Trial Outcomes & Findings for Safety and Immunogenicity of 2 Formulations of Tuberculosis Vaccine GSK692342 Given at 0,1 Months to Healthy Adults (NCT NCT00397943)
NCT ID: NCT00397943
Last Updated: 2019-06-19
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
110 participants
Primary outcome timeframe
During the 7-day (Days 0-6) follow-up period after each vaccine dose and across doses
Results posted on
2019-06-19
Participant Flow
Participant milestones
| Measure |
M72/AS01B Group
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
M72/AS02A Group
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Mtb72F/AS02A Group
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Non-adjuvanted Group
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator GSK Biologicals' candidate recombinant M. tuberculosis vaccine, non-adjuvanted, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Control Group
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the adjuvant system alone, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
28
|
31
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
12
|
9
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
M72/AS01B Group
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
M72/AS02A Group
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Mtb72F/AS02A Group
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Non-adjuvanted Group
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator GSK Biologicals' candidate recombinant M. tuberculosis vaccine, non-adjuvanted, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Control Group
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the adjuvant system alone, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
|---|---|---|---|---|---|
|
Overall Study
Unspecified reasons
|
12
|
9
|
0
|
0
|
0
|
Baseline Characteristics
Safety and Immunogenicity of 2 Formulations of Tuberculosis Vaccine GSK692342 Given at 0,1 Months to Healthy Adults
Baseline characteristics by cohort
| Measure |
M72/AS01B Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
M72/AS02A Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Mtb72F/AS02A Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Non-adjuvanted Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator GSK Biologicals' candidate recombinant M. tuberculosis vaccine, non-adjuvanted, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Control Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the adjuvant system alone, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
25.0 Years
STANDARD_DEVIATION 6.50 • n=5 Participants
|
26.4 Years
STANDARD_DEVIATION 7.97 • n=7 Participants
|
28.5 Years
STANDARD_DEVIATION 6.95 • n=5 Participants
|
24.8 Years
STANDARD_DEVIATION 5.33 • n=4 Participants
|
25.9 Years
STANDARD_DEVIATION 7.95 • n=21 Participants
|
25.89 Years
STANDARD_DEVIATION 7.11 • n=8 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
67 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
43 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White-Arabic/North African heritage
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White-Caucasian/European heritage
|
38 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
107 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Unspecified
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: During the 7-day (Days 0-6) follow-up period after each vaccine dose and across dosesPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
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 |
M72/AS01B Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
M72/AS02A Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Mtb72F/AS02A Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Non-adjuvanted Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator GSK Biologicals' candidate recombinant M. tuberculosis vaccine, non-adjuvanted, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Control Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the adjuvant system alone, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
|---|---|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Across doses
|
6 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 1
|
38 Participants
|
40 Participants
|
9 Participants
|
1 Participants
|
10 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 1
|
7 Participants
|
5 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 1
|
4 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 1
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 1
|
4 Participants
|
8 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 1
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 2
|
39 Participants
|
37 Participants
|
9 Participants
|
2 Participants
|
10 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 2
|
7 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 2
|
10 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 2
|
6 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 2
|
7 Participants
|
9 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 2
|
1 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Across doses
|
40 Participants
|
40 Participants
|
10 Participants
|
2 Participants
|
10 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Across doses
|
13 Participants
|
6 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Across doses
|
12 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Across doses
|
9 Participants
|
10 Participants
|
5 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Across doses
|
3 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: During the 7-day (Days 0-6) follow-up period after each vaccine dose and across dosesPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
Assessed solicited general symptoms were fatigue, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], gastrointestinal symptoms and headache. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.5 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
M72/AS01B Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
M72/AS02A Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Mtb72F/AS02A Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Non-adjuvanted Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator GSK Biologicals' candidate recombinant M. tuberculosis vaccine, non-adjuvanted, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Control Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the adjuvant system alone, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
|---|---|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue, Dose 1
|
27 Participants
|
21 Participants
|
6 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue, Dose 1
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue, Dose 1
|
26 Participants
|
19 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever, Dose 1
|
5 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 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
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever, Dose 1
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal symptoms, Dose 1
|
9 Participants
|
7 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal symptoms, Dose 1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal symptoms, Dose 1
|
6 Participants
|
7 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache, Dose 1
|
19 Participants
|
12 Participants
|
9 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache, Dose 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache, Dose 1
|
15 Participants
|
11 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue, Dose 2
|
33 Participants
|
24 Participants
|
7 Participants
|
2 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue, Dose 2
|
4 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue, Dose 2
|
33 Participants
|
23 Participants
|
7 Participants
|
1 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever, Dose 2
|
24 Participants
|
10 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever, Dose 2
|
24 Participants
|
10 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal symptoms, Dose 2
|
18 Participants
|
10 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal symptoms, Dose 2
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal symptoms, Dose 2
|
17 Participants
|
8 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache, Dose 2
|
32 Participants
|
22 Participants
|
6 Participants
|
2 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache, Dose 2
|
8 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache, Dose 2
|
32 Participants
|
19 Participants
|
6 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue, Across doses
|
36 Participants
|
29 Participants
|
8 Participants
|
3 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue, Across doses
|
4 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue, Across doses
|
36 Participants
|
28 Participants
|
7 Participants
|
3 Participants
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever, Across doses
|
25 Participants
|
10 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever, Across doses
|
25 Participants
|
10 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal symptoms, Across doses
|
23 Participants
|
10 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal symptoms, Across doses
|
3 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal symptoms, Across doses
|
20 Participants
|
9 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache, Across doses
|
33 Participants
|
27 Participants
|
9 Participants
|
3 Participants
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache, Across doses
|
8 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache, Across doses
|
32 Participants
|
24 Participants
|
7 Participants
|
2 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: During the 30-day (Days 0-29) follow-up period after each vaccine dosePopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
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 |
M72/AS01B Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
M72/AS02A Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Mtb72F/AS02A Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Non-adjuvanted Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator GSK Biologicals' candidate recombinant M. tuberculosis vaccine, non-adjuvanted, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Control Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the adjuvant system alone, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
|---|---|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Any AE(s)
|
37 Participants
|
33 Participants
|
10 Participants
|
7 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Grade 3 AE(s)
|
12 Participants
|
7 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Related AE(s)
|
31 Participants
|
21 Participants
|
8 Participants
|
2 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: During the Active Vaccination Phase (from Day 0 up to Month 2)Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
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 |
M72/AS01B Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
M72/AS02A Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Mtb72F/AS02A Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Non-adjuvanted Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator GSK Biologicals' candidate recombinant M. tuberculosis vaccine, non-adjuvanted, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Control Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the adjuvant system alone, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
|---|---|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Month 2 up to Month 12Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
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 |
M72/AS01B Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
M72/AS02A Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Mtb72F/AS02A Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Non-adjuvanted Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator GSK Biologicals' candidate recombinant M. tuberculosis vaccine, non-adjuvanted, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Control Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the adjuvant system alone, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
|---|---|---|---|---|---|
|
Number of Subjects With SAEs
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From Month 12 up to Month 24Population: The analysis was performed on the Total Vaccinated cohort (all subjects with at least one vaccine administration documented and with the symptom sheet filled in) and focused on the subjects included in the Year 2 Safety Follow-Up (M72/AS01B and M72/AS02A groups).
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Note: Follow-up during Year 2 continued only for the M72/AS01B Group and M72/AS02A Group.
Outcome measures
| Measure |
M72/AS01B Group
n=32 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
M72/AS02A Group
n=37 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Mtb72F/AS02A Group
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Non-adjuvanted Group
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator GSK Biologicals' candidate recombinant M. tuberculosis vaccine, non-adjuvanted, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Control Group
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the adjuvant system alone, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
|---|---|---|---|---|---|
|
Number of Subjects With SAEs
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Month 24 up to Month 36Population: The analysis was performed on the Total Vaccinated cohort (all subjects with at least one vaccine administration documented and with the symptom sheet filled in) and focused on the subjects included in the Year 3 Safety Follow-Up (M72/AS01B and M72/AS02A groups).
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Note: Follow-up during Year 3 continued only for the M72/AS01B Group and M72/AS02A Group.
