Trial · NCT01755598
Study to Evaluate the Efficacy of GlaxoSmithKline (GSK) Biologicals' Candidate Tuberculosis (TB) Vaccine in Adults
NCT01755598, Phase 2, Completed, GlaxoSmithKline; results first posted 2019-12-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate the Efficacy of GlaxoSmithKline (GSK) Biologicals' Candidate Tuberculosis (TB) Vaccine in Adults. Trials, record NCT01755598. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01755598
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Efficacy of GlaxoSmithKline (GSK) Biologicals' Candidate Tuberculosis (TB) Vaccine in Adults
- NCT number
- NCT01755598
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 3,575 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Tuberculosis, Tuberculosis Vaccines
- Interventions
- GSK Biologicals' investigational TB vaccine (GSK692342), Placebo
- First posted
- 2012-12-24
- Last updated
- 2019-12-03
- Results first posted
- 2019-12-03
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incident Rates of Definite Pulmonary Tuberculosis (TB) Disease, Not Associated With HIV-infection, Meeting the Case Definition 1 | 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 | 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. |
| Secondary | Incident Rates of Definite Xpert MTB/Rif Positive Pulmonary TB Disease, Not Associated With HIV-infection, Meeting the Case Definition 2 | 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 | 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. |
| Secondary | Incident Rates of Definite Pulmonary TB Disease, Not Associated With HIV-infection Meeting the Case Definition 3 | 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 | 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. |
| Secondary | Incident Rates of Microbiological Pulmonary TB Disease, Meeting the Case Definition 4 | 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 | 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. |
| Secondary | Incidence Rates of Clinical TB Disease, Meeting the Case Definition 5 | 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 | 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. |
| Secondary | Number of Subjects With Serious Adverse Events (SAEs). | From Day 0 up to Year 3 (during the entire study period) | 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. |
| Secondary | Number of Subjects With Any Unsolicited Adverse Events (AEs). | During the 30-day follow-up period following vaccination, across doses (i.e. day of vaccination and 29 subsequent days after each vaccine dose) | 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. |
| Secondary | Number of Subjects With Any Solicited Local AEs in the Safety and Immune Sub-cohort | During the 7-day follow-up period (i.e. day of vaccination and 6 subsequent days) after each vaccine dose | 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). |
| Secondary | Number of Subjects With Any Solicited General AEs in the Safety and Immune Sub-cohort | 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. |
| Secondary | Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) | From Day 0 to 6 months post-dose 2 (i.e. at Month 7) | 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. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incident Rates of Definite Pulmonary Tuberculosis (TB) Disease, Not Associated With HIV-infection, Meeting the Case Definition 1 | 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 | 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). | cases per 100 person-years | NUMBER |
| SECONDARY | Incident Rates of Definite Xpert MTB/Rif Positive Pulmonary TB Disease, Not Associated With HIV-infection, Meeting the Case Definition 2 | 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 | 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). | cases per 100 person-years | NUMBER |
| SECONDARY | Incident Rates of Definite Pulmonary TB Disease, Not Associated With HIV-infection Meeting the Case Definition 3 | 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 | 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). | cases per 100 person-years | NUMBER |
| SECONDARY | Incident Rates of Microbiological Pulmonary TB Disease, Meeting the Case Definition 4 | 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 | 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). | cases per 100 person-years | NUMBER |
| SECONDARY | Incidence Rates of Clinical TB Disease, Meeting the Case Definition 5 | 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 | 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). | cases per 100 person-years | NUMBER |
