alexa BCG Trial 2012-2013 In 4262 Danish Newborns To Study Potential Non-specific Effects: Results And Adverse Events | 68139
ISSN: 2161-0665

Pediatrics & Therapeutics
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Lone Graff Stensballe
Rigshospitalet, Denmark
Posters & Accepted Abstracts: Pediatr Ther
DOI: 10.4172/2161-0665-C1-040
Abstract
Background: The Bacillus Calmette-Guérin (BCG) vaccine is administered to protect against tuberculosis, but studies from lowincome countries suggest that there may also be non-specific beneficial effects upon the infant immune system, reducing early nontargeted infections and atopic diseases. The Danish Calmette Study, a large-scale randomised single-blind trial in Denmark to test the effect of BCG given at birth on childhood morbidity, including hospitalisation, infections, atopic disease, growth, development and immunological indicators; the primary outcome being all-cause hospitalisations analysed as repeated events from birth to 15 months of age. The rate of adverse events was registered. Methods: Pregnant women planning to give birth at three Danish hospitals were invited to participate. After parental consent, newborn children were allocated to BCG or no intervention within 7 days of age. Randomisation was stratified by prematurity. Hospitalisations were identified using The Danish National Patient Register. Primary outcome data were analysed by Cox proportional hazard models in intention-to-treat and per-protocol analyses according to the statistical analysis plan deposited at the Data Safety Monitoring Board before data was un-blinded. Results: 4184 pregnant women were randomised and their 4262 children allocated to BCG or no intervention. There was no difference in risk of hospitalisation up to 15 months of age. In primary analyses of secondary outcomes, no significant effect of BCG have been identified. The rate of local reactions and suppurative lymphadenitis was fivefold of what was expected. Conclusion: In affluent countries, BCG at birth is not likely to have a major impact on common illness in infancy.
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