Trial Outcomes & Findings for Study to Evaluate the Efficacy of GlaxoSmithKline (GSK) Biologicals' Candidate Tuberculosis (TB) Vaccine in Adults (NCT NCT01755598)

Last Updated: 2019-12-03

Results Overview

The incidence rate of definite pulmonary TB disease (or 100 Person-years rate) was calculated as the number of subjects reporting at least one case (n) in a group, over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100. Case definition 1 = subject with clinical suspicion of pulmonary TB disease\*, with Mycobacterium tuberculosis (Mtb) complex identified from sputum specimen, taken before initiation of TB treatment, by Xpert MTB/RIF (Nucleic Acid Amplification Test to detect Mtb complex and resistance to rifampicin in sputum samples) and/or microbiological culture and confirmed Human Immunodeficiency Virus (HIV)-negative at the time of TB diagnosis. \*Clinical suspicion of pulmonary TB defined as subject presenting with 1 or more of the following symptoms: unexplained cough \> 2 weeks, unexplained fever \> 1 week, night sweats, unintentional weight loss, pleuritic chest pains, haemoptysis, fatigue or shortness of breath on exertion.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

3575 participants

Primary outcome timeframe

From Day 60 (i.e one month after Dose 2) up to Year 3: follow-up period for cases ends at the first occurrence of an event. For the non-cases: follow-up period ends at the date of the Month 36 visit or last contact date whichever comes first

Results posted on

2019-12-03

Participant Flow

Out of 3575 subjects enrolled in the study, 2 subjects did not get any vaccination and therefore were not included in any analysis.

Participant milestones

Participant milestones
Measure	M72AS01 Group Subjects, between, and including, 18 and 50 years of age, who received 2 doses of M72/AS01E according to random assignment, one month apart (Day 0 and Day 30) by intramuscular injection in the deltoid region of the arm.	Control Group Subjects, between, and including,18 and 50 years of age, who received 2 doses of Placebo according to random assignment, one month apart (Day 0 and Day 30) by intramuscular injection in the deltoid region of the arm.
Overall Study STARTED	1786	1787
Overall Study COMPLETED	1521	1504
Overall Study NOT COMPLETED	265	283

Reasons for withdrawal

Reasons for withdrawal
Measure	M72AS01 Group Subjects, between, and including, 18 and 50 years of age, who received 2 doses of M72/AS01E according to random assignment, one month apart (Day 0 and Day 30) by intramuscular injection in the deltoid region of the arm.	Control Group Subjects, between, and including,18 and 50 years of age, who received 2 doses of Placebo according to random assignment, one month apart (Day 0 and Day 30) by intramuscular injection in the deltoid region of the arm.
Overall Study Other	109	109
Overall Study Lost to Follow-up	32	43
Overall Study Migrated/moved from study area	76	65
Overall Study Withdrawal by Subject	22	31
Overall Study Protocol Violation	7	7
Overall Study Adverse Event	19	28

Baseline Characteristics

Study to Evaluate the Efficacy of GlaxoSmithKline (GSK) Biologicals' Candidate Tuberculosis (TB) Vaccine in Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	M72AS01 Group n=1786 Participants Subjects, between, and including, 18 and 50 years of age, who received 2 doses of M72/AS01E according to random assignment, one month apart (Day 0 and Day 30) by intramuscular injection in the deltoid region of the arm.	Control Group n=1787 Participants Subjects, between, and including,18 and 50 years of age, who received 2 doses of Placebo according to random assignment, one month apart (Day 0 and Day 30) by intramuscular injection in the deltoid region of the arm.	Total n=3573 Participants Total of all reporting groups
Age, Continuous	28.9 Years STANDARD_DEVIATION 8.3 • n=5 Participants	28.9 Years STANDARD_DEVIATION 8.3 • n=7 Participants	28.9 Years STANDARD_DEVIATION 8.3 • n=5 Participants
Sex: Female, Male Female	763 Participants n=5 Participants	766 Participants n=7 Participants	1529 Participants n=5 Participants
Sex: Female, Male Male	1023 Participants n=5 Participants	1021 Participants n=7 Participants	2044 Participants n=5 Participants
Race/Ethnicity, Customized African Heritage / African American	1346 Participants n=5 Participants	1329 Participants n=7 Participants	2675 Participants n=5 Participants
Race/Ethnicity, Customized Other, Not Specified	440 Participants n=5 Participants	458 Participants n=7 Participants	898 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Day 60 (i.e one month after Dose 2) up to Year 3: follow-up period for cases ends at the first occurrence of an event. For the non-cases: follow-up period ends at the date of the Month 36 visit or last contact date whichever comes first

Population: Analysis was performed on the According-to-Protocol cohort for efficacy which included all subjects who received all vaccinations according to protocol procedures within specified intervals that contributed time at risk in the follow-up period starting one month post dose 2 (Day 60).

