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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01906853
Registration number
NCT01906853
Ethics application status
Date submitted
21/07/2013
Date registered
24/07/2013
Date last updated
2/02/2024
Titles & IDs
Public title
Melbourne Infant Study - Bacille Calmette Guérin (BCG) for Allergy & Infection Reduction
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Scientific title
A Randomised, Controlled Trial to Determine if BCG Immunisation at Birth Reduces Allergy and Infection in Infants
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Secondary ID [1]
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0
1051228
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Secondary ID [2]
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BCG12/01
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Universal Trial Number (UTN)
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Trial acronym
MIS BAIR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Allergy
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0
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Eczema
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0
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Respiratory Tract Infections
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0
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Condition category
Condition code
Infection
0
0
0
0
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Studies of infection and infectious agents
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Infection
0
0
0
0
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Other infectious diseases
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Infection
0
0
0
0
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Sexually transmitted infections
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Respiratory
0
0
0
0
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Other respiratory disorders / diseases
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Inflammatory and Immune System
0
0
0
0
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Allergies
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - BCG
No Intervention: No BCG - No BCG
Experimental: BCG - Mycobacterium bovis BCG (Bacille Calmette Guérin) vaccine, Danish Strain 1331
Other interventions: BCG
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Atopic sensitisation measured by skin prick test (SPT)
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Assessment method [1]
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Proportion of participants with a positive SPT defined as wheal diameter =2 mm greater than negative control at 15 min to one or more of a panel of food and aeroallergens
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Timepoint [1]
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1 year of age
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Primary outcome [2]
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Atopic sensitisation measured by skin prick test (SPT)
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Assessment method [2]
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Proportion of participants with a positive SPT defined as wheal diameter =2 mm greater than negative control at 15 min to one or more of a panel of food and aeroallergens
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Timepoint [2]
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5 years of age
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Primary outcome [3]
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Lower respiratory tract infection (LRTI)
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Assessment method [3]
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Measured by parent report
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Timepoint [3]
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0-12 months
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Primary outcome [4]
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Lower respiratory tract infection (LRTI) hospital admissions
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Assessment method [4]
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Proportion of participants with =1 hospital admission for LRTI reported by parent
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Timepoint [4]
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0-5 years of age
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Primary outcome [5]
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Eczema ever
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Assessment method [5]
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Proportion of participants with eczema measured by Williams' UK diagnostic criteria using parental report of symptoms
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Timepoint [5]
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0-12 months
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Primary outcome [6]
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Eczema ever
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Assessment method [6]
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Proportion of participants with eczema measured by Williams' UK diagnostic criteria using parental report of symptoms
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Timepoint [6]
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0-5 years of age
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Primary outcome [7]
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Current asthma
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Assessment method [7]
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Using ISAAC definitions
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Timepoint [7]
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5 years of age
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Primary outcome [8]
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Asthma ever
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Assessment method [8]
0
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Using ISAAC definitions
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Timepoint [8]
0
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5 years of age
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Secondary outcome [1]
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Clinical food allergy
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Assessment method [1]
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Proportion of participants with challenge-proven food allergy OR convincing history of food allergy in participants with a SPT wheal diameter =2 mm greater than negative control at 15 min to one or more of a panel of food allergens
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Timepoint [1]
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1 year of age
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Secondary outcome [2]
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Clinical food allergy
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Assessment method [2]
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Proportion of participants with challenge-proven food allergy OR convincing history of food allergy in participants with a SPT wheal diameter =2 mm greater than negative control at 15 min to one or more of a panel of food allergens
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Timepoint [2]
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5 years of age
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Secondary outcome [3]
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Atopic sensitisation measured by SPT using a more stringent cut-off
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Assessment method [3]
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Proportion of participants with a positive SPT defined as wheal diameter =3 mm greater than negative control at 15 min to one or more of a panel of food allergens and aeroallergens
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Timepoint [3]
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1 year of age
