Post-marketing Surveillance Study of an Inactivated Split-Virion Influenza Vaccine in Korea.
- Author:
Jae Won HUH
1
;
Sang Hyuk MA
;
Hyun Kyun KIM
;
Bhavyashree GUNAPALAIAH
;
Hans L BOCK
Author Information
1. Department of Pediatrics, Il-sin Christian Hospital, Chwacheondong, Dongu, Busan, Korea.
- Publication Type:Original Article
- Keywords:
Influenza vaccine;
Reactogenicity;
Safety
- MeSH:
Aged;
Fever;
Follow-Up Studies;
Humans;
Immunization Programs;
Incidence;
Influenza Vaccines;
Influenza, Human;
Korea;
Seasons;
Vaccination
- From:Korean Journal of Pediatric Infectious Diseases
2011;18(1):68-79
- CountryRepublic of Korea
- Language:English
-
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 <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, > or =6 years: 34.7%), fever (<6 years: 1.3%) and myalgia (> 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.