Outcome measures

Outcome measures
Measure	Control Group n=1663 Participants Subjects, between, and including,18 and 50 years of age, who received 2 doses of Placebo according to random assignment, one month apart (Day 0 and Day 30) by intramuscular injection in the deltoid region of the arm.	M72AS01 Group n=1626 Participants Subjects, between, and including, 18 and 50 years of age, who received 2 doses of M72/AS01E according to random assignment, one month apart (Day 0 and Day 30) by intramuscular injection in the deltoid region of the arm.
Incident Rates of Definite Pulmonary Tuberculosis (TB) Disease, Not Associated With HIV-infection, Meeting the Case Definition 1	0.6 cases per 100 person-years Interval 0.4 to 0.8	0.3 cases per 100 person-years Interval 0.2 to 0.5

SECONDARY outcome

The incidence rate of definite Xpert MTB/Rif positive pulmonary TB disease, expressed in terms of 100 Person-years rate, was calculated as the number of subjects reporting at least one case (n) in a group over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100. Case definition 2 = a subject with clinical suspicion\* of pulmonary TB disease, with Mtb complex identified from a sputum specimen, taken before initiation of TB treatment, by Xpert MTB/RIF and confirmed HIV-negative at the time of TB diagnosis. \*Clinical suspicion of pulmonary TB was defined as a subject presenting with one or more of the following symptoms: unexplained cough \> 2 weeks, unexplained fever \> 1 week, night sweats, unintentional weight loss, pleuritic chest pains, haemoptysis, fatigue or shortness of breath on exertion.

Outcome measures

Outcome measures
Measure	Control Group n=1663 Participants Subjects, between, and including,18 and 50 years of age, who received 2 doses of Placebo according to random assignment, one month apart (Day 0 and Day 30) by intramuscular injection in the deltoid region of the arm.	M72AS01 Group n=1626 Participants Subjects, between, and including, 18 and 50 years of age, who received 2 doses of M72/AS01E according to random assignment, one month apart (Day 0 and Day 30) by intramuscular injection in the deltoid region of the arm.
Incident Rates of Definite Xpert MTB/Rif Positive Pulmonary TB Disease, Not Associated With HIV-infection, Meeting the Case Definition 2	0.470 cases per 100 person-years Interval 0.328 to 0.673	0.181 cases per 100 person-years Interval 0.101 to 0.323

SECONDARY outcome

The incidence rate of definite pulmonary TB disease (or 100 Person-years rate) was calculated as the number of subjects reporting at least one case (n) in a group, over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100. Case definition 3 = a subject with clinical suspicion\* of pulmonary TB disease, with Mtb complex identified from a sputum specimen, taken up to four weeks after initiation of TB treatment, by Xpert MTB/RIF and/or microbiological culture and confirmed HIV-negative at the time of TB diagnosis.\*Clinical suspicion of pulmonary TB was defined as a subject presenting with one or more of the following symptoms: unexplained cough \> 2 weeks, unexplained fever \> 1 week, night sweats, unintentional weight loss, pleuritic chest pains, haemoptysis, fatigue or shortness of breath on exertion.

