Post-marketing Surveillance Study of an Inactivated Split-Virion Influenza Vaccine in Korea / 소아감염
Korean Journal of Pediatric Infectious Diseases
;
: 68-79, 2011.
Article
in English
| WPRIM
| ID: wpr-217561
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.
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Seasons
/
Influenza Vaccines
/
Incidence
/
Follow-Up Studies
/
Vaccination
/
Immunization Programs
/
Influenza, Human
/
Fever
/
Korea
Type of study:
Incidence study
/
Observational study
/
Prognostic study
/
Screening study
Limits:
Aged
/
Humans
Country/Region as subject:
Asia
Language:
English
Journal:
Korean Journal of Pediatric Infectious Diseases
Year:
2011
Type:
Article
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