This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Evaluation of Safety, Immunogenicity, and Prevention of TB With AERAS-404 and BCG Revaccination in Healthy Adolescents (NCT02075203), a randomized phase 2 study. The primary outcome is Safety Profile of H4:IC31 and BCG Revaccination in HIV-uninfected, Remotely BCG Vaccinated Adolescents..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02075203 |
| Phase | Phase 2 |
| Condition | Tuberculosis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 989 |
| Arms in the primary outcome | 3 |
| Lead sponsor | Aeras |
| Results posted | Yes |
2. Clinical Question
Population
Healthy adolescents, with the primary safety outcome specified for HIV-uninfected, remotely BCG-vaccinated adolescents. The record describes the study population as healthy adolescents but does not report further eligibility details in the registry record.
Intervention
AERAS-404, identified in the arm description as 15 mcgH4/500 nmol IC31, given as 2 doses on Study Days 0 and 56. The other active regimen was 1 dose of Bacillus Calmette-Guérin (BCG) on Study Day 0.
Comparator
Placebo, given as 2 doses on Study Days 0 and 56. The trial also included a direct BCG revaccination arm, so the record contains comparisons of each active regimen with placebo.
Primary question
What numbers of solicited and unsolicited adverse events were recorded after vaccination in the AERAS-404, BCG and placebo groups? The primary outcome is a count of adverse events, not a single comparative estimate of benefit or risk.
The study title frames a broader set of questions: safety, immunogenicity and prevention of infection with Mycobacterium tuberculosis. Its primary posted outcome is specifically the safety profile of H4:IC31 and BCG revaccination. The registry record also lists sustained conversion to Mtb-positive and immune response outcomes as secondary outcomes. Those questions should not be conflated: an adverse-event count describes events recorded under specified observation windows, while sustained conversion and immune response address different outcomes.
The record describes a randomized, placebo-controlled, partially blinded Phase II study. It lists healthy adolescents as the population and includes three groups: AERAS-404, BCG revaccination and placebo. The posted safety results give total event counts by arm. They do not, by themselves, show how many participants experienced at least one event, how events were distributed over time, or whether event counts differ statistically between groups. The secondary conversion results offer a separate, limited view of infection-related outcomes; the registry record does not report secondary analyses for the immune response outcome.
3. Trial Design
This was a randomized, parallel-group Phase II study with 989 participants enrolled. The registry record labels the masking as quadruple, while the official title describes the study as partially blinded. The record does not explain the masking arrangements or how the two descriptions relate, so the practical extent of blinding cannot be determined from the posted information alone.
Participants were assigned to one of three groups. The AERAS-404 group received 2 doses on Study Days 0 and 56. The placebo group also received 2 doses on Study Days 0 and 56. The BCG group received 1 dose on Study Day 0. The safety outcome lists 330 participants in the AERAS-404 arm, 330 in the BCG arm and 329 in the placebo arm. The secondary sustained-conversion outcome uses smaller analysis denominators: 308, 312 and 310, respectively. The reason for the difference between the enrolled safety groups and those denominators is not reported in the registry record.
The primary outcome was a number of adverse events, collected over several observation windows. Solicited events were followed for 7 days after each vaccination, with diary cards used for the Safety and Immunogenicity Cohort only. Unsolicited events were followed for 28 days after each vaccination. Injection-site reactions had different windows by group: 84 days after vaccination for BCG and 28 days after each vaccination for H4:IC31 and placebo. Serious adverse events, adverse events of special interest and SUSARs were recorded over the study period, with a minimum of 6 months following the last dose of study vaccine.
