Trial Outcomes & Findings for Dose-ranging Study to Evaluate the Safety & Immunogenicity of a HIV Vaccine 732461 in Healthy HIV Seronegative Volunteers (NCT NCT00434512)
NCT ID: NCT00434512
Last Updated: 2019-10-01
Results Overview
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
180 participants
Primary outcome timeframe
During the 7-day (Days 0-6) follow-up period after each vaccination and overall (across doses)
Results posted on
2019-10-01
Participant Flow
A total of 229 subjects were enrolled and screened in this study, and 49 of these were excluded before vaccination.
Participant milestones
| Measure |
SB732461 Non-adjuvanted_LD Group
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted low-antigen dose \[LD\] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 Non-adjuvanted_MD Group
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted medium-antigen dose \[MD\] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 Non-adjuvanted_HD Group
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted high-antigen dose \[HD\] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_LD Group
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted low-antigen dose \[LD\] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_MD Group
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted medium-antigen dose \[MD\] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_HD Group
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted high-antigen dose \[HD\] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
50
|
50
|
50
|
|
Overall Study
COMPLETED
|
10
|
9
|
10
|
49
|
49
|
49
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
SB732461 Non-adjuvanted_LD Group
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted low-antigen dose \[LD\] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 Non-adjuvanted_MD Group
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted medium-antigen dose \[MD\] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 Non-adjuvanted_HD Group
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted high-antigen dose \[HD\] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_LD Group
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted low-antigen dose \[LD\] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_MD Group
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted medium-antigen dose \[MD\] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_HD Group
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted high-antigen dose \[HD\] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
|---|---|---|---|---|---|---|
|
Overall Study
Migrated/moved from study area
|
0
|
0
|
0
|
1
|
1
|
1
|
|
Overall Study
Other
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Dose-ranging Study to Evaluate the Safety & Immunogenicity of a HIV Vaccine 732461 in Healthy HIV Seronegative Volunteers
Baseline characteristics by cohort
| Measure |
SB732461 Non-adjuvanted_LD Group
n=10 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted low-antigen dose \[LD\] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 Non-adjuvanted_MD Group
n=10 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted medium-antigen dose \[MD\] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 Non-adjuvanted_HD Group
n=10 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted high-antigen dose \[HD\] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_LD Group
n=50 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted low-antigen dose \[LD\] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_MD Group
n=50 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted medium-antigen dose \[MD\] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_HD Group
n=50 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted high-antigen dose \[HD\] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
Total
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
21.4 Years
STANDARD_DEVIATION 3.75 • n=5 Participants
|
21.8 Years
STANDARD_DEVIATION 3.19 • n=7 Participants
|
22.5 Years
STANDARD_DEVIATION 4.99 • n=5 Participants
|
22.0 Years
STANDARD_DEVIATION 5.04 • n=4 Participants
|
22.2 Years
STANDARD_DEVIATION 3.66 • n=21 Participants
|
22.9 Years
STANDARD_DEVIATION 5.43 • n=10 Participants
|
22.3 Years
STANDARD_DEVIATION 4.62 • n=115 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
32 Participants
n=10 Participants
|
114 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
18 Participants
n=10 Participants
|
66 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
White - Arabic/North African heritage
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
White - Caucasian/European heritage
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
50 Participants
n=10 Participants
|
174 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Other - Unspecified
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: During the 7-day (Days 0-6) follow-up period after each vaccination and overall (across doses)Population: The analysis was performed on the Total Vaccinated Cohort, which included vaccinated subjects with at least one vaccine administration documented for whom data were available and who had their symptom sheets filled in.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
Outcome measures
| Measure |
SB732461 Non-adjuvanted_LD Group
n=10 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted low-antigen dose \[LD\] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 Non-adjuvanted_MD Group
n=10 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted medium-antigen dose \[MD\] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 Non-adjuvanted_HD Group
n=10 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted high-antigen dose \[HD\] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_LD Group
n=50 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted low-antigen dose \[LD\] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_MD Group
n=50 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted medium-antigen dose \[MD\] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_HD Group
n=50 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted high-antigen dose \[HD\] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 1
|
2 Participants
|
0 Participants
|
2 Participants
|
49 Participants
|
49 Participants
|
49 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
18 Participants
|
9 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
9 Participants
|
2 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
9 Participants
|
12 Participants
|
5 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 2
|
3 Participants
|
2 Participants
|
4 Participants
|
47 Participants
|
49 Participants
|
48 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
14 Participants
|
17 Participants
|
25 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
11 Participants
|
10 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
11 Participants
|
13 Participants
|
17 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Overall
|
3 Participants
|
2 Participants
|
5 Participants
|
49 Participants
|
50 Participants
|
50 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Overall
|
0 Participants
|
0 Participants
|
0 Participants
|
7 Participants
|
5 Participants
|
10 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Overall
|
0 Participants
|
0 Participants
|
0 Participants
|
14 Participants
|
23 Participants
|
25 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Overall
|
0 Participants
|
0 Participants
|
0 Participants
|
7 Participants
|
13 Participants
|
12 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Overall
|
0 Participants
|
0 Participants
|
0 Participants
|
6 Participants
|
3 Participants
|
4 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
4 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
6 Participants
|
4 Participants
|
6 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Overall
|
0 Participants
|
0 Participants
|
0 Participants
|
13 Participants
|
18 Participants
|
19 Participants
|
PRIMARY outcome
Timeframe: During the 7-day (Days 0-6) follow-up period after each vaccination and overall (across doses)Population: The analysis was performed on the Total Vaccinated Cohort, which included vaccinated subjects with at least one vaccine administration documented for whom data were available and who had their symptom sheets filled in.
Assessed solicited general symptoms were fatigue, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], headache, myalgia, sweating, gastrointestinal symptoms(nausea, vomiting, diarrhea, and/or abdominal pain). Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
SB732461 Non-adjuvanted_LD Group
n=10 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted low-antigen dose \[LD\] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 Non-adjuvanted_MD Group
n=10 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted medium-antigen dose \[MD\] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 Non-adjuvanted_HD Group
n=10 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted high-antigen dose \[HD\] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_LD Group
n=50 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted low-antigen dose \[LD\] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_MD Group
n=50 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted medium-antigen dose \[MD\] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_HD Group
n=50 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted high-antigen dose \[HD\] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue, Dose 1
|
3 Participants
|
5 Participants
|
5 Participants
|
27 Participants
|
28 Participants
|
33 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue, Dose 1
|
2 Participants
|
4 Participants
|
3 Participants
|
26 Participants
|
24 Participants
|
32 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal, Dose 1
|
1 Participants
|
1 Participants
|
1 Participants
|
9 Participants
|
9 Participants
|
8 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal, Dose 1
|
1 Participants
|
0 Participants
|
1 Participants
|
8 Participants
|
6 Participants
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache, Dose 1
|
2 Participants
|
4 Participants
|
3 Participants
|
24 Participants
|
21 Participants
|
24 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache, Dose 1
|
0 Participants
|
3 Participants
|
2 Participants
|
20 Participants
|
19 Participants
|
21 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia, Dose 1
|
2 Participants
|
1 Participants
|
1 Participants
|
13 Participants
|
20 Participants
|
23 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia, Dose 1
|
2 Participants
|
1 Participants
|
1 Participants
|
13 Participants
|
19 Participants
|
21 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Sweating, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Sweating, Dose 1
|
0 Participants
|
0 Participants
|
2 Participants
|
6 Participants
|
6 Participants
|
10 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue, Dose 2
|
3 Participants
|
2 Participants
|
4 Participants
|
39 Participants
|
43 Participants
|
44 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
9 Participants
|
7 Participants
|
11 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue, Dose 2
|
3 Participants
|
1 Participants
|
3 Participants
|
39 Participants
|
43 Participants
|
44 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
29 Participants
|
29 Participants
|
25 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
29 Participants
|
29 Participants
|
25 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal, Dose 2
|
1 Participants
|
1 Participants
|
2 Participants
|
20 Participants
|
15 Participants
|
13 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal, Dose 2
|
1 Participants
|
1 Participants
|
2 Participants
|
19 Participants
|
12 Participants
|
11 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache, Dose 2
|
2 Participants
|
1 Participants
|
2 Participants
|
38 Participants
|
37 Participants
|
37 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
8 Participants
|
5 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache, Dose 2
|
1 Participants
|
1 Participants
|
2 Participants
|
37 Participants
|
37 Participants
|
37 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia, Dose 2
|
0 Participants
|
1 Participants
|
1 Participants
|
31 Participants
|
31 Participants
|
28 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
6 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia, Dose 2
|
0 Participants
|
1 Participants
|
1 Participants
|
31 Participants
|
31 Participants
|
28 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Sweating, Dose 2
|
1 Participants
|
1 Participants
|
1 Participants
|
28 Participants
|
24 Participants
|
23 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Sweating, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Sweating, Dose 2
|
1 Participants
|
1 Participants
|
1 Participants
|
26 Participants
|
24 Participants
|
23 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue, Overall
|
5 Participants
|
5 Participants
|
6 Participants
|
40 Participants
|
47 Participants
|
46 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue, Overall
|
0 Participants
|
0 Participants
|
0 Participants
|
11 Participants
|
7 Participants
|
12 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue, Overall
|
5 Participants
|
4 Participants
|
5 Participants
|
40 Participants
|
46 Participants
|
46 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever, Overall
|
0 Participants
|
0 Participants
|
0 Participants
|
30 Participants
|
29 Participants
|
26 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever, Overall
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever, Overall
|
0 Participants
|
0 Participants
|
0 Participants
|
30 Participants
|
29 Participants
|
26 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal, Overall
|
2 Participants
|
2 Participants
|
2 Participants
|
23 Participants
|
21 Participants
|
17 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal, Overall
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal, Overall
|
2 Participants
|
1 Participants
|
2 Participants
|
22 Participants
|
16 Participants
|
13 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache, Overall
|
4 Participants
|
4 Participants
|
5 Participants
|
42 Participants
|
42 Participants
|
41 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache, Overall
|
0 Participants
|
0 Participants
|
0 Participants
|
10 Participants
|
5 Participants
|
8 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache, Overall
|
1 Participants
|
3 Participants
|
4 Participants
|
40 Participants
|
42 Participants
|
41 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia, Overall
|
2 Participants
|
1 Participants
|
2 Participants
|
31 Participants
|
35 Participants
|
36 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia, Overall
|
2 Participants
|
1 Participants
|
2 Participants
|
31 Participants
|
35 Participants
|
35 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Sweating, Overall
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Sweating, Overall
|
1 Participants
|
1 Participants
|
3 Participants
|
27 Participants
|
27 Participants
|
26 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Sweating, Dose 1
|
0 Participants
|
0 Participants
|
2 Participants
|
7 Participants
|
8 Participants
|
11 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia, Overall
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
6 Participants
|
8 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Sweating, Overall
|
1 Participants
|
1 Participants
|
3 Participants
|
28 Participants
|
27 Participants
|
26 Participants
|
PRIMARY outcome
Timeframe: During the 30-day (Days 0-29) follow-up period after vaccination (across doses)Population: The analysis was performed on the Total Vaccinated Cohort, which included vaccinated subjects with at least one vaccine administration documented for whom data were available and who had their symptom sheets filled in.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
SB732461 Non-adjuvanted_LD Group
n=10 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted low-antigen dose \[LD\] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 Non-adjuvanted_MD Group
n=10 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted medium-antigen dose \[MD\] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 Non-adjuvanted_HD Group
n=10 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted high-antigen dose \[HD\] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_LD Group
n=50 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted low-antigen dose \[LD\] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_MD Group
n=50 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted medium-antigen dose \[MD\] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_HD Group
n=50 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted high-antigen dose \[HD\] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Any AE(s)
|
5 Participants
|
6 Participants
|
7 Participants
|
42 Participants
|
30 Participants
|
33 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Grade 3 AE(s)
|
0 Participants
|
1 Participants
|
0 Participants
|
9 Participants
|
5 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Related AE(s)
|
0 Participants
|
0 Participants
|
1 Participants
|
22 Participants
|
15 Participants
|
15 Participants
|
PRIMARY outcome
Timeframe: During the whole study period (From Month 0 up to Month 12)Population: The analysis was performed on the Total Vaccinated Cohort, which included vaccinated subjects with at least one vaccine administration documented for whom data were available and who had their symptom sheets filled in.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Outcome measures
| Measure |
SB732461 Non-adjuvanted_LD Group
n=10 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted low-antigen dose \[LD\] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 Non-adjuvanted_MD Group
n=10 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted medium-antigen dose \[MD\] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 Non-adjuvanted_HD Group
n=10 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted high-antigen dose \[HD\] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_LD Group
n=50 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted low-antigen dose \[LD\] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_MD Group
n=50 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted medium-antigen dose \[MD\] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_HD Group
n=50 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted high-antigen dose \[HD\] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs) and Related SAEs
Related SAEs · SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Serious Adverse Events (SAEs) and Related SAEs
SAEs · SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: At Month 0Population: The analysis was performed on the Total Vaccinated cohort, which included vaccinated subjects with at least one vaccine administration documented for whom data were available and who had their symptom sheets filled in.