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Secondary outcome [4]
0
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Atopic sensitisation measured by SPT using a more stringent cut-off
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Assessment method [4]
0
0
Proportion of participants with a positive SPT defined as wheal diameter =3 mm greater than negative control at 15 min to one or more of a panel of food allergens and aeroallergens
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Timepoint [4]
0
0
5 years of age
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Secondary outcome [5]
0
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Atopic sensitisation to multiple allergens measured by SPT
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Assessment method [5]
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Proportion of participants with a positive SPT defined as wheal diameter =2 mm greater than negative control at 15 min to two or more of a panel of food allergens and aeroallergens
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Timepoint [5]
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1 year of age
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Secondary outcome [6]
0
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Atopic sensitisation to multiple allergens measured by SPT
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Assessment method [6]
0
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Proportion of participants with a positive SPT defined as wheal diameter =2 mm greater than negative control at 15 min to two or more of a panel of food allergens and aeroallergens
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Timepoint [6]
0
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5 years of age
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Secondary outcome [7]
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Parent report of food allergy
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Assessment method [7]
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Proportion of participants with an allergic reaction to any food reported by parent
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Timepoint [7]
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0-12 months of age
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Secondary outcome [8]
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Parent report of food allergy
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Assessment method [8]
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Proportion of participants with an allergic reaction to any food reported by parent
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Timepoint [8]
0
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0-5 years of age
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Secondary outcome [9]
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Egg sensitisation
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Assessment method [9]
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Proportion of participants with a positive SPT defined as wheal diameter =2 mm greater than negative control at 15 min to egg allergen
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Timepoint [9]
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1 year of age
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Secondary outcome [10]
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Egg sensitisation
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Assessment method [10]
0
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Proportion of participants with a positive SPT defined as wheal diameter =2 mm greater than negative control at 15 min to egg allergen
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Timepoint [10]
0
0
5 years of age
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Secondary outcome [11]
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Egg allergy
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Assessment method [11]
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Proportion of participants with a challenge-proven egg allergy OR convincing history of egg allergy in participants with a SPT wheal diameter =2 mm greater than negative control at 15 min to egg
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Timepoint [11]
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1 year of age
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Secondary outcome [12]
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Egg allergy
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Assessment method [12]
0
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Proportion of participants with a challenge-proven egg allergy OR convincing history of egg allergy in participants with a SPT wheal diameter =2 mm greater than negative control at 15 min to egg
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Timepoint [12]
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5 years of age
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Secondary outcome [13]
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Atopic wheeze
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Assessment method [13]
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Proportion of participants with a positive SPT defined as wheal diameter =2 mm greater than negative control at 15 min to one or more of a panel of food and aeroallergens together with parent-reported wheeze
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Timepoint [13]
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1 year of age
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Secondary outcome [14]
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Atopic wheeze
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Assessment method [14]
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Proportion of participants with a positive SPT defined as wheal diameter =2 mm greater than negative control at 15 min to one or more of a panel of food and aeroallergens together with parent-reported wheeze
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Timepoint [14]
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5 years of age
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Secondary outcome [15]
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Lower respiratory tract infection (LRTI)
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Assessment method [15]
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Proportion of participants with =1 episode of LRTI, by parental report
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Timepoint [15]
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Prior to first Diphtheria, Tetanus, Pertussis (DTP) vaccination
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Secondary outcome [16]
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Lower respiratory tract infection (LRTI)
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Assessment method [16]
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Proportion of participants with =1 episode of LRTI, by parental report
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Timepoint [16]
0
0
0-5 years of age
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Secondary outcome [17]
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Rate of lower respiratory tract infection (LRTI)
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Assessment method [17]
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Number of clinical episodes of LRTI, by parental report
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Timepoint [17]
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0
0-12 months
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Secondary outcome [18]
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Rate of lower respiratory tract infection (LRTI)
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Assessment method [18]
0
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Number of clinical episodes of LRTI, by parental report
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Timepoint [18]
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0
Prior to first DTP vaccination
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Secondary outcome [19]
