Trial · NCT04152161
Bacille Calmette Guerin (BCG) Revaccination of Healthy Adolescents for the Prevention of Mycobacterium Tuberculosis Sustained Infection
NCT04152161, Phase 2, Terminated, Gates Medical Research Institute; results first posted 2025-06-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Bacille Calmette Guerin (BCG) Revaccination of Healthy Adolescents for the Prevention of Mycobacterium Tuberculosis Sustained Infection. Trials, record NCT04152161. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04152161
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bacille Calmette Guerin (BCG) Revaccination of Healthy Adolescents for the Prevention of Mycobacterium Tuberculosis Sustained Infection
- NCT number
- NCT04152161
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 1,836 participants, actual
- Lead sponsor
- Gates Medical Research Institute
- Conditions
- Tuberculosis
- Interventions
- BCG vaccine SSI, Placebo
- First posted
- 2019-11-05
- Last updated
- 2025-06-19
- Results first posted
- 2025-06-19
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Sustained QuantiFERON®-TB Gold Plus Assay (QFT) Conversion From a Negative to Positive Test Based on Positive QFT Test Results | Up to 48 months | Sustained conversion was defined as sustained QFT conversion from a negative to positive test, with initial conversion at any time after a first negative QFT result post randomization (Day 71 or subsequent visit if Day 71 result was not available), and remaining QFT positive at 3- and 6-months post-conversion. |
| Secondary | Number of Participants With Sustained QFT Conversion From a Negative to Positive Test Based on Positive QFT Test Results at 36-Months Follow-up or Discontinued Early | 36 Months Follow-up | Sustained conversion was defined as sustained QFT conversion from a negative to positive test, with initial conversion at any time after a first negative QFT result post randomization (Day 71 or subsequent visit if Day 71 result was not available), and remaining QFT positive at 3- and 6-months post-conversion. |
| Secondary | Number of Participants With Sustained QFT Conversion From a Negative to Positive Test Based on Positive QFT Test Results at 48-Months Follow-up or Discontinued Early | 48 Months Follow-up | Sustained conversion was defined as sustained QFT conversion from a negative to positive test, with initial conversion at any time after a first negative QFT result post randomization (Day 71 or subsequent visit if Day 71 result was not available), and remaining QFT positive at 3- and 6-months post-conversion. |
| Secondary | Number of Participants With Serious and Non-serious Solicited Adverse Events (AEs) Through 7 Days Post Vaccination | Day 1 through Day 7 | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An AE does not necessarily have a causal relationship with the intervention. Solicited AEs were defined as events that participants were specifically asked about and which were noted by participants in the diary card. Solicited AEs included injection site symptoms of injections site pain, redness and swelling and general body symptoms such as headache, fatigue, gastrointestinal symptoms, and fever. |
| Secondary | Number of Participants With Unsolicited AEs Through Day 28, as Well as Solicited AEs That Were Ongoing at Day 7 After Vaccination | Day 1 through Day 28 | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An AE does not necessarily have a causal relationship with the intervention. Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participant diary card, as well as solicited AEs that were ongoing at Day 7 after vaccination. Number of Participants With Unsolicited AEs Through 28 Days after vaccination has been presented. |
| Secondary | Number of Participants With Serious Adverse Events (SAEs) | Up to 6 months | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Number of Participants reporting SAEs has been presented. |
| Secondary | Number of Participants With AEs of Special Interest | Up to 6 months | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AE of special interest are AEs that the sponsor closely monitors. The AEs of special interest to be collected and reported include immune system disorders (anaphylactic reaction), general disorders (disseminated BCG disease), infections and infestations (osteomyelitis, suppurative lymphadenitis, injection site abscess), skin and subcutaneous tissue disorders (injection site lupus vulgaris, injection site keloid formation), and bone disorders (osteitis). |
| Secondary | Number of Participants With Serious Adverse Drug Reactions (ADRs) | Up to 48 months | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. When an AE is judged to be serious and related to an investigational product, it is a Serious ADR. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Sustained QuantiFERON®-TB Gold Plus Assay (QFT) Conversion From a Negative to Positive Test Based on Positive QFT Test Results | Up to 48 months | Modified Intention to Treat Efficacy Population comprised of all participants randomly assigned to study intervention who received the study intervention, and are QFT negative at the Day 71 visit, or at the first study visit post Day 71 for which a QFT result is available if the Day 71 study visit was missed or the Day 71 QFT result was not available. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Sustained QFT Conversion From a Negative to Positive Test Based on Positive QFT Test Results at 36-Months Follow-up or Discontinued Early | 36 Months Follow-up | mITT Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Sustained QFT Conversion From a Negative to Positive Test Based on Positive QFT Test Results at 48-Months Follow-up or Discontinued Early | 48 Months Follow-up | mITT Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Serious and Non-serious Solicited Adverse Events (AEs) Through 7 Days Post Vaccination | Day 1 through Day 7 | Safety Population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Unsolicited AEs Through Day 28, as Well as Solicited AEs That Were Ongoing at Day 7 After Vaccination | Day 1 through Day 28 | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Serious Adverse Events (SAEs) | Up to 6 months | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With AEs of Special Interest | Up to 6 months | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Serious Adverse Drug Reactions (ADRs) | Up to 48 months | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Sustained QuantiFERON®-TB Gold Plus Assay (QFT) Conversion From a Negative to Positive Test Based on Positive QFT Test Results | Bacille Calmette Guerin (BCG) Group | 82 | Participants | ||