The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells \[RBC\] count, haemoglobin, haematocrit, white blood cell \[WBC\] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase \[ALT\] and aspartate aminotransferase \[AST\].
Outcome measures
| Measure |
SB732461 Non-adjuvanted_LD Group
n=10 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted low-antigen dose \[LD\] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 Non-adjuvanted_MD Group
n=50 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted medium-antigen dose \[MD\] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 Non-adjuvanted_HD Group
n=10 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted high-antigen dose \[HD\] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_LD Group
n=50 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted low-antigen dose \[LD\] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_MD Group
n=10 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted medium-antigen dose \[MD\] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_HD Group
n=50 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted high-antigen dose \[HD\] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
RBC · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
RBC · Below
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
Hematocrit · Within
|
10 Participants
|
47 Participants
|
9 Participants
|
49 Participants
|
9 Participants
|
48 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
RBC · Within
|
10 Participants
|
48 Participants
|
9 Participants
|
49 Participants
|
9 Participants
|
48 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
RBC · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
Haemoglobin · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
Haemoglobin · Below
|
0 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
Haemoglobin · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
Hematocrit · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
Hematocrit · Below
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
Hematocrit · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
WBC · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
WBC · Within
|
9 Participants
|
47 Participants
|
10 Participants
|
45 Participants
|
10 Participants
|
44 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
WBC · Above
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
Neutrophils · Below
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
Neutrophils · Within
|
9 Participants
|
43 Participants
|
10 Participants
|
46 Participants
|
10 Participants
|
47 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
Neutrophils · Above
|
1 Participants
|
5 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
Eosinophils · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
Lymphocytes · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
Lymphocytes · Within
|
9 Participants
|
44 Participants
|
10 Participants
|
46 Participants
|
10 Participants
|
48 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
Lymphocytes · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
Monocytes · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
Monocytes · Below
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
Monocytes · Within
|
9 Participants
|
40 Participants
|
7 Participants
|
40 Participants
|
7 Participants
|
39 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
Monocytes · Above
|
1 Participants
|
7 Participants
|
3 Participants
|
10 Participants
|
3 Participants
|
11 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
Eosinophils · Within
|
7 Participants
|
47 Participants
|
9 Participants
|
49 Participants
|
10 Participants
|
49 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
Eosinophils · Above
|
3 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
Basophils · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
Basophils · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
Basophils · Within
|
10 Participants
|
50 Participants
|
10 Participants
|
50 Participants
|
10 Participants
|
50 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
Sodium · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
Sodium · Above
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
Potassium · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
AST · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
AST · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
AST · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
ALT · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
Basophils · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
Potassium · Below
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
Potassium · Within
|
10 Participants
|
48 Participants
|
10 Participants
|
49 Participants
|
9 Participants
|
50 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
Haemoglobin · Within
|
10 Participants
|
46 Participants
|
9 Participants
|
49 Participants
|
10 Participants
|
49 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
WBC · Below
|
1 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
6 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
Neutrophils · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
Potassium · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
Lymphocytes · Below
|
1 Participants
|
6 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
Eosinophils · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
Urea Nitrogen · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
Urea Nitrogen · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
Urea Nitrogen · Within
|
10 Participants
|
49 Participants
|
10 Participants
|
50 Participants
|
10 Participants
|
50 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
Urea Nitrogen · Above
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
Creatinine · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
Creatinine · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
Creatinine · Within
|
10 Participants
|
49 Participants
|
9 Participants
|
48 Participants
|
10 Participants
|
49 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
Creatinine · Above
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
AST · Within
|
10 Participants
|
50 Participants
|
10 Participants
|
48 Participants
|
10 Participants
|
49 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
ALT · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
ALT · Below
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
ALT · Within
|
10 Participants
|
48 Participants
|
10 Participants
|
50 Participants
|
10 Participants
|
49 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
Platelets · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
Platelets · Below
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
Platelets · Within
|
9 Participants
|
50 Participants
|
10 Participants
|
48 Participants
|
9 Participants
|
49 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
Platelets · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
Sodium · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
Sodium · Within
|
10 Participants
|
49 Participants
|
10 Participants
|
50 Participants
|
10 Participants
|
50 Participants
|
PRIMARY outcome
Timeframe: At Month 1Population: The analysis was preformed on the Total Vaccinated cohort, which included vaccinated subjects with at least one vaccine administration documented for whom data were available and who had their symptom sheets filled in.
The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells \[RBC\] count, haemoglobin, haematocrit, white blood cell \[WBC\] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase \[ALT\] and aspartate aminotransferase \[AST\].
Outcome measures
| Measure |
SB732461 Non-adjuvanted_LD Group
n=10 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted low-antigen dose \[LD\] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 Non-adjuvanted_MD Group
n=50 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted medium-antigen dose \[MD\] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 Non-adjuvanted_HD Group
n=10 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted high-antigen dose \[HD\] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_LD Group
n=50 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted low-antigen dose \[LD\] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_MD Group
n=10 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted medium-antigen dose \[MD\] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_HD Group
n=50 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted high-antigen dose \[HD\] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
Hematocrit · Below
|
0 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
WBC · Below
|
0 Participants
|
1 Participants
|
0 Participants
|
7 Participants
|
0 Participants
|
4 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
WBC · Above
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
Neutrophils · Above
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
ALT · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
ALT · Below
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
Platelets · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
Sodium · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
Sodium · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
Sodium · Within
|
10 Participants
|
50 Participants
|
10 Participants
|
48 Participants
|
9 Participants
|
49 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
Sodium · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
Potassium · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
Potassium · Below
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
Potassium · Within
|
10 Participants
|
47 Participants
|
10 Participants
|
47 Participants
|
10 Participants
|
45 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
Potassium · Above
|
0 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
5 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
Urea Nitrogen · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
Urea Nitrogen · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
Urea Nitrogen · Within
|
10 Participants
|
49 Participants
|
9 Participants
|
50 Participants
|
10 Participants
|
49 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
Urea Nitrogen · Above
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
Creatinine · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
Creatinine · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
Creatinine · Within
|
10 Participants
|
48 Participants
|
10 Participants
|
48 Participants
|
10 Participants
|
50 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
Creatinine · Above
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
AST · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
AST · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
AST · Within
|
10 Participants
|
49 Participants
|
10 Participants
|
49 Participants
|
10 Participants
|
47 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
AST · Above
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
ALT · Within
|
10 Participants
|
49 Participants
|
10 Participants
|
48 Participants
|
10 Participants
|
47 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
ALT · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
RBC · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
RBC · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
RBC · Within
|
10 Participants
|
50 Participants
|
10 Participants
|
50 Participants
|
10 Participants
|
49 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
RBC · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
Haemoglobin · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
Haemoglobin · Below
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
Haemoglobin · Within
|
10 Participants
|
48 Participants
|
10 Participants
|
49 Participants
|
10 Participants
|
50 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
Haemoglobin · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
Hematocrit · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
Hematocrit · Within
|
10 Participants
|
46 Participants
|
10 Participants
|
49 Participants
|
10 Participants
|
50 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
Hematocrit · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
WBC · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
WBC · Within
|
10 Participants
|
48 Participants
|
10 Participants
|
42 Participants
|
10 Participants
|
45 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
Neutrophils · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
Eosinophils · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
Eosinophils · Within
|
9 Participants
|
44 Participants
|
9 Participants
|
44 Participants
|
10 Participants
|
47 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
Neutrophils · Below
|
0 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
0 Participants
|
4 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
Neutrophils · Within
|
10 Participants
|
46 Participants
|
9 Participants
|
44 Participants
|
10 Participants
|
43 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
Lymphocytes · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
Lymphocytes · Below
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
Lymphocytes · Within
|
10 Participants
|
47 Participants
|
9 Participants
|
47 Participants
|
10 Participants
|
43 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
Lymphocytes · Above
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
4 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
Monocytes · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
Monocytes · Below
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
Monocytes · Within
|
7 Participants
|
38 Participants
|
6 Participants
|
39 Participants
|
5 Participants
|
31 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
Monocytes · Above
|
3 Participants
|
11 Participants
|
4 Participants
|
11 Participants
|
5 Participants
|
19 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
Eosinophils · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
Eosinophils · Above
|
1 Participants
|
6 Participants
|
1 Participants
|
6 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
Basophils · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
Basophils · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
Basophils · Within
|
10 Participants
|
50 Participants
|
10 Participants
|
50 Participants
|
10 Participants
|
50 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
Basophils · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
Platelets · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
Platelets · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
Platelets · Within
|
10 Participants
|
50 Participants
|
10 Participants
|
50 Participants
|
9 Participants
|
48 Participants
|
PRIMARY outcome
Timeframe: At Day 44Population: The analysis was preformed on the Total Vaccinated cohort, which included vaccinated subjects with at least one vaccine administration documented for whom data were available and who had their symptom sheets filled in.
The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells \[RBC\] count, haemoglobin, haematocrit, white blood cell \[WBC\] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase \[ALT\] and aspartate aminotransferase \[AST\].