Outcome measures

Outcome measures
Measure	Control Group n=1663 Participants Subjects, between, and including,18 and 50 years of age, who received 2 doses of Placebo according to random assignment, one month apart (Day 0 and Day 30) by intramuscular injection in the deltoid region of the arm.	M72AS01 Group n=1626 Participants Subjects, between, and including, 18 and 50 years of age, who received 2 doses of M72/AS01E according to random assignment, one month apart (Day 0 and Day 30) by intramuscular injection in the deltoid region of the arm.
Incident Rates of Definite Pulmonary TB Disease, Not Associated With HIV-infection Meeting the Case Definition 3	0.672 cases per 100 person-years Interval 0.498 to 0.908	0.429 cases per 100 person-years Interval 0.294 to 0.626

SECONDARY outcome

The incidence rate of Microbiological pulmonary TB disease (or 100 Person-years rate) was calculated as the number of subjects reporting at least one case (n) in a group, over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100. Case definition 4 = a subject with clinical suspicion\* of pulmonary TB disease, with Mtb complex identified from a sputum specimen, taken up to four weeks after initiation of TB treatment, by Xpert MTB/RIF and/or microbiological culture.\*Clinical suspicion of pulmonary TB was defined as a subject presenting with one or more of the following symptoms: unexplained cough \> 2 weeks, unexplained fever \> 1 week, night sweats, unintentional weight loss, pleuritic chest pains, haemoptysis, fatigue or shortness of breath on exertion.

Outcome measures

Outcome measures
Measure	Control Group n=1663 Participants Subjects, between, and including,18 and 50 years of age, who received 2 doses of Placebo according to random assignment, one month apart (Day 0 and Day 30) by intramuscular injection in the deltoid region of the arm.	M72AS01 Group n=1626 Participants Subjects, between, and including, 18 and 50 years of age, who received 2 doses of M72/AS01E according to random assignment, one month apart (Day 0 and Day 30) by intramuscular injection in the deltoid region of the arm.
Incident Rates of Microbiological Pulmonary TB Disease, Meeting the Case Definition 4	0.717 cases per 100 person-years Interval 0.536 to 0.959	0.429 cases per 100 person-years Interval 0.294 to 0.626

SECONDARY outcome

The incidence rate of Clinical TB disease (or 100 Person-years rate) was calculated as the number of subjects reporting at least one case (n) in a group, over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100. Case definition 5 = a subject for whom a clinician has diagnosed TB disease and has decided to treat the patient with TB treatment.

Outcome measures

Outcome measures
Measure	Control Group n=1663 Participants Subjects, between, and including,18 and 50 years of age, who received 2 doses of Placebo according to random assignment, one month apart (Day 0 and Day 30) by intramuscular injection in the deltoid region of the arm.	M72AS01 Group n=1626 Participants Subjects, between, and including, 18 and 50 years of age, who received 2 doses of M72/AS01E according to random assignment, one month apart (Day 0 and Day 30) by intramuscular injection in the deltoid region of the arm.
Incidence Rates of Clinical TB Disease, Meeting the Case Definition 5	0.850 cases per 100 person-years Interval 0.651 to 1.109	0.586 cases per 100 person-years Interval 0.425 to 0.81

SECONDARY outcome

Timeframe: From Day 0 up to Year 3 (during the entire study period)

Population: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects with at least one dose administered.

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Outcome measures
Measure	Control Group n=1787 Participants Subjects, between, and including,18 and 50 years of age, who received 2 doses of Placebo according to random assignment, one month apart (Day 0 and Day 30) by intramuscular injection in the deltoid region of the arm.	M72AS01 Group n=1786 Participants Subjects, between, and including, 18 and 50 years of age, who received 2 doses of M72/AS01E according to random assignment, one month apart (Day 0 and Day 30) by intramuscular injection in the deltoid region of the arm.
Number of Subjects With Serious Adverse Events (SAEs).	62 Participants	51 Participants

SECONDARY outcome

Timeframe: During the 30-day follow-up period following vaccination, across doses (i.e. day of vaccination and 29 subsequent days after each vaccine dose)

Population: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects with at least one dose administered.

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.

Outcome measures

Outcome measures
Measure	Control Group n=1787 Participants Subjects, between, and including,18 and 50 years of age, who received 2 doses of Placebo according to random assignment, one month apart (Day 0 and Day 30) by intramuscular injection in the deltoid region of the arm.	M72AS01 Group n=1786 Participants Subjects, between, and including, 18 and 50 years of age, who received 2 doses of M72/AS01E according to random assignment, one month apart (Day 0 and Day 30) by intramuscular injection in the deltoid region of the arm.
Number of Subjects With Any Unsolicited Adverse Events (AEs).	816 Participants	1207 Participants

SECONDARY outcome

Timeframe: During the 7-day follow-up period (i.e. day of vaccination and 6 subsequent days) after each vaccine dose

Population: Analysis was performed on the "safety and immunogenicity" sub-cohort (i.e. about 150 subjects enrolled in each group and from 2 of the 3 countries \[the third country study start was delayed as awaiting regulatory approval\]) which included subjects with at least 1 vaccination dose documented.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Any redness/swelling symptom was scored as injection site redness/swelling with a diameter equal or larger than (≥) 20 millimeters (mm).

