Outcomes15

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

1 to 15 of 15

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
SECONDARY	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	Days 0, 7, 30 and 37	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 laboratory value documented.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Desciptive Statistics of the Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers in the Safety and Immune Sub-cohort	Prior to dose 1 (Day 0) and post-dose 2 (Day 60, Year 1, Year 2 and Year 3)	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 immune result documented.	T cells per million cells	MEDIAN
SECONDARY	Desciptive Statistics of the Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Immune Markers in the Safety and Immune Sub-cohort	Prior to dose 1 (Day 0) and post-dose 2 (Day 60, Year 1, Year 2 and Year 3)	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 immune result documented.	T cells per million cells	MEDIAN
SECONDARY	M72-specific Antibody Concentrations as Measured by Enzyme Linked Immuno Sorbent Assay (ELISA) in the Safety and Immune Sub-cohort	Prior to dose 1 (Day 0) and post-dose 2 (Day 60, Year 1, Year 2 and Year 3)	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 cell-mediated immune result documented.	EU/mL	GEOMETRIC_MEAN
SECONDARY	Number of Seropositive Subjects for M72 Antibodies Measured by ELISA in the Safety and Immune Sub-cohort	Prior to dose 1 (Day 0) and post-dose 2 (Day 60, Year 1, Year 2 and Year 3)	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 cell-mediated immune result documented.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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.

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