The registry record lists rates of sustained conversion to Mtb-positive and immune response to vaccine as secondary outcomes. The conversion outcome is described over 6 months after initial conversion. The record is marked completed, with a start of 2014-02 and primary completion on 2017-08-28. It does not report the allocation sequence method, the concealment process, the sample-size justification, or the detailed statistical analysis plan.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | AERAS-404 (15 mcgH4/500 Nmol IC31) | Bacillus Calmette-Guérin (BCG) | Placebo |
|---|---|---|---|
| STARTED | 330 | 330 | 329 |
| COMPLETED | 327 | 330 | 328 |
| NOT COMPLETED | 3 | 0 | 1 |
Reasons for not completing this period:
| Reason | AERAS-404 (15 mcgH4/500 Nmol IC31) | Bacillus Calmette-Guérin (BCG) | Placebo |
|---|---|---|---|
| Withdrawal by Subject | 1 | 0 | 1 |
| Adverse Event | 1 | 0 | 0 |
| participant refused to use contraception | 1 | 0 | 0 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | AERAS-404 (15 mcgH4/500 Nmol IC31) | Bacillus Calmette-Guérin (BCG) | Placebo | Total |
|---|---|---|---|---|---|
| Participants analysed | 330 | 330 | 329 | 989 | |
| Age, Categorical: <=18 years | Participants | 330 | 330 | 329 | 989 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 | 0 | 0 | 0 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 | 0 |
| Age, Continuous | years | 14.1 (SD 1.47) | 14.2 (SD 1.49) | 14.3 (SD 1.54) | 14.2 (SD 1.50) |
| Sex: Female, Male: Female | Participants | 189 | 162 | 169 | 520 |
| Sex: Female, Male: Male | Participants | 141 | 168 | 160 | 469 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 330 | 330 | 329 | 989 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 1 | 1 | 1 | 3 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 120 | 126 | 120 | 366 |
| Race (NIH/OMB): White | Participants | 1 | 3 | 1 | 5 |
| Race (NIH/OMB): More than one race | Participants | 208 | 200 | 207 | 615 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Region of Enrollment: South Africa | Participants | 330 | 330 | 329 | 989 |
6. Primary Endpoint
The registry lists the primary outcome as Safety Profile of H4:IC31 and BCG Revaccination in HIV-uninfected, Remotely BCG Vaccinated Adolescents., measured over Study day 7 thru 6 months after last vaccination.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | number of AEs |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint counts unsolicited and solicited adverse events recorded after vaccination. It is a safety outcome, not a measure of infection prevention or immune response. An event count is useful for describing the volume of events recorded in each group, especially when the study has several types of event and distinct follow-up windows. The count can include more than one event for a participant; the registry record does not say that each event count represents a different person.
The observation windows matter to interpretation. Solicited adverse events were recorded for 7 days after each vaccination, while unsolicited events were recorded for 28 days after each vaccination. Solicited and unsolicited injection-site reaction events were collected for 84 days after vaccination in the BCG group and for 28 days after each vaccination in the H4:IC31 and placebo groups. Serious adverse events, adverse events of special interest and SUSARs were monitored for the entire study, with a minimum of 6 months following the last dose of study vaccine. These windows are not interchangeable, and event counts should be read in light of the stated follow-up.
The posted primary outcome gives counts of 286 for AERAS-404, 1257 for BCG and 272 for placebo, with group sizes of 330, 330 and 329. The higher BCG count is a count of events, not proof that more participants experienced an event or that a specific causal mechanism is responsible. The registry record does not provide a primary comparative estimate, confidence interval or statistical test for these counts. It also does not provide event-level breakdowns sufficient to distinguish the contribution of each event category to the total. As a result, the endpoint supports descriptive safety reading, but not a formal comparative conclusion from the count alone.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The primary posted results are adverse-event counts: 286 in the AERAS-404 group, 1257 in the BCG group and 272 in the placebo group. These should be interpreted as counts of recorded events under the trial’s stated collection windows. They are not participant risks, and the record does not identify how many participants had at least one event for this primary outcome. Nor does it report an adjusted or unadjusted comparison of the three counts. The data therefore describe what was recorded, without establishing a statistical difference between groups.
The adverse-event summary separately reports serious events in 5 of 330 participants in the AERAS-404 group, 7 of 330 in the BCG group and 7 of 329 in the placebo group. It reports other adverse events affecting 118, 329 and 104 participants, respectively, and deaths of 0, 0 and 1. These participant figures are distinct from the primary endpoint’s total event counts. The record gives a short list of serious-event terms and percentages, but not enough detail to assess event timing, relatedness, severity beyond the serious classification, or the circumstances of the death. A small number of serious events also makes descriptive counts a limited basis for comparing groups.
