
|
18 U/L
Interval 13.0 to 25.0
|
16 U/L
Interval 12.0 to 23.0
|
19 U/L
Interval 17.0 to 21.0
|
PRIMARY outcome
Timeframe: Measured at Month 0 (Screening) ,0.5(Day 14), 1.5 (Day 42) , 3.5 (Day 98) and 6.5 (Day 182)Population: The "overall number of participants analyzed" represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit.
Laboratory results are summarized by analyte and timepoint.
Outcome measures
| Measure |
Vaccine w/ MF59
n=50 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/MF59 at Months 3 and 6
|
Vaccine w/ AS01B - High Dose
n=50 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/AS01B at Months 3 and 6
|
Vaccine w/ AS01B - Low Dose
n=50 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 20mcg Protein/AS01B at Months 3 and 6
|
Placebo
n=10 Participants
Placebo at Months 0, 1, 3, and 6
|
|---|---|---|---|---|
|
Hemoglobin, Creatinine in g/dL
Hemoglobin (g/dL)- Screening
|
14.45 g/dL
Interval 13.4 to 15.7
|
15.05 g/dL
Interval 13.6 to 16.4
|
14.7 g/dL
Interval 13.4 to 16.4
|
14.9 g/dL
Interval 14.7 to 16.1
|
|
Hemoglobin, Creatinine in g/dL
Hemoglobin (g/dL)- Day14
|
14.1 g/dL
Interval 12.9 to 15.7
|
14.5 g/dL
Interval 13.2 to 16.1
|
14 g/dL
Interval 12.95 to 15.5
|
14.9 g/dL
Interval 14.1 to 15.2
|
|
Hemoglobin, Creatinine in g/dL
Hemoglobin (g/dL)- Day42
|
14.45 g/dL
Interval 13.2 to 15.25
|
14.6 g/dL
Interval 13.5 to 16.1
|
14.05 g/dL
Interval 12.9 to 16.0
|
14.8 g/dL
Interval 14.6 to 15.0
|
|
Hemoglobin, Creatinine in g/dL
Hemoglobin (g/dL)- Day98
|
14.5 g/dL
Interval 13.2 to 15.55
|
14.8 g/dL
Interval 13.8 to 16.25
|
14.1 g/dL
Interval 13.3 to 16.3
|
14.45 g/dL
Interval 14.1 to 15.45
|
|
Hemoglobin, Creatinine in g/dL
Hemoglobin (g/dL)- Day182
|
14 g/dL
Interval 12.8 to 14.8
|
14.25 g/dL
Interval 13.3 to 15.95
|
14 g/dL
Interval 12.7 to 15.5
|
14.45 g/dL
Interval 14.0 to 15.95
|
|
Hemoglobin, Creatinine in g/dL
Creatinine (g/dL)- Screening
|
0.00073 g/dL
Interval 0.00061 to 0.00087
|
0.00079 g/dL
Interval 0.00068 to 0.0009
|
0.000785 g/dL
Interval 0.00069 to 0.00089
|
0.00086 g/dL
Interval 0.00074 to 0.00097
|
|
Hemoglobin, Creatinine in g/dL
Creatinine (g/dL)- Day14
|
0.00076 g/dL
Interval 0.00066 to 0.00085
|
0.0008 g/dL
Interval 0.00068 to 0.00086
|
0.00076 g/dL
Interval 0.0007 to 0.00086
|
0.000765 g/dL
Interval 0.0007 to 0.00091
|
|
Hemoglobin, Creatinine in g/dL
Creatinine (g/dL)- Day42
|
0.00075 g/dL
Interval 0.000615 to 0.00086
|
0.00075 g/dL
Interval 0.00064 to 0.00086
|
0.0008 g/dL
Interval 0.0007 to 0.00087
|
0.00081 g/dL
Interval 0.0007 to 0.00084
|
|
Hemoglobin, Creatinine in g/dL
Creatinine (g/dL)- Day98
|
0.000775 g/dL
Interval 0.000665 to 0.00086
|
0.000775 g/dL
Interval 0.000685 to 0.000835
|
0.0008 g/dL
Interval 0.0007 to 0.0009
|
0.000885 g/dL
Interval 0.000765 to 0.00095
|
|
Hemoglobin, Creatinine in g/dL
Creatinine (g/dL)- Day182
|
0.00071 g/dL
Interval 0.00066 to 0.0009
|
0.0008 g/dL
Interval 0.0007 to 0.00086
|
0.0008 g/dL
Interval 0.0007 to 0.00088
|
0.000895 g/dL
Interval 0.0007 to 0.00102
|
PRIMARY outcome
Timeframe: Measured at Month 0 (Screening) ,0.5(Day 14), 1.5 (Day 42) , 3.5 (Day 98) and 6.5 (Day 182)Population: The "overall number of participants analyzed" represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit.
Laboratory results are summarized by analyte and timepoint.
