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Trial · NCT01694108

Outcomes25

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYAll-cause Hospitalisations0-15 months of ageIntention-to-treatEventsNUMBER
SECONDARYAntibiotics0-15 months of ageIntention-to-treatparticipantsNUMBER
SECONDARYAtopic Dermatitis13 months of age
This analysis includes children with follow-up data from clinical examination or telephone interview. As opposed to the register-based primary outcome, adherence to telephone-interview and clinical examination was slightly lower than 100%.
participantsNUMBER
SECONDARYSpecific IgE13 months of ageThis analysis includes children who participated with blood samples for this sub-study regarding specific IgE.participantsNUMBER
SECONDARYStandardized Weight at 13 Months13 months of ageThis analysis only includes children with available follow-up data from telephone interviews or clinical examinations. As opposed to the primary outcome, follow-up was lower than 100%.Weight z-score at 13 monthsMEAN
SECONDARYPsychomotor Development in Premature Infants13 months of ageThis analysis only includes children from a particular subgroup (premature children, N = 144), who had with available follow-up data. As opposed to the primary outcome, follow-up was lower than 100%.Score on ASQ scaleMEAN
SECONDARYDTaP-IPV-Hib Vaccination Coverage at 12 Months of Age13 months of agePer-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.participantsNUMBER
SECONDARYStandardized Weight, Length and Head Circumference of Premature Children at 13 Months13 months of age
Premature children born with gestational age 32-36 weeks. This analysis only includes children from a particular subgroup (premature children, N = 144), who had with available follow-up data. As opposed to the primary outcome, follow-up was lower than 100%.
z-scoreMEAN
SECONDARYEpisodic Viral Wheeze13 monthsThis analysis only includes children with available follow-up telephone interview data. As opposed to the primary outcome, follow-up was lower than 100%.participantsNUMBER
SECONDARYFood Allergy13 monthsThis analysis only includes children with available follow-up telephone interview data. As opposed to the primary outcome, follow-up was lower than 100%.participantsNUMBER
SECONDARYLength at 13 Months of Age13monthsThis analysis only includes children with available follow-up data. As opposed to the primary outcome, follow-up for this outcome was lower than 100%.Length z-scoreMEAN
SECONDARYStandardized Head Circumference at 13 Months of Age13 monthsThis analysis only includes children with available follow-up data. As opposed to the primary outcome, follow-up for this outcome was lower than 100%.Head circumference z-scoreMEAN
SECONDARYThymic Gland Size at 3 Months of Age3 months of ageThis outcome was a sub-study to The Danish Calmette Study with 301 (BCG 153, Control 148) participating children.Thymic indexMEAN
SECONDARYLeucocyte Count 4 Days After Randomisation/Vaccination4 days after randomisation/vaccination within 7 days after birthThis was a sub study among 153 children with blood-samples at 4 days after randomisation/vaccination.cell concentrations (GM*10^9 cells/L)GEOMETRIC_MEAN
SECONDARYMonocyte Count 4 Days After Randomisation/Vaccination4 days after randomisation/vaccination within 7 days after birthThis was a sub study among 153 children with blood-samples at 4 days after randomisation/vaccination.Cell concentrations (GM*10^9 cells/L)GEOMETRIC_MEAN
SECONDARYInterferon Gamma Response13 months of ageThis is a sub study using bloodsamples. Only a small sub population from the overall trial participated.participantsNUMBER
SECONDARYNumber of Participants With Antibody Concentration (AC) Against Tetanus of > 0.1 IU/mL13 months of ageThis outcome was a sub-study with 158 participants. Antibody concentration (AC) of \> 0.1 IU/mL was considered protectiveparticipantsNUMBER
SECONDARYNumber of Events of Common Cold13 months of ageThis analysis only includes children with available follow-up data. As opposed to the primary outcome, follow-up for this outcome was lower than 100%.EventsNUMBER
SECONDARYNumber of Events of Pneumonia13 months of ageThis analysis only includes children with available follow-up data. As opposed to the primary outcome, follow-up for this outcome was lower than 100%.EventsNUMBER
SECONDARYNumber of Events of Febrile Episodes13 months of ageThis analysis only includes children with available follow-up data. As opposed to the primary outcome, follow-up for this outcome was lower than 100%.EventsNUMBER

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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.

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