For sustained conversion to Mtb-positive, the posted summary lists 25 participants in the AERAS-404 group, 21 in the BCG group and 36 in the placebo group, using denominators of 308, 312 and 310. The comparison values in the accompanying table are recalculated, unadjusted summaries from those posted counts; the registry record lists no reported analyses for this outcome. The AERAS-404 comparison has a confidence interval that includes no difference, while the BCG comparison’s interval does not. The displayed unadjusted p-values are 0.145 and 0.035, respectively. These are not sponsor-reported analysis results, and the registry record does not report adjustment for multiple comparisons.
Those secondary findings should not be treated as a substitute for a prespecified primary analysis. They concern a different outcome and do not resolve interpretation of the primary safety counts. In particular, an unadjusted secondary comparison does not show that a treatment caused a change, and the registry record does not state whether these comparisons were planned, how missing outcomes were handled, or which analysis population was intended. The registry record lists no posted analysis of the immune response outcome. Overall, the posted material supports a descriptive account of safety and some secondary conversion counts, but it does not provide a complete inferential analysis of the trial’s stated objectives.
9. Statistical Methods Explained
Several statistical distinctions help keep the posted results in perspective. The primary outcome is a count of adverse events, whereas the secondary conversion outcome is a count of participants who sustained conversion to Mtb-positive. These are different data types and answer different questions. A count of events may include repeated events in the same participant; a participant count, by definition, counts people meeting the outcome. The registry record does not provide enough detail to determine the number of participants represented in the primary event totals.
What does an unadjusted risk difference mean?
General explanation: for a binary outcome, a risk difference compares the proportion with the outcome in one group with the proportion in a reference group. A negative value indicates that the observed proportion in the active group was lower than in placebo. The accompanying secondary table uses this scale for sustained conversion. Its estimates are recalculated, unadjusted comparisons based on posted summary counts, rather than analyses reported by the study sponsor. The registry record lists no reported analyses, so the recalculations should be read as descriptive statistical summaries, not as a substitute for a sponsor’s analysis plan or findings.
A confidence interval expresses the uncertainty around an estimate under the assumptions of the method used. General explanation: intervals compatible with no difference indicate that the observed data do not sharply distinguish a difference from no difference at the chosen confidence level. An interval that excludes no difference is still not proof of a causal effect, especially when an outcome is secondary and several comparisons may be examined. For the AERAS-404 secondary conversion comparison, the interval includes no difference; for BCG, it excludes no difference. These results are unadjusted and should be interpreted with the multiplicity and reporting limitations described elsewhere on the page.
What does the p-value add?
General explanation: a p-value describes how unusual data at least as incompatible with a specified null hypothesis would be under the statistical model used, if the null hypothesis and model assumptions held. It is not the probability that the null hypothesis is true, nor does it measure clinical importance. The recalculated unadjusted p-values for the secondary conversion comparisons are 0.145 for AERAS-404 and 0.035 for BCG. Because the registry record does not state a multiplicity plan or report sponsor analyses, these p-values should not be treated as definitive confirmatory findings. No primary-endpoint p-value is reported.
Why do event counts need special care?
General explanation: count data may show over-dispersion when their variability is greater than expected under a simple count model. This can occur when some people have repeated events or when event rates vary across people or follow-up periods. A model that ignores over-dispersion can understate uncertainty. The registry record gives aggregate primary event counts but does not report their distribution by participant, a dispersion estimate, or a count-model analysis. It is therefore not possible to determine from the record whether a particular count model was used or whether over-dispersion was assessed.
The primary endpoint also pools solicited and unsolicited events, while the collection windows differ by event type and group. General explanation: when exposure or observation time differs, raw counts may not be directly comparable without accounting for those differences. Here, injection-site reaction windows differ for BCG and the H4:IC31/placebo groups. The posted totals do not provide a person-time denominator or an adjusted analysis that accounts for those windows. This limits what can be inferred from the larger BCG event count.
How should the sample-size illustrations be read?
The sample-size section is a planning illustration based on the observed secondary effects, not the trial’s own design justification. It assumes a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. Its rows show participants per arm for 80% power and participants per arm for 90% power. They are hypothetical planning quantities, not observed power and not evidence about the probability that this completed trial detected an effect. The registry record does not report the trial’s original sample-size assumptions or justification.