Outcome measures
| Measure |
SB732461 Non-adjuvanted_LD Group
n=10 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted low-antigen dose \[LD\] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 Non-adjuvanted_MD Group
n=50 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted medium-antigen dose \[MD\] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 Non-adjuvanted_HD Group
n=10 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted high-antigen dose \[HD\] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_LD Group
n=50 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted low-antigen dose \[LD\] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_MD Group
n=10 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted medium-antigen dose \[MD\] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_HD Group
n=50 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted high-antigen dose \[HD\] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
Hematocrit · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
Neutrophils · Below
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
RBC · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
RBC · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
RBC · Within
|
10 Participants
|
50 Participants
|
10 Participants
|
49 Participants
|
10 Participants
|
47 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
RBC · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
Haemoglobin · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
Haemoglobin · Below
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
Haemoglobin · Within
|
9 Participants
|
49 Participants
|
10 Participants
|
48 Participants
|
8 Participants
|
46 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
Haemoglobin · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
Hematocrit · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
Hematocrit · Below
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
Hematocrit · Within
|
9 Participants
|
48 Participants
|
10 Participants
|
48 Participants
|
8 Participants
|
44 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
WBC · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
WBC · Below
|
1 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
WBC · Within
|
9 Participants
|
48 Participants
|
9 Participants
|
46 Participants
|
10 Participants
|
47 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
WBC · Above
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
Neutrophils · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
Neutrophils · Within
|
10 Participants
|
47 Participants
|
9 Participants
|
47 Participants
|
8 Participants
|
46 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
Neutrophils · Above
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
Lymphocytes · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
Lymphocytes · Below
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
Lymphocytes · Within
|
10 Participants
|
46 Participants
|
9 Participants
|
47 Participants
|
8 Participants
|
45 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
Lymphocytes · Above
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
Monocytes · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
Monocytes · Below
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
Monocytes · Within
|
6 Participants
|
44 Participants
|
7 Participants
|
42 Participants
|
6 Participants
|
34 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
Monocytes · Above
|
3 Participants
|
6 Participants
|
3 Participants
|
8 Participants
|
4 Participants
|
12 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
Eosinophils · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
Eosinophils · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
Eosinophils · Within
|
8 Participants
|
46 Participants
|
9 Participants
|
46 Participants
|
10 Participants
|
47 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
Eosinophils · Above
|
2 Participants
|
4 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
Basophils · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
Basophils · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
Basophils · Within
|
10 Participants
|
50 Participants
|
10 Participants
|
50 Participants
|
10 Participants
|
48 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
Basophils · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
Platelets · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
Platelets · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
Platelets · Within
|
10 Participants
|
50 Participants
|
10 Participants
|
50 Participants
|
10 Participants
|
47 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
Platelets · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
Sodium · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
Sodium · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
Sodium · Within
|
9 Participants
|
50 Participants
|
10 Participants
|
50 Participants
|
10 Participants
|
48 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
Sodium · Above
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
Potassium · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
Potassium · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
Potassium · Within
|
10 Participants
|
48 Participants
|
10 Participants
|
49 Participants
|
10 Participants
|
46 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
Potassium · Above
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
Urea Nitrogen · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
Urea Nitrogen · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
Urea Nitrogen · Within
|
10 Participants
|
48 Participants
|
10 Participants
|
49 Participants
|
10 Participants
|
47 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
Urea Nitrogen · Above
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
Creatinine · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
Creatinine · Below
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
Creatinine · Within
|
9 Participants
|
47 Participants
|
10 Participants
|
50 Participants
|
9 Participants
|
43 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
Creatinine · Above
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
AST · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
AST · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
AST · Within
|
10 Participants
|
50 Participants
|
10 Participants
|
49 Participants
|
10 Participants
|
48 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
AST · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
ALT · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
ALT · Below
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
ALT · Within
|
10 Participants
|
48 Participants
|
10 Participants
|
49 Participants
|
10 Participants
|
47 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
ALT · Above
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Month 2Population: The analysis was preformed on the Total Vaccinated cohort, which included vaccinated subjects with at least one vaccine administration documented for whom data were available and who had their symptom sheets filled in.
The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells \[RBC\] count, haemoglobin, haematocrit, white blood cell \[RBC\] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase \[ALT\] and aspartate aminotransferase \[AST\].
Outcome measures
| Measure |
SB732461 Non-adjuvanted_LD Group
n=10 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted low-antigen dose \[LD\] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 Non-adjuvanted_MD Group
n=50 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted medium-antigen dose \[MD\] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 Non-adjuvanted_HD Group
n=10 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted high-antigen dose \[HD\] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_LD Group
n=50 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted low-antigen dose \[LD\] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_MD Group
n=10 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted medium-antigen dose \[MD\] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_HD Group
n=50 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted high-antigen dose \[HD\] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
Potassium · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
Creatinine · Below
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
RBC · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
RBC · Below
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
RBC · Within
|
10 Participants
|
50 Participants
|
9 Participants
|
48 Participants
|
10 Participants
|
49 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
RBC · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
Haemoglobin · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
Haemoglobin · Below
|
1 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
Haemoglobin · Within
|
9 Participants
|
47 Participants
|
9 Participants
|
47 Participants
|
9 Participants
|
48 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
Haemoglobin · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
Hematocrit · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
Hematocrit · Below
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
Hematocrit · Within
|
9 Participants
|
47 Participants
|
9 Participants
|
48 Participants
|
9 Participants
|
49 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
Hematocrit · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
WBC · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
WBC · Below
|
2 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
1 Participants
|
5 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
WBC · Within
|
8 Participants
|
48 Participants
|
10 Participants
|
43 Participants
|
9 Participants
|
43 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
WBC · Above
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
Neutrophils · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
Neutrophils · Below
|
1 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
5 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
Neutrophils · Within
|
9 Participants
|
45 Participants
|
9 Participants
|
45 Participants
|
10 Participants
|
42 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
Neutrophils · Above
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
Lymphocytes · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
Lymphocytes · Below
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
Lymphocytes · Within
|
10 Participants
|
48 Participants
|
9 Participants
|
43 Participants
|
10 Participants
|
42 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
Lymphocytes · Above
|
0 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
0 Participants
|
4 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
Monocytes · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
Monocytes · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
Monocytes · Within
|
6 Participants
|
43 Participants
|
5 Participants
|
37 Participants
|
9 Participants
|
33 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
Monocytes · Above
|
4 Participants
|
7 Participants
|
5 Participants
|
12 Participants
|
1 Participants
|
16 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
Eosinophils · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
Eosinophils · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
Eosinophils · Within
|
7 Participants
|
47 Participants
|
9 Participants
|
41 Participants
|
10 Participants
|
46 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
Eosinophils · Above
|
3 Participants
|
3 Participants
|
1 Participants
|
8 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
Basophils · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
Basophils · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
Basophils · Within
|
10 Participants
|
50 Participants
|
10 Participants
|
49 Participants
|
10 Participants
|
49 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
Basophils · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
Platelets · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
Platelets · Below
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
Platelets · Within
|
10 Participants
|
48 Participants
|
10 Participants
|
48 Participants
|
9 Participants
|
48 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
Platelets · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
Sodium · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
Sodium · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
Sodium · Within
|
10 Participants
|
50 Participants
|
9 Participants
|
48 Participants
|
9 Participants
|
49 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
Sodium · Above
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
Potassium · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
Potassium · Within
|
10 Participants
|
50 Participants
|
10 Participants
|
48 Participants
|
9 Participants
|
49 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
Potassium · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
Urea Nitrogen · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
Urea Nitrogen · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
Urea Nitrogen · Within
|
9 Participants
|
48 Participants
|
10 Participants
|
48 Participants
|
10 Participants
|
48 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
Urea Nitrogen · Above
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
Creatinine · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
Creatinine · Within
|
9 Participants
|
49 Participants
|
10 Participants
|
48 Participants
|
10 Participants
|
47 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
Creatinine · Above
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
AST · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
AST · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
AST · Within
|
10 Participants
|
50 Participants
|
10 Participants
|
48 Participants
|
10 Participants
|
49 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
AST · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
ALT · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
ALT · Below
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
ALT · Within
|
10 Participants
|
48 Participants
|
10 Participants
|
48 Participants
|
10 Participants
|
48 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
ALT · Above
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: At Month 6Population: The analysis was preformed on the Total Vaccinated cohort, which included vaccinated subjects with at least one vaccine administration documented for whom data were available and who had their symptom sheets filled in.
The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells \[RBC\] count, haemoglobin, haematocrit, white blood cell \[WBC\] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase \[ALT\] and aspartate aminotransferase \[AST\].
Outcome measures
| Measure |
SB732461 Non-adjuvanted_LD Group
n=10 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted low-antigen dose \[LD\] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 Non-adjuvanted_MD Group
n=50 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted medium-antigen dose \[MD\] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 Non-adjuvanted_HD Group
n=10 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted high-antigen dose \[HD\] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_LD Group
n=50 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted low-antigen dose \[LD\] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_MD Group
n=10 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted medium-antigen dose \[MD\] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_HD Group
n=50 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted high-antigen dose \[HD\] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
WBC · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
Eosinophils · Unknwon
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
WBC · Within
|
9 Participants
|
47 Participants
|
9 Participants
|
42 Participants
|
8 Participants
|
42 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
Urea Nitrogen · Above
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
Haemoglobin · Unknwon
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
Haemoglobin · Below
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
Lymphocytes · Below
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
Haemoglobin · Within
|
10 Participants
|
48 Participants
|
9 Participants
|
47 Participants
|
8 Participants
|
47 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
Haemoglobin · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
Monocytes · Unknwon
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
Monocytes · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
Monocytes · Within
|
8 Participants
|
41 Participants
|
7 Participants
|
34 Participants
|
6 Participants
|
30 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
Monocytes · Above
|
2 Participants
|
8 Participants
|
2 Participants
|
15 Participants
|
2 Participants
|
18 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
Sodium · Unknwon
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
Sodium · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
Sodium · Within
|
10 Participants
|
49 Participants
|
9 Participants
|
48 Participants
|
8 Participants
|
49 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
Sodium · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
Potassium · Unknwon
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
Potassium · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
Lymphocytes · Unknwon
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
Potassium · Within
|
10 Participants
|
49 Participants
|
9 Participants
|
49 Participants
|
7 Participants
|
47 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
Potassium · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
RBC · Unknwon
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
Neutrophils · Unknwon
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
RBC · Below
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
RBC · Within
|
10 Participants
|
48 Participants
|
9 Participants
|
49 Participants
|
8 Participants
|
47 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
RBC · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
Lymphocytes · Within
|
10 Participants
|
48 Participants
|
8 Participants
|
44 Participants
|
8 Participants
|
44 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
Lymphocytes · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
4 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
Platelets · Unknwon
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
Platelets · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
Platelets · Within
|
10 Participants
|
49 Participants
|
9 Participants
|
48 Participants
|
8 Participants
|
45 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
Platelets · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
Urea Nitrogen · Unknwon
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
Urea Nitrogen · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
Urea Nitrogen · Within
|
10 Participants
|
48 Participants
|
9 Participants
|
49 Participants
|
8 Participants
|
49 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
Hematocrit · Unknwon
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
Hematocrit · Below
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
Hematocrit · Within
|
9 Participants
|
48 Participants
|
8 Participants
|
47 Participants
|
8 Participants
|
46 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
Hematocrit · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
Creatinine · Unknwon
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
Creatinine · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
Creatinine · Within
|
10 Participants
|
49 Participants
|
8 Participants
|
48 Participants
|
8 Participants
|
46 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
Creatinine · Above
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
AST · Unknwon
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
AST · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
AST · Within
|
10 Participants
|
48 Participants
|
9 Participants
|
49 Participants
|
8 Participants
|
49 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
AST · Above
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
ALT · Unknwon
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
ALT · Below
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
ALT · Within
|
10 Participants
|
46 Participants
|
9 Participants
|
49 Participants
|
7 Participants
|
48 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
ALT · Above
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
Basophils · Unknwon
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
Neutrophils · Below
|
0 Participants
|
1 Participants
|
0 Participants
|
6 Participants
|
0 Participants
|
4 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
Neutrophils · Within
|
10 Participants
|
48 Participants
|
8 Participants
|
43 Participants
|
8 Participants
|
44 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
Neutrophils · Above
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
Basophils · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
Basophils · Within
|
10 Participants
|
49 Participants
|
9 Participants
|
49 Participants
|
8 Participants
|
48 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
Basophils · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
Eosinophils · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
Eosinophils · Within
|
9 Participants
|
46 Participants
|
8 Participants
|
42 Participants
|
8 Participants
|
48 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
Eosinophils · Above
|
1 Participants
|
3 Participants
|
1 Participants
|
7 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
WBC · Unknwon
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
WBC · Below
|
1 Participants
|
2 Participants
|
0 Participants
|
7 Participants
|
0 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: At Month 9Population: The analysis was preformed on the Total Vaccinated cohort, which included vaccinated subjects with at least one vaccine administration documented for whom data were available and who had their symptom sheets filled in.
