Comparison · NCT01694108-3e3b0413
BCG-vaccine vs Control Children: Number of Participants With Antibody Concentration (AC) Against Tetanus of > 0.1 IU/mL
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. BCG-vaccine vs Control Children: Number of Participants With Antibody Concentration (AC) Against Tetanus of > 0.1 IU/mL. Trial comparisons, record NCT01694108-3e3b0413. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01694108-3e3b0413
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 1 | 0.954 | 1 | wilson | |
| Risk in group 2 | 1 | 0.953 | 1 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.0458 | 0.0469 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 1 | 1 | log | |
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: control.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | BCG-vaccine | SSI strain 1331 standard dose | 80 | 80 | OG000 |
| Group 2 | Control Children | No intervention | 78 | 78 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Antibody Concentration (AC) Against Tetanus of > 0.1 IU/mL
- Description
To test the tetenus antibody response in BCG-vaccinated vs. non-BCG vaccinated children following routine immunisation against tetanus at 3, 5 and 12 months of age in blood samples obtained 13 months of age.
- Time frame
- 13 months of age
- Population
- This outcome was a sub-study with 158 participants. Antibody concentration (AC) of \> 0.1 IU/mL was considered protective
Source ClinicalTrials.gov
Trial
- Title
- Bacille Calmette Guérin Immunisation at Birth and Childhood Morbidity in Danish Children.
- NCT number
- NCT01694108
- Phases
- PHASE4
- Conditions
- Prospective, Single-blind, Clinical, Trial, Intervention
- Interventions
- BCG-vaccine (SSI)
- Lead sponsor
- Lone Graff Stensballe
- Results first posted
- 2016-01-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01694108?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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