2011•Korean Journal of Pediatric Infectious DiseasesRequires access
Post-marketing Surveillance Study of an Inactivated Split-Virion Influenza Vaccine in Korea
Jaewon Huh, Sang Hyuk, Hyun-Kyun Kim, Bhavyashree Gunapalaiah, Hans L. Bock, on behalf of the Fluarix-054 Study Group
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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 6 months received a single dose of the vaccine; an additional dose was administered to those aged 6 years: 34.7%), fever (6 years: 13.9%) were the most frequently recorded solicited local and general adverse events. Grade 3 solicited adverse events were reported by 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.