Table 34Summary of evidence: neonatal BCG vaccination

OutcomesIntervention: BCG vaccinated vs. unvaccinated infantsResultsAssociation/statistical significanceRef and NICE grade
Pulmonary TB diseaseFour RCTsProtective effect 0.74Combined RR 0.26 (95% CI 0.17 to 0.38, p< 0.05){288} 1+
Nine case control studiesProtective effect 0.52Combined OR 0.48 (95% CI 0.37 to 0.62, p<0.05){288} 2+
TB deathsFive RCTsProtective effect 0.65Combined RR 0.35 (95% CI 0.14 to 0.88, p<0.05){288} 1+
TB meningitisFive case control studiesProtective effect 0.64 (based on 181 cases of TB meningitis)Combined OR 0.36 (95% CI 0.18 to 0.70, p<0.05){288} 2+
One cohort study0/770,000 intervention vs. 57/2,100,000 (0.0048%) control cases developed TB diseaseNot reported{289} 2+
Laboratory-confirmed TB casesThree case control studiesProtective effect 0.83 (based on results of 108 TB cases confirmed by either histology or culture)Combined OR 0.17 (95% CI 0.07 to 0.42, p<0.05){288} 2+
Disseminated TBThree case control studiesProtective effect 0.78Combined 0.22 (95% CI 0.12 to 0.42, p<0.05){288} 2+

From: 11, BCG vaccination

Cover of Tuberculosis
Tuberculosis: Clinical Diagnosis and Management of Tuberculosis, and Measures for Its Prevention and Control.
NICE Clinical Guidelines, No. 117.
National Collaborating Centre for Chronic Conditions (UK); Centre for Clinical Practice at NICE (UK).
Copyright © 2006, Royal College of Physicians of London.

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