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Rate of lower respiratory tract infection (LRTI)
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Assessment method [19]
0
0
Number of clinical episodes of LRTI, by parental report
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Timepoint [19]
0
0
0-5 years of age
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Secondary outcome [20]
0
0
Infections
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Assessment method [20]
0
0
Hospital admissions for any infection by parental report
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Timepoint [20]
0
0
0-12 months
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Secondary outcome [21]
0
0
Infections
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Assessment method [21]
0
0
Hospital admissions for any infection by parental report
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Timepoint [21]
0
0
Prior to first DTP vaccination
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Secondary outcome [22]
0
0
Infections
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Assessment method [22]
0
0
Hospital admissions for any infection by parental report
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Timepoint [22]
0
0
0-5 years of age
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Secondary outcome [23]
0
0
Hospitalisation for respiratory tract infection (RTI)
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Assessment method [23]
0
0
Proportion of participants with =1 hospital admission for a RTI, by parent report
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Timepoint [23]
0
0
0-12 months of age
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Secondary outcome [24]
0
0
Hospitalisation for respiratory tract infection (RTI)
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Assessment method [24]
0
0
Proportion of participants with =1 hospital admission for a RTI, by parent report
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Timepoint [24]
0
0
Prior to first DTP vaccination
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Secondary outcome [25]
0
0
Hospitalisation for respiratory tract infection (RTI)
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Assessment method [25]
0
0
Proportion of participants with =1 hospital admission for a RTI, by parent report
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Timepoint [25]
0
0
0-5 years of age
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Secondary outcome [26]
0
0
Rate of any infection
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Assessment method [26]
0
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Number of clinical episodes of where an infant had symptoms of: wheeze, rattle/rattly chest, fever, runny/blocked nose, cough, or diarrhoea (with vomiting), by parent report
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Timepoint [26]
0
0
0-12 months of age
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Secondary outcome [27]
0
0
Rate of any infection
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Assessment method [27]
0
0
Number of clinical episodes of where an infant had symptoms of: wheeze, rattle/rattly chest, fever, runny/blocked nose, cough, or diarrhoea (with vomiting), by parent report
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Timepoint [27]
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0
Prior to first DTP vaccination
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Secondary outcome [28]
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0
Rate of upper respiratory tract infection (URTI)
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Assessment method [28]
0
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Number of clinical episodes of upper respiratory tract infections, by parent report
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Timepoint [28]
0
0
0-12 months of age
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Secondary outcome [29]
0
0
Rate of upper respiratory tract infection (URTI)
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Assessment method [29]
0
0
Number of clinical episodes of upper respiratory tract infections, by parent report
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Timepoint [29]
0
0
Prior to first DTP vaccination
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Secondary outcome [30]
0
0
Rate of fever
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Assessment method [30]
0
0
Number of clinical episodes of fever, by parent report
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Timepoint [30]
0
0
0-12 months of age
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Secondary outcome [31]
0
0
Rate of fever
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Assessment method [31]
0
0
Number of clinical episodes of fever, by parent report
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Timepoint [31]
0
0
Prior to first DTP vaccination
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Secondary outcome [32]
0
0
Diarrhoea
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Assessment method [32]
0
0
Proportion of participants with =1 episodes of diarrhoea
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Timepoint [32]
0
0
0-12 months of age
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Secondary outcome [33]
0
0
Diarrhoea
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Assessment method [33]
0
0
Proportion of participants with =1 episodes of diarrhoea
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Timepoint [33]
0
0
Prior to first DTP vaccination
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Secondary outcome [34]
0
0
Rash with fever
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Assessment method [34]
0
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Proportion of participants with =1 episodes of rash with fever
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Timepoint [34]
0
0
0-12 months of age
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Secondary outcome [35]
0
0
Rash with fever
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Assessment method [35]
0
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Proportion of participants with =1 episodes of rash with fever
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Timepoint [35]
0
0
Prior to first DTP vaccination
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Secondary outcome [36]
0
0
Eczema ever
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Assessment method [36]
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Proportion of participants with eczema measured by a combined eczema measure
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Timepoint [36]
0
0
0-12 months of age
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Secondary outcome [37]
0
0
Eczema ever
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Assessment method [37]
0
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Proportion of participants with eczema measured by a combined eczema measure
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Timepoint [37]
0
0
0-5 years of age
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Secondary outcome [38]
0
0
Eczema
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Assessment method [38]
0
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Proportion of clinician-diagnosed eczema, by parental report
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Timepoint [38]
0
0
0-12 months
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Secondary outcome [39]
0
0
Eczema
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Assessment method [39]
0
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Proportion of clinician-diagnosed eczema, by parental report
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Timepoint [39]
0
0
0-5 years of age
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Secondary outcome [40]
0
0
Eczema onset
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Assessment method [40]
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Age of onset of eczema, by parental report
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Timepoint [40]
0
0
0-12 months
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Secondary outcome [41]
0
0
Eczema onset