Outcome measures

Outcome measures
Measure	Control Group n=151 Participants Subjects, between, and including,18 and 50 years of age, who received 2 doses of Placebo according to random assignment, one month apart (Day 0 and Day 30) by intramuscular injection in the deltoid region of the arm.	M72AS01 Group n=148 Participants Subjects, between, and including, 18 and 50 years of age, who received 2 doses of M72/AS01E according to random assignment, one month apart (Day 0 and Day 30) by intramuscular injection in the deltoid region of the arm.
Number of Subjects With Any Solicited Local AEs in the Safety and Immune Sub-cohort Any Pain after Dose 1	48 Participants	111 Participants
Number of Subjects With Any Solicited Local AEs in the Safety and Immune Sub-cohort Any Redness after Dose 1	0 Participants	12 Participants
Number of Subjects With Any Solicited Local AEs in the Safety and Immune Sub-cohort Any Swelling after Dose 1	1 Participants	25 Participants
Number of Subjects With Any Solicited Local AEs in the Safety and Immune Sub-cohort Any Pain after Dose 2	22 Participants	86 Participants
Number of Subjects With Any Solicited Local AEs in the Safety and Immune Sub-cohort Any Redness after Dose 2	2 Participants	5 Participants
Number of Subjects With Any Solicited Local AEs in the Safety and Immune Sub-cohort Any Swelling after Dose 2	2 Participants	12 Participants

SECONDARY outcome

Timeframe: During the 7-day follow-up period (i.e.: day of vaccination and 6 subsequent days) after each vaccine dose

Assessed solicited general symptoms were fatigue, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], respiratory symptoms (including cough, blood in sputum, purulent sputum, shortness of breath or difficulties breathing, chest wall pain) headache, malaise and myalgia. Any = occurrence of the symptom regardless of intensity grade and relation to vaccination.

Outcome measures

Outcome measures
Measure	Control Group n=151 Participants Subjects, between, and including,18 and 50 years of age, who received 2 doses of Placebo according to random assignment, one month apart (Day 0 and Day 30) by intramuscular injection in the deltoid region of the arm.	M72AS01 Group n=148 Participants Subjects, between, and including, 18 and 50 years of age, who received 2 doses of M72/AS01E according to random assignment, one month apart (Day 0 and Day 30) by intramuscular injection in the deltoid region of the arm.
Number of Subjects With Any Solicited General AEs in the Safety and Immune Sub-cohort Any Headache after Dose 1	60 Participants	81 Participants
Number of Subjects With Any Solicited General AEs in the Safety and Immune Sub-cohort Any Malaise after Dose 1	29 Participants	68 Participants
Number of Subjects With Any Solicited General AEs in the Safety and Immune Sub-cohort Any Myalgia after Dose 1	34 Participants	75 Participants
Number of Subjects With Any Solicited General AEs in the Safety and Immune Sub-cohort Any Respiratory symptoms after Dose 1	13 Participants	23 Participants
Number of Subjects With Any Solicited General AEs in the Safety and Immune Sub-cohort Any Fatigue after Dose 1	63 Participants	91 Participants
Number of Subjects With Any Solicited General AEs in the Safety and Immune Sub-cohort Any Fever after Dose 1	16 Participants	33 Participants
Number of Subjects With Any Solicited General AEs in the Safety and Immune Sub-cohort Any Fatigue after Dose 2	31 Participants	70 Participants
Number of Subjects With Any Solicited General AEs in the Safety and Immune Sub-cohort Any Headache after Dose 2	39 Participants	75 Participants
Number of Subjects With Any Solicited General AEs in the Safety and Immune Sub-cohort Any Malaise after Dose 2	21 Participants	57 Participants
Number of Subjects With Any Solicited General AEs in the Safety and Immune Sub-cohort Any Myalgia after Dose 2	21 Participants	55 Participants
Number of Subjects With Any Solicited General AEs in the Safety and Immune Sub-cohort Any Respiratory symptoms after Dose 2	5 Participants	14 Participants
Number of Subjects With Any Solicited General AEs in the Safety and Immune Sub-cohort Any Fever after Dose 2	10 Participants	37 Participants

SECONDARY outcome

Timeframe: From Day 0 to 6 months post-dose 2 (i.e. at Month 7)

Population: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects with at least one dose administered.

Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.

Outcome measures

Outcome measures
Measure	Control Group n=1787 Participants Subjects, between, and including,18 and 50 years of age, who received 2 doses of Placebo according to random assignment, one month apart (Day 0 and Day 30) by intramuscular injection in the deltoid region of the arm.	M72AS01 Group n=1786 Participants Subjects, between, and including, 18 and 50 years of age, who received 2 doses of M72/AS01E according to random assignment, one month apart (Day 0 and Day 30) by intramuscular injection in the deltoid region of the arm.
Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)	6 Participants	2 Participants

SECONDARY outcome

Timeframe: Days 0, 7, 30 and 37

Abnormal laboratory values include haematological abnormalities (haemoglobin level, white blood cells and platelets) and biochemical abnormalities (alanine aminotransferase, aspartate aminotransferase and creatinine). Grading was defined based on the Food and Drug Administration \[FDA\], 2007. Guidance for Industry, Toxicity Grading Scale for Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Alanine Aminotransferase = ALA; Aspartate Aminotransferase = ASP; Creatinine = CREA; Hemoglobin (Change from baseline) = HEM (baseline); Hemoglobin (decrease) = HEM (decrease); Leukocytes (White Blood Cells) (Decrease) = WBC (decrease); Leukocytes (White Blood Cells) (Increase) = WBC (increase); Platelets = PLA; Total Bilirubin = BIL.

