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Comparison · NCT01694108-73d8624e

BCG-vaccine vs Control Children: DTaP-IPV-Hib Vaccination Coverage at 12 Months of Age

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: DTaP-IPV-Hib Vaccination Coverage at 12 Months of Age. Trial comparisons, record NCT01694108-73d8624e. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01694108-73d8624e

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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 10.5820.5610.604wilson
Risk in group 20.5760.5540.597wilson
Risk difference, group 1 minus group 20.00668-0.02350.0368newcombe hybrid score
Risk ratio, group 1 over group 21.010.961.07log
Odds ratio, group 1 over group 21.030.9081.16log
Number needed to treat, for one more participant with the outcome on BCG-vaccine than on Control Children150from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: control.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1BCG-vaccineSSI strain 1331 standard dose1,1752,018OG000
Group 2Control ChildrenNo intervention1,2072,097OG001

Outcome

Type
SECONDARY
Title
DTaP-IPV-Hib Vaccination Coverage at 12 Months of Age
Description
To test that infants who get the BCG vaccine at birth has unaffected coverage with the subsequent 3rd diphtheria, tetanus, acellular pertussis, polio, Haemophilus influenzae type b (DTaP-IPV-Hib) vaccination scheduled to 12 months of age according to the Danish child vaccination programme. Since we did not expect all children to get their immunizations exactly at 12 months of age, the children were followed up until 13-months of age.
Time frame
13 months of age
Population
Per-protocol analysis excluding 11 children randomised to BCG who did not receive the vaccine, and 36 children randomised to control who received the BCG vaccine.

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

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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