Outcome measures
| Measure |
Vaccine w/ MF59
n=50 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/MF59 at Months 3 and 6
|
Vaccine w/ AS01B - High Dose
n=50 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/AS01B at Months 3 and 6
|
Vaccine w/ AS01B - Low Dose
n=50 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 20mcg Protein/AS01B at Months 3 and 6
|
Placebo
n=10 Participants
Placebo at Months 0, 1, 3, and 6
|
|---|---|---|---|---|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
WBC (1000/cubic mm)- Day14
|
5.3 thousand cells/cubic mm
Interval 4.1 to 6.7
|
5.8 thousand cells/cubic mm
Interval 4.3 to 6.81
|
5.535 thousand cells/cubic mm
Interval 4.22 to 6.4
|
4.94 thousand cells/cubic mm
Interval 4.36 to 5.2
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
WBC (1000/cubic mm)- Day42
|
5.065 thousand cells/cubic mm
Interval 4.375 to 6.405
|
5.28 thousand cells/cubic mm
Interval 4.4 to 6.5
|
5.025 thousand cells/cubic mm
Interval 3.9 to 6.2
|
4.58 thousand cells/cubic mm
Interval 4.1 to 5.3
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
WBC (1000/cubic mm)- Day98
|
4.805 thousand cells/cubic mm
Interval 4.355 to 5.645
|
5.33 thousand cells/cubic mm
Interval 4.35 to 6.85
|
5.15 thousand cells/cubic mm
Interval 4.36 to 6.6
|
4.79 thousand cells/cubic mm
Interval 3.475 to 7.085
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
WBC (1000/cubic mm)- Day182
|
4.93 thousand cells/cubic mm
Interval 4.23 to 6.59
|
5.36 thousand cells/cubic mm
Interval 4.305 to 6.67
|
5.28 thousand cells/cubic mm
Interval 4.01 to 6.98
|
5.28 thousand cells/cubic mm
Interval 4.74 to 5.68
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
Platelets (1000/cubic mm)- Screening
|
263.5 thousand cells/cubic mm
Interval 220.0 to 297.0
|
263.5 thousand cells/cubic mm
Interval 209.0 to 301.0
|
233 thousand cells/cubic mm
Interval 215.0 to 275.0
|
223.5 thousand cells/cubic mm
Interval 211.0 to 280.0
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
Platelets (1000/cubic mm)- Day14
|
264 thousand cells/cubic mm
Interval 226.0 to 303.0
|
248 thousand cells/cubic mm
Interval 222.0 to 297.0
|
238 thousand cells/cubic mm
Interval 214.0 to 279.0
|
236.5 thousand cells/cubic mm
Interval 222.0 to 247.0
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
Lymphocytes (1000/cubic mm)- Day14
|
1.825 thousand cells/cubic mm
Interval 1.578 to 2.29
|
1.98 thousand cells/cubic mm
Interval 1.647 to 2.593
|
1.7945 thousand cells/cubic mm
Interval 1.5855 to 2.231
|
1.705 thousand cells/cubic mm
Interval 1.2 to 2.01
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
Lymphocytes (1000/cubic mm)- Day42
|
1.9135 thousand cells/cubic mm
Interval 1.5945 to 2.319
|
1.88 thousand cells/cubic mm
Interval 1.62 to 2.25
|
1.7995 thousand cells/cubic mm
Interval 1.498 to 2.12
|
1.668 thousand cells/cubic mm
Interval 1.36 to 1.97
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
Lymphocytes (1000/cubic mm)- Day98
|
1.86 thousand cells/cubic mm
Interval 1.5805 to 2.314
|
1.99 thousand cells/cubic mm
Interval 1.625 to 2.231
|
1.812 thousand cells/cubic mm
Interval 1.532 to 2.18
|
1.7145 thousand cells/cubic mm
Interval 1.346 to 2.475
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
Lymphocytes (1000/cubic mm)- Day182
|
1.913 thousand cells/cubic mm
Interval 1.65 to 2.27
|
1.91 thousand cells/cubic mm
Interval 1.556 to 2.2505
|
1.767 thousand cells/cubic mm
Interval 1.447 to 2.265
|
1.7905 thousand cells/cubic mm
Interval 1.54 to 2.585
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
Neutrophils (1000/cubic mm)- Screening
|
2.6835 thousand cells/cubic mm
Interval 2.13 to 3.64
|
2.9995 thousand cells/cubic mm
Interval 2.499 to 4.18
|
2.8925 thousand cells/cubic mm
Interval 2.211 to 3.87
|
2.415 thousand cells/cubic mm
Interval 2.207 to 3.02
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
Neutrophils (1000/cubic mm)- Day14
|
2.8755 thousand cells/cubic mm
Interval 1.936 to 3.866
|
3.07 thousand cells/cubic mm
Interval 2.08 to 3.79
|
2.896 thousand cells/cubic mm
Interval 2.0355 to 3.5425
|
2.529 thousand cells/cubic mm
Interval 2.44 to 3.38
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
Neutrophils (1000/cubic mm)- Day42
|
2.577 thousand cells/cubic mm
Interval 2.02 to 3.75
|
2.82 thousand cells/cubic mm
Interval 2.023 to 3.47
|
2.662 thousand cells/cubic mm
Interval 1.914 to 3.441
|
2.55 thousand cells/cubic mm
Interval 2.013 to 2.86
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
Neutrophils (1000/cubic mm)- Day98
|
2.37 thousand cells/cubic mm
Interval 2.053 to 2.954
|
2.605 thousand cells/cubic mm
Interval 1.818 to 3.988
|
2.66 thousand cells/cubic mm
Interval 2.176 to 3.709
|
2.105 thousand cells/cubic mm
Interval 1.6215 to 4.06
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
Neutrophils (1000/cubic mm)- Day182
|
2.66 thousand cells/cubic mm
Interval 1.884 to 3.29
|
2.776 thousand cells/cubic mm
Interval 2.23 to 3.7575
|
2.98 thousand cells/cubic mm
Interval 2.01 to 4.0
|
2.45 thousand cells/cubic mm
Interval 2.355 to 3.22
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
WBC (1000/cubic mm)- Screening
|
5.29 thousand cells/cubic mm
Interval 4.43 to 6.54
|
5.92 thousand cells/cubic mm
Interval 5.0 to 6.8
|
5.4 thousand cells/cubic mm
Interval 4.53 to 6.5
|
5.125 thousand cells/cubic mm
Interval 4.11 to 5.9
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
Platelets (1000/cubic mm)- Day42
|
254 thousand cells/cubic mm
Interval 224.5 to 283.5
|
266 thousand cells/cubic mm
Interval 213.0 to 316.0
|
242.5 thousand cells/cubic mm
Interval 207.0 to 270.0
|
234 thousand cells/cubic mm
Interval 230.0 to 265.0
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