Outcome measures
| Measure |
M72/AS01B Group
n=28 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
M72/AS02A Group
n=31 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Mtb72F/AS02A Group
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Non-adjuvanted Group
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator GSK Biologicals' candidate recombinant M. tuberculosis vaccine, non-adjuvanted, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Control Group
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the adjuvant system alone, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
|---|---|---|---|---|---|
|
Number of Subjects With SAEs
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 0Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
Among haematological and biochemical parameters assessed were Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Basophils, Creatinine, Eosinophils, Haemoglobin, Haematocrite, Lymphocytes, Monocytes, Neutrophils, Platelets, Red blood cells (RBC), White blood cells (WBC). Inside = within laboratory reference range; Above = above laboratory reference range; Below = below laboratory reference range.
Outcome measures
| Measure |
M72/AS01B Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
M72/AS02A Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Mtb72F/AS02A Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Non-adjuvanted Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator GSK Biologicals' candidate recombinant M. tuberculosis vaccine, non-adjuvanted, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Control Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the adjuvant system alone, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
|---|---|---|---|---|---|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Neutrophils, Inside
|
38 Participants
|
38 Participants
|
9 Participants
|
9 Participants
|
9 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Lymphocytes, Inside
|
39 Participants
|
39 Participants
|
10 Participants
|
8 Participants
|
8 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Lymphocytes, Above
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Lymphocytes, Below
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Lymphocytes, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Monocytes, Inside
|
29 Participants
|
32 Participants
|
8 Participants
|
6 Participants
|
6 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Monocytes, Above
|
10 Participants
|
8 Participants
|
1 Participants
|
4 Participants
|
4 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Monocytes, Below
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
ALT, Inside
|
39 Participants
|
39 Participants
|
9 Participants
|
10 Participants
|
10 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
ALT, Above
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
ALT, Below
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
ALT, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
AST, Inside
|
39 Participants
|
40 Participants
|
10 Participants
|
10 Participants
|
10 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
AST, Above
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
AST, Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
AST, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Basophils, Inside
|
40 Participants
|
40 Participants
|
10 Participants
|
10 Participants
|
10 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Basophils, Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Basophils, Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Basophils, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Creatinine, Inside
|
39 Participants
|
39 Participants
|
9 Participants
|
10 Participants
|
10 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Creatinine, Above
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Creatinine, Below
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Monocytes, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Creatinine, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Eosinophils, Inside
|
37 Participants
|
40 Participants
|
10 Participants
|
10 Participants
|
10 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Eosinophils, Above
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Eosinophils, Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Eosinophils, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Haemoglobin, Inside
|
40 Participants
|
38 Participants
|
10 Participants
|
9 Participants
|
10 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Haemoglobin, Above
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Haemoglobin, Below
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Haemoglobin, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Haematocrite, Inside
|
37 Participants
|
37 Participants
|
10 Participants
|
9 Participants
|
10 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Haematocrite, Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Haematocrite, Below
|
3 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Haematocrite, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Neutrophils, Above
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Neutrophils, Below
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Neutrophils, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Platelets, Inside
|
38 Participants
|
39 Participants
|
10 Participants
|
9 Participants
|
10 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Platelets, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Platelets, Above
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Platelets, Below
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
RBC, Inside
|
40 Participants
|
39 Participants
|
10 Participants
|
10 Participants
|
10 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
RBC, Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
RBC, Below
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
RBC, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
WBC, Inside
|
36 Participants
|
36 Participants
|
10 Participants
|
9 Participants
|
9 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
WBC, Above
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
WBC, Below
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
WBC, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 7Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
Among haematological and biochemical parameters assessed were Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Basophils, Creatinine, Eosinophils, Haemoglobin, Haematocrite, Lymphocytes, Monocytes, Neutrophils, Platelets, Red blood cells (RBC), White blood cells (WBC). Inside = within laboratory reference range; Above = above laboratory reference range; Below = below laboratory reference range.
Outcome measures
| Measure |
M72/AS01B Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
M72/AS02A Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Mtb72F/AS02A Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Non-adjuvanted Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator GSK Biologicals' candidate recombinant M. tuberculosis vaccine, non-adjuvanted, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Control Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the adjuvant system alone, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
|---|---|---|---|---|---|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
ALT, Inside
|
38 Participants
|
40 Participants
|
10 Participants
|
10 Participants
|
10 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
ALT, Above
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
ALT, Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
ALT, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
AST, Inside
|
39 Participants
|
39 Participants
|
10 Participants
|
10 Participants
|
10 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
AST, Above
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
AST, Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
AST, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
Basophils, Inside
|
40 Participants
|
40 Participants
|
10 Participants
|
10 Participants
|
10 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
Haematocrite, Inside
|
39 Participants
|
36 Participants
|
10 Participants
|
9 Participants
|
10 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
Basophils, Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
Basophils, Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
Basophils, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
Creatinine, Inside
|
37 Participants
|
39 Participants
|
10 Participants
|
10 Participants
|
9 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
Creatinine, Above
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
Creatinine, Below
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
Creatinine, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
Eosinophils, Inside
|
39 Participants
|
39 Participants
|
10 Participants
|
10 Participants
|
10 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
Eosinophils, Above
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
Eosinophils, Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
Eosinophils, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
Haemoglobin, Inside
|
40 Participants
|
38 Participants
|
10 Participants
|
9 Participants
|
10 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
Haemoglobin, Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
Haemoglobin, Below
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
Haemoglobin, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
Haematocrite, Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
Haematocrite, Below
|
1 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
Haematocrite, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
Lymphocytes, Inside
|
40 Participants
|
38 Participants
|
8 Participants
|
10 Participants
|
8 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
Lymphocytes, Above
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
Lymphocytes, Below
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
Lymphocytes, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
Monocytes, Inside
|
29 Participants
|
33 Participants
|
7 Participants
|
9 Participants
|
8 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
Monocytes, Above
|
11 Participants
|
7 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
Monocytes, Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
Monocytes, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
Neutrophils, Inside
|
40 Participants
|
39 Participants
|
7 Participants
|
10 Participants
|
8 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
Neutrophils, Above
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
Neutrophils, Below
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
Neutrophils, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
Platelets, Inside
|
40 Participants
|
39 Participants
|
10 Participants
|
9 Participants
|
10 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
Platelets, Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
Platelets, Below
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
Platelets, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
RBC, Inside
|
40 Participants
|
39 Participants
|
10 Participants
|
10 Participants
|
10 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
RBC, Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
RBC, Below
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
RBC, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
WBC, Inside
|
37 Participants
|
38 Participants
|
9 Participants
|
10 Participants
|
10 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
WBC, Above
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
WBC, Below
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
WBC, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 30Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
Among haematological and biochemical parameters assessed were Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Basophils, Creatinine, Eosinophils, Haemoglobin, Haematocrite, Lymphocytes, Monocytes, Neutrophils, Platelets, Red blood cells (RBC), White blood cells (WBC). Inside = within laboratory reference range; Above = above laboratory reference range; Below = below laboratory reference range.