Outcome measures

Outcome measures
Measure	Control Group n=151 Participants Subjects, between, and including,18 and 50 years of age, who received 2 doses of Placebo according to random assignment, one month apart (Day 0 and Day 30) by intramuscular injection in the deltoid region of the arm.	M72AS01 Group n=149 Participants Subjects, between, and including, 18 and 50 years of age, who received 2 doses of M72/AS01E according to random assignment, one month apart (Day 0 and Day 30) by intramuscular injection in the deltoid region of the arm.
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 2 ALA at Day 0	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 3 ALA at Day 0	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 4 ALA at Day 0	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 2 ALA at Day 7	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 2 CREA at Day 30	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 3 ALA at Day 7	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 4 ALA at Day 7	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 2 ALA at Day 30	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 3 ALA at Day 30	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 4 ALA at Day 30	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 2 ALA at Day 37	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 3 ALA at Day 37	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 4 ALA at Day 37	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 2 ASP at Day 0	0 Participants	1 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 3 ASP at Day 0	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 4 ASP at Day 0	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 2 ASP at Day 7	0 Participants	1 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 3 ASP at Day 7	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 4 ASP at Day 7	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 2 ASP at Day 30	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 3 ASP at Day 30	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 4 ASP at Day 30	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 2 ASP at Day 37	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 3 ASP at Day 37	0 Participants	1 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 4 ASP at Day 37	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 2 CREA at Day 0	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 3 CREA at Day 0	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 4 CREA at Day 0	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 2 CREA at Day 7	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 3 CREA at Day 7	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 4 CREA at Day 7	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 3 CREA at Day 30	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 4 CREA at Day 30	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 2 CREA at Day 37	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 3 CREA at Day 37	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 4 CREA at Day 37	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 2 HEM (baseline) at Day 0	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 3 HEM (baseline) at Day 0	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 4 HEM (baseline) at Day 0	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 2 HEM (baseline) at Day 7	5 Participants	1 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 3 HEM (baseline) at Day 7	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 4 HEM (baseline) at Day 7	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 2 HEM (baseline) at Day 30	2 Participants	2 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 3 HEM (baseline) at Day 30	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 4 HEM (baseline) at Day 30	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 2 HEM (baseline) at Day 37	0 Participants	2 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 3 HEM (baseline) at Day 37	0 Participants	1 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 4 HEM (baseline) at Day 37	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 2 HEM (decrease) at Day 0	5 Participants	5 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 3 HEM (decrease) at Day 0	1 Participants	2 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 4 HEM (decrease) at Day 0	0 Participants	1 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 2 HEM (decrease) at Day 7	5 Participants	10 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 3 HEM (decrease) at Day 7	2 Participants	2 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 4 HEM (decrease) at Day 7	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 2 HEM (decrease) at Day 30	4 Participants	5 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 3 HEM (decrease) at Day 30	1 Participants	2 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 4 HEM (decrease) at Day 30	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 2 HEM (decrease) at Day 37	4 Participants	4 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 3 HEM (decrease) at Day 37	0 Participants	1 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 4 HEM (decrease) at Day 37	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 2 WBC (decrease) at Day 0	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 3 WBC (decrease) at Day 0	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 4 WBC (decrease) at Day 0	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 2 WBC (decrease) at Day 7	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 3 WBC (decrease) at Day 7	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 4 WBC (decrease) at Day 7	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 2 WBC (decrease) at Day 30	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 3 WBC (decrease) at Day 30	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 4 WBC (decrease) at Day 30	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 2 WBC (decrease) at Day 37	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 3 WBC (decrease) at Day 37	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 4 WBC (decrease) at Day 37	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 2 WBC (increase) at Day 0	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 3 WBC (increase) at Day 0	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 4 WBC (increase) at Day 0	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 2 WBC (increase) at Day 7	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 3 WBC (increase) at Day 7	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 4 WBC (increase) at Day 7	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 2 WBC (increase) at Day 30	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 3 WBC (increase) at Day 30	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 4 WBC (increase) at Day 30	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 2 WBC (increase) at Day 37	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 3 WBC (increase) at Day 37	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 4 WBC (increase) at Day 37	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 2 PLA at Day 0	2 Participants	3 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 3 PLA at Day 0	0 Participants	4 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 4 PLA at Day 0	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 2 PLA at Day 7	1 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 3 PLA at Day 7	0 Participants	3 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 4 PLA at Day 7	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 2 PLA at Day 30	3 Participants	1 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 3 PLA at Day 30	1 Participants	3 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 4 PLA at Day 30	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 2 PLA at Day 37	1 Participants	1 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 3 PLA at Day 37	0 Participants	3 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 4 PLA at Day 37	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 2 BIL at Day 0	4 Participants	1 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 3 BIL at Day 0	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 4 BIL at Day 0	1 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 2 BIL at Day 7	1 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 3 BIL at Day 7	1 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 4 BIL at Day 7	1 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 2 BIL at Day 30	1 Participants	1 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 3 BIL at Day 30	1 Participants	1 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 4 BIL at Day 30	1 Participants	3 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 2 BIL at Day 37	2 Participants	1 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 3 BIL at Day 37	0 Participants	0 Participants
Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort Grade 4 BIL at Day 37	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Prior to dose 1 (Day 0) and post-dose 2 (Day 60, Year 1, Year 2 and Year 3)

The frequency of M72-specific CD4 + T-cells per million cells were identified after in vitro stimulation expressing any combination of immune markers ( Interleukin-2 (IL-2), cluster of differentiation 40-ligand (CD40-L), tumor necrosis factor alpha (TNF-) and interferon-gamma (IFN-) after background subtraction for each treatment group.

Outcome measures

SECONDARY outcome

Timeframe: Prior to dose 1 (Day 0) and post-dose 2 (Day 60, Year 1, Year 2 and Year 3)

The frequency of M72-specific CD8 + T-cells per million cells were identified after in vitro stimulation expressing any combination of immune markers ( Interleukin-2 (IL-2), cluster of differentiation 40-ligand (CD40-L), tumor necrosis factor alpha (TNF-) and interferon-gamma (IFN-) after background subtraction for each treatment group.

Outcome measures

SECONDARY outcome

Timeframe: Prior to dose 1 (Day 0) and post-dose 2 (Day 60, Year 1, Year 2 and Year 3)

Mycobacterium tuberculosis M72-specific antibody geometric mean concentrations (GMCs) with exact 95% Confidence Interval (CI) were measured by Enzyme Linked Immuno Sorbent Assay (ELISA) and expressed in ELISA unit per milliliter (EU/mL). The cut-off of the assay was 2.8 EU/mL. The Geometric Mean Concentration (GMC) calculations were performed by taking the anti-log of the mean of the log10 concentration transformations. For descriptive statistics purposes only, antibody concentrations below the cut-off value of the assay was given an arbitrary value of half the cut-off value for the purpose of GMC calculation.