Platelets (1000/cubic mm)- Day98
|
264.5 thousand cells/cubic mm
Interval 223.5 to 293.0
|
267 thousand cells/cubic mm
Interval 214.5 to 304.0
|
246.5 thousand cells/cubic mm
Interval 202.0 to 292.0
|
221 thousand cells/cubic mm
Interval 187.5 to 275.5
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
Platelets (1000/cubic mm)- Day182
|
264 thousand cells/cubic mm
Interval 239.0 to 293.0
|
260 thousand cells/cubic mm
Interval 224.5 to 308.5
|
251.1 thousand cells/cubic mm
Interval 218.0 to 301.0
|
245.5 thousand cells/cubic mm
Interval 193.0 to 315.0
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
Lymphocytes (1000/cubic mm)- Screening
|
1.935 thousand cells/cubic mm
Interval 1.59 to 2.31
|
2.014 thousand cells/cubic mm
Interval 1.67 to 2.361
|
1.84 thousand cells/cubic mm
Interval 1.56 to 2.4
|
1.9455 thousand cells/cubic mm
Interval 1.58 to 2.32
|
PRIMARY outcome
Timeframe: Measured through month 12From the study product discontinuation form, study product administration reasons are tabulated by treatment arm
Outcome measures
| Measure |
Vaccine w/ MF59
n=50 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/MF59 at Months 3 and 6
|
Vaccine w/ AS01B - High Dose
n=50 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/AS01B at Months 3 and 6
|
Vaccine w/ AS01B - Low Dose
n=50 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 20mcg Protein/AS01B at Months 3 and 6
|
Placebo
n=10 Participants
Placebo at Months 0, 1, 3, and 6
|
|---|---|---|---|---|
|
AEs or Reactro Leading to Early Participant Withdrawal or Early Discontinuation of Study Products Administration Throughout the Study.
Clinical Event
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
AEs or Reactro Leading to Early Participant Withdrawal or Early Discontinuation of Study Products Administration Throughout the Study.
Reactogenicity
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
AEs or Reactro Leading to Early Participant Withdrawal or Early Discontinuation of Study Products Administration Throughout the Study.
Other reason
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
AEs or Reactro Leading to Early Participant Withdrawal or Early Discontinuation of Study Products Administration Throughout the Study.
No discontinuation
|
49 Participants
|
48 Participants
|
48 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: Measured at Month 6.5Population: In this report, the "overall number of participants analyzed" represents the HIV uninfected participants with specimens at Month6.5. The "Number Analyzed" in the Outcome Measure Data Table shows the number of participants with available ICS 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 IL-2/IFNy 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. A response is positive if p\<=0.00001.The number and percentage of participants with positive responses are summarized by peptide pool.
Outcome measures
| Measure |
Vaccine w/ MF59
n=49 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/MF59 at Months 3 and 6
|
Vaccine w/ AS01B - High Dose
n=48 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/AS01B at Months 3 and 6
|
Vaccine w/ AS01B - Low Dose
n=47 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 20mcg Protein/AS01B at Months 3 and 6
|
Placebo
n=8 Participants
Placebo at Months 0, 1, 3, and 6
|
|---|---|---|---|---|
|
Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry.
Env-1-ZM96
|
19 Participants
|
34 Participants
|
37 Participants
|
0 Participants
|
|
Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry.
Env-2-ZM96
|
6 Participants
|
17 Participants
|
16 Participants
|
0 Participants
|
|
Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry.
LAI Gag
|
0 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry.
LAI gp41TM
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
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
|
23 Participants
|
39 Participants
|
37 Participants
|
0 Participants
|
|
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
|
18 Participants
|
38 Participants
|
35 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured at Month 6.5Population: In this report, the "overall number of participants analyzed" represents the HIV uninfected participants with specimens at Month6.5. The "Number Analyzed" in the Outcome Measure Data Table shows the number of participants with available ICS 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 percentage of T-cells expressing IL-1/IFNy are summarized for positive responders only.
Outcome measures
| Measure |
Vaccine w/ MF59
n=49 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/MF59 at Months 3 and 6
|
Vaccine w/ AS01B - High Dose
n=48 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/AS01B at Months 3 and 6
|
Vaccine w/ AS01B - Low Dose
n=47 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 20mcg Protein/AS01B at Months 3 and 6
|
Placebo
n=8 Participants
Placebo at Months 0, 1, 3, and 6
|
|---|---|---|---|---|
|
Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry.
1086 gp120
|
0.043625715 % CD4+ T-cells
Interval 0.01686033 to 0.14821546
|
0.21257737 % CD4+ T-cells
Interval 0.13504277 to 0.3292746
|
0.236469065 % CD4+ T-cells
Interval 0.18752656 to 0.50737339
|
-0.00430092 % CD4+ T-cells
Interval -0.00747952 to 0.0069845
|
|
Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry.
Env-1-ZM96
|
0.045957505 % CD4+ T-cells
Interval 0.01215409 to 0.11491243
|
0.17245457 % CD4+ T-cells
Interval 0.08842416 to 0.26856661
|
0.204674615 % CD4+ T-cells
Interval 0.12129456 to 0.33604536
|
0.00005561 % CD4+ T-cells
Interval -0.01538362 to 0.0212081
|
|
Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry.