Outcome measures
| Measure |
M72/AS01B Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
M72/AS02A Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Mtb72F/AS02A Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Non-adjuvanted Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator GSK Biologicals' candidate recombinant M. tuberculosis vaccine, non-adjuvanted, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Control Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the adjuvant system alone, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
|---|---|---|---|---|---|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Lymphocytes, Above
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Platelets, Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
ALT, Inside
|
40 Participants
|
39 Participants
|
10 Participants
|
10 Participants
|
10 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Lymphocytes, Below
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Lymphocytes, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Monocytes, Inside
|
33 Participants
|
29 Participants
|
7 Participants
|
8 Participants
|
6 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
ALT, Above
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
ALT, Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
ALT, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
AST, Inside
|
40 Participants
|
39 Participants
|
10 Participants
|
10 Participants
|
10 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
AST, Above
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
AST, Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
AST, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Basophils, Inside
|
40 Participants
|
40 Participants
|
10 Participants
|
10 Participants
|
10 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Basophils, Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Basophils, Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Basophils, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Creatinine, Inside
|
40 Participants
|
38 Participants
|
9 Participants
|
10 Participants
|
10 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Creatinine, Above
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Creatinine, Below
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Creatinine, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Eosinophils, Inside
|
38 Participants
|
38 Participants
|
10 Participants
|
10 Participants
|
10 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Eosinophils, Above
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Eosinophils, Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Eosinophils, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Haemoglobin, Inside
|
38 Participants
|
39 Participants
|
10 Participants
|
9 Participants
|
10 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Haemoglobin, Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Haemoglobin, Below
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Haemoglobin, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Haematocrite, Inside
|
38 Participants
|
40 Participants
|
10 Participants
|
10 Participants
|
10 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Haematocrite, Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Haematocrite, Below
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Haematocrite, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Lymphocytes, Inside
|
39 Participants
|
36 Participants
|
10 Participants
|
8 Participants
|
10 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Monocytes, Above
|
7 Participants
|
11 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Monocytes, Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Monocytes, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Neutrophils, Inside
|
39 Participants
|
39 Participants
|
10 Participants
|
9 Participants
|
10 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Neutrophils, Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Neutrophils, Below
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Neutrophils, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Platelets, Inside
|
38 Participants
|
38 Participants
|
10 Participants
|
9 Participants
|
10 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Platelets, Below
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Platelets, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
RBC, Inside
|
39 Participants
|
40 Participants
|
10 Participants
|
10 Participants
|
10 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
RBC, Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
RBC, Below
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
RBC, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
WBC, Inside
|
38 Participants
|
37 Participants
|
10 Participants
|
9 Participants
|
9 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
WBC, Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
WBC, Below
|
2 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
WBC, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 37Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
Among haematological and biochemical parameters assessed were Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Basophils, Creatinine, Eosinophils, Haemoglobin, Haematocrite, Lymphocytes, Monocytes, Neutrophils, Platelets, Red blood cells (RBC), White blood cells (WBC). Inside = within laboratory reference range; Above = above laboratory reference range; Below = below laboratory reference range.
Outcome measures
| Measure |
M72/AS01B Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
M72/AS02A Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Mtb72F/AS02A Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Non-adjuvanted Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator GSK Biologicals' candidate recombinant M. tuberculosis vaccine, non-adjuvanted, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Control Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the adjuvant system alone, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
|---|---|---|---|---|---|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Haematocrite, Below
|
3 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Lymphocytes, Below
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
ALT, Inside
|
39 Participants
|
39 Participants
|
10 Participants
|
10 Participants
|
10 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
ALT, Above
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
ALT, Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
ALT, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
AST, Inside
|
40 Participants
|
40 Participants
|
10 Participants
|
10 Participants
|
10 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
AST, Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
AST, Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
AST, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Basophils, Inside
|
40 Participants
|
40 Participants
|
10 Participants
|
10 Participants
|
10 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Basophils, Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Basophils, Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Basophils, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Creatinine, Inside
|
39 Participants
|
38 Participants
|
10 Participants
|
10 Participants
|
10 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Creatinine, Above
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Creatinine, Below
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Creatinine, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Eosinophils, Inside
|
39 Participants
|
38 Participants
|
10 Participants
|
10 Participants
|
10 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Eosinophils, Above
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Eosinophils, Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Eosinophils, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Haemoglobin, Inside
|
38 Participants
|
39 Participants
|
10 Participants
|
9 Participants
|
10 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Haemoglobin, Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Haemoglobin, Below
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Haemoglobin, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Haematocrite, Inside
|
37 Participants
|
37 Participants
|
10 Participants
|
9 Participants
|
10 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Haematocrite, Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Lymphocytes, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Monocytes, Inside
|
30 Participants
|
35 Participants
|
9 Participants
|
7 Participants
|
7 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Haematocrite, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Lymphocytes, Inside
|
38 Participants
|
38 Participants
|
10 Participants
|
10 Participants
|
9 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Lymphocytes, Above
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Monocytes, Above
|
8 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Monocytes, Below
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Monocytes, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Neutrophils, Inside
|
38 Participants
|
38 Participants
|
10 Participants
|
10 Participants
|
9 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Neutrophils, Above
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Neutrophils, Below
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Neutrophils, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Platelets, Inside
|
38 Participants
|
39 Participants
|
10 Participants
|
9 Participants
|
10 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Platelets, Above
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Platelets, Below
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Platelets, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
RBC, Inside
|
40 Participants
|
40 Participants
|
10 Participants
|
10 Participants
|
10 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
RBC, Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
RBC, Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
RBC, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
WBC, Inside
|
37 Participants
|
39 Participants
|
10 Participants
|
9 Participants
|
10 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
WBC, Above
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
WBC, Below
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
WBC, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 60Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
Among haematological and biochemical parameters assessed were Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Basophils, Creatinine, Eosinophils, Haemoglobin, Haematocrite, Lymphocytes, Monocytes, Neutrophils, Platelets, Red blood cells (RBC), White blood cells (WBC). Inside = within laboratory reference range; Above = above laboratory reference range; Below = below laboratory reference range.
Outcome measures
| Measure |
M72/AS01B Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
M72/AS02A Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Mtb72F/AS02A Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Non-adjuvanted Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator GSK Biologicals' candidate recombinant M. tuberculosis vaccine, non-adjuvanted, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Control Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the adjuvant system alone, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
|---|---|---|---|---|---|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
ALT, Inside
|
39 Participants
|
39 Participants
|
10 Participants
|
10 Participants
|
10 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
ALT, Above
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
ALT, Below
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
ALT, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
AST, Inside
|
38 Participants
|
40 Participants
|
10 Participants
|
10 Participants
|
9 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
AST, Above
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
AST, Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
AST, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Basophils, Inside
|
40 Participants
|
40 Participants
|
10 Participants
|
10 Participants
|
10 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Basophils, Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Basophils, Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Basophils, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Creatinine, Inside
|
40 Participants
|
39 Participants
|
10 Participants
|
10 Participants
|
9 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Creatinine, Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Creatinine, Below
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Creatinine, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Eosinophils, Inside
|
38 Participants
|
38 Participants
|
10 Participants
|
10 Participants
|
10 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Eosinophils, Above
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Eosinophils, Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Eosinophils, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Haemoglobin, Inside
|
39 Participants
|
40 Participants
|
10 Participants
|
9 Participants
|
10 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Haemoglobin, Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Haemoglobin, Below
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Haemoglobin, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Haematocrite, Inside
|
38 Participants
|
36 Participants
|
10 Participants
|
9 Participants
|
10 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Monocytes, Inside
|
29 Participants
|
35 Participants
|
8 Participants
|
9 Participants
|
7 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Monocytes, Above
|
11 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Monocytes, Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Monocytes, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Haematocrite, Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Neutrophils, Inside
|
39 Participants
|
36 Participants
|
10 Participants
|
10 Participants
|
8 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Haematocrite, Below
|
2 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Haematocrite, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Lymphocytes, Inside
|
38 Participants
|
38 Participants
|
10 Participants
|
9 Participants
|
8 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Lymphocytes, Above
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Lymphocytes, Below
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Lymphocytes, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Neutrophils, Above
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Neutrophils, Below
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Neutrophils, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Platelets, Inside
|
39 Participants
|
38 Participants
|
10 Participants
|
10 Participants
|
10 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Platelets, Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Platelets, Below
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Platelets, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
RBC, Inside
|
40 Participants
|
39 Participants
|
10 Participants
|
9 Participants
|
10 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
RBC, Above
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
RBC, Below
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
RBC, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
WBC, Inside
|
38 Participants
|
37 Participants
|
9 Participants
|
9 Participants
|
9 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
WBC, Above
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
WBC, Below
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
WBC, Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 0Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
The levels of C-reactive protein are expressed in milligram per deciliter (mg/dL).
Outcome measures
| Measure |
M72/AS01B Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
M72/AS02A Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Mtb72F/AS02A Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Non-adjuvanted Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator GSK Biologicals' candidate recombinant M. tuberculosis vaccine, non-adjuvanted, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Control Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the adjuvant system alone, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
|---|---|---|---|---|---|
|
Levels of C-reactive Protein
|
0.10 mg/dL
Interval 0.05 to 0.3
|
0.10 mg/dL
Interval 0.1 to 0.3
|
0.15 mg/dL
Interval 0.05 to 0.2
|
0.10 mg/dL
Interval 0.05 to 0.1
|
0.30 mg/dL
Interval 0.05 to 0.3
|
PRIMARY outcome
Timeframe: At Day 1Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
The levels of C-reactive protein are expressed in milligram per deciliter (mg/dL).
