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Original Articles
A Study on the Clinical Efficacy and Immunogenicity of Split Influenza Vaccine
Heung-Jeong Woo, Dong Rin Kim, Hee Jin Cheong, Byung Chul Chun, Joo Yeon Lee, Jeong Bae Ahn, Jee Hee Kim, Chan Park, Young Kyoo Shin, Woo Joo Kim, Min Ja Kim, Seung Chull Park
Department of Internal Medicine and Pediatrics*, Institute of Emerging Infectious Disease, College of Medicine, Korea University, Department of Preventive Medicine, College of Medicine, Konyang University, Division of Respiratory Viruses, Department of Viral Diseases, National Institute of Health of Korea
Vol.17 Num