General explanation: a power calculation depends on the effect size, outcome frequency, variance assumptions, allocation and analysis method. When an observed effect is used as the planning target, the result is sensitive to the uncertainty and possible selection in that observed estimate. A smaller effect target generally requires more participants than a larger one, all else equal, but the illustration does not establish what size of effect would be important. Its assumptions should not be confused with the original trial protocol, which is not reported in the registry record.
The registry record includes 4 outcome measures and reports 0 analyses. The secondary comparison values displayed on the page are therefore recalculations from the posted summaries, rather than inferential results reported by the trial investigators. Without a reported analysis plan, the record does not establish which tests were prespecified, how covariates were handled, how missing outcomes were addressed, or which population was used for each formal analysis. These omissions limit reproducibility and the strength of confirmatory interpretation.
10. Multiplicity, Missing Data and Analysis Populations
The registry record does not report how multiplicity was handled. It lists a primary safety outcome and secondary outcomes for sustained conversion to Mtb-positive and immune response, but does not give a testing hierarchy, family of hypotheses, adjustment method or rule for interpreting multiple comparisons. The displayed p-values for the conversion comparisons are unadjusted recalculations from posted summary counts, not reported sponsor analyses. They therefore should not be read as multiplicity-adjusted evidence.
The record also does not report a missing-data method. For the conversion outcome, the displayed group denominators are 308, 312 and 310, while the safety outcome lists 330, 330 and 329. The reason for this difference, the number and reasons for missing observations, and the handling of participants without complete follow-up are not reported in the registry record. No missing-data assumptions, imputation methods, sensitivity analyses or handling of withdrawals are described.
Analysis populations are also not specified in the posted results. The registry record does not say whether a comparison used all randomized participants, participants who received a vaccine, those with evaluable outcome data, or another population. It does not describe exclusions or protocol deviations. This matters because the interpretation of a randomized comparison depends in part on knowing who was included and how that population was defined.
There is no reported primary comparative analysis, and the record lists 0 analyses. It does not report a statistical analysis plan, models, covariate adjustments, interim analyses or sample-size justification. These details should not be inferred from the displayed counts or from the sample-size planning illustration. The illustration is based on observed secondary effects and is not evidence of the trial’s original design assumptions. In combination, the missing multiplicity, missing-data and analysis-population information means the posted results can be described, but the extent to which they represent prespecified confirmatory tests cannot be established from the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| AERAS-404 (15 mcgH4/500 Nmol IC31) | 5 | 330 | 1.5% |
| Bacillus Calmette-Guerin (BCG) | 7 | 330 | 2.1% |
| Placebo | 7 | 329 | 2.1% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| AERAS-404 (15 mcgH4/500 Nmol IC31) | 0 of 330 |
| Bacillus Calmette-Guerin (BCG) | 0 of 330 |
| Placebo | 1 of 329 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| AERAS-404 (15 mcgH4/500 Nmol IC31) | 118 of 330 |
| Bacillus Calmette-Guerin (BCG) | 329 of 330 |
| Placebo | 104 of 329 |
Most frequent serious adverse event terms
| Event term | Organ system | AERAS-404 (15 mcgH4/500 Nmol IC31) | Bacillus Calmette-Guerin (BCG) | Placebo |
|---|---|---|---|---|
| Gastroenteritis | Infections and infestations | 0 of 330 | 2 of 330 | 0 of 329 |
| Pyelonephritis | Infections and infestations | 2 of 330 | 0 of 330 | 0 of 329 |
| Intentional self-injury | Psychiatric disorders | 1 of 330 | 1 of 330 | 0 of 329 |
| Small intestinal obstruction | Gastrointestinal disorders | 0 of 330 | 1 of 330 | 0 of 329 |
| Breast abscess | Infections and infestations | 0 of 330 | 0 of 330 | 1 of 329 |
| Cellulitis | Infections and infestations | 0 of 330 | 0 of 330 | 1 of 329 |
| Meningitis viral | Infections and infestations | 1 of 330 | 0 of 330 | 0 of 329 |
| Subcutaneous abscess | Infections and infestations | 0 of 330 | 0 of 330 | 1 of 329 |