Outcome measures

Outcome measures
Measure	Control Group n=124 Participants Subjects, between, and including,18 and 50 years of age, who received 2 doses of Placebo according to random assignment, one month apart (Day 0 and Day 30) by intramuscular injection in the deltoid region of the arm.	M72AS01 Group n=120 Participants Subjects, between, and including, 18 and 50 years of age, who received 2 doses of M72/AS01E according to random assignment, one month apart (Day 0 and Day 30) by intramuscular injection in the deltoid region of the arm.
M72-specific Antibody Concentrations as Measured by Enzyme Linked Immuno Sorbent Assay (ELISA) in the Safety and Immune Sub-cohort Anti-M72 at Day 0	1.6 EU/mL Interval 1.5 to 1.7	1.6 EU/mL Interval 1.5 to 1.8
M72-specific Antibody Concentrations as Measured by Enzyme Linked Immuno Sorbent Assay (ELISA) in the Safety and Immune Sub-cohort Anti-M72 at Day 60	1.6 EU/mL Interval 1.4 to 1.7	547.0 EU/mL Interval 471.1 to 635.1
M72-specific Antibody Concentrations as Measured by Enzyme Linked Immuno Sorbent Assay (ELISA) in the Safety and Immune Sub-cohort Anti-M72 at Year 1	1.7 EU/mL Interval 1.5 to 1.8	41.5 EU/mL Interval 35.4 to 48.6
M72-specific Antibody Concentrations as Measured by Enzyme Linked Immuno Sorbent Assay (ELISA) in the Safety and Immune Sub-cohort Anti-M72 at Year 2	1.6 EU/mL Interval 1.5 to 1.8	30.6 EU/mL Interval 26.2 to 35.6
M72-specific Antibody Concentrations as Measured by Enzyme Linked Immuno Sorbent Assay (ELISA) in the Safety and Immune Sub-cohort Anti-M72 at Year 3	1.6 EU/mL Interval 1.4 to 1.7	27.0 EU/mL Interval 22.7 to 32.0

SECONDARY outcome

Timeframe: Prior to dose 1 (Day 0) and post-dose 2 (Day 60, Year 1, Year 2 and Year 3)

A seronegative subject was a subject whose antibody concentration was below 2.8 EU/mL, while a seropositive subject was a subject whose antibody concentration was greater than or equal to 2.8 EU/mL.

Outcome measures

Outcome measures
Measure	Control Group n=124 Participants Subjects, between, and including,18 and 50 years of age, who received 2 doses of Placebo according to random assignment, one month apart (Day 0 and Day 30) by intramuscular injection in the deltoid region of the arm.	M72AS01 Group n=120 Participants Subjects, between, and including, 18 and 50 years of age, who received 2 doses of M72/AS01E according to random assignment, one month apart (Day 0 and Day 30) by intramuscular injection in the deltoid region of the arm.
Number of Seropositive Subjects for M72 Antibodies Measured by ELISA in the Safety and Immune Sub-cohort Anti-M72 at Day 0	12 Participants	11 Participants
Number of Seropositive Subjects for M72 Antibodies Measured by ELISA in the Safety and Immune Sub-cohort Anti-M72 at Day 60	8 Participants	99 Participants
Number of Seropositive Subjects for M72 Antibodies Measured by ELISA in the Safety and Immune Sub-cohort Anti-M72 at Year 1	14 Participants	117 Participants
Number of Seropositive Subjects for M72 Antibodies Measured by ELISA in the Safety and Immune Sub-cohort Anti-M72 at Year 2	11 Participants	108 Participants
Number of Seropositive Subjects for M72 Antibodies Measured by ELISA in the Safety and Immune Sub-cohort Anti-M72 at Year 3	8 Participants	83 Participants

Adverse Events

M72AS01 Group

Serious events: 51 serious events

Other events: 1204 other events

Deaths: 19 deaths

Control Group

Serious events: 62 serious events

Other events: 809 other events

Deaths: 28 deaths

Serious adverse events

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

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