Safety Profile of Japanese Encephalitis Vaccine in Chidren and Adolescents in Bali Province: An Active Vaccine Safety Surveillance

Background: Indonesian Expanded Program of Immunization has implemented Japanese Emcephalitis vaccination in endemic area in Indonesia such as Bali Province, was initiated by catch up campaign program in children 9 months to 15 years of age.

Objectives:The objectives of this study are to assess the immediate serious systemic reactions within 30 minutes after immunization and also local reactions, systemic events and any serious adverse event, until 28 days following immunization.

Method: An observational study was conducted in 1000 subjects. Local reactions and systemic events within 28 days following immunization, were recorded into daily cards and will be confirmed by trained primary health center staffs.

Result: Totally, 1000 children and adolescents completed the study and can be analyzed. The most common local reaction was pain, occured in 21.1% subjects and mild swelling in 14.1% subjects within 30 minutes after vaccination. Redness occurred more frequent in 15.8% subjects at 24 hours following immunization. Fever, occured only in 0.8%, no serious adverse event reported during the observation.

Conclusion: This JE live vaccine was safe and well tolerated in children and adolescents.