Env-2-ZM96
|
0.00239069 % CD4+ T-cells
Interval -0.0083648 to 0.01101768
|
0.03477023 % CD4+ T-cells
Interval 0.01804551 to 0.07310345
|
0.034977865 % CD4+ T-cells
Interval 0.00768028 to 0.11871884
|
-0.00905211 % CD4+ T-cells
Interval -0.01435048 to 0.00545363
|
|
Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry.
LAI Gag
|
0.00479596 % CD4+ T-cells
Interval -0.00373824 to 0.01146808
|
0.00389424 % CD4+ T-cells
Interval -0.00241976 to 0.01205637
|
0.0069258 % CD4+ T-cells
Interval -0.00376213 to 0.0148364
|
0.00050871 % CD4+ T-cells
Interval -0.01603156 to 0.0050394
|
|
Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry.
LAI gp41TM
|
-0.006455715 % CD4+ T-cells
Interval -0.01597738 to 0.00338559
|
-0.00486893 % CD4+ T-cells
Interval -0.01386022 to -0.00082034
|
-0.00631803 % CD4+ T-cells
Interval -0.01802868 to 0.00093287
|
-0.00614691 % CD4+ T-cells
Interval -0.0264412 to 0.0013653
|
|
Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry.
TV1 gp120
|
0.064060235 % CD4+ T-cells
Interval 0.02449973 to 0.16682458
|
0.217194305 % CD4+ T-cells
Interval 0.13906679 to 0.29238706
|
0.333606595 % CD4+ T-cells
Interval 0.20594237 to 0.51844985
|
-0.00195339 % CD4+ T-cells
Interval -0.01595152 to -0.00044574
|
PRIMARY outcome
Timeframe: Measured at Month 12Population: Overall number of participants analyzed represents the HIV uninfected participants with specimens at Month 12. Number Analyzed shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 dilution. 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. Values outside the linear range of the assay are not meaningful and are truncated: net MFI less than 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Samples from post-enrollment visits have positive responses if: (1) net MFI \>= an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), and (2) net MFI \> 3 times baseline net MFI, and (3) experimental antigen MFI \> 3 times baseline MFI.
Outcome measures
| Measure |
Vaccine w/ MF59
n=47 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/MF59 at Months 3 and 6
|
Vaccine w/ AS01B - High Dose
n=45 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/AS01B at Months 3 and 6
|
Vaccine w/ AS01B - Low Dose
n=46 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 20mcg Protein/AS01B at Months 3 and 6
|
Placebo
n=10 Participants
Placebo at Months 0, 1, 3, and 6
|
|---|---|---|---|---|
|
Number of Participants With HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 12.]
1086C_D7gp120.avi/293F at Month 12
|
46 Participants
|
43 Participants
|
42 Participants
|
0 Participants
|
|
Number of Participants With HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 12.]
96ZM651.D11gp120.avi at Month 12
|
14 Participants
|
22 Participants
|
20 Participants
|
0 Participants
|
|
Number of Participants With HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 12.]
TV1c8_D11gp120.avi/293F at Month 12
|
38 Participants
|
43 Participants
|
40 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured at Month 12Population: Overall number of participants analyzed represents the HIV uninfected participants with specimens at Month 12. Number Analyzed shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 dilution. 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. Values outside the linear range of the assay are not meaningful and are truncated: net MFI less than 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500.
Outcome measures
| Measure |
Vaccine w/ MF59
n=47 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/MF59 at Months 3 and 6
|
Vaccine w/ AS01B - High Dose
n=45 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/AS01B at Months 3 and 6
|
Vaccine w/ AS01B - Low Dose
n=46 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 20mcg Protein/AS01B at Months 3 and 6
|
Placebo
n=10 Participants
Placebo at Months 0, 1, 3, and 6
|
|---|---|---|---|---|
|
Level of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 12.]
1086C_D7gp120.avi/293F at Month 12
|
7686.25 relative fluorescence units
Interval 3514.25 to 18708.125
|
19787.75 relative fluorescence units
Interval 14907.5 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
1 relative fluorescence units
Interval 1.0 to 5.0
|
|
Level of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 12.]
96ZM651.D11gp120.avi at Month 12
|
938 relative fluorescence units
Interval 491.5 to 2366.75
|
2202.5 relative fluorescence units
Interval 1321.375 to 4108.375
|
2580.5 relative fluorescence units
Interval 1294.375 to 4934.875
|
7.875 relative fluorescence units
Interval 4.0625 to 43.1875
|
|
Level of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 12.]
TV1c8_D11gp120.avi/293F at Month 12
|
1342.75 relative fluorescence units
Interval 658.125 to 5138.875
|
6409.5 relative fluorescence units
Interval 3978.625 to 12420.625
|
8421 relative fluorescence units
Interval 2659.5 to 18775.625
|
1 relative fluorescence units
Interval 1.0 to 19.75
|
SECONDARY outcome
Timeframe: Measured at Month 12Population: In this report, the "overall number of participants analyzed" represents the HIV uninfected participants with specimens at Month12. The "Number Analyzed" in the Outcome Measure Data Table shows the number of participants with available ICS 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 IL-2/IFNy 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. A response is positive if p\<=0.00001.The number and percentage of participants with positive responses are summarized by peptide pool.
Outcome measures
| Measure |
Vaccine w/ MF59
n=47 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/MF59 at Months 3 and 6
|
Vaccine w/ AS01B - High Dose
n=45 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/AS01B at Months 3 and 6
|
Vaccine w/ AS01B - Low Dose
n=46 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 20mcg Protein/AS01B at Months 3 and 6
|
Placebo
n=10 Participants
Placebo at Months 0, 1, 3, and 6
|
|---|---|---|---|---|
|
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
|
17 Participants
|
34 Participants
|
33 Participants
|
0 Participants
|
|
Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry.