Outcome measures
| Measure |
M72/AS01B Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
M72/AS02A Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Mtb72F/AS02A Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Non-adjuvanted Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator GSK Biologicals' candidate recombinant M. tuberculosis vaccine, non-adjuvanted, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Control Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the adjuvant system alone, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
|---|---|---|---|---|---|
|
Levels of C-reactive Protein
|
1.45 mg/dL
Interval 0.65 to 2.35
|
1.05 mg/dL
Interval 0.7 to 1.5
|
0.70 mg/dL
Interval 0.6 to 1.0
|
0.10 mg/dL
Interval 0.05 to 0.1
|
1.10 mg/dL
Interval 0.6 to 1.7
|
PRIMARY outcome
Timeframe: At Day 7Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
The levels of C-reactive protein are expressed in milligram per deciliter (mg/dL).
Outcome measures
| Measure |
M72/AS01B Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
M72/AS02A Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Mtb72F/AS02A Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Non-adjuvanted Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator GSK Biologicals' candidate recombinant M. tuberculosis vaccine, non-adjuvanted, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Control Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the adjuvant system alone, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
|---|---|---|---|---|---|
|
Levels of C-reactive Protein
|
0.20 mg/dL
Interval 0.1 to 0.3
|
0.20 mg/dL
Interval 0.1 to 0.3
|
0.20 mg/dL
Interval 0.1 to 0.6
|
0.10 mg/dL
Interval 0.05 to 0.2
|
0.15 mg/dL
Interval 0.1 to 0.3
|
PRIMARY outcome
Timeframe: At Day 30Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
The levels of C-reactive protein are expressed in milligram per deciliter (mg/dL).
Outcome measures
| Measure |
M72/AS01B Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
M72/AS02A Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Mtb72F/AS02A Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Non-adjuvanted Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator GSK Biologicals' candidate recombinant M. tuberculosis vaccine, non-adjuvanted, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Control Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the adjuvant system alone, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
|---|---|---|---|---|---|
|
Levels of C-reactive Protein
|
0.10 mg/dL
Interval 0.05 to 0.2
|
0.10 mg/dL
Interval 0.08 to 0.2
|
0.10 mg/dL
Interval 0.05 to 0.2
|
0.10 mg/dL
Interval 0.05 to 0.1
|
0.20 mg/dL
Interval 0.1 to 0.4
|
PRIMARY outcome
Timeframe: At Day 31Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
The levels of C-reactive protein are expressed in milligram per deciliter (mg/dL).
Outcome measures
| Measure |
M72/AS01B Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
M72/AS02A Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Mtb72F/AS02A Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Non-adjuvanted Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator GSK Biologicals' candidate recombinant M. tuberculosis vaccine, non-adjuvanted, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Control Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the adjuvant system alone, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
|---|---|---|---|---|---|
|
Levels of C-reactive Protein
|
1.65 mg/dL
Interval 1.0 to 2.45
|
1.25 mg/dL
Interval 0.8 to 2.05
|
1.15 mg/dL
Interval 0.6 to 1.6
|
0.10 mg/dL
Interval 0.05 to 0.2
|
0.75 mg/dL
Interval 0.6 to 1.4
|
PRIMARY outcome
Timeframe: At Day 37Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
The levels of C-reactive protein are expressed in milligram per deciliter (mg/dL).
Outcome measures
| Measure |
M72/AS01B Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
M72/AS02A Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Mtb72F/AS02A Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Non-adjuvanted Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator GSK Biologicals' candidate recombinant M. tuberculosis vaccine, non-adjuvanted, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Control Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the adjuvant system alone, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
|---|---|---|---|---|---|
|
Levels of C-reactive Protein
|
0.30 mg/dL
Interval 0.2 to 0.6
|
0.20 mg/dL
Interval 0.2 to 0.4
|
0.20 mg/dL
Interval 0.2 to 0.3
|
0.10 mg/dL
Interval 0.05 to 0.1
|
0.25 mg/dL
Interval 0.1 to 0.4
|
PRIMARY outcome
Timeframe: At Day 0Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
The levels of Immunoglobulin E are expressed in 1000 units per liter (1000 U/L).
Outcome measures
| Measure |
M72/AS01B Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
M72/AS02A Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Mtb72F/AS02A Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Non-adjuvanted Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator GSK Biologicals' candidate recombinant M. tuberculosis vaccine, non-adjuvanted, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Control Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the adjuvant system alone, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
|---|---|---|---|---|---|
|
Levels of Immunoglobulin E
|
30.10 1000 U/L
Interval 14.85 to 160.5
|
61.55 1000 U/L
Interval 25.0 to 122.5
|
46.75 1000 U/L
Interval 14.9 to 99.8
|
39.55 1000 U/L
Interval 14.3 to 49.9
|
45.25 1000 U/L
Interval 28.2 to 82.4
|
PRIMARY outcome
Timeframe: At Day 1Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
The levels of Immunoglobulin E are expressed in 1000 units per liter (1000 U/L).
Outcome measures
| Measure |
M72/AS01B Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
M72/AS02A Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Mtb72F/AS02A Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Non-adjuvanted Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator GSK Biologicals' candidate recombinant M. tuberculosis vaccine, non-adjuvanted, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Control Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the adjuvant system alone, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
|---|---|---|---|---|---|
|
Levels of Immunoglobulin E
|
29.55 1000 U/L
Interval 13.8 to 159.0
|
61.90 1000 U/L
Interval 27.7 to 132.0
|
46.50 1000 U/L
Interval 13.6 to 95.3
|
41.05 1000 U/L
Interval 11.2 to 49.3
|
41.75 1000 U/L
Interval 30.1 to 78.8
|
PRIMARY outcome
Timeframe: At Day 7Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
The levels of Immunoglobulin E are expressed in 1000 units per liter (1000 U/L).
Outcome measures
| Measure |
M72/AS01B Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
M72/AS02A Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Mtb72F/AS02A Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Non-adjuvanted Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator GSK Biologicals' candidate recombinant M. tuberculosis vaccine, non-adjuvanted, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Control Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the adjuvant system alone, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
|---|---|---|---|---|---|
|
Levels of Immunoglobulin E
|
36.10 1000 U/L
Interval 14.6 to 160.5
|
65.50 1000 U/L
Interval 29.8 to 127.0
|
43.25 1000 U/L
Interval 13.8 to 78.5
|
38.00 1000 U/L
Interval 15.7 to 47.1
|
45.80 1000 U/L
Interval 27.7 to 77.6
|
PRIMARY outcome
Timeframe: At Day 30Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
The levels of Immunoglobulin E are expressed in 1000 units per liter (1000 U/L).
Outcome measures
| Measure |
M72/AS01B Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
M72/AS02A Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Mtb72F/AS02A Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Non-adjuvanted Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator GSK Biologicals' candidate recombinant M. tuberculosis vaccine, non-adjuvanted, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Control Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the adjuvant system alone, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
|---|---|---|---|---|---|
|
Levels of Immunoglobulin E
|
31.05 1000 U/L
Interval 13.7 to 149.0
|
58.60 1000 U/L
Interval 29.25 to 131.0
|
43.70 1000 U/L
Interval 15.9 to 66.9
|
38.10 1000 U/L
Interval 12.6 to 44.2
|
43.55 1000 U/L
Interval 27.1 to 67.9
|
PRIMARY outcome
Timeframe: At Day 31Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
The levels of Immunoglobulin E are expressed in 1000 units per liter (1000 U/L).
Outcome measures
| Measure |
M72/AS01B Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
M72/AS02A Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Mtb72F/AS02A Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Non-adjuvanted Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator GSK Biologicals' candidate recombinant M. tuberculosis vaccine, non-adjuvanted, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Control Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the adjuvant system alone, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
|---|---|---|---|---|---|
|
Levels of Immunoglobulin E
|
34.20 1000 U/L
Interval 14.9 to 156.0
|
64.10 1000 U/L
Interval 29.8 to 126.0
|
46.40 1000 U/L
Interval 14.4 to 71.2
|
39.05 1000 U/L
Interval 13.0 to 45.3
|
45.35 1000 U/L
Interval 25.7 to 72.3
|
PRIMARY outcome
Timeframe: At Day 37Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
The levels of Immunoglobulin E are expressed in 1000 units per liter (1000 U/L).
