RESUMEN
INTRODUCTION: Bacillus Calmette-Guerin (BCG) vaccination is given as a part of the national immunization schedule in India and its most common complication is BCG lymphadenitis. The reported incidence of BCG lymphadenitis ranges from 0.1 to 9.9% in various studies. In our country, though most babies get BCG vaccination during the neonatal period, the incidence of BCG lymphadenitis is not studied well. AIMS: To study the incidence of lymphadenitis following BCG vaccination at tertiary care hospital in North India. METHODS: It was a prospective longitudinal observational study. All newborns weighing ≥1.5 kg at birth without any significant illness who received BCG vaccination at our institute were enrolled and followed up for 16 weeks after vaccination. Babies were examined at 6, 10 and 14 weeks for the development of lymphadenopathy. Meta-analysis of studies evaluating incidence of BCG adenitis in children was also performed. RESULTS: Out of 817 babies vaccinated during the enrolment period, 605 babies could be followed up till 16.2 ± 0.9 weeks post BCG vaccination. One case of BCG lymphadenitis was detected at 14 weeks. Thus, the observed incidence of BCG lymphadenitis was 0.16% (95% CI of 0.004%-0.92%). Meta-analysis of 21 studies showed mean incidence estimate of 0.336% (95% CI: 0.315%-0.358%) using fixed effect model whereas random effect model showed mean incidence of 4.45% (95% CI: 3.02%-6.15%). CONCLUSION: The lower incidence of lymphadenitis in our study can probably be attributed to a less immunogenic vaccine (Danish 1331), proper technique, experience of the vaccinator and good storage facilities available at our institute.