The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells \[RBC\] count, haemoglobin, haematocrit, white blood cell \[WBC\] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase \[ALT\] and aspartate aminotransferase \[AST\].
Outcome measures
| Measure |
SB732461 Non-adjuvanted_LD Group
n=10 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted low-antigen dose \[LD\] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 Non-adjuvanted_MD Group
n=50 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted medium-antigen dose \[MD\] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 Non-adjuvanted_HD Group
n=10 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted high-antigen dose \[HD\] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_LD Group
n=50 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted low-antigen dose \[LD\] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_MD Group
n=10 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted medium-antigen dose \[MD\] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_HD Group
n=50 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted high-antigen dose \[HD\] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
Monocytes · Unknown
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
Monocytes · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
Monocytes · Within
|
8 Participants
|
32 Participants
|
8 Participants
|
38 Participants
|
6 Participants
|
35 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
Monocytes · Above
|
2 Participants
|
17 Participants
|
2 Participants
|
11 Participants
|
3 Participants
|
13 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
Sodium · Unknown
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
Sodium · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
Sodium · Within
|
10 Participants
|
49 Participants
|
10 Participants
|
50 Participants
|
9 Participants
|
46 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
Sodium · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
Potassium · Above
|
1 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
RBC · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
RBC · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
Lymphocytes · Unknown
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
Urea Nitrogen · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
Urea Nitrogen · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
Hematocrit · Below
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
Hematocrit · Within
|
10 Participants
|
46 Participants
|
10 Participants
|
50 Participants
|
9 Participants
|
45 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
Hematocrit · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
Creatinine · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
Creatinine · Above
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
ALT · Within
|
10 Participants
|
48 Participants
|
10 Participants
|
49 Participants
|
9 Participants
|
45 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
AST · Above
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
ALT · Unknown
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
ALT · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
ALT · Above
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
Neutrophils · Below
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
Potassium · Within
|
9 Participants
|
46 Participants
|
10 Participants
|
48 Participants
|
9 Participants
|
48 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
Haemoglobin · Unknown
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
Haemoglobin · Below
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
Haemoglobin · Within
|
10 Participants
|
47 Participants
|
10 Participants
|
50 Participants
|
9 Participants
|
45 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
Haemoglobin · Above
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
Potassium · Unknown
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
Potassium · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
RBC · Unknown
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
Lymphocytes · Below
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
Lymphocytes · Within
|
9 Participants
|
46 Participants
|
9 Participants
|
47 Participants
|
9 Participants
|
44 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
Lymphocytes · Above
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
RBC · Within
|
10 Participants
|
49 Participants
|
10 Participants
|
50 Participants
|
9 Participants
|
46 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
Platelets · Below
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
Platelets · Within
|
9 Participants
|
48 Participants
|
10 Participants
|
50 Participants
|
9 Participants
|
48 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
Platelets · Above
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
Urea Nitrogen · Unknown
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
Urea Nitrogen · Within
|
10 Participants
|
49 Participants
|
10 Participants
|
49 Participants
|
8 Participants
|
47 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
Platelets · Unknown
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
Hematocrit · Unknown
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
Creatinine · Unknown
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
Creatinine · Within
|
10 Participants
|
48 Participants
|
10 Participants
|
50 Participants
|
9 Participants
|
45 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
AST · Within
|
10 Participants
|
48 Participants
|
10 Participants
|
50 Participants
|
9 Participants
|
46 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
AST · Unknown
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
AST · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
Neutrophils · Unknown
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
Neutrophils · Within
|
8 Participants
|
46 Participants
|
10 Participants
|
46 Participants
|
9 Participants
|
47 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
Neutrophils · Above
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
Basophils · Unknown
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
Basophils · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
Basophils · Within
|
10 Participants
|
49 Participants
|
10 Participants
|
50 Participants
|
9 Participants
|
48 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
Basophils · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
Eosinophils · Unknown
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
Eosinophils · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
Eosinophils · Within
|
8 Participants
|
45 Participants
|
10 Participants
|
46 Participants
|
9 Participants
|
48 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
Eosinophils · Above
|
2 Participants
|
4 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
WBC · Unknown
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
WBC · Below
|
0 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
WBC · Within
|
10 Participants
|
46 Participants
|
9 Participants
|
47 Participants
|
9 Participants
|
43 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
WBC · Above
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: At Month 12Population: The analysis was preformed on the Total Vaccinated cohort, which included vaccinated subjects with at least one vaccination administration documented for whom data were available and who had their symptom sheets filled in.
The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells \[RBC\] count, haemoglobin, haematocrit, white blood cell \[WBC\] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase \[ALT\] and aspartate aminotransferase \[AST\].
Outcome measures
| Measure |
SB732461 Non-adjuvanted_LD Group
n=10 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted low-antigen dose \[LD\] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 Non-adjuvanted_MD Group
n=50 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted medium-antigen dose \[MD\] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 Non-adjuvanted_HD Group
n=10 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted high-antigen dose \[HD\] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_LD Group
n=50 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted low-antigen dose \[LD\] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_MD Group
n=10 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted medium-antigen dose \[MD\] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_HD Group
n=50 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted high-antigen dose \[HD\] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
WBC · Unknown
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
AST · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
AST · Whitin
|
10 Participants
|
49 Participants
|
8 Participants
|
48 Participants
|
9 Participants
|
48 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
AST · Above
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
ALT · Unknown
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
ALT · Below
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
ALT · Whitin
|
10 Participants
|
47 Participants
|
8 Participants
|
47 Participants
|
9 Participants
|
47 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
ALT · Above
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
Neutrophils · Unknown
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
Neutrophils · Below
|
1 Participants
|
5 Participants
|
1 Participants
|
7 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
Neutrophils · Whitin
|
9 Participants
|
41 Participants
|
8 Participants
|
42 Participants
|
10 Participants
|
46 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
Neutrophils · Above
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
Basophils · Unknown
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
Basophils · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
Basophils · Whitin
|
10 Participants
|
49 Participants
|
9 Participants
|
49 Participants
|
10 Participants
|
49 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
Basophils · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
Eosinophils · Unknown
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
Eosinophils · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
Eosinophils · Whitin
|
8 Participants
|
46 Participants
|
8 Participants
|
46 Participants
|
10 Participants
|
47 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
Eosinophils · Above
|
2 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
WBC · Below
|
2 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
6 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
WBC · Whitin
|
8 Participants
|
45 Participants
|
9 Participants
|
46 Participants
|
10 Participants
|
43 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
WBC · Above
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
Monocytes · Above
|
2 Participants
|
4 Participants
|
3 Participants
|
10 Participants
|
2 Participants
|
8 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
Sodium · Unknown
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
Haemoglobin · Unknown
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
Haemoglobin · Below
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
Urea Nitrogen · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
Haemoglobin · Whitin
|
10 Participants
|
47 Participants
|
8 Participants
|
47 Participants
|
10 Participants
|
49 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
Haemoglobin · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
Monocytes · Unknown
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
Monocytes · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
Monocytes · Whitin
|
8 Participants
|
45 Participants
|
6 Participants
|
38 Participants
|
8 Participants
|
41 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
Sodium · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
Sodium · Whitin
|
10 Participants
|
45 Participants
|
9 Participants
|
44 Participants
|
10 Participants
|
49 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
Sodium · Above
|
0 Participants
|
4 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
Potassium · Unknown
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
Potassium · Below
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
Potassium · Whitin
|
9 Participants
|
48 Participants
|
9 Participants
|
48 Participants
|
9 Participants
|
49 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
Potassium · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
RBC · Unknown
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
RBC · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
RBC · Whitin
|
10 Participants
|
49 Participants
|
9 Participants
|
48 Participants
|
10 Participants
|
47 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
RBC · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
Lymphocytes · Unknown
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
Lymphocytes · Below
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
Lymphocytes · Whitin
|
10 Participants
|
43 Participants
|
7 Participants
|
43 Participants
|
10 Participants
|
45 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
Lymphocytes · Above
|
0 Participants
|
3 Participants
|
1 Participants
|
6 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
Platelets · Unknown
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
Platelets · Below
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
Platelets · Whitin
|
9 Participants
|
49 Participants
|
9 Participants
|
49 Participants
|
10 Participants
|
49 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
Platelets · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
Urea Nitrogen · Unknown
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
Urea Nitrogen · Whitin
|
10 Participants
|
46 Participants
|
7 Participants
|
49 Participants
|
10 Participants
|
48 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
Urea Nitrogen · Above
|
0 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
Hematocrit · Unknown
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
Hematocrit · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
Hematocrit · Whitin
|
10 Participants
|
49 Participants
|
9 Participants
|
49 Participants
|
10 Participants
|
48 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
Hematocrit · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
Creatinine · Unknown
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
Creatinine · Below
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
Creatinine · Whitin
|
9 Participants
|
46 Participants
|
9 Participants
|
48 Participants
|
10 Participants
|
49 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
Creatinine · Above
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
AST · Unknown
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: At Day 44Population: Analysis was performed on the According-to-Protocol cohort for Immunogenicity that included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with procedures and intervals defined in protocol, with no elimination criteria during study) for whom data concerning immunogenicity outcome measures were available.
Antigen-specific CD4+ T-cells can express cluster of differentiation 40-ligand (CD40-L) and produce the cytokines Interleukin 2 (IL-2) and/or Tumor Necrosis Factor alpha (TNF-α) and/or Interferon-gamma (IFN-γ). The frequency of antigen specific CD4+T-cells was calculated as the difference between the frequency of CD4+T-cells producing at least 2 cytokines (among IFN-g, IL-2, TNF-a and/or CD40L), upon in vitro stimulation with the peptide pools derived from the antigen minus the frequency of CD4+T-cells producing at least 2 cytokines upon in vitro stimulation in medium only.A responder was a subject with an antigen-stimulated CD4+T cells response greater than or equal to the cut-off value. The same cut-off value was used for all subjects and all antigen responses post-vaccination. It was calculated from the pre-vaccination CD4+T cell responses (the frequency of antigen-stimulated CD4+T cells expressing at least two markers; i.e. all doubles) for all subjects.