Outcome measures
| Measure |
M72/AS01B Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
M72/AS02A Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Mtb72F/AS02A Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Non-adjuvanted Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator GSK Biologicals' candidate recombinant M. tuberculosis vaccine, non-adjuvanted, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Control Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the adjuvant system alone, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
|---|---|---|---|---|---|
|
Levels of Immunoglobulin E
|
35.00 1000 U/L
Interval 14.3 to 159.5
|
60.35 1000 U/L
Interval 28.8 to 154.5
|
49.15 1000 U/L
Interval 16.4 to 77.1
|
40.85 1000 U/L
Interval 13.6 to 44.9
|
44.20 1000 U/L
Interval 26.1 to 68.8
|
SECONDARY outcome
Timeframe: At Day 0, prior to Dose 2 (Month 1), 1 month post-Dose 2 (Month 2) and Year 1 (Month 12)Population: The analysis was performed on the According to protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in Enzyme-Linked Immunosorbent Assay (ELISA) units per milliliter (EU/mL). The reference seropositivity cut-off values for anti-M72 and anti-Mtb72F antibodies were ≥ 2.8 EU/mL and ≥ 1.0 EU/mL, respectively.
Outcome measures
| Measure |
M72/AS01B Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
M72/AS02A Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Mtb72F/AS02A Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Non-adjuvanted Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator GSK Biologicals' candidate recombinant M. tuberculosis vaccine, non-adjuvanted, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Control Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the adjuvant system alone, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
|---|---|---|---|---|---|
|
Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F
Anti-M72, Day 0
|
1.4 EU/mL
Interval 1.4 to 1.4
|
1.4 EU/mL
Interval 1.4 to 1.4
|
1.4 EU/mL
Interval 1.4 to 1.4
|
1.4 EU/mL
Interval 1.4 to 1.4
|
1.4 EU/mL
Interval 1.4 to 1.4
|
|
Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F
Anti-M72, Month 1
|
24.7 EU/mL
Interval 18.6 to 33.0
|
10.4 EU/mL
Interval 7.8 to 13.8
|
14.4 EU/mL
Interval 8.2 to 25.1
|
1.8 EU/mL
Interval 1.0 to 3.0
|
1.4 EU/mL
Interval 1.4 to 1.4
|
|
Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F
Anti-M72, Month 2
|
722.6 EU/mL
Interval 583.5 to 894.9
|
470.8 EU/mL
Interval 394.0 to 562.5
|
491.9 EU/mL
Interval 306.4 to 789.5
|
5.3 EU/mL
Interval 1.5 to 18.2
|
1.4 EU/mL
Interval 1.4 to 1.4
|
|
Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F
Anti-M72, Month 12
|
59.5 EU/mL
Interval 48.8 to 72.6
|
42.5 EU/mL
Interval 34.2 to 52.6
|
43.2 EU/mL
Interval 25.3 to 73.8
|
2.7 EU/mL
Interval 1.3 to 5.7
|
1.4 EU/mL
Interval 1.4 to 1.4
|
|
Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F
Anti-Mtb72F, Day 0
|
0.5 EU/mL
Interval 0.5 to 0.5
|
0.5 EU/mL
Interval 0.5 to 0.5
|
0.5 EU/mL
Interval 0.5 to 0.5
|
0.5 EU/mL
Interval 0.5 to 0.5
|
0.5 EU/mL
Interval 0.5 to 0.5
|
|
Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F
Anti-Mtb72F, Month 1
|
27.6 EU/mL
Interval 20.8 to 36.8
|
11.5 EU/mL
Interval 8.7 to 15.1
|
16.0 EU/mL
Interval 9.3 to 27.8
|
0.8 EU/mL
Interval 0.4 to 1.9
|
0.5 EU/mL
Interval 0.5 to 0.5
|
|
Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F
Anti-Mtb72F, Month 12
|
731.6 EU/mL
Interval 589.0 to 908.8
|
473.1 EU/mL
Interval 398.0 to 562.4
|
512.1 EU/mL
Interval 314.6 to 833.6
|
3.2 EU/mL
Interval 0.7 to 15.5
|
0.5 EU/mL
Interval 0.5 to 0.5
|
|
Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F
Anti-Mtb72F, Month 2
|
44.7 EU/mL
Interval 36.2 to 55.2
|
30.1 EU/mL
Interval 24.4 to 37.1
|
31.6 EU/mL
Interval 19.3 to 51.7
|
1.4 EU/mL
Interval 0.5 to 3.8
|
0.5 EU/mL
Interval 0.5 to 0.5
|
SECONDARY outcome
Timeframe: At Year 2 (Month 24) and Year 3 (Month 36)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the Month 24 and Month 36 time points (M72/AS01B group and M72/AS02A group).
Antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EU/mL). The reference seropositivity cut-off value for anti-M72 antibodies was ≥ 2.8 EU/mL.
Outcome measures
| Measure |
M72/AS01B Group
n=31 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
M72/AS02A Group
n=37 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Mtb72F/AS02A Group
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Non-adjuvanted Group
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator GSK Biologicals' candidate recombinant M. tuberculosis vaccine, non-adjuvanted, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Control Group
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the adjuvant system alone, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
|---|---|---|---|---|---|
|
Antibody Concentrations Against M. Tuberculosis Fusion Protein M72
Anti-M72, Month 24
|
38.9 EU/mL
Interval 29.5 to 51.1
|
21.6 EU/mL
Interval 17.0 to 27.6
|
—
|
—
|
—
|
|
Antibody Concentrations Against M. Tuberculosis Fusion Protein M72
Anti-M72, Month 36
|
29.2 EU/mL
Interval 21.0 to 40.6
|
19.3 EU/mL
Interval 14.0 to 26.6
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0, prior to Dose 2 (Month 1), 1 month post-Dose 2 (Month 2) and Year 1 (Month 12)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Among cytokines expressed were interleukin-2 \[IL-2\] and/or interferon-gamma \[IFN-γ\] and/or tumour necrosis factor-alpha \[TNF-α\] and/or cluster of differentiation 40-ligand \[CD40-L\]. The analysis of cytokines expression was performed by flow cytometry using intracellular cytokine staining (ICS) on frozen peripheral blood mononuclear cell (PBMCs). Note: No vaccine induced responses were observed for CD8+ T-cells, so no results are presented throughout the record.
Outcome measures
| Measure |
M72/AS01B Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
M72/AS02A Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Mtb72F/AS02A Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Non-adjuvanted Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator GSK Biologicals' candidate recombinant M. tuberculosis vaccine, non-adjuvanted, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Control Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the adjuvant system alone, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
|---|---|---|---|---|---|
|
Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/CD8+) T-cells Expressing at Least Two Different Cytokines
CD4+ All doubles, Day 0
|
90.5 CD4+ T-cells/million cells
Interval 17.5 to 149.0
|
65.5 CD4+ T-cells/million cells
Interval 1.0 to 121.5
|
58.0 CD4+ T-cells/million cells
Interval 1.0 to 131.0
|
134.5 CD4+ T-cells/million cells
Interval 1.0 to 186.0
|
45.0 CD4+ T-cells/million cells
Interval 1.0 to 107.0
|
|
Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/CD8+) T-cells Expressing at Least Two Different Cytokines
CD4+ All doubles, Month 1
|
955.5 CD4+ T-cells/million cells
Interval 629.0 to 1395.0
|
484.0 CD4+ T-cells/million cells
Interval 351.0 to 873.0
|
745.5 CD4+ T-cells/million cells
Interval 515.0 to 818.0
|
173.0 CD4+ T-cells/million cells
Interval 4.0 to 323.0
|
95.5 CD4+ T-cells/million cells
Interval 30.0 to 160.0
|
|
Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/CD8+) T-cells Expressing at Least Two Different Cytokines
CD4+ All doubles, Month 2
|
2641.0 CD4+ T-cells/million cells
Interval 2029.0 to 4080.0
|
1589.0 CD4+ T-cells/million cells
Interval 1206.0 to 2241.0
|
2082.5 CD4+ T-cells/million cells
Interval 1451.0 to 2403.0
|
278.0 CD4+ T-cells/million cells
Interval 80.0 to 514.0
|
43.0 CD4+ T-cells/million cells
Interval 1.0 to 139.0
|
|
Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/CD8+) T-cells Expressing at Least Two Different Cytokines
CD4+ All doubles, Month 12
|
1282.0 CD4+ T-cells/million cells
Interval 940.0 to 1613.0
|
769.0 CD4+ T-cells/million cells
Interval 492.0 to 1161.0
|
642.0 CD4+ T-cells/million cells
Interval 504.0 to 758.0
|
153.5 CD4+ T-cells/million cells
Interval 1.0 to 226.0
|
82.0 CD4+ T-cells/million cells
Interval 1.0 to 165.0
|
SECONDARY outcome
Timeframe: At Year 2 (Month 24) and Year 3 (Month 36)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the Month 24 and Month 36 time points (M72/AS01B group and M72/AS02A group).