| Chest injury | Injury, poisoning and procedural complications | 0 of 330 | 1 of 330 | 0 of 329 |
| Near drowning | Injury, poisoning and procedural complications | 0 of 330 | 0 of 330 | 1 of 329 |
Most frequent non-serious adverse event terms
| Event term | Organ system | AERAS-404 (15 mcgH4/500 Nmol IC31) | Bacillus Calmette-Guerin (BCG) | Placebo |
|---|---|---|---|---|
| Vaccination site scar | General disorders | 0 of 330 | 255 of 330 | 0 of 329 |
| Vaccination site swelling | General disorders | 0 of 330 | 172 of 330 | 0 of 329 |
| Vaccination site induration | General disorders | 0 of 330 | 171 of 330 | 0 of 329 |
| Vaccination site discharge | General disorders | 0 of 330 | 163 of 330 | 0 of 329 |
| Vaccination site erythema | General disorders | 0 of 330 | 147 of 330 | 0 of 329 |
| Vaccination site scab | General disorders | 0 of 330 | 145 of 330 | 0 of 329 |
| Vaccination site ulcer | General disorders | 0 of 330 | 104 of 330 | 0 of 329 |
| Vaccination site exfoliation | General disorders | 0 of 330 | 90 of 330 | 0 of 329 |
| Headache | Nervous system disorders | 25 of 330 | 27 of 330 | 31 of 329 |
| Upper respiratory tract infection | Infections and infestations | 31 of 330 | 7 of 330 | 26 of 329 |
Serious events with the highest arm-level rate: gastroenteritis (0.6%), pyelonephritis (0.6%), breast abscess (0.3%), cellulitis (0.3%), subcutaneous abscess (0.3%).
The adverse-event summary reports serious adverse events in 5 of 330 participants in the AERAS-404 group, 7 of 330 in the BCG group and 7 of 329 in the placebo group. It reports other adverse events in 118, 329 and 104 participants, respectively, and deaths of 0, 0 and 1. These are participant counts in the adverse-event summary, whereas the primary endpoint reports total adverse-event counts. The two summaries should not be conflated.
The registry record lists gastroenteritis and pyelonephritis at 0.6% each, and breast abscess, cellulitis, subcutaneous abscess and near drowning at 0.3% each, among the top serious-event terms. It does not provide enough information to determine event relatedness, timing, recurrence, severity details beyond the serious classification, or which group each term occurred in. The summary also does not describe the circumstances of the reported death.
These figures are descriptive. The registry record does not report a comparative statistical analysis of serious events or enough detail to establish whether differences reflect chance, exposure time, or other factors. Counts alone do not establish causation or a group-level difference. Serious events are important to review, but the small counts and limited detail mean the posted summary should be read as a safety listing rather than a definitive comparison.
12. What the Result Does, and Does Not, Mean
The posted results establish what the registry record reports: adverse-event counts by randomized group, separate participant counts for serious and other adverse events, deaths, and summary counts for sustained conversion to Mtb-positive. They also show that the conversion comparisons were recalculated from posted summary statistics for this page, rather than reported as sponsor analyses. The figures provide a basis for transparent description, but their meaning is limited by the level of detail available.
They do not establish that AERAS-404 or BCG does or does not prevent infection, nor do they establish a comparative safety advantage. The primary endpoint is a count of events, without a posted comparative estimate or uncertainty interval. The secondary conversion comparisons are unadjusted and lack a reported multiplicity plan and analysis population. The immune-response outcome is listed, but results for it are not reported in the registry record.
General explanation: statistical evidence is not the same as a treatment decision or a causal conclusion. A comparison needs a defined estimand, an analysis population, an appropriate method and transparent handling of missing data and multiple testing. Uncertainty intervals help show how precisely an estimate is determined, but they do not resolve limitations in the design or reporting. Here, the record supplies only part of that information, so conclusions must remain bounded by the posted summaries.
The sample-size section should also be interpreted narrowly. Its values are planning illustrations based on observed effects, not observed power and not the trial’s original sample-size justification. They do not show that the study was adequately or inadequately powered for its original objectives. The record does not state those objectives in the level of statistical detail needed to make such an assessment.