Outcome measures
| Measure |
SB732461 Non-adjuvanted_LD Group
n=8 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted low-antigen dose \[LD\] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 Non-adjuvanted_MD Group
n=9 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted medium-antigen dose \[MD\] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 Non-adjuvanted_HD Group
n=9 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted high-antigen dose \[HD\] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_LD Group
n=46 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted low-antigen dose \[LD\] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_MD Group
n=40 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted medium-antigen dose \[MD\] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_HD Group
n=35 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted high-antigen dose \[HD\] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With a Response in Terms of Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least Two Cytokines Including IL-2 Equal or Above the Cut-off to at Least 1, 2, 3 Antigens and to All 4 Antigens
At least 1 antigen
|
1 Participants
|
2 Participants
|
2 Participants
|
46 Participants
|
40 Participants
|
35 Participants
|
|
Number of Subjects With a Response in Terms of Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least Two Cytokines Including IL-2 Equal or Above the Cut-off to at Least 1, 2, 3 Antigens and to All 4 Antigens
At least 2 antigens
|
0 Participants
|
1 Participants
|
2 Participants
|
46 Participants
|
38 Participants
|
34 Participants
|
|
Number of Subjects With a Response in Terms of Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least Two Cytokines Including IL-2 Equal or Above the Cut-off to at Least 1, 2, 3 Antigens and to All 4 Antigens
At least 3 antigens
|
0 Participants
|
1 Participants
|
0 Participants
|
46 Participants
|
34 Participants
|
31 Participants
|
|
Number of Subjects With a Response in Terms of Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least Two Cytokines Including IL-2 Equal or Above the Cut-off to at Least 1, 2, 3 Antigens and to All 4 Antigens
All 4 antigens
|
0 Participants
|
0 Participants
|
0 Participants
|
37 Participants
|
22 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: At Month 0, Day 44, Month 2, Month 6 and Month 12Population: Analysis was performed on the According-to-Protocol cohort for Immunogenicity that included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with procedures and intervals defined in protocol, with no elimination criteria during study) for whom data concerning immunogenicity outcome measures were available.
Antigen-specific CD4+ T-cells can express CD40 ligand (CD40-L) and produce the cytokines Interleukin 2 (IL-2) and/or Tumor Necrosis Factor alpha (TNF-α) and/or Interferon-gamma (IFN-γ). Frequency of CD4+ T-cells expressing markers in response to the F4co fusion protein (all antigens) was estimated by adding individual frequencies of CD4+ T-cells to each of the 4 antigens (p17, p24, Nef, RT). Results are presented as determined by Intracellular Cytokine Staining (ICS).
Outcome measures
| Measure |
SB732461 Non-adjuvanted_LD Group
n=9 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted low-antigen dose \[LD\] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 Non-adjuvanted_MD Group
n=9 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted medium-antigen dose \[MD\] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 Non-adjuvanted_HD Group
n=9 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted high-antigen dose \[HD\] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_LD Group
n=46 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted low-antigen dose \[LD\] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_MD Group
n=40 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted medium-antigen dose \[MD\] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_HD Group
n=35 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted high-antigen dose \[HD\] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
|---|---|---|---|---|---|---|
|
Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing IL-2 and at Least Another Marker
RT, Month 6
|
46.67 CD4+ T-cells/million T-cells
Standard Deviation 61.07
|
140.75 CD4+ T-cells/million T-cells
Standard Deviation 210.46
|
103.88 CD4+ T-cells/million T-cells
Standard Deviation 165.37
|
3157.02 CD4+ T-cells/million T-cells
Standard Deviation 2345.20
|
1539.85 CD4+ T-cells/million T-cells
Standard Deviation 1100.27
|
1198.74 CD4+ T-cells/million T-cells
Standard Deviation 748.47
|
|
Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing IL-2 and at Least Another Marker
p17, Day 0
|
32.56 CD4+ T-cells/million T-cells
Standard Deviation 46.31
|
16.78 CD4+ T-cells/million T-cells
Standard Deviation 16.08
|
7.89 CD4+ T-cells/million T-cells
Standard Deviation 10.86
|
17.95 CD4+ T-cells/million T-cells
Standard Deviation 25.64
|
21.90 CD4+ T-cells/million T-cells
Standard Deviation 44.84
|
30.60 CD4+ T-cells/million T-cells
Standard Deviation 49.28
|
|
Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing IL-2 and at Least Another Marker
p17, Day 44
|
58.25 CD4+ T-cells/million T-cells
Standard Deviation 67.23
|
102.00 CD4+ T-cells/million T-cells
Standard Deviation 171.17
|
57.22 CD4+ T-cells/million T-cells
Standard Deviation 76.97
|
1724.07 CD4+ T-cells/million T-cells
Standard Deviation 1335.80
|
696.78 CD4+ T-cells/million T-cells
Standard Deviation 592.73
|
740.91 CD4+ T-cells/million T-cells
Standard Deviation 637.48
|
|
Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing IL-2 and at Least Another Marker
p17, Month 2
|
17.33 CD4+ T-cells/million T-cells
Standard Deviation 28.18
|
60.11 CD4+ T-cells/million T-cells
Standard Deviation 79.90
|
30.22 CD4+ T-cells/million T-cells
Standard Deviation 40.38
|
1238.82 CD4+ T-cells/million T-cells
Standard Deviation 968.59
|
517.38 CD4+ T-cells/million T-cells
Standard Deviation 440.05
|
625.88 CD4+ T-cells/million T-cells
Standard Deviation 525.66
|
|
Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing IL-2 and at Least Another Marker
p17, Month 6
|
22.22 CD4+ T-cells/million T-cells
Standard Deviation 28.83
|
80.50 CD4+ T-cells/million T-cells
Standard Deviation 119.81
|
61.63 CD4+ T-cells/million T-cells
Standard Deviation 74.83
|
762.59 CD4+ T-cells/million T-cells
Standard Deviation 608.13
|
376.80 CD4+ T-cells/million T-cells
Standard Deviation 291.36
|
360.32 CD4+ T-cells/million T-cells
Standard Deviation 324.15
|
|
Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing IL-2 and at Least Another Marker
p17, Month 12
|
28.50 CD4+ T-cells/million T-cells
Standard Deviation 42.64
|
70.13 CD4+ T-cells/million T-cells
Standard Deviation 140.50
|
25.00 CD4+ T-cells/million T-cells
Standard Deviation 28.14
|
766.55 CD4+ T-cells/million T-cells
Standard Deviation 620.56
|
345.55 CD4+ T-cells/million T-cells
Standard Deviation 320.76
|
462.29 CD4+ T-cells/million T-cells
Standard Deviation 439.06
|
|
Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing IL-2 and at Least Another Marker
p24, Day 0
|
51.67 CD4+ T-cells/million T-cells
Standard Deviation 55.49
|
27.56 CD4+ T-cells/million T-cells
Standard Deviation 48.52
|
29.11 CD4+ T-cells/million T-cells
Standard Deviation 43.11
|
30.60 CD4+ T-cells/million T-cells
Standard Deviation 41.68
|
54.95 CD4+ T-cells/million T-cells
Standard Deviation 68.53
|
52.14 CD4+ T-cells/million T-cells
Standard Deviation 80.65
|
|
Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing IL-2 and at Least Another Marker
p24, Day 44
|
47.25 CD4+ T-cells/million T-cells
Standard Deviation 38.39
|
205.22 CD4+ T-cells/million T-cells
Standard Deviation 375.13
|
119.22 CD4+ T-cells/million T-cells
Standard Deviation 160.14
|
3078.59 CD4+ T-cells/million T-cells
Standard Deviation 1694.26
|
1441.93 CD4+ T-cells/million T-cells
Standard Deviation 1286.57
|
1446.17 CD4+ T-cells/million T-cells
Standard Deviation 990.24
|
|
Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing IL-2 and at Least Another Marker
p24, Month 2
|
31.56 CD4+ T-cells/million T-cells
Standard Deviation 58.84
|
142.67 CD4+ T-cells/million T-cells
Standard Deviation 138.05
|
87.22 CD4+ T-cells/million T-cells
Standard Deviation 83.82
|
2228.00 CD4+ T-cells/million T-cells
Standard Deviation 1255.40
|
1171.50 CD4+ T-cells/million T-cells
Standard Deviation 1220.16
|
1120.58 CD4+ T-cells/million T-cells
Standard Deviation 654.53
|
|
Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing IL-2 and at Least Another Marker
p24, Month 6
|
53.78 CD4+ T-cells/million T-cells
Standard Deviation 85.56
|
83.75 CD4+ T-cells/million T-cells
Standard Deviation 122.43
|
143.63 CD4+ T-cells/million T-cells
Standard Deviation 130.22
|
1320.63 CD4+ T-cells/million T-cells
Standard Deviation 1002.27
|
775.63 CD4+ T-cells/million T-cells
Standard Deviation 588.91
|
562.26 CD4+ T-cells/million T-cells
Standard Deviation 402.53
|
|
Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing IL-2 and at Least Another Marker
p24, Month 12
|
34.25 CD4+ T-cells/million T-cells
Standard Deviation 38.37
|
74.00 CD4+ T-cells/million T-cells
Standard Deviation 77.45
|
101.78 CD4+ T-cells/million T-cells
Standard Deviation 108.18
|
1282.00 CD4+ T-cells/million T-cells
Standard Deviation 819.01
|
766.55 CD4+ T-cells/million T-cells
Standard Deviation 549.94
|
718.17 CD4+ T-cells/million T-cells
Standard Deviation 533.47
|
|
Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing IL-2 and at Least Another Marker
Nef, Day 0
|
25.78 CD4+ T-cells/million T-cells
Standard Deviation 45.94
|
22.00 CD4+ T-cells/million T-cells
Standard Deviation 40.81
|
78.11 CD4+ T-cells/million T-cells
Standard Deviation 98.18
|
40.02 CD4+ T-cells/million T-cells
Standard Deviation 49.98
|
39.53 CD4+ T-cells/million T-cells
Standard Deviation 59.12
|
58.97 CD4+ T-cells/million T-cells
Standard Deviation 101.11
|
|
Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing IL-2 and at Least Another Marker
Nef, Day 44
|
52.63 CD4+ T-cells/million T-cells
Standard Deviation 65.28
|
89.00 CD4+ T-cells/million T-cells
Standard Deviation 81.17
|
108.22 CD4+ T-cells/million T-cells
Standard Deviation 97.17
|
1822.50 CD4+ T-cells/million T-cells
Standard Deviation 1553.80
|
872.83 CD4+ T-cells/million T-cells
Standard Deviation 706.00
|
862.20 CD4+ T-cells/million T-cells
Standard Deviation 721.64
|
|
Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing IL-2 and at Least Another Marker
Nef, Month 2
|
30.56 CD4+ T-cells/million T-cells
Standard Deviation 55.59
|
75.67 CD4+ T-cells/million T-cells
Standard Deviation 104.05
|
73.00 CD4+ T-cells/million T-cells
Standard Deviation 93.10
|
1307.89 CD4+ T-cells/million T-cells
Standard Deviation 1080.10
|
678.78 CD4+ T-cells/million T-cells
Standard Deviation 503.13
|
713.33 CD4+ T-cells/million T-cells
Standard Deviation 490.14
|
|
Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing IL-2 and at Least Another Marker
Nef, Month 6
|
46.67 CD4+ T-cells/million T-cells
Standard Deviation 70.30
|
36.25 CD4+ T-cells/million T-cells
Standard Deviation 56.89
|
38.75 CD4+ T-cells/million T-cells
Standard Deviation 40.15
|
855.13 CD4+ T-cells/million T-cells
Standard Deviation 901.48
|
532.80 CD4+ T-cells/million T-cells
Standard Deviation 508.78
|
374.32 CD4+ T-cells/million T-cells
Standard Deviation 302.71
|
|
Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing IL-2 and at Least Another Marker
Nef, Month 12
|
23.00 CD4+ T-cells/million T-cells
Standard Deviation 36.26
|
20.75 CD4+ T-cells/million T-cells
Standard Deviation 47.65
|
42.56 CD4+ T-cells/million T-cells
Standard Deviation 66.95
|
722.80 CD4+ T-cells/million T-cells
Standard Deviation 780.58
|
404.98 CD4+ T-cells/million T-cells
Standard Deviation 364.64
|
426.34 CD4+ T-cells/million T-cells
Standard Deviation 447.54
|
|
Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing IL-2 and at Least Another Marker
RT, Day 0
|
77.44 CD4+ T-cells/million T-cells
Standard Deviation 83.84
|
31.67 CD4+ T-cells/million T-cells
Standard Deviation 44.13
|
21.33 CD4+ T-cells/million T-cells
Standard Deviation 27.16
|
52.53 CD4+ T-cells/million T-cells
Standard Deviation 109.33
|
52.85 CD4+ T-cells/million T-cells
Standard Deviation 96.57
|
63.80 CD4+ T-cells/million T-cells
Standard Deviation 74.44
|
|
Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing IL-2 and at Least Another Marker
RT, Day 44
|
107.75 CD4+ T-cells/million T-cells
Standard Deviation 115.20
|
250.00 CD4+ T-cells/million T-cells
Standard Deviation 351.18
|
262.00 CD4+ T-cells/million T-cells
Standard Deviation 327.68
|
6760.11 CD4+ T-cells/million T-cells
Standard Deviation 3832.30
|
2787.43 CD4+ T-cells/million T-cells
Standard Deviation 1785.69
|
2518.71 CD4+ T-cells/million T-cells
Standard Deviation 1389.15
|
|
Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing IL-2 and at Least Another Marker
RT, Month 2
|
109.22 CD4+ T-cells/million T-cells
Standard Deviation 67.04
|
242.22 CD4+ T-cells/million T-cells
Standard Deviation 349.31
|
209.89 CD4+ T-cells/million T-cells
Standard Deviation 363.37
|
4731.64 CD4+ T-cells/million T-cells
Standard Deviation 2761.73
|
2304.75 CD4+ T-cells/million T-cells
Standard Deviation 1798.00
|
2107.61 CD4+ T-cells/million T-cells
Standard Deviation 1107.18
|
|
Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing IL-2 and at Least Another Marker
RT, Month 12
|
54.50 CD4+ T-cells/million T-cells
Standard Deviation 59.96
|
99.38 CD4+ T-cells/million T-cells
Standard Deviation 106.52
|
132.33 CD4+ T-cells/million T-cells
Standard Deviation 216.98
|
2965.34 CD4+ T-cells/million T-cells
Standard Deviation 2148.86
|
1433.63 CD4+ T-cells/million T-cells
Standard Deviation 1020.80
|
1347.26 CD4+ T-cells/million T-cells
Standard Deviation 988.06
|
SECONDARY outcome
Timeframe: At Month 0, Day 44, Month 2, Month 6 and Month 12Population: Analysis was performed on the According-to-Protocol cohort for Immunogenicity that included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with procedures and intervals defined in protocol, with no elimination criteria during study) for whom data concerning immunogenicity outcome measures were available.