Env-2-ZM96
|
2 Participants
|
8 Participants
|
10 Participants
|
0 Participants
|
|
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
|
24 Participants
|
32 Participants
|
32 Participants
|
0 Participants
|
|
Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry.
Env-1-ZM96
|
24 Participants
|
34 Participants
|
33 Participants
|
1 Participants
|
|
Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry.
LAI Gag
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Measured at Month 12Population: In this report, the "overall number of participants analyzed" represents the HIV uninfected participants with specimens at Month12. The "Number Analyzed" in the Outcome Measure Data Table shows the number of participants with available ICS 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 percentage of T-cells expressing IL-1/IFNy are summarized for positive responders only.
Outcome measures
| Measure |
Vaccine w/ MF59
n=47 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/MF59 at Months 3 and 6
|
Vaccine w/ AS01B - High Dose
n=45 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/AS01B at Months 3 and 6
|
Vaccine w/ AS01B - Low Dose
n=46 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 20mcg Protein/AS01B at Months 3 and 6
|
Placebo
n=10 Participants
Placebo at Months 0, 1, 3, and 6
|
|---|---|---|---|---|
|
Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry.
1086 gp120
|
0.044319625 % CD4+ T-cells
Interval 0.009665425 to 0.09187594
|
0.10802498 % CD4+ T-cells
Interval 0.07815074 to 0.18406719
|
0.15160478 % CD4+ T-cells
Interval 0.09475396 to 0.30774528
|
0.000078395 % CD4+ T-cells
Interval -0.00629445 to 0.00168892
|
|
Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry.
Env-1-ZM96
|
0.060435485 % CD4+ T-cells
Interval 0.01622735 to 0.085696555
|
0.09662109 % CD4+ T-cells
Interval 0.05888084 to 0.17217561
|
0.1209486 % CD4+ T-cells
Interval 0.066832855 to 0.24448282
|
0.00009746 % CD4+ T-cells
Interval -0.0063057 to 0.01311592
|
|
Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry.
LAI Gag
|
0.003934455 % CD4+ T-cells
Interval -0.00521375 to 0.007967745
|
0.00199785 % CD4+ T-cells
Interval -0.0062505 to 0.00771792
|
0.002998855 % CD4+ T-cells
Interval -0.00754884 to 0.01064116
|
0.000049675 % CD4+ T-cells
Interval -0.01131992 to 0.00378357
|
|
Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry.
TV1 gp120
|
0.04961613 % CD4+ T-cells
Interval 0.01083952 to 0.110185075
|
0.10101452 % CD4+ T-cells
Interval 0.06202808 to 0.14821607
|
0.145474815 % CD4+ T-cells
Interval 0.064903025 to 0.24267272
|
-0.005495385 % CD4+ T-cells
Interval -0.01339975 to -0.00049045
|
|
Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry.
Env-2-ZM96
|
0.004117915 % CD4+ T-cells
Interval -0.002599175 to 0.01463184
|
0.01003653 % CD4+ T-cells
Interval 0.00256448 to 0.03750046
|
0.020232585 % CD4+ T-cells
Interval 0.002113855 to 0.040018475
|
-0.004564435 % CD4+ T-cells
Interval -0.01614768 to -0.00172824
|
SECONDARY outcome
Timeframe: Measured at Month 6.5Population: Overall number of participants analyzed represents the HIV uninfected participants with specimens at Month 6.5. Number Analyzed shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 dilution. 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. Values outside the linear range of the assay are not meaningful and are truncated: net MFI less than 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Samples from post-enrollment visits have positive responses if: (1) net MFI \>= an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), and (2) net MFI \> 3 times baseline net MFI, and (3) experimental antigen MFI \> 3 times baseline MFI.
Outcome measures
| Measure |
Vaccine w/ MF59
n=49 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/MF59 at Months 3 and 6
|
Vaccine w/ AS01B - High Dose
n=48 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/AS01B at Months 3 and 6
|
Vaccine w/ AS01B - Low Dose
n=47 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 20mcg Protein/AS01B at Months 3 and 6
|
Placebo
n=8 Participants
Placebo at Months 0, 1, 3, and 6
|
|---|---|---|---|---|
|
Number of Participants With HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5.]
1086C_D7gp120.avi/293F at Month 6.5
|
49 Participants
|
45 Participants
|
41 Participants
|
0 Participants
|
|
Number of Participants With HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5.]
96ZM651.D11gp120.avi at Month 6.5
|
47 Participants
|
45 Participants
|
39 Participants
|
0 Participants
|
|
Number of Participants With HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5.]
TV1c8_D11gp120.avi/293F at Month 6.5
|
49 Participants
|
46 Participants
|
42 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Measured at Month 6.5Population: Overall number of participants analyzed represents the HIV uninfected participants with specimens at Month 6.5. Number Analyzed shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 dilution. 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. Values outside the linear range of the assay are not meaningful and are truncated: net MFI less than 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500.