Among cytokines expressed were interleukin-2 \[IL-2\] and/or interferon-gamma \[IFN-γ\] and/or tumour necrosis factor-alpha \[TNF-α\] and/or cluster of differentiation 40-ligand \[CD40-L\]. The analysis of cytokines expression was performed by flow cytometry using intracellular cytokine staining (ICS) on frozen peripheral blood mononuclear cell (PBMCs).
Outcome measures
| Measure |
M72/AS01B Group
n=31 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
M72/AS02A Group
n=37 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Mtb72F/AS02A Group
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Non-adjuvanted Group
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator GSK Biologicals' candidate recombinant M. tuberculosis vaccine, non-adjuvanted, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Control Group
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the adjuvant system alone, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
|---|---|---|---|---|---|
|
Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least Two Different Cytokines
CD4+ All doubles, Month 24
|
1506.0 CD4+ T-cells/million cells
Interval 1000.0 to 2200.0
|
826.0 CD4+ T-cells/million cells
Interval 520.0 to 1293.0
|
—
|
—
|
—
|
|
Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least Two Different Cytokines
CD4+ All doubles, Month 36
|
1313.0 CD4+ T-cells/million cells
Interval 1013.5 to 1886.5
|
507.0 CD4+ T-cells/million cells
Interval 373.0 to 800.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0, prior to Dose 2 (Month 1), 1 month post-Dose 2 (Month 2) and Year 1 (Month 12)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Expressed cytokine combinations for CD4+ T-cells were CD40-L and interleukin-2 \[IL-2\] or interferon-gamma \[IFN-γ\] or tumour necrosis factor-alpha \[TNF-α\]; IL-2 and CD40-L, or IFN-γ, or TNF-α; IFN-γ and CD40-L, or IL-2, or TNF-α; TNF-α and CD40-L, or IL-2, or IFN-γ.
Outcome measures
| Measure |
M72/AS01B Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
M72/AS02A Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Mtb72F/AS02A Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Non-adjuvanted Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator GSK Biologicals' candidate recombinant M. tuberculosis vaccine, non-adjuvanted, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Control Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the adjuvant system alone, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
|---|---|---|---|---|---|
|
Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule
CD4+ CD40-L, Day 0
|
63.0 CD4+ T-cells/million cells
Interval 27.5 to 146.5
|
50.0 CD4+ T-cells/million cells
Interval 1.5 to 129.5
|
90.0 CD4+ T-cells/million cells
Interval 1.0 to 156.0
|
81.5 CD4+ T-cells/million cells
Interval 1.0 to 143.0
|
37.0 CD4+ T-cells/million cells
Interval 1.0 to 89.0
|
|
Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule
CD4+ CD40-L, Month 1
|
883.0 CD4+ T-cells/million cells
Interval 505.5 to 1282.0
|
420.5 CD4+ T-cells/million cells
Interval 281.0 to 782.0
|
715.0 CD4+ T-cells/million cells
Interval 435.0 to 818.0
|
158.5 CD4+ T-cells/million cells
Interval 3.0 to 263.0
|
56.5 CD4+ T-cells/million cells
Interval 28.0 to 137.0
|
|
Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule
CD4+ CD40-L, Month 2
|
2333.0 CD4+ T-cells/million cells
Interval 1877.0 to 3605.0
|
1466.0 CD4+ T-cells/million cells
Interval 1077.0 to 2167.0
|
1997.5 CD4+ T-cells/million cells
Interval 1413.0 to 2208.0
|
238.0 CD4+ T-cells/million cells
Interval 102.0 to 418.0
|
29.0 CD4+ T-cells/million cells
Interval 1.0 to 127.0
|
|
Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule
CD4+ CD40-L, Month 12
|
1234.0 CD4+ T-cells/million cells
Interval 881.0 to 1562.0
|
718.0 CD4+ T-cells/million cells
Interval 474.0 to 1074.0
|
597.0 CD4+ T-cells/million cells
Interval 496.0 to 694.0
|
137.0 CD4+ T-cells/million cells
Interval 1.0 to 253.0
|
77.5 CD4+ T-cells/million cells
Interval 1.0 to 166.0
|
|
Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule
CD4+ TNF-α, Day 0
|
65.0 CD4+ T-cells/million cells
Interval 2.5 to 121.0
|
33.5 CD4+ T-cells/million cells
Interval 1.0 to 79.5
|
45.0 CD4+ T-cells/million cells
Interval 1.0 to 63.0
|
34.0 CD4+ T-cells/million cells
Interval 1.0 to 204.0
|
40.5 CD4+ T-cells/million cells
Interval 1.0 to 97.0
|
|
Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule
CD4+ TNF-α, Month 1
|
466.0 CD4+ T-cells/million cells
Interval 330.0 to 684.5
|
250.0 CD4+ T-cells/million cells
Interval 104.0 to 410.0
|
291.5 CD4+ T-cells/million cells
Interval 243.0 to 465.0
|
59.0 CD4+ T-cells/million cells
Interval 2.0 to 219.0
|
82.0 CD4+ T-cells/million cells
Interval 35.0 to 113.0
|
|
Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule
CD4+ TNF-α, Month 2
|
1394.0 CD4+ T-cells/million cells
Interval 954.0 to 1964.0
|
744.0 CD4+ T-cells/million cells
Interval 512.0 to 1293.0
|
863.0 CD4+ T-cells/million cells
Interval 727.0 to 1133.0
|
110.5 CD4+ T-cells/million cells
Interval 1.0 to 225.0
|
15.5 CD4+ T-cells/million cells
Interval 1.0 to 111.0
|
|
Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule
CD4+ TNF-α, Month 12
|
545.0 CD4+ T-cells/million cells
Interval 377.0 to 821.0
|
321.0 CD4+ T-cells/million cells
Interval 221.0 to 515.0
|
314.0 CD4+ T-cells/million cells
Interval 166.0 to 434.0
|
50.0 CD4+ T-cells/million cells
Interval 4.0 to 140.0
|
1.0 CD4+ T-cells/million cells
Interval 1.0 to 76.0
|
|
Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule
CD4+ IL-2, Day 0
|
41.5 CD4+ T-cells/million cells
Interval 2.0 to 107.5
|
44.5 CD4+ T-cells/million cells
Interval 1.5 to 101.0
|
41.0 CD4+ T-cells/million cells
Interval 1.0 to 156.0
|
50.5 CD4+ T-cells/million cells
Interval 1.0 to 153.0
|
54.0 CD4+ T-cells/million cells
Interval 1.0 to 74.0
|
|
Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule
CD4+ IL-2, Month 1
|
886.5 CD4+ T-cells/million cells
Interval 494.5 to 1359.0
|
451.5 CD4+ T-cells/million cells
Interval 297.0 to 762.0
|
732.0 CD4+ T-cells/million cells
Interval 446.0 to 831.0
|
141.0 CD4+ T-cells/million cells
Interval 1.0 to 254.0
|
62.0 CD4+ T-cells/million cells
Interval 16.0 to 80.0
|
|
Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule
CD4+ IL-2, Month 2
|
2325.0 CD4+ T-cells/million cells
Interval 1809.0 to 3338.0
|
1489.0 CD4+ T-cells/million cells
Interval 1096.0 to 2107.0
|
1729.5 CD4+ T-cells/million cells
Interval 1304.0 to 2130.0
|
223.5 CD4+ T-cells/million cells
Interval 95.0 to 450.0
|
29.0 CD4+ T-cells/million cells
Interval 1.0 to 138.0
|
|
Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule
CD4+ IL-2, Month 12
|
1212.0 CD4+ T-cells/million cells
Interval 803.0 to 1530.0
|