Antigen-specific CD4+ T-cells can express CD40 ligand (CD40-L) and produce the cytokines Interleukin 2 (IL-2) and/or Tumor Necrosis Factor alpha (TNF-α) and/or Interferon-gamma (IFN-γ). Frequency of CD4+ T-cells expressing markers in response to the F4co fusion protein (all antigens) was estimated by adding individual frequencies of CD4+ T-cells to each of the 4 antigens (p17, p24, Nef, RT). Results are presented as determined by Intracellular Cytokine Staining (ICS).
Outcome measures
| Measure |
SB732461 Non-adjuvanted_LD Group
n=9 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted low-antigen dose \[LD\] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 Non-adjuvanted_MD Group
n=9 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted medium-antigen dose \[MD\] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 Non-adjuvanted_HD Group
n=9 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted high-antigen dose \[HD\] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_LD Group
n=46 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted low-antigen dose \[LD\] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_MD Group
n=40 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted medium-antigen dose \[MD\] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_HD Group
n=35 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted high-antigen dose \[HD\] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
|---|---|---|---|---|---|---|
|
Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing at Least 2 Immune Markers
p17, Day 44
|
59.75 CD4+ T-cells/million T-cells
Standard Deviation 76.90
|
104.22 CD4+ T-cells/million T-cells
Standard Deviation 146.67
|
69.67 CD4+ T-cells/million T-cells
Standard Deviation 84.30
|
1937.11 CD4+ T-cells/million T-cells
Standard Deviation 1457.55
|
777.68 CD4+ T-cells/million T-cells
Standard Deviation 662.55
|
850.86 CD4+ T-cells/million T-cells
Standard Deviation 724.32
|
|
Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing at Least 2 Immune Markers
p17, Day 0
|
21.89 CD4+ T-cells/million T-cells
Standard Deviation 30.92
|
5.56 CD4+ T-cells/million T-cells
Standard Deviation 10.45
|
30.44 CD4+ T-cells/million T-cells
Standard Deviation 63.90
|
23.58 CD4+ T-cells/million T-cells
Standard Deviation 34.72
|
32.75 CD4+ T-cells/million T-cells
Standard Deviation 62.91
|
39.80 CD4+ T-cells/million T-cells
Standard Deviation 65.83
|
|
Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing at Least 2 Immune Markers
p17, Month 2
|
15.11 CD4+ T-cells/million T-cells
Standard Deviation 24.79
|
65.56 CD4+ T-cells/million T-cells
Standard Deviation 84.74
|
23.00 CD4+ T-cells/million T-cells
Standard Deviation 30.72
|
1308.50 CD4+ T-cells/million T-cells
Standard Deviation 1000.94
|
562.63 CD4+ T-cells/million T-cells
Standard Deviation 473.95
|
682.70 CD4+ T-cells/million T-cells
Standard Deviation 553.88
|
|
Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing at Least 2 Immune Markers
p17, Month 6
|
57.78 CD4+ T-cells/million T-cells
Standard Deviation 72.39
|
101.38 CD4+ T-cells/million T-cells
Standard Deviation 132.38
|
94.13 CD4+ T-cells/million T-cells
Standard Deviation 112.30
|
791.54 CD4+ T-cells/million T-cells
Standard Deviation 636.43
|
411.95 CD4+ T-cells/million T-cells
Standard Deviation 290.81
|
398.62 CD4+ T-cells/million T-cells
Standard Deviation 348.32
|
|
Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing at Least 2 Immune Markers
p17, Month 12
|
32.13 CD4+ T-cells/million T-cells
Standard Deviation 45.05
|
101.25 CD4+ T-cells/million T-cells
Standard Deviation 197.89
|
31.00 CD4+ T-cells/million T-cells
Standard Deviation 36.44
|
784.57 CD4+ T-cells/million T-cells
Standard Deviation 613.62
|
374.65 CD4+ T-cells/million T-cells
Standard Deviation 319.92
|
501.60 CD4+ T-cells/million T-cells
Standard Deviation 451.23
|
|
Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing at Least 2 Immune Markers
p24, Day 0
|
46.67 CD4+ T-cells/million T-cells
Standard Deviation 51.44
|
46.56 CD4+ T-cells/million T-cells
Standard Deviation 78.36
|
93.56 CD4+ T-cells/million T-cells
Standard Deviation 155.14
|
60.05 CD4+ T-cells/million T-cells
Standard Deviation 67.01
|
77.98 CD4+ T-cells/million T-cells
Standard Deviation 87.63
|
68.31 CD4+ T-cells/million T-cells
Standard Deviation 100.00
|
|
Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing at Least 2 Immune Markers
p24, Day 44
|
80.13 CD4+ T-cells/million T-cells
Standard Deviation 47.22
|
243.00 CD4+ T-cells/million T-cells
Standard Deviation 441.48
|
161.56 CD4+ T-cells/million T-cells
Standard Deviation 161.44
|
3536.04 CD4+ T-cells/million T-cells
Standard Deviation 1850.10
|
1662.85 CD4+ T-cells/million T-cells
Standard Deviation 1462.02
|
1661.03 CD4+ T-cells/million T-cells
Standard Deviation 1108.49
|
|
Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing at Least 2 Immune Markers
p24, Month 2
|
49.11 CD4+ T-cells/million T-cells
Standard Deviation 83.84
|
145.56 CD4+ T-cells/million T-cells
Standard Deviation 179.74
|
121.89 CD4+ T-cells/million T-cells
Standard Deviation 152.43
|
2429.89 CD4+ T-cells/million T-cells
Standard Deviation 1309.28
|
1306.25 CD4+ T-cells/million T-cells
Standard Deviation 1320.29
|
1253.06 CD4+ T-cells/million T-cells
Standard Deviation 685.13
|
|
Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing at Least 2 Immune Markers
p24, Month 6
|
53.78 CD4+ T-cells/million T-cells
Standard Deviation 53.78
|
83.75 CD4+ T-cells/million T-cells
Standard Deviation 122.43
|
143.63 CD4+ T-cells/million T-cells
Standard Deviation 130.22
|
1320.63 CD4+ T-cells/million T-cells
Standard Deviation 1002.27
|
775.63 CD4+ T-cells/million T-cells
Standard Deviation 588.91
|
562.26 CD4+ T-cells/million T-cells
Standard Deviation 402.53
|
|
Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing at Least 2 Immune Markers
p24, Month 12
|
34.25 CD4+ T-cells/million T-cells
Standard Deviation 38.37
|
74.00 CD4+ T-cells/million T-cells
Standard Deviation 77.45
|
101.78 CD4+ T-cells/million T-cells
Standard Deviation 108.18
|
1282.00 CD4+ T-cells/million T-cells
Standard Deviation 819.01
|
766.55 CD4+ T-cells/million T-cells
Standard Deviation 549.94
|
718.17 CD4+ T-cells/million T-cells
Standard Deviation 533.47
|
|
Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing at Least 2 Immune Markers
Nef, Day 0
|
18.67 CD4+ T-cells/million T-cells
Standard Deviation 36.54
|
30.00 CD4+ T-cells/million T-cells
Standard Deviation 57.59
|
157.56 CD4+ T-cells/million T-cells
Standard Deviation 206.05
|
52.74 CD4+ T-cells/million T-cells
Standard Deviation 64.54
|
60.70 CD4+ T-cells/million T-cells
Standard Deviation 91.26
|
80.51 CD4+ T-cells/million T-cells
Standard Deviation 126.89
|
|
Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing at Least 2 Immune Markers
Nef, Day 44
|
61.00 CD4+ T-cells/million T-cells
Standard Deviation 77.57
|
87.11 CD4+ T-cells/million T-cells
Standard Deviation 64.23
|
138.44 CD4+ T-cells/million T-cells
Standard Deviation 123.44
|
2133.76 CD4+ T-cells/million T-cells
Standard Deviation 1825.49
|
1039.80 CD4+ T-cells/million T-cells
Standard Deviation 830.73
|
1034.77 CD4+ T-cells/million T-cells
Standard Deviation 836.85
|
|
Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing at Least 2 Immune Markers
Nef, Month 2
|
51.78 CD4+ T-cells/million T-cells
Standard Deviation 82.87
|
69.89 CD4+ T-cells/million T-cells
Standard Deviation 143.34
|
99.78 CD4+ T-cells/million T-cells
Standard Deviation 123.76
|
1470.00 CD4+ T-cells/million T-cells
Standard Deviation 1160.99
|
751.35 CD4+ T-cells/million T-cells
Standard Deviation 521.38
|
826.45 CD4+ T-cells/million T-cells
Standard Deviation 539.88
|
|
Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing at Least 2 Immune Markers
Nef, Month 6
|
66.67 CD4+ T-cells/million T-cells
Standard Deviation 64.44
|
29.75 CD4+ T-cells/million T-cells
Standard Deviation 46.20
|
73.75 CD4+ T-cells/million T-cells
Standard Deviation 55.65
|
906.78 CD4+ T-cells/million T-cells
Standard Deviation 935.03
|
574.18 CD4+ T-cells/million T-cells
Standard Deviation 536.34
|
435.71 CD4+ T-cells/million T-cells
Standard Deviation 293.58
|
|
Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing at Least 2 Immune Markers
Nef, Month 12
|
60.50 CD4+ T-cells/million T-cells
Standard Deviation 61.35
|
45.63 CD4+ T-cells/million T-cells
Standard Deviation 50.45
|
50.44 CD4+ T-cells/million T-cells
Standard Deviation 54.97
|
786.23 CD4+ T-cells/million T-cells
Standard Deviation 803.67
|
432.85 CD4+ T-cells/million T-cells
Standard Deviation 379.08
|
485.23 CD4+ T-cells/million T-cells
Standard Deviation 478.78
|
|
Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing at Least 2 Immune Markers
RT, Day 0
|
158.56 CD4+ T-cells/million T-cells
Standard Deviation 363.46
|
60.78 CD4+ T-cells/million T-cells
Standard Deviation 71.21
|
47.22 CD4+ T-cells/million T-cells
Standard Deviation 44.13
|
107.84 CD4+ T-cells/million T-cells
Standard Deviation 225.52
|
81.00 CD4+ T-cells/million T-cells
Standard Deviation 143.07
|
148.37 CD4+ T-cells/million T-cells
Standard Deviation 346.73
|
|
Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing at Least 2 Immune Markers
RT, Day 44
|
328.25 CD4+ T-cells/million T-cells
Standard Deviation 556.42
|
311.00 CD4+ T-cells/million T-cells
Standard Deviation 352.09
|
297.78 CD4+ T-cells/million T-cells
Standard Deviation 368.77
|
7843.87 CD4+ T-cells/million T-cells
Standard Deviation 4284.29
|
3231.88 CD4+ T-cells/million T-cells
Standard Deviation 2077.15
|
3041.74 CD4+ T-cells/million T-cells
Standard Deviation 1961.13
|
|
Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing at Least 2 Immune Markers
RT, Month 2
|
365.00 CD4+ T-cells/million T-cells
Standard Deviation 729.94
|
261.78 CD4+ T-cells/million T-cells
Standard Deviation 385.82
|
283.56 CD4+ T-cells/million T-cells
Standard Deviation 380.40
|
5291.91 CD4+ T-cells/million T-cells
Standard Deviation 2921.62
|
2575.98 CD4+ T-cells/million T-cells
Standard Deviation 1972.59
|
2471.94 CD4+ T-cells/million T-cells
Standard Deviation 1509.43
|
|
Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing at Least 2 Immune Markers
RT, Month 6
|
46.67 CD4+ T-cells/million T-cells
Standard Deviation 61.07
|
140.75 CD4+ T-cells/million T-cells
Standard Deviation 210.46
|
103.88 CD4+ T-cells/million T-cells
