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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT00146302 |
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Date of registration:
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05/09/2005 |
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Primary sponsor: |
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Public title:
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Should Low Birth Weight Infants Be Vaccinated With BCG Vaccine at Birth in Developing Countries?
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Scientific title:
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BCG Vaccination and Childhood Morbidity and Mortality: Interventions With Possible Implications for the Immunisation Policy in Developing Countries. Should Low Birth Weight Infants Be Vaccinated With BCG Vaccine at Birth? |
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Date of first enrolment:
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November 2002 |
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Target sample size:
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2320 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00146302 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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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 |
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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:
- Must weigh less than 2500 g at birth
- Must be able to nurse
- Must be healthy enough to be discharged from the hospital
Exclusion Criteria:
- Overt illness
- Malformation
Age minimum:
N/A
Age maximum:
30 Days
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Tuberculosis
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Intervention(s)
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Biological: Bacille Calmette Guerin (BCG)
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Primary Outcome(s)
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Adverse events within 12 months after intervention
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Hospitalisations until 12 months of age
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Mortality until 12 months of age
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Secondary Outcome(s)
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Assessment of antibody and cellular immune responses following intervention
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BCG scar reaction 2 and 6 months after intervention
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Tuberculin reaction 2 and 6 months after intervention
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Secondary ID(s)
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#6-FY04-51
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ICA4-CT-2002-10053
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ICA4-CT-2002-10053LBW
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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