650.0 CD4+ T-cells/million cells
Interval 437.0 to 1054.0
|
569.0 CD4+ T-cells/million cells
Interval 443.0 to 672.0
|
98.0 CD4+ T-cells/million cells
Interval 1.0 to 212.0
|
77.5 CD4+ T-cells/million cells
Interval 14.0 to 110.0
|
|
Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule
CD4+ IFN-γ, Day 0
|
34.5 CD4+ T-cells/million cells
Interval 1.0 to 94.5
|
34.5 CD4+ T-cells/million cells
Interval 1.0 to 70.0
|
35.0 CD4+ T-cells/million cells
Interval 21.0 to 100.0
|
46.5 CD4+ T-cells/million cells
Interval 1.0 to 75.0
|
57.0 CD4+ T-cells/million cells
Interval 22.0 to 82.0
|
|
Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule
CD4+ IFN-γ, Month 1
|
168.5 CD4+ T-cells/million cells
Interval 91.5 to 479.5
|
112.0 CD4+ T-cells/million cells
Interval 41.0 to 197.0
|
107.0 CD4+ T-cells/million cells
Interval 97.0 to 188.0
|
33.0 CD4+ T-cells/million cells
Interval 1.0 to 138.0
|
62.5 CD4+ T-cells/million cells
Interval 22.0 to 80.0
|
|
Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule
CD4+ IFN-γ, Month 2
|
820.0 CD4+ T-cells/million cells
Interval 370.0 to 1277.0
|
275.0 CD4+ T-cells/million cells
Interval 84.0 to 502.0
|
335.0 CD4+ T-cells/million cells
Interval 148.0 to 529.0
|
58.0 CD4+ T-cells/million cells
Interval 42.0 to 109.0
|
1.0 CD4+ T-cells/million cells
Interval 1.0 to 33.0
|
|
Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule
CD4+ IFN-γ, Month 12
|
317.0 CD4+ T-cells/million cells
Interval 164.0 to 471.0
|
109.0 CD4+ T-cells/million cells
Interval 57.0 to 160.0
|
120.0 CD4+ T-cells/million cells
Interval 59.0 to 224.0
|
27.5 CD4+ T-cells/million cells
Interval 1.0 to 88.0
|
41.5 CD4+ T-cells/million cells
Interval 1.0 to 72.0
|
SECONDARY outcome
Timeframe: At Year 2 (Month 24) and Year 3 (Month 36)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the Month 24 and Month 36 time points (M72/AS01B group and M72/AS02A group).
Expressed cytokine combinations for CD4+ T cells were CD40-L and interleukin-2 \[IL-2\] or interferon-gamma \[IFN-γ\] or tumour necrosis factor-alpha \[TNF-α\]; IL-2 and CD40-L, or IFN-γ, or TNF-α; IFN-γ and CD40-L, or IL-2, or TNF-α; TNF-α and CD40-L, or IL-2, or IFN-γ.
Outcome measures
| Measure |
M72/AS01B Group
n=31 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
M72/AS02A Group
n=37 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Mtb72F/AS02A Group
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Non-adjuvanted Group
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator GSK Biologicals' candidate recombinant M. tuberculosis vaccine, non-adjuvanted, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Control Group
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the adjuvant system alone, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
|---|---|---|---|---|---|
|
Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule
CD4+ CD40-L, Month 24
|
1467.0 CD4+ T-cells/million cells
Interval 973.0 to 1920.0
|
800.0 CD4+ T-cells/million cells
Interval 520.0 to 1293.0
|
—
|
—
|
—
|
|
Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule
CD4+ CD40-L, Month 36
|
1106.5 CD4+ T-cells/million cells
Interval 900.0 to 1846.5
|
493.5 CD4+ T-cells/million cells
Interval 373.0 to 773.0
|
—
|
—
|
—
|
|
Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule
CD4+ TNF-α, Month 24
|
574.0 CD4+ T-cells/million cells
Interval 426.0 to 1226.0
|
307.0 CD4+ T-cells/million cells
Interval 227.0 to 560.0
|
—
|
—
|
—
|
|
Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule
CD4+ TNF-α, Month 36
|
833.5 CD4+ T-cells/million cells
Interval 593.5 to 1170.0
|
293.0 CD4+ T-cells/million cells
Interval 214.0 to 454.0
|
—
|
—
|
—
|
|
Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule
CD4+ IL-2, Month 24
|
1320.0 CD4+ T-cells/million cells
Interval 906.0 to 1800.0
|
787.0 CD4+ T-cells/million cells
Interval 520.0 to 1174.0
|
—
|
—
|
—
|
|
Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule
CD4+ IL-2, Month 36
|
1087.0 CD4+ T-cells/million cells
Interval 799.5 to 1727.0
|
479.5 CD4+ T-cells/million cells
Interval 307.0 to 693.0
|
—
|
—
|
—
|
|
Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule
CD4+ IFN-γ, Month 24
|
387.0 CD4+ T-cells/million cells
Interval 226.0 to 894.0
|
200.0 CD4+ T-cells/million cells
Interval 134.0 to 254.0
|
—
|
—
|
—
|
|
Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule
CD4+ IFN-γ, Month 36
|
373.0 CD4+ T-cells/million cells
Interval 152.5 to 700.0
|
106.5 CD4+ T-cells/million cells
Interval 66.0 to 187.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0, prior to Dose 2 (Month 1), 1 month post-Dose 2 (Month 2) and Year 1 (Month 12)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
The cut-off value used for analysis of the frequency of cells expressing cytokines/immune markers was the 313 CD4+ T-cells per million CD4+ T-cells, i.e. the 95th percentile of the pre-vaccination level of cells expressing cytokines/immune markers.
Outcome measures
| Measure |
M72/AS01B Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
M72/AS02A Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Mtb72F/AS02A Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Non-adjuvanted Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator GSK Biologicals' candidate recombinant M. tuberculosis vaccine, non-adjuvanted, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Control Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the adjuvant system alone, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
|---|---|---|---|---|---|
|
Number of Subjects With Response to M72-specific CD4+ T-cells Secreting at Least Two Different Cytokines/Activation Markers
Day 0
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Response to M72-specific CD4+ T-cells Secreting at Least Two Different Cytokines/Activation Markers
Month 1
|
38 Participants
|
33 Participants
|
9 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Response to M72-specific CD4+ T-cells Secreting at Least Two Different Cytokines/Activation Markers
Month 2
|
39 Participants
|
39 Participants
|
10 Participants
|
5 Participants
|
0 Participants
|
|
Number of Subjects With Response to M72-specific CD4+ T-cells Secreting at Least Two Different Cytokines/Activation Markers
Month 12
|
39 Participants
|
35 Participants
|
8 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At Year 2 (Month 24) and Year 3 (Month 36)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the Month 24 and Month 36 time points (M72/AS01B group and M72/AS02A group).
The cut-off value used for analysis of the frequency of cells expressing cytokines/immune markers was the 313 CD4+ T-cells per million CD4+ T-cells, i.e. the 95th percentile of the pre-vaccination level of cells expressing cytokines/immune markers.