| Number of Participants With Sustained QuantiFERON®-TB Gold Plus Assay (QFT) Conversion From a Negative to Positive Test Based on Positive QFT Test Results | Placebo Group | 78 | Participants | ||
| Number of Participants With Sustained QFT Conversion From a Negative to Positive Test Based on Positive QFT Test Results at 36-Months Follow-up or Discontinued Early | Bacille Calmette Guerin (BCG) Group | 74 | Participants | ||
| Number of Participants With Sustained QFT Conversion From a Negative to Positive Test Based on Positive QFT Test Results at 36-Months Follow-up or Discontinued Early | Placebo Group | 73 | Participants | ||
| Number of Participants With Sustained QFT Conversion From a Negative to Positive Test Based on Positive QFT Test Results at 48-Months Follow-up or Discontinued Early | Bacille Calmette Guerin (BCG) Group | 82 | Participants | ||
| Number of Participants With Sustained QFT Conversion From a Negative to Positive Test Based on Positive QFT Test Results at 48-Months Follow-up or Discontinued Early | Placebo Group | 78 | Participants | ||
| Number of Participants With Serious and Non-serious Solicited Adverse Events (AEs) Through 7 Days Post Vaccination | Bacille Calmette Guerin (BCG) Group | Any injection site symptom | 754 | Participants | |
| Number of Participants With Serious and Non-serious Solicited Adverse Events (AEs) Through 7 Days Post Vaccination | Placebo Group | Any injection site symptom | 381 | Participants | |
| Number of Participants With Serious and Non-serious Solicited Adverse Events (AEs) Through 7 Days Post Vaccination | Bacille Calmette Guerin (BCG) Group | Any general body symptom | 371 | Participants | |
| Number of Participants With Serious and Non-serious Solicited Adverse Events (AEs) Through 7 Days Post Vaccination | Placebo Group | Any general body symptom | 314 | Participants |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bacille Calmette Guerin (BCG) Group | 919 | |
| Overall Study | STARTED | Placebo Group | 917 | |
| Overall Study | Did Not Receive the Intervention | Bacille Calmette Guerin (BCG) Group | 1 | |
| Overall Study | Did Not Receive the Intervention | Placebo Group | 0 | |
| Overall Study | COMPLETED | Bacille Calmette Guerin (BCG) Group | 110 | |
| Overall Study | COMPLETED | Placebo Group | 111 | |
| Overall Study | NOT COMPLETED | Bacille Calmette Guerin (BCG) Group | 809 | |
| Overall Study | NOT COMPLETED | Placebo Group | 806 |
Source ClinicalTrials.gov
Adverse events40
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 | Gastrointestinal Symptoms | Gastrointestinal disorders | Bacille Calmette Guerin (BCG) Group | 136 | 918 | |
| other | Gastrointestinal Symptoms | Gastrointestinal disorders | Placebo Group | 140 | 917 | |
| other | Injection site swelling | General disorders | Bacille Calmette Guerin (BCG) Group | 657 | 918 | |
| other | Injection site swelling | General disorders | Placebo Group | 248 | 917 | |
| other | Injection site pain | General disorders | Bacille Calmette Guerin (BCG) Group | 381 | 918 | |
| other | Injection site pain | General disorders | Placebo Group | 148 | 917 | |
| other | Injection site erythema | General disorders | Bacille Calmette Guerin (BCG) Group | 349 | 918 | |
| other | Injection site erythema | General disorders | Placebo Group | 111 | 917 | |
| other | Fatigue | General disorders | Bacille Calmette Guerin (BCG) Group | 229 | 918 | |
| other | Fatigue | General disorders | Placebo Group | 184 | 917 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bacille Calmette Guerin (BCG) Group | 0 | 918 |
| Total, all-cause mortality | Placebo Group | 1 | 917 |
| Total, other adverse events | Bacille Calmette Guerin (BCG) Group | 800 | 918 |
| Total, other adverse events | Placebo Group | 540 | 917 |
| Total, serious adverse events | Bacille Calmette Guerin (BCG) Group | 3 | 918 |
| Total, serious adverse events | Placebo Group | 3 | 917 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40334156 | DERIVED |
Source PubMed
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 comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Bacille Calmette Guerin (BCG) Group vs Placebo Group: Number of Participants With Serious Adverse Events (SAEs) | Trial comparisons |
Bacille Calmette Guerin (BCG) Group vs Placebo Group: Number of Participants With Sustained QuantiFERON®-TB Gold Plus Assay (QFT) Conversion From a Negative to Positive Test Based on Positive QFT Test Results | Trial comparisons |
Bacille Calmette Guerin (BCG) Group vs Placebo Group: Number of Participants With Sustained QFT Conversion From a Negative to Positive Test Based on Positive QFT Test Results at 36-Months Follow-up or Discontinued Early | Trial comparisons |
| Bacille Calmette Guerin (BCG) Group vs Placebo Group: Number of Participants With Serious Adverse Drug Reactions (ADRs) | Trial comparisons |
| Bacille Calmette Guerin (BCG) Group vs Placebo Group: Number of Participants With Unsolicited AEs Through Day 28, as Well as Solicited AEs That Were Ongoing at Day 7 After Vaccination | Trial comparisons |
| Bacille Calmette Guerin (BCG) Group vs Placebo Group: deaths from any cause | Trial comparisons |
Bacille Calmette Guerin (BCG) Group vs Placebo Group: Number of Participants With Sustained QFT Conversion From a Negative to Positive Test Based on Positive QFT Test Results at 48-Months Follow-up or Discontinued Early | Trial comparisons |
| Bacille Calmette Guerin (BCG) Group vs Placebo 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.
GET https://conductscience.org/api/trials/v1/NCT04152161
GET https://conductscience.org/api/trials/v1/NCT04152161/results?page=2