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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01906853
Registration number
NCT01906853
Ethics application status
Date submitted
21/07/2013
Date registered
24/07/2013
Date last updated
8/07/2024
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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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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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
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0
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0
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Studies of infection and infectious agents
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Infection
0
0
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0
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Other infectious diseases
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Infection
0
0
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0
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Sexually transmitted infections
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Respiratory
0
0
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0
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Other respiratory disorders / diseases
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Inflammatory and Immune System
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0
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Allergies
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
No intervention: No BCG - No BCG
Experimental: BCG - Mycobacterium bovis BCG (Bacille Calmette Guérin) vaccine, Danish Strain 1331
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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]
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Using ISAAC definitions
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Timepoint [8]
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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]
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Atopic sensitisation measured by SPT using a more stringent cut-off
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Assessment method [4]
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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
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5 years of age
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Secondary outcome [5]
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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]
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Atopic sensitisation to multiple allergens measured by SPT
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Assessment method [6]
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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]
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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]
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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]
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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
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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]
0
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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
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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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0-12 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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0
Rate of lower respiratory tract infection (LRTI)
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Assessment method [19]
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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]
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0
Rate of any infection
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Assessment method [26]
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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]
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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 [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]
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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]
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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]
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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]
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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]
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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]
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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
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0-12 months of age
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Secondary outcome [37]
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Eczema ever
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Assessment method [37]
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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]
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0
Eczema
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Assessment method [38]
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Proportion of clinician-diagnosed eczema, by parental report
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Timepoint [38]
0
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0-12 months
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Secondary outcome [39]
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Eczema
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Assessment method [39]
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Proportion of clinician-diagnosed eczema, by parental report
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Timepoint [39]
0
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0-5 years of age
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Secondary outcome [40]
0
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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]
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0-12 months
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Secondary outcome [41]
0
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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]
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Measured by parental report (POEM score)
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Timepoint [42]
0
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0-12 months
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Secondary outcome [43]
0
0
Eczema severity
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Assessment method [43]
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Measured by clinical assessment (SCORAD)
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Timepoint [43]
0
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0-12 months
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Secondary outcome [44]
0
0
Eczema severity
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Assessment method [44]
0
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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
30/12/2024
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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]
0
0
Mercy Hospital for Women - Heidelberg
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Recruitment hospital [2]
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0
Royal Children's Hospital - Melbourne
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Recruitment postcode(s) [1]
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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/study/NCT01906853
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Trial related presentations / publications
Pittet LF, Messina NL, Gardiner K, Freyne B, Abruzzo V, Morrison C, Vuillermin P, Allen KJ, Ponsonby AL, Robins-Browne R, Shann F, Flanagan KL, Donath S, Casalaz D, Phillips R, Curtis N. Discordance Between Diagnosis Tools for Assessing Eczema in Infants: A Challenge for Intervention Trials. Dermatitis. 2022 May-Jun 01;33(3):207-214. doi: 10.1097/DER.0000000000000842. Epub 2022 Feb 16. Pittet LF, Messina NL, Gardiner K, Freyne B, Abruzzo V, Francis KL, Morrison C, Zufferey C, Vuillermin P, Allen KJ, Ponsonby AL, Robins-Browne R, Shann F, Flanagan KL, Phillips R, Donath S, Casalaz D, Curtis N. Prevention of infant eczema by neonatal Bacillus Calmette-Guerin vaccination: The MIS BAIR randomized controlled trial. Allergy. 2022 Mar;77(3):956-965. doi: 10.1111/all.15022. Epub 2021 Aug 9. Cirovic B, de Bree LCJ, Groh L, Blok BA, Chan J, van der Velden WJFM, Bremmers MEJ, van Crevel R, Handler K, Picelli S, Schulte-Schrepping J, Klee K, Oosting M, Koeken VACM, van Ingen J, Li Y, Benn CS, Schultze JL, Joosten LAB, Curtis N, Netea MG, Schlitzer A. BCG Vaccination in Humans Elicits Trained Immunity via the Hematopoietic Progenitor Compartment. Cell Host Microbe. 2020 Aug 12;28(2):322-334.e5. doi: 10.1016/j.chom.2020.05.014. Epub 2020 Jun 15. Messina NL, Gardiner K, Donath S, Flanagan K, Ponsonby AL, Shann F, Robins-Browne R, Freyne B, Abruzzo V, Morison C, Cox L, Germano S, Zufferey C, Zimmermann P, Allen KJ, Vuillermin P, South M, Casalaz D, Curtis N. Study protocol for the Melbourne Infant Study: BCG for Allergy and Infection Reduction (MIS BAIR), a randomised controlled trial to determine the non-specific effects of neonatal BCG vaccination in a low-mortality setting. BMJ Open. 2019 Dec 15;9(12):e032844. doi: 10.1136/bmjopen-2019-032844. Zimmermann P, Perrett KP, van der Klis FR, Curtis N. The immunomodulatory effects of measles-mumps-rubella vaccination on persistence of heterologous vaccine responses. Immunol Cell Biol. 2019 Jul;97(6):577-585. doi: 10.1111/imcb.12246. Epub 2019 Mar 28.
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Public notes
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Contacts
Principal investigator
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Prof Nigel Curtis, MBBS DCH DTM&H MRCP FRCPCH PhD
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Murdoch Children's Research Institute, Royal Children's Hospital, University of Melbourne
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Results not provided in
https://clinicaltrials.gov/study/NCT01906853
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