Outcome measures
| Measure |
Vaccine w/ MF59
n=49 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/MF59 at Months 3 and 6
|
Vaccine w/ AS01B - High Dose
n=48 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/AS01B at Months 3 and 6
|
Vaccine w/ AS01B - Low Dose
n=47 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 20mcg Protein/AS01B at Months 3 and 6
|
Placebo
n=8 Participants
Placebo at Months 0, 1, 3, and 6
|
|---|---|---|---|---|
|
Level of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5]
1086C_D7gp120.avi/293F at Month 6.5
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
1 relative fluorescence units
Interval 1.0 to 1.0
|
|
Level of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5]
96ZM651.D11gp120.avi at Month 6.5
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
14.125 relative fluorescence units
Interval 6.375 to 118.8125
|
|
Level of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5]
TV1c8_D11gp120.avi/293F at Month 6.5
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
1 relative fluorescence units
Interval 1.0 to 107.625
|
SECONDARY outcome
Timeframe: Measured at Month 6.5Population: Overall number of participants analyzed represents the HIV uninfected participants with specimens at Month 6.5. Number Analyzed shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
Area under titration curve from serial dilution (AUTC) is calculated using the trapezoidal rule based on the raw MFI values truncated at zero across the log base 10 dilution factors, i.e., the summation of products of raw MFI values and log10(dilution factor). The dilution factor refers to the ratio of the volume of the initial (concentrated) solution (V1) to the volume of the final (dilute) solution (V2), and therefore it is unitless. For example, for a dilution of V1:V2=1:50 of a solution, the corresponding dilution factor is V2/V1=50/1=50.
Outcome measures
| Measure |
Vaccine w/ MF59
n=49 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/MF59 at Months 3 and 6
|
Vaccine w/ AS01B - High Dose
n=48 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/AS01B at Months 3 and 6
|
Vaccine w/ AS01B - Low Dose
n=47 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 20mcg Protein/AS01B at Months 3 and 6
|
Placebo
n=8 Participants
Placebo at Months 0, 1, 3, and 6
|
|---|---|---|---|---|
|
Area Under Titration Curve of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Breadth as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5.]
1086C_D7gp120.avi/293F at Month 6.5
|
40433.144898 RFU*log10(dilution factor)
Interval 35303.066969 to 44156.283884
|
42528.614697 RFU*log10(dilution factor)
Interval 41103.049524 to 46165.358075
|
43564.082625 RFU*log10(dilution factor)
Interval 40648.306087 to 45130.341692
|
0 RFU*log10(dilution factor)
Interval 0.0 to 0.1505149978
|
|
Area Under Titration Curve of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Breadth as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5.]
96ZM651.D11gp120.avi at Month 6.5
|
19137.530429 RFU*log10(dilution factor)
Interval 12994.975739 to 24038.844376
|
26284.001341 RFU*log10(dilution factor)
Interval 18696.286306 to 32366.350032
|
19206.42867 RFU*log10(dilution factor)
Interval 12004.060251 to 26698.726603
|
6.5850311551 RFU*log10(dilution factor)
Interval 1.2605631068 to 42.962624694
|
|
Area Under Titration Curve of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Breadth as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5.]
TV1c8_D11gp120.avi/293F at Month 6.5
|
29381.844583 RFU*log10(dilution factor)
Interval 22547.410076 to 33602.924811
|
36046.799202 RFU*log10(dilution factor)
Interval 29934.75202 to 39085.348942
|
33717.692497 RFU*log10(dilution factor)
Interval 26403.115147 to 37738.032754
|
0.0752574989 RFU*log10(dilution factor)
Interval 0.0 to 32.30428141
|
SECONDARY outcome
Timeframe: Measured at Month 6.5Population: Overall number of participants analyzed represents the HIV uninfected participants with specimens at Month 6.5. Number Analyzed shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 dilution. 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. Values outside the linear range of the assay are not meaningful and are truncated: net MFI less than 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Samples from post-enrollment visits have positive responses if: (1) net MFI \>= an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), and (2) net MFI \> 3 times baseline net MFI, and (3) experimental antigen MFI \> 3 times baseline MFI.
Outcome measures
| Measure |
Vaccine w/ MF59
n=49 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/MF59 at Months 3 and 6
|
Vaccine w/ AS01B - High Dose
n=48 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/AS01B at Months 3 and 6
|
Vaccine w/ AS01B - Low Dose
n=47 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 20mcg Protein/AS01B at Months 3 and 6
|
Placebo
n=8 Participants
Placebo at Months 0, 1, 3, and 6
|
|---|---|---|---|---|
|
Number of Participants With Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 6.5.]
C.1086C_V1_V2 Tags at Month 6.5
|
20 Participants
|
27 Participants
|
19 Participants
|
0 Participants
|
|
Number of Participants With Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 6.5.]
gp70-96ZM651.02 V1v2 at Month 6.5
|
17 Participants
|
24 Participants
|
17 Participants
|
0 Participants
|
|
Number of Participants With Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 6.5.]
gp70-TV1.21 V1V2 at Month 6.5
|
24 Participants
|
26 Participants
|
11 Participants
|
0 Participants
|
|
Number of Participants With Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 6.5.]
gp70-TV1.GSKvacV1V2/293F at Month 6.5
|
29 Participants
|
31 Participants
|
16 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Measured at Month 6.5Population: Overall number of participants analyzed represents the HIV uninfected participants with specimens at Month 6.5. Number Analyzed shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 dilution. 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. Values outside the linear range of the assay are not meaningful and are truncated: net MFI less than 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500.
Outcome measures
| Measure |
Vaccine w/ MF59
n=49 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/MF59 at Months 3 and 6
|
Vaccine w/ AS01B - High Dose
n=48 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/AS01B at Months 3 and 6
|
Vaccine w/ AS01B - Low Dose
n=47 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 20mcg Protein/AS01B at Months 3 and 6
|
Placebo
n=8 Participants
Placebo at Months 0, 1, 3, and 6
|
|---|---|---|---|---|
|
Level of Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 6.5.]