Standard Deviation 165.37
|
3157.02 CD4+ T-cells/million T-cells
Standard Deviation 2345.20
|
1539.85 CD4+ T-cells/million T-cells
Standard Deviation 1100.27
|
1198.74 CD4+ T-cells/million T-cells
Standard Deviation 748.47
|
|
Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing at Least 2 Immune Markers
RT, Month 12
|
54.50 CD4+ T-cells/million T-cells
Standard Deviation 59.96
|
99.38 CD4+ T-cells/million T-cells
Standard Deviation 106.52
|
132.33 CD4+ T-cells/million T-cells
Standard Deviation 216.98
|
2965.34 CD4+ T-cells/million T-cells
Standard Deviation 2148.86
|
1433.63 CD4+ T-cells/million T-cells
Standard Deviation 1020.80
|
1347.26 CD4+ T-cells/million T-cells
Standard Deviation 988.06
|
SECONDARY outcome
Timeframe: At Month 0, Day 44, Month 2, Month 6 and Month 12Population: Analysis was performed on the According-to-Protocol cohort for Immunogenicity that included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with procedures and intervals defined in protocol, with no elimination criteria during study) for whom data concerning immunogenicity outcome measures were available.
Anti-p17, -p24, -Nef, -RT and -F4co antibody titers were measured by Enzyme Linked Immunosorbent Assay (ELISA) and presented as geometric mean titers (GMTs).
Outcome measures
| Measure |
SB732461 Non-adjuvanted_LD Group
n=9 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted low-antigen dose \[LD\] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 Non-adjuvanted_MD Group
n=9 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted medium-antigen dose \[MD\] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 Non-adjuvanted_HD Group
n=9 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted high-antigen dose \[HD\] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_LD Group
n=49 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted low-antigen dose \[LD\] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_MD Group
n=41 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted medium-antigen dose \[MD\] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_HD Group
n=35 Participants
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted high-antigen dose \[HD\] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
|---|---|---|---|---|---|---|
|
Antibody Titers Against p17, p24, Nef, RT and F4co Antigens
Anti-p17, Day 0
|
93.5 Titers
Interval 93.5 to 93.5
|
109.5 Titers
Interval 76.1 to 157.4
|
93.5 Titers
Interval 93.5 to 93.5
|
93.5 Titers
Interval 93.5 to 93.5
|
93.5 Titers
Interval 93.5 to 93.5
|
96.3 Titers
Interval 90.7 to 102.1
|
|
Antibody Titers Against p17, p24, Nef, RT and F4co Antigens
Anti-p17, Day 44
|
93.5 Titers
Interval 93.5 to 93.5
|
133.3 Titers
Interval 76.4 to 232.7
|
104.2 Titers
Interval 81.2 to 133.8
|
824.9 Titers
Interval 518.6 to 1312.1
|
1416.4 Titers
Interval 888.0 to 2259.4
|
1499.7 Titers
Interval 872.1 to 2579.0
|
|
Antibody Titers Against p17, p24, Nef, RT and F4co Antigens
Anti-p17, Month 2
|
93.5 Titers
Interval 93.5 to 93.5
|
107.6 Titers
Interval 77.8 to 148.9
|
93.5 Titers
Interval 93.5 to 93.5
|
553.2 Titers
Interval 354.8 to 862.6
|
808.2 Titers
Interval 529.1 to 1234.5
|
1189.3 Titers
Interval 730.5 to 1936.3
|
|
Antibody Titers Against p17, p24, Nef, RT and F4co Antigens
Anti-p17, Month 6
|
93.5 Titers
Interval 93.5 to 93.5
|
93.5 Titers
Interval 93.5 to 93.5
|
93.5 Titers
Interval 93.5 to 93.5
|
169.0 Titers
Interval 128.3 to 222.7
|
167.4 Titers
Interval 121.1 to 231.4
|
146.6 Titers
Interval 112.7 to 190.8
|
|
Antibody Titers Against p17, p24, Nef, RT and F4co Antigens
Anti-p17, Month 12
|
93.5 Titers
Interval 93.5 to 93.5
|
93.5 Titers
Interval 93.5 to 93.5
|
93.5 Titers
Interval 93.5 to 93.5
|
128.0 Titers
Interval 101.6 to 161.2
|
140.5 Titers
Interval 109.4 to 180.5
|
133.7 Titers
Interval 102.8 to 173.9
|
|
Antibody Titers Against p17, p24, Nef, RT and F4co Antigens
Anti-p24, Day 0
|
59.5 Titers
Interval 59.5 to 59.5
|
64.7 Titers
Interval 53.3 to 78.6
|
59.5 Titers
Interval 59.5 to 59.5
|
59.5 Titers
Interval 59.5 to 59.5
|
59.5 Titers
Interval 59.5 to 59.5
|
62.1 Titers
Interval 56.9 to 67.8
|
|
Antibody Titers Against p17, p24, Nef, RT and F4co Antigens
Anti-p24, Day 44
|
65.3 Titers
Interval 52.7 to 80.8
|
120.3 Titers
Interval 57.0 to 253.9
|
88.8 Titers
Interval 43.1 to 183.0
|
18765.3 Titers
Interval 14750.4 to 23872.9
|
18788.8 Titers
Interval 15248.4 to 23151.4
|
21089.3 Titers
Interval 16184.8 to 27480.0
|
|
Antibody Titers Against p17, p24, Nef, RT and F4co Antigens
Anti-p24, Month 2
|
69.7 Titers
Interval 48.4 to 100.2
|
97.5 Titers
Interval 52.7 to 180.2
|
87.4 Titers
Interval 44.6 to 171.4
|
12453.4 Titers
Interval 9769.4 to 15874.8
|
11238.4 Titers
Interval 8896.3 to 14197.0
|
12541.9 Titers
Interval 9459.6 to 16628.4
|
|
Antibody Titers Against p17, p24, Nef, RT and F4co Antigens
Anti-p24, Month 6
|
59.5 Titers
Interval 59.5 to 59.5
|
59.5 Titers
Interval 59.5 to 59.5
|
83.0 Titers
Interval 37.8 to 182.3
|
2800.2 Titers
Interval 2069.1 to 3789.6
|
1898.0 Titers
Interval 1393.0 to 2586.1
|
2082.9 Titers
Interval 1483.5 to 2924.3
|
|
Antibody Titers Against p17, p24, Nef, RT and F4co Antigens
Anti-p24, Month 12
|
59.5 Titers
Interval 59.5 to 59.5
|
59.5 Titers
Interval 59.5 to 59.5
|
70.8 Titers
Interval 47.4 to 105.6
|
1254.8 Titers
Interval 917.2 to 1716.6
|
840.6 Titers
Interval 587.7 to 1202.4
|
762.6 Titers
Interval 561.3 to 1035.9
|
|
Antibody Titers Against p17, p24, Nef, RT and F4co Antigens
Anti-Nef, Day 0
|
116.0 Titers
Interval 116.0 to 116.0
|
138.0 Titers
Interval 92.4 to 206.2
|
116.0 Titers
Interval 116.0 to 116.0
|
120.0 Titers
Interval 112.1 to 128.4
|
129.6 Titers
Interval 109.3 to 153.7
|
136.1 Titers
Interval 118.4 to 156.4
|
|
Antibody Titers Against p17, p24, Nef, RT and F4co Antigens
Anti-Nef, Day 44
|
157.8 Titers
Interval 94.2 to 264.4
|
229.2 Titers
Interval 113.2 to 464.1
|
184.6 Titers
Interval 85.0 to 400.9
|
27263.0 Titers
Interval 21515.5 to 34545.9
|
20504.6 Titers
Interval 15547.5 to 27042.3
|
26844.9 Titers
Interval 19335.8 to 37270.1
|
|
Antibody Titers Against p17, p24, Nef, RT and F4co Antigens
Anti-Nef, Month 2
|
152.1 Titers
Interval 81.5 to 283.8
|
185.3 Titers
Interval 89.8 to 382.2
|
168.4 Titers
Interval 88.5 to 320.5
|
12467.6 Titers
Interval 9650.8 to 16106.5
|
12378.1 Titers
Interval 9440.1 to 16230.5
|
17926.2 Titers
Interval 13040.6 to 24642.0
|
|
Antibody Titers Against p17, p24, Nef, RT and F4co Antigens
Anti-Nef, Month 6
|
144.9 Titers
Interval 86.8 to 241.8
|
135.4 Titers
Interval 94.0 to 195.0
|
173.8 Titers
Interval 66.8 to 452.5
|
2133.7 Titers
Interval 1548.8 to 2939.4
|
1617.1 Titers
Interval 1126.4 to 2321.4
|
2712.2 Titers
Interval 1930.5 to 3810.2
|
|
Antibody Titers Against p17, p24, Nef, RT and F4co Antigens
Anti-Nef, Month 12
|
135.9 Titers
Interval 94.3 to 195.9
|
154.2 Titers
Interval 99.3 to 239.5
|
116.0 Titers
Interval 116.0 to 116.0
|
1032.4 Titers
Interval 716.9 to 1486.6
|
710.4 Titers
Interval 491.2 to 1027.4
|
1330.2 Titers
Interval 948.8 to 1865.0
|
|
Antibody Titers Against p17, p24, Nef, RT and F4co Antigens
Anti-RT, Day 0
|
62.5 Titers
Interval 62.5 to 62.5
|
62.5 Titers
Interval 62.5 to 62.5
|
69.1 Titers
Interval 54.8 to 87.3
|
62.5 Titers
Interval 62.5 to 62.5
|
64.2 Titers
Interval 60.8 to 67.8
|
62.5 Titers
Interval 62.5 to 62.5
|
|
Antibody Titers Against p17, p24, Nef, RT and F4co Antigens
Anti-RT, Day 44
|
62.5 Titers
Interval 62.5 to 62.5
|
95.5 Titers
Interval 56.5 to 161.6
|
100.1 Titers
Interval 43.3 to 231.3
|
8979.1 Titers
Interval 6928.2 to 11637.1
|
10019.9 Titers
Interval 8074.8 to 12433.5
|
11812.0 Titers
Interval 9008.8 to 15487.6
|
|
Antibody Titers Against p17, p24, Nef, RT and F4co Antigens
Anti-RT, Month 2
|
76.7 Titers
Interval 47.8 to 122.9
|
85.6 Titers
Interval 52.8 to 138.7
|
96.5 Titers
Interval 46.0 to 202.2
|
5761.6 Titers
Interval 4628.7 to 7171.8
|
6543.3 Titers
Interval 5128.8 to 8347.9
|
6959.8 Titers
Interval 5315.5 to 9112.7
|
|
Antibody Titers Against p17, p24, Nef, RT and F4co Antigens
Anti-RT, Month 6
|
71.4 Titers
Interval 52.6 to 96.9
|
75.7 Titers
Interval 48.2 to 118.8
|
62.5 Titers
Interval 62.5 to 62.5
|
705.5 Titers
Interval 567.5 to 877.0
|
902.5 Titers
Interval 672.6 to 1211.1
|
883.9 Titers
Interval 682.3 to 1145.0
|
|
Antibody Titers Against p17, p24, Nef, RT and F4co Antigens
Anti-RT, Month 12
|
74.3 Titers
Interval 49.9 to 110.5
|
62.5 Titers
Interval 62.5 to 62.5
|
72.0 Titers
Interval 51.9 to 99.9
|
462.1 Titers
Interval 358.9 to 595.0
|
428.7 Titers
Interval 316.1 to 581.5
|
471.1 Titers
Interval 374.6 to 592.5
|
|
Antibody Titers Against p17, p24, Nef, RT and F4co Antigens
Anti-F4co, Month 0
|
21.0 Titers
Interval 21.0 to 21.0
|
24.6 Titers
Interval 17.1 to 35.4
|
21.0 Titers
Interval 21.0 to 21.0
|
21.0 Titers
Interval 21.0 to 21.0
|
21.0 Titers
Interval 21.0 to 21.0
|
21.5 Titers
Interval 20.5 to 22.4
|
|
Antibody Titers Against p17, p24, Nef, RT and F4co Antigens
Anti-F4co, Day 44
|
23.8 Titers
Interval 17.8 to 31.8
|
42.1 Titers
Interval 18.7 to 94.9
|
42.7 Titers
Interval 16.4 to 111.7
|
7027.2 Titers
Interval 5768.4 to 8560.6
|
11151.6 Titers
Interval 9207.1 to 13506.9
|
12359.6 Titers
Interval 9291.4 to 16441.0
|
|
Antibody Titers Against p17, p24, Nef, RT and F4co Antigens
Anti-F4co, Month 2
|
26.1 Titers
Interval 18.6 to 36.5
|
34.7 Titers
Interval 18.3 to 65.8
|
31.5 Titers
Interval 15.2 to 65.1
|
4770.3 Titers
Interval 3900.0 to 5834.9
|
4607.8 Titers
Interval 3701.8 to 5735.4
|
5438.7 Titers
Interval 4126.5 to 7168.2
|
|
Antibody Titers Against p17, p24, Nef, RT and F4co Antigens
Anti-F4co, Month 6
|
22.9 Titers
Interval 18.7 to 28.0
|
25.5 Titers
Interval 18.9 to 34.6
|
31.0 Titers
Interval 12.3 to 77.8
|
1303.1 Titers
Interval 1065.2 to 1594.2
|
1081.4 Titers
Interval 813.9 to 1436.8
|
1081.4 Titers
Interval 780.0 to 1499.3
|
|
Antibody Titers Against p17, p24, Nef, RT and F4co Antigens
Anti-F4co, Month 12
|
25.1 Titers
Interval 16.6 to 38.1
|
23.6 Titers
Interval 17.9 to 31.2
|
33.1 Titers
Interval 17.9 to 61.5
|
790.7 Titers
Interval 633.4 to 987.0
|
1154.0 Titers
Interval 839.3 to 1586.7
|
837.5 Titers
Interval 605.2 to 1158.9
|
Adverse Events
SB732461 Non-adjuvanted_LD Group
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
SB732461 Non-adjuvanted_MD Group
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
SB732461 Non-adjuvanted_HD Group
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