| SECONDARY | Number of Subjects With Serious Adverse Events (SAEs). | From Day 0 up to Year 3 (during the entire study period) | Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects with at least one dose administered. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Any Unsolicited Adverse Events (AEs). | During the 30-day follow-up period following vaccination, across doses (i.e. day of vaccination and 29 subsequent days after each vaccine dose) | Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects with at least one dose administered. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Any Solicited Local AEs in the Safety and Immune Sub-cohort | During the 7-day follow-up period (i.e. day of vaccination and 6 subsequent days) after each vaccine dose | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Any Solicited General AEs in the Safety and Immune Sub-cohort | During the 7-day follow-up period (i.e.: day of vaccination and 6 subsequent days) after each vaccine dose | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) | From Day 0 to 6 months post-dose 2 (i.e. at Month 7) | Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects with at least one dose administered. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group588
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incident Rates of Definite Pulmonary Tuberculosis (TB) Disease, Not Associated With HIV-infection, Meeting the Case Definition 1 | M72AS01 Group | 0.3 | 90% Confidence Interval 0.2 to 0.5 | cases per 100 person-years | |
| Incident Rates of Definite Pulmonary Tuberculosis (TB) Disease, Not Associated With HIV-infection, Meeting the Case Definition 1 | Control Group | 0.6 | 90% Confidence Interval 0.4 to 0.8 | cases per 100 person-years | |
| Incident Rates of Definite Xpert MTB/Rif Positive Pulmonary TB Disease, Not Associated With HIV-infection, Meeting the Case Definition 2 | M72AS01 Group | 0.181 | 90% Confidence Interval 0.101 to 0.323 | cases per 100 person-years | |
| Incident Rates of Definite Xpert MTB/Rif Positive Pulmonary TB Disease, Not Associated With HIV-infection, Meeting the Case Definition 2 | Control Group | 0.470 | 90% Confidence Interval 0.328 to 0.673 | cases per 100 person-years | |
| Incident Rates of Definite Pulmonary TB Disease, Not Associated With HIV-infection Meeting the Case Definition 3 | M72AS01 Group | 0.429 | 90% Confidence Interval 0.294 to 0.626 | cases per 100 person-years | |
| Incident Rates of Definite Pulmonary TB Disease, Not Associated With HIV-infection Meeting the Case Definition 3 | Control Group | 0.672 | 90% Confidence Interval 0.498 to 0.908 | cases per 100 person-years | |
| Incident Rates of Microbiological Pulmonary TB Disease, Meeting the Case Definition 4 | M72AS01 Group | 0.429 | 90% Confidence Interval 0.294 to 0.626 | cases per 100 person-years | |
| Incident Rates of Microbiological Pulmonary TB Disease, Meeting the Case Definition 4 | Control Group | 0.717 | 90% Confidence Interval 0.536 to 0.959 | cases per 100 person-years | |
| Incidence Rates of Clinical TB Disease, Meeting the Case Definition 5 | M72AS01 Group | 0.586 | 90% Confidence Interval 0.425 to 0.810 | cases per 100 person-years | |
| Incidence Rates of Clinical TB Disease, Meeting the Case Definition 5 | Control Group | 0.850 | 90% Confidence Interval 0.651 to 1.109 | cases per 100 person-years |
1 to 10 of 588Source ClinicalTrials.gov
See all 588 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | M72AS01 Group | 1,786 | |
| Overall Study | STARTED | Control Group | 1,787 | |
| Overall Study | COMPLETED | M72AS01 Group | 1,521 | |
| Overall Study | COMPLETED | Control Group | 1,504 | |
| Overall Study | NOT COMPLETED | M72AS01 Group | 265 | |
| Overall Study | NOT COMPLETED | Control Group | 283 |
Source ClinicalTrials.gov
Adverse events954
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | M72AS01 Group | 5 | 1,786 | 5 |
| other | Anaemia | Blood and lymphatic system disorders | Control Group | 3 | 1,787 | 3 |
| other | Eosinophilia | Blood and lymphatic system disorders | M72AS01 Group | 3 | 1,786 | 3 |
| other | Eosinophilia | Blood and lymphatic system disorders | Control Group | 1 | 1,787 | 1 |
| other | Hypochromic anaemia | Blood and lymphatic system disorders | M72AS01 Group | 1 | 1,786 | 1 |
| other | Hypochromic anaemia | Blood and lymphatic system disorders | Control Group | 0 | 1,787 | 0 |
| other | Immune thrombocytopenic purpura | Blood and lymphatic system disorders | M72AS01 Group | 1 | 1,786 | 1 |
| other | Immune thrombocytopenic purpura | Blood and lymphatic system disorders | Control Group | 0 | 1,787 | 0 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | M72AS01 Group | 3 | 1,786 | 3 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Control Group | 0 | 1,787 | 0 |
1 to 10 of 954Source ClinicalTrials.gov
See all 954 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | M72AS01 Group | 19 | 1,786 |
| Total, all-cause mortality | Control Group | 28 | 1,787 |
| Total, other adverse events | M72AS01 Group | 1,204 | 1,786 |
| Total, other adverse events | Control Group | 809 | 1,787 |
| Total, serious adverse events | M72AS01 Group | 51 | 1,786 |
| Total, serious adverse events | Control Group | 62 | 1,787 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| M72AS01 Group vs Control Group: Number of Subjects With Serious Adverse Events (SAEs). | Trial comparisons |
| M72AS01 Group vs Control Group: Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) | Trial comparisons |
| M72AS01 Group vs Control Group: Number of Subjects With Any Unsolicited Adverse Events (AEs). | Trial comparisons |
| M72AS01 Group vs Control Group: deaths from any cause | Trial comparisons |
| M72AS01 Group vs Control Group: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT01755598/results?page=2