In practical terms, this registry record is useful for identifying the design, intervention schedules, endpoint definitions and some outcome counts. It is not a complete clinical study report. Readers should distinguish what is directly listed from what would require unavailable information, including detailed event-level data, prespecified analyses, missing-data handling, and immune-response results.
13. Why This Trial Matters Statistically
This trial is statistically instructive because it places several outcome types and observation windows side by side. The primary outcome is a count of adverse events, while the secondary conversion outcome is a count of participants reaching a defined status. Treating these as equivalent would obscure what is actually measured. The trial also uses different follow-up windows for solicited, unsolicited and injection-site events, including a longer injection-site observation period for BCG than for H4:IC31 and placebo.
The registry record shows why raw counts need context. A total event count can be driven by repeated events in some participants, while a participant count records whether people met an outcome. Without event distributions or an analysis accounting for relevant follow-up, the larger primary count in the BCG group cannot be translated directly into a difference in the chance that a participant experienced an event. This is a general issue in the analysis of count outcomes, especially when event frequency and observation time may differ.
The record also illustrates the distinction between posted outcomes and reported analyses. There are posted summaries for sustained conversion, but the registry lists no reported analyses. The pairwise values are recalculations from aggregate counts. That distinction matters: a recalculation can make the data easier to interpret, but it cannot reveal the prespecified analysis strategy, adjustment for multiple testing, or decisions about missing observations.
Finally, the planning illustration shows how observed effects can be used to explore future sample-size requirements, while also emphasizing that such an exercise is not a reconstruction of the original trial design. Planning assumptions and observed outcomes answer different questions. Taken together, these features make the study a useful example of careful separation between endpoint definition, descriptive results, inferential comparisons and prospective planning.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The registry record leaves several trial-specific uncertainties. It describes the study as partially blinded in the official title but labels masking as quadruple in the design information. It does not explain which participants or study personnel were blinded, or how blinding was implemented. The allocation method and concealment process are also not reported in the registry record.
The primary safety result is presented as total event counts, without a breakdown by event type, participant, severity, timing or relatedness in the primary outcome summary. The record does not provide a comparative estimate or interval for those counts. Since collection windows vary across event categories and groups, the total counts do not by themselves account for differences in observation time. The adverse-event summary adds participant counts for serious and other events, but does not provide enough detail to assess the circumstances or relatedness of individual events.
For sustained conversion, the reported denominators differ from the safety group sizes. The reasons are not stated, and the record does not describe missing outcomes, exclusions or analysis populations. The comparison statistics are unadjusted recalculations, with no reported sponsor analyses or stated multiplicity strategy. The immune-response outcome is listed, but its results are not reported in the registry record. This leaves an important part of the stated study objectives without a posted quantitative result.
The registry record also does not report the original sample-size justification, a statistical analysis plan, interim analyses, covariate adjustment or sensitivity analyses. Therefore, the page cannot establish whether the trial met its original statistical objectives or whether the observed secondary comparisons were prespecified. These limitations are about the scope of the posted information; they should not be replaced with assumptions about what may have been done in the protocol or in analyses not included in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Evaluation of Safety, Immunogenicity, and Prevention of TB With AERAS-404 and BCG Revaccination in Healthy Adolescents — NCT02075203.
- Registry record last updated 2019-09-04; status last verified 2019-05.
- Results first posted 2019-07-29.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
Continue through the Clinical Biostats statistical pathway
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18. Record Summary
The registry record describes NCT02075203, a completed randomized, placebo-controlled, parallel Phase II study of AERAS-404 and BCG revaccination in healthy adolescents. It lists 989 participants enrolled and three arms: AERAS-404, BCG and placebo. AERAS-404 and placebo were each given in 2 doses on Study Days 0 and 56; BCG was given as 1 dose on Study Day 0.
The primary outcome was the number of solicited and unsolicited adverse events, collected under specified post-vaccination windows. The posted totals were 286 for AERAS-404, 1257 for BCG and 272 for placebo. Secondary outcomes included sustained conversion to Mtb-positive and immune response. The record contains conversion summaries but lists no reported analyses and does not report immune-response results.
The record lists a study start of 2014-02, primary completion on 2017-08-28 and status as completed. It does not report the detailed statistical plan, the sample-size justification, or the handling of multiplicity and missing data.