Post-marketing Surveillance Study of an Inactivated Split-Virion Influenza Vaccine in Korea
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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 <9 years and unprimed with an influenza vaccine. Four hundred and eleven subjects used diary cards to record safety information; this report presents data from these subjects. Incidence of solicited local, general and unsolicited adverse events (4-days and 21-days post-vaccination follow-up periods, respectively) were recorded. Serious adverse events (SAEs) were recorded throughout the study period. Results:Injection site pain (subjects aged <6 years: 12.6% of subjects, ≥6 years: 34.7%), fever (<6 years: 1.3%) and myalgia (≥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.
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 <9 years and unprimed with an influenza vaccine. Four hundred and eleven subjects used diary cards to record safety information; this report presents data from these subjects. Incidence of solicited local, general and unsolicited adverse events (4-days and 21-days post-vaccination follow-up periods, respectively) were recorded. Serious adverse events (SAEs) were recorded throughout the study period. Results:Injection site pain (subjects aged <6 years: 12.6% of subjects, ≥6 years: 34.7%), fever (<6 years: 1.3%) and myalgia (≥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.
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