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Comparison · NCT04542330-deaths

BCG-Denmark vs Control: deaths from any cause

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-Denmark vs Control: deaths from any cause. Trial comparisons, record NCT04542330-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04542330-deaths

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.001190.0002110.00673wilson
Risk in group 20.003580.001220.0105wilson
Risk difference, group 1 minus group 2-0.00239-0.009350.00363newcombe hybrid score
Risk ratio, group 1 over group 20.3330.03473.2log
Odds ratio, group 1 over group 20.3330.03453.2log
Number needed to treat, for one fewer death from any cause on BCG-Denmark than on Control419from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: control.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1BCG-Denmark
Participants that are randomized to the active comparator arm will receive an adult 0.1 ml dose of BCG vaccine (BCG-Denmark, AJ Vaccines) in the skin covering the left upper deltoid muscle.~Each 0.1 ml dose of vaccine contains between 200,000 to 800,000 colony forming units of the live attenuated strain of Mycobacterium bovis (BCG), Danish strain 1331.~BCG-Denmark: Mycobacterium bovis BCG live attenuated BCG-Denmark vaccine (AJ Vaccines, Copenhagen, Denmark) administered by intradermal injection in the left deltoid region.
1838EG000
Group 2Control
Participants randomized to the control group will receive one 0.1 ml dose sterile 0.9 % NaCl by intradermal injection in the left deltoid region.~Saline: Participants randomized to the control group will receive one 0.1 ml dose sterile 0.9 % NaCl by intradermal injection in the left deltoid region.
3838EG001

Harm

What it counts
Total, all-cause mortality
Time frame
12 months

Source ClinicalTrials.gov

Trial

Title
Using BCG to Protect Senior Citizens During the COVID-19 Pandemic
NCT number
NCT04542330
Phases
PHASE3
Conditions
Covid19, Non-specific Effects of Vaccines, Heterologous Immunity, Morbidity, Immunosenescence, Vaccine Preventable Disease
Interventions
BCG-Denmark, Saline
Lead sponsor
Bandim Health Project
Results first posted
2024-08-22

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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