SB732461 adjuvanted_LD Group
Serious events: 2 serious events
Other events: 50 other events
Deaths: 0 deaths
SB732461 adjuvanted_MD Group
Serious events: 2 serious events
Other events: 50 other events
Deaths: 0 deaths
SB732461 adjuvanted_HD Group
Serious events: 2 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SB732461 Non-adjuvanted_LD Group
n=10 participants at risk
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted low-antigen dose \[LD\] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 Non-adjuvanted_MD Group
n=10 participants at risk
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted medium-antigen dose \[MD\] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 Non-adjuvanted_HD Group
n=10 participants at risk
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted high-antigen dose \[HD\] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_LD Group
n=50 participants at risk
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted low-antigen dose \[LD\] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_MD Group
n=50 participants at risk
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted medium-antigen dose \[MD\] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_HD Group
n=50 participants at risk
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted high-antigen dose \[HD\] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Skin and subcutaneous tissue disorders
Henoch-schonlein purpura
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
Other adverse events
| Measure |
SB732461 Non-adjuvanted_LD Group
n=10 participants at risk
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted low-antigen dose \[LD\] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 Non-adjuvanted_MD Group
n=10 participants at risk
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted medium-antigen dose \[MD\] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 Non-adjuvanted_HD Group
n=10 participants at risk
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted high-antigen dose \[HD\] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_LD Group
n=50 participants at risk
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted low-antigen dose \[LD\] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_MD Group
n=50 participants at risk
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted medium-antigen dose \[MD\] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
SB732461 adjuvanted_HD Group
n=50 participants at risk
Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted high-antigen dose \[HD\] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
10.0%
1/10 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
General disorders
Axillary pain
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
6.0%
3/50 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
10.0%
1/10 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
General disorders
Chills
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
18.0%
9/50 • Number of events 11 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
6.0%
3/50 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
10.0%
1/10 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
4.0%
2/50 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
10.0%
1/10 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
4.0%
2/50 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
6.0%
3/50 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
10.0%
1/10 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
28.0%
14/50 • Number of events 19 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
46.0%
23/50 • Number of events 35 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
50.0%
25/50 • Number of events 34 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
General disorders
Fatigue
|
50.0%
5/10 • Number of events 6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
50.0%
5/10 • Number of events 7 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
60.0%
6/10 • Number of events 9 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
82.0%
41/50 • Number of events 67 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
94.0%
47/50 • Number of events 71 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
92.0%
46/50 • Number of events 77 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
20.0%
2/10 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
20.0%
2/10 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
20.0%
2/10 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
46.0%
23/50 • Number of events 29 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
42.0%
21/50 • Number of events 24 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
34.0%
17/50 • Number of events 21 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
General disorders
Hangover
|
10.0%
1/10 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
10.0%
1/10 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Nervous system disorders
Headache
|
50.0%
5/10 • Number of events 5 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
40.0%
4/10 • Number of events 8 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
50.0%
5/10 • Number of events 5 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
86.0%
43/50 • Number of events 78 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
84.0%
42/50 • Number of events 65 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
82.0%
41/50 • Number of events 65 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
10.0%
1/10 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
10.0%
1/10 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
30.0%
3/10 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
56.0%
28/50 • Number of events 35 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
56.0%
28/50 • Number of events 33 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
52.0%
26/50 • Number of events 34 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
General disorders
Influenza like illness
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
10.0%
1/10 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
8.0%
4/50 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
6.0%
3/50 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
4.0%
2/50 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Metabolism and nutrition disorders
Iron deficiency
|
10.0%
1/10 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
6.0%
3/50 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
10.0%
5/50 • Number of events 6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
12.0%
6/50 • Number of events 6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
2/10 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
10.0%
1/10 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
20.0%
2/10 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
62.0%
31/50 • Number of events 45 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
70.0%
35/50 • Number of events 52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
72.0%
36/50 • Number of events 52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Infections and infestations
Nasopharyngitis
|
20.0%
2/10 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
6.0%
3/50 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
10.0%
1/10 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
6.0%
3/50 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
2.0%
1/50 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Infections and infestations
Oral herpes
|
10.0%
1/10 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
20.0%
2/10 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
8.0%
4/50 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
8.0%
4/50 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
6.0%
3/50 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
General disorders
Pain
|
30.0%
3/10 • Number of events 5 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
20.0%
2/10 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
50.0%
5/10 • Number of events 6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
98.0%
49/50 • Number of events 96 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
100.0%
50/50 • Number of events 98 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
100.0%
50/50 • Number of events 97 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
10.0%
1/10 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
10.0%
1/10 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
6.0%
3/50 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
General disorders
Pyrexia
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
60.0%
30/50 • Number of events 34 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
58.0%
29/50 • Number of events 32 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
52.0%
26/50 • Number of events 29 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Infections and infestations
Rhinitis
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
10.0%
1/10 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
6.0%
3/50 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Psychiatric disorders
Stress
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
10.0%
1/10 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
General disorders
Swelling
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
26.0%
13/50 • Number of events 20 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
36.0%
18/50 • Number of events 25 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
38.0%
19/50 • Number of events 22 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Nervous system disorders
Syncope
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
10.0%
1/10 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Nervous system disorders
Tension headache
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
10.0%
1/10 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
10.0%
1/10 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Gastrointestinal disorders
Toothache
|
10.0%
1/10 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
10.0%
5/50 • Number of events 5 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
6.0%
3/50 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
0.00%
0/50 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
6.0%
3/50 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER