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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01420705 |
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Date of registration:
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12/08/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Bacille Calmette-Guérin (BCG) Vaccine and Atopy
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Scientific title:
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The Effect of Giving BCG Vaccine at Birth to Low Birth-weight Infants on Development of Allergy and Asthma in Childhood - Follow up of a Randomised Trial in Guinea-Bissau |
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Date of first enrolment:
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October 2011 |
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Target sample size:
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487 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01420705 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Retrospective
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Phase:
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N/A
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Countries of recruitment
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Guinea-Bissau
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Contacts
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Name:
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Peter Aaby, DMSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bandim Health Project |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Previous enrolment in NCT00146302
- Living within Bandim Health Project study area
Exclusion Criteria:
- Children with known history of anaphylaxis
- Children with skin infections or severe skin conditions for who SPT could not be
reliably performed
- Children currently taking anti-histamine medication
Age minimum:
3 Years
Age maximum:
9 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Food Hypersensitivity
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Asthma
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Eczema
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Primary Outcome(s)
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Skin prick test
[Time Frame: Single observation at time of consent - DAY 1]
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Secondary Outcome(s)
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Symptoms of asthma
[Time Frame: Single observation at time of consent - DAY 1]
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Symptoms of food allergy
[Time Frame: Single observation at time of consent - DAY 1]
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Symptoms of eczema
[Time Frame: Single observation at time of consent - DAY 1]
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Secondary ID(s)
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2011-BHP-LBW-BCG-atopy
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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