Outcome measures
| Measure |
M72/AS01B Group
n=31 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
M72/AS02A Group
n=37 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Mtb72F/AS02A Group
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Non-adjuvanted Group
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator GSK Biologicals' candidate recombinant M. tuberculosis vaccine, non-adjuvanted, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Control Group
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the adjuvant system alone, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
|---|---|---|---|---|---|
|
Number of Subjects With Response to M72-specific CD4+ T-cells Secreting at Least Two Different Cytokines/Activation Markers
Month 24
|
31 Participants
|
36 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Response to M72-specific CD4+ T-cells Secreting at Least Two Different Cytokines/Activation Markers
Month 36
|
24 Participants
|
23 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Prior to (Day 0 and Day 30) and one day (Day 1 and Day 31) after each vaccinationPopulation: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Concentrations are presented as geometric mean concentrations (GMCs), expressed in picogram per milliliter (pg/mL). The reference seropositivity cut-off value was equal to or above (≥) 1 pg/mL.
Outcome measures
| Measure |
M72/AS01B Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
M72/AS02A Group
n=40 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Mtb72F/AS02A Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Non-adjuvanted Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator GSK Biologicals' candidate recombinant M. tuberculosis vaccine, non-adjuvanted, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Control Group
n=10 Participants
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the adjuvant system alone, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
|---|---|---|---|---|---|
|
Concentrations of IFN-γ Produced in Serum Samples
IFN-γ, Day 0
|
0.6 pg/mL
Interval 0.5 to 0.6
|
0.6 pg/mL
Interval 0.5 to 0.6
|
0.6 pg/mL
Interval 0.4 to 0.9
|
1.0 pg/mL
Interval 0.4 to 2.2
|
1.0 pg/mL
Interval 0.4 to 2.7
|
|
Concentrations of IFN-γ Produced in Serum Samples
IFN-γ, Day 1
|
4.5 pg/mL
Interval 2.8 to 7.1
|
1.0 pg/mL
Interval 0.7 to 1.5
|
2.2 pg/mL
Interval 0.7 to 6.6
|
0.7 pg/mL
Interval 0.3 to 1.3
|
3.3 pg/mL
Interval 0.8 to 14.2
|
|
Concentrations of IFN-γ Produced in Serum Samples
IFN-γ, Day 30
|
0.6 pg/mL
Interval 0.5 to 0.7
|
0.6 pg/mL
Interval 0.5 to 0.7
|
0.6 pg/mL
Interval 0.4 to 1.0
|
1.1 pg/mL
Interval 0.4 to 2.7
|
1.1 pg/mL
Interval 0.3 to 3.5
|
|
Concentrations of IFN-γ Produced in Serum Samples
IFN-γ, Day 31
|
77.2 pg/mL
Interval 57.8 to 103.0
|
20.1 pg/mL
Interval 13.2 to 30.4
|
23.4 pg/mL
Interval 7.4 to 73.6
|
1.4 pg/mL
Interval 0.5 to 3.8
|
4.1 pg/mL
Interval 1.2 to 14.7
|
Adverse Events
Non-adjuvanted Group
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Control Group
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
M72/AS01B Group
Serious events: 2 serious events
Other events: 40 other events
Deaths: 0 deaths
M72/AS02A Group
Serious events: 0 serious events
Other events: 40 other events
Deaths: 0 deaths
Mtb72F/AS02A Group
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Non-adjuvanted Group
n=10 participants at risk
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator GSK Biologicals' candidate recombinant M. tuberculosis vaccine, non-adjuvanted, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Control Group
n=10 participants at risk
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the adjuvant system alone, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
M72/AS01B Group
n=40 participants at risk
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
M72/AS02A Group
n=40 participants at risk
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Mtb72F/AS02A Group
n=10 participants at risk
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
|---|---|---|---|---|---|
|
Congenital, familial and genetic disorders
Ventricular septal defect
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
0.00%
0/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
0.00%
0/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
2.5%
1/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
0.00%
0/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
0.00%
0/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
0.00%
0/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
2.5%
1/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
0.00%
0/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
Other adverse events
| Measure |
Non-adjuvanted Group
n=10 participants at risk
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator GSK Biologicals' candidate recombinant M. tuberculosis vaccine, non-adjuvanted, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Control Group
n=10 participants at risk
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the adjuvant system alone, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
M72/AS01B Group
n=40 participants at risk
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
M72/AS02A Group
n=40 participants at risk
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
Mtb72F/AS02A Group
n=10 participants at risk
Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
0.00%
0/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
5.0%
2/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
2.5%
1/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
5.0%
2/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
|
Gastrointestinal disorders
Constipation
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
0.00%
0/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
0.00%
0/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
|
Respiratory, thoracic and mediastinal disorders
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
5.0%
2/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
2.5%
1/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
0.00%
0/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
0.00%
0/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
2.5%
1/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
5.0%
2/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
7.5%
3/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
0.00%
0/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
|
Gastrointestinal disorders
Dyspepsia
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
0.00%
0/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
0.00%
0/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
32.5%
13/40 • Number of events 15 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
10.0%
4/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
|
General disorders
Fatigue
|
30.0%
3/10 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
60.0%
6/10 • Number of events 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
90.0%
36/40 • Number of events 61 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
72.5%
29/40 • Number of events 46 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
80.0%
8/10 • Number of events 13 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
|
General disorders
Feeling of body temperature change
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
5.0%
2/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
10.0%
4/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
|
Gastrointestinal disorders
Gastritis
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
0.00%
0/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
2.5%
1/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
|
Infections and infestations
Gastroenteritis
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
5.0%
2/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
10.0%
4/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
|
Infections and infestations
Gastroenteritis viral
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
0.00%
0/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
0.00%
0/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
20.0%
2/10 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
57.5%
23/40 • Number of events 27 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
25.0%
10/40 • Number of events 17 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
|
Infections and infestations
Genital candidiasis
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
0.00%
0/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
0.00%
0/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
|
Nervous system disorders
Headache
|
40.0%
4/10 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
60.0%
6/10 • Number of events 13 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
85.0%
34/40 • Number of events 61 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
67.5%
27/40 • Number of events 39 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
90.0%
9/10 • Number of events 17 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
17.5%
7/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
10.0%
4/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
|
Infections and infestations
Infection
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
0.00%
0/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
2.5%
1/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
25.0%
10/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
10.0%
4/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
|
General disorders
Injection site haematoma
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
0.00%
0/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
2.5%
1/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
|
General disorders
Injection site induration
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
2.5%
1/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
5.0%
2/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
|
General disorders
Injection site movement impairment
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
2.5%
1/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
2.5%
1/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
|
General disorders
Injection site paraesthesia
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
0.00%
0/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
0.00%
0/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
|
General disorders
Injection site warmth
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
5.0%
2/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
0.00%
0/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
|
Psychiatric disorders
Insomnia
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
2.5%
1/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
2.5%
1/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
|
Nervous system disorders
Lethargy
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
0.00%
0/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
2.5%
1/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
|
General disorders
Malaise
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
22.5%
9/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
10.0%
4/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
20.0%
2/10 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
10.0%
4/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
10.0%
4/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
22.5%
9/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
7.5%
3/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
5.0%
2/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
0.00%
0/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
|
Infections and infestations
Nasopharyngitis
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
60.0%
6/10 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
27.5%
11/40 • Number of events 12 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
20.0%
8/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
|
Gastrointestinal disorders
Nausea
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
2.5%
1/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
5.0%
2/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
2.5%
1/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
0.00%
0/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
0.00%
0/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
0.00%
0/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
15.0%
6/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
12.5%
5/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
|
General disorders
Pain
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
100.0%
10/10 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
100.0%
40/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
100.0%
40/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
100.0%
10/10 • Number of events 18 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
10.0%
1/10 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
62.5%
25/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
25.0%
10/40 • Number of events 12 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
40.0%
4/10 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
|
Infections and infestations
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
0.00%
0/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
2.5%
1/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
|
General disorders
Swelling
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
30.0%
3/10 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
22.5%
9/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
25.0%
10/40 • Number of events 17 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
|
Gastrointestinal disorders
Toothache
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
0.00%
0/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
0.00%
0/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
0.00%
0/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
0.00%
0/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
0.00%
0/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
0.00%
0/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
2.5%
1/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
2.5%
1/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
0.00%
0/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
0.00%
0/40 • 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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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 Day 0 up to Month 36) for the M72/AS01B Group and M72/AS02A Group, up to Month 12 for the Mtb72F/AS02A Group, Non-adjuvanted Group, and Control Group.
|
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