C.1086C_V1_V2 Tags at Month 6.5
|
1193.125 relative fluorescence units
Interval 258.5625 to 5013.0625
|
4296.5 relative fluorescence units
Interval 953.25 to 11383.0
|
1555.5 relative fluorescence units
Interval 381.4375 to 7860.875
|
66.375 relative fluorescence units
Interval 5.5 to 266.9375
|
|
Level of Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 6.5.]
gp70-96ZM651.02 V1v2 at Month 6.5
|
429.5 relative fluorescence units
Interval 13.0 to 2044.875
|
1327.75 relative fluorescence units
Interval 275.25 to 8008.5
|
455.375 relative fluorescence units
Interval 1.0 to 1275.5625
|
1 relative fluorescence units
Interval 1.0 to 30.0
|
|
Level of Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 6.5.]
gp70-TV1.21 V1V2 at Month 6.5
|
209.125 relative fluorescence units
Interval 1.0 to 1897.0625
|
442.25 relative fluorescence units
Interval 27.75 to 2621.5
|
1 relative fluorescence units
Interval 1.0 to 543.25
|
1 relative fluorescence units
Interval 1.0 to 1.0
|
|
Level of Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 6.5.]
gp70-TV1.GSKvacV1V2/293F at Month 6.5
|
225 relative fluorescence units
Interval 1.0 to 1940.75
|
709.75 relative fluorescence units
Interval 115.75 to 4134.25
|
80.875 relative fluorescence units
Interval 1.0 to 444.1875
|
1 relative fluorescence units
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: Measured at Month Month 12Population: Overall number of participants analyzed represents the HIV uninfected participants with specimens at Month 12. Number Analyzed shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 dilution. 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. Values outside the linear range of the assay are not meaningful and are truncated: net MFI less than 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Samples from post-enrollment visits have positive responses if: (1) net MFI \>= an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), and (2) net MFI \> 3 times baseline net MFI, and (3) experimental antigen MFI \> 3 times baseline MFI.
Outcome measures
| Measure |
Vaccine w/ MF59
n=47 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/MF59 at Months 3 and 6
|
Vaccine w/ AS01B - High Dose
n=45 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/AS01B at Months 3 and 6
|
Vaccine w/ AS01B - Low Dose
n=46 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 20mcg Protein/AS01B at Months 3 and 6
|
Placebo
n=10 Participants
Placebo at Months 0, 1, 3, and 6
|
|---|---|---|---|---|
|
Number of Participants With Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 10.]
C.1086C_V1_V2 Tags at Month 12
|
2 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 10.]
gp70-96ZM651.02 V1v2 at Month 12
|
3 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 10.]
gp70-TV1.21 V1V2 at Month 12
|
5 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 10.]
gp70-TV1.GSKvacV1V2/293F at Month 12
|
7 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Measured at Month 12Population: Overall number of participants analyzed represents the HIV uninfected participants with specimens at Month 12. Number Analyzed shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 dilution. 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. Values outside the linear range of the assay are not meaningful and are truncated: net MFI less than 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500.
Outcome measures
| Measure |
Vaccine w/ MF59
n=47 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/MF59 at Months 3 and 6
|
Vaccine w/ AS01B - High Dose
n=45 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/AS01B at Months 3 and 6
|
Vaccine w/ AS01B - Low Dose
n=46 Participants
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 20mcg Protein/AS01B at Months 3 and 6
|
Placebo
n=10 Participants
Placebo at Months 0, 1, 3, and 6
|
|---|---|---|---|---|
|
Level of Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 12.]
C.1086C_V1_V2 Tags at Month 12
|
90 relative fluorescence units
Interval 23.375 to 264.625
|
235.875 relative fluorescence units
Interval 55.1875 to 502.5
|
153 relative fluorescence units
Interval 60.25 to 471.5
|
18.375 relative fluorescence units
Interval 1.1875 to 99.6875
|
|
Level of Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 12.]
gp70-96ZM651.02 V1v2 at Month 12
|
1 relative fluorescence units
Interval 1.0 to 84.6875
|
1.75 relative fluorescence units
Interval 1.0 to 258.0625
|
1 relative fluorescence units
Interval 1.0 to 119.1875
|
1 relative fluorescence units
Interval 1.0 to 11.1875
|
|
Level of Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 12.]
gp70-TV1.21 V1V2 at Month 12
|
1 relative fluorescence units
Interval 1.0 to 82.75
|
1 relative fluorescence units
Interval 1.0 to 30.5
|
1 relative fluorescence units
Interval 1.0 to 1.0
|
1 relative fluorescence units
Interval 1.0 to 1.0
|
|
Level of Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 12.]
