Post-marketing Surveillance Study of an Inactivated Split-Virion Influenza Vaccine in Korea / 소아감염

ABSTRACT

PURPOSE: This post-marketing surveillance study (NCT00750360) assessed the safety and reactogenicity of an inactivated, trivalent split-virion influenza vaccine licensed for use in the Korea since 2002. METHODS: Eight hundred and eighty three subjects aged > or =6 months received a single dose of the vaccine; an additional dose was administered to those aged or =6 years: 34.7%), fever ( or =6 years: 13.9%) were the most frequently recorded solicited local and general adverse events. Grade 3 solicited adverse events were reported by < or =4.0% subjects. No vaccine-related SAEs were recorded (KFDA criteria). CONCLUSION: Considering the vaccine's well-established immunogenicity and its favourable safety and reactogenicity profile across all age groups and its high coverage rate in Korea, it may be recommended as a candidate to facilitate annual seasonal influenza vaccination for all ages as part of the Korean National Immunization Program.