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Assessment method [41]
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Age of onset of eczema, by parental report
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Timepoint [41]
0
0
0-5 years of age
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Secondary outcome [42]
0
0
Eczema severity
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Assessment method [42]
0
0
Measured by parental report (POEM score)
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Timepoint [42]
0
0
0-12 months
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Secondary outcome [43]
0
0
Eczema severity
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Assessment method [43]
0
0
Measured by clinical assessment (SCORAD)
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Timepoint [43]
0
0
0-12 months
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Secondary outcome [44]
0
0
Eczema severity
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Assessment method [44]
0
0
Eczema medication use, by parental report
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Timepoint [44]
0
0
0-12 months
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Secondary outcome [45]
0
0
Eczema severity
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Assessment method [45]
0
0
Measured by parental report (POEM score)
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Timepoint [45]
0
0
0-5 years of age
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Secondary outcome [46]
0
0
Eczema severity
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Assessment method [46]
0
0
Measured by clinical assessment (SCORAD)
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Timepoint [46]
0
0
0-5 years of age
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Secondary outcome [47]
0
0
Eczema severity
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Assessment method [47]
0
0
Eczema medication use, by parental report
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Timepoint [47]
0
0
0-5 years of age
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Secondary outcome [48]
0
0
Asthma severity
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Assessment method [48]
0
0
Measured by asthma control test (ACT), by parental/participant report
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Timepoint [48]
0
0
4 years of age
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Secondary outcome [49]
0
0
Asthma severity
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Assessment method [49]
0
0
Measured by asthma control test (ACT), by parental/participant report
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Timepoint [49]
0
0
5 years of age
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Secondary outcome [50]
0
0
Asthma severity
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Assessment method [50]
0
0
Hospital admissions for asthma, by parental report
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Timepoint [50]
0
0
2-5 years of age
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Secondary outcome [51]
0
0
Laboratory measures of the immune response
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Assessment method [51]
0
0
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Timepoint [51]
0
0
Time Frame: 0-5 years of age
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Eligibility
Key inclusion criteria
Inclusion criteria:
- Less than 10 days old;
- English speaking mother;
- An informed consent form must be signed and dated by their parent(s) or legally
acceptable representative after the nature of the study has been explained and prior
to any study assessments/procedures;
- The infant's mother has screened negative for HIV during this pregnancy;
- Born no earlier than eight weeks before estimated date of delivery;
- Birth weight >1500g.
- The legal guardian expects to be able to complete four online/phone questionnaires
over the infant's first 12 months of life and for the infant to be available for skin
prick testing at RCH between 12-16 months of age.
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Minimum age
No limit
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Maximum age
10
Days
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Exclusion criteria:
- Any indication for BCG immunisation in the first 12 months of life including:
- likely travel to a high tuberculosis (TB) incidence country in the first year of
life.
- Aboriginal and Torres Strait Islander babies living in parts of Australia where
the incidence of TB is higher
- newborn babies, if either parent has leprosy or a family history of leprosy
- newborn in contact with a patient with TB.
- Known or suspected HIV infection
- Treatment with corticosteroids or other immunosuppressive therapy, including
monoclonal antibodies against tumour necrosis factor-alpha (TNF-alpha) (e.g.
infliximab, etanercept, adalimumab).
- Born to a mother treated with bDMARDS (e.g. TNF-alpha blocking monoclonal antibodies)
in the 3rd trimester;
- Congenital cellular immunodeficiencies including specific deficiencies of the
interferon gamma pathway;
- Malignancies involving bone marrow or lymphoid systems;
- Serious underlying illness including severe malnutrition;
- Medically unstable;
- Generalised septic skin disease and skin conditions such as eczema, dermatitis and
psoriasis;
- Significant febrile illness;
- Mother immunosuppressed;
- Family history of immunodeficiency;
- Consanguineous parents;
- Multiple births more than twins.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/06/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
1272
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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0
Mercy Hospital for Women - Heidelberg
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Recruitment hospital [2]
0
0
Royal Children's Hospital - Melbourne
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Recruitment postcode(s) [1]
0
0
3084 - Heidelberg
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Recruitment postcode(s) [2]
0
0
3052 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Murdoch Childrens Research Institute
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Address
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Country
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Other collaborator category [1]
0
0
Other
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Name [1]
0
0
Royal Children's Hospital
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Address [1]
0
0
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Country [1]
0
0
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Other collaborator category [2]
0
0
Other
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Name [2]
0
0
Mercy Hospital for Women, Australia
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Address [2]
0
0
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Country [2]
0
0
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Other collaborator category [3]
0
0
Other
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Name [3]
0
0
University of Melbourne
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Address [3]
0
0
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Country [3]
0
0
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Ethics approval
Ethics application status
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Summary
Brief summary
1. To determine if BCG immunisation at birth, compared to no BCG immunisation, leads to a
reduction in measures of allergy and infection in the first 12 months of life.
2. To evaluate the immunological mechanisms underlying the non-specific effects of BCG by
comparing markers of immunity between the BCG and non-BCG groups.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01906853
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Prof Nigel Curtis, MBBS DCH DTM&H MRCP FRCPCH PhD
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Address
0
0
Murdoch Children's Research Institute, Royal Children's Hospital, University of Melbourne
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
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Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01906853
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