gp70-TV1.GSKvacV1V2/293F at Month 12
|
1 relative fluorescence units
Interval 1.0 to 90.5625
|
1 relative fluorescence units
Interval 1.0 to 60.8125
|
1 relative fluorescence units
Interval 1.0 to 11.5
|
1 relative fluorescence units
Interval 1.0 to 1.0
|
Adverse Events
Vaccine w/ MF59
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Vaccine w/ AS01B - High Dose
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Vaccine w/ AS01B - Low Dose
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vaccine w/ MF59
n=50 participants at risk
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/MF59 at Months 3 and 6
|
Vaccine w/ AS01B - High Dose
n=50 participants at risk
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/AS01B at Months 3 and 6
|
Vaccine w/ AS01B - Low Dose
n=50 participants at risk
ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 20mcg Protein/AS01B at Months 3 and 6
|
Placebo
n=10 participants at risk
Placebo at Months 0, 1, 3, and 6
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Any Event in SOC
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Ear and labyrinth disorders
Any Event in SOC
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Eye disorders
Any Event in SOC
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Eye disorders
Conjunctivitis allergic
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Gastrointestinal disorders
Any Event in SOC
|
8.0%
4/50 • Number of events 4 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
8.0%
4/50 • Number of events 6 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Gastrointestinal disorders
Anal pruritus
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.0%
2/50 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
4.0%
2/50 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
General disorders
Any Event in SOC
|
8.0%
4/50 • Number of events 4 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
10.0%
5/50 • Number of events 7 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
6.0%
3/50 • Number of events 3 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
General disorders
Chest discomfort
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
General disorders
Fatigue
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
General disorders
Influenza like illness
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
General disorders
Injection site hypoaesthesia
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
General disorders
Injection site pruritus
|
4.0%
2/50 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
6.0%
3/50 • Number of events 3 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
4.0%
2/50 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
General disorders
Malaise
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
General disorders
Tenderness
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Infections and infestations
Any Event in SOC
|
38.0%
19/50 • Number of events 23 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
26.0%
13/50 • Number of events 18 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
32.0%
16/50 • Number of events 20 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
20.0%
2/10 • Number of events 3 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Infections and infestations
Bacterial vaginosis
|
6.0%
3/50 • Number of events 3 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Infections and infestations
Bronchitis
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
10.0%
1/10 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Infections and infestations
Gastroenteritis
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Infections and infestations
Gastrointestinal infection
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Infections and infestations
Genitourinary chlamydia infection
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
8.0%
4/50 • Number of events 4 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Infections and infestations
Malaria
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Infections and infestations
Pneumonia
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Infections and infestations
Subcutaneous abscess
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Infections and infestations
Upper respiratory tract infection
|
14.0%
7/50 • Number of events 7 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
12.0%
6/50 • Number of events 8 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
18.0%
9/50 • Number of events 10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
10.0%
1/10 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Infections and infestations
Urinary tract infection staphylococcal
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Infections and infestations
Viral infection
|
4.0%
2/50 • Number of events 3 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
4.0%
2/50 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
10.0%
1/10 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Infections and infestations
Vulvovaginitis trichomonal
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Injury, poisoning and procedural complications
Any Event in SOC
|
8.0%
4/50 • Number of events 5 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
6.0%
3/50 • Number of events 4 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
6.0%
3/50 • Number of events 3 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Injury, poisoning and procedural complications
Hypobarism
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Injury, poisoning and procedural complications
Limb injury
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Injury, poisoning and procedural complications
Post concussion syndrome
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
4.0%
2/50 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Investigations
Any Event in SOC
|
22.0%
11/50 • Number of events 20 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
26.0%
13/50 • Number of events 26 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
12.0%
6/50 • Number of events 17 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
10.0%
1/10 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Investigations
Alanine aminotransferase increased
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
6.0%
3/50 • Number of events 3 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Investigations
Aspartate aminotransferase increased
|
4.0%
2/50 • Number of events 3 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Investigations
Blood creatinine increased
|
14.0%
7/50 • Number of events 8 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
8.0%
4/50 • Number of events 5 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Investigations
Blood pressure increased
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
4.0%
2/50 • Number of events 5 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Investigations
Creatinine renal clearance decreased
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
10.0%
1/10 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Investigations
Neutrophil count decreased
|
6.0%
3/50 • Number of events 6 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
4.0%
2/50 • Number of events 5 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
6.0%
3/50 • Number of events 8 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Investigations
Platelet count decreased
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Investigations
Protein urine present
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Investigations
White blood cell count decreased
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
4.0%
2/50 • Number of events 4 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
6.0%
3/50 • Number of events 5 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Metabolism and nutrition disorders
Any Event in SOC
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Musculoskeletal and connective tissue disorders
Any Event in SOC
|
10.0%
5/50 • Number of events 6 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
6.0%
3/50 • Number of events 3 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
20.0%
2/10 • Number of events 3 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
10.0%
1/10 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.0%
2/50 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
10.0%
1/10 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
10.0%
1/10 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.0%
2/50 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Nervous system disorders
Any Event in SOC
|
8.0%
4/50 • Number of events 4 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
4.0%
2/50 • Number of events 3 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
10.0%
1/10 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Nervous system disorders
Ageusia
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
10.0%
1/10 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Nervous system disorders
Headache
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Nervous system disorders
Migraine
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Nervous system disorders
Presyncope
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Psychiatric disorders
Any Event in SOC
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
4.0%
2/50 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Psychiatric disorders
Attention deficit/hyperactivity disorder
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Psychiatric disorders
Depression
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Renal and urinary disorders
Any Event in SOC
|
10.0%
5/50 • Number of events 6 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
6.0%
3/50 • Number of events 3 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
4.0%
2/50 • Number of events 3 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
10.0%
1/10 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Renal and urinary disorders
Glycosuria
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Renal and urinary disorders
Haematuria
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Renal and urinary disorders
Proteinuria
|
8.0%
4/50 • Number of events 4 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
4.0%
2/50 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
4.0%
2/50 • Number of events 3 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
10.0%
1/10 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Respiratory, thoracic and mediastinal disorders
Any Event in SOC
|
10.0%
5/50 • Number of events 5 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
4.0%
2/50 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Skin and subcutaneous tissue disorders
Any Event in SOC
|
2.0%
1/50 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
6.0%
3/50 • Number of events 3 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Skin and subcutaneous tissue disorders
Dyshidrotic eczema
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.0%
1/50 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
2.0%
1/50 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/50 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
0.00%
0/10 • Serious adverse events are collected throughout the study (months 0-18). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6).
Adverse events of special interest (AESI) are defined in Protocol Version 3, Section 6.4.3.2 and Appendix H.
|
Additional Information
Jessica Andriesen, PhD, Associate Director of HVTN SDMC Operations
Fred Hutchinson Cancer Center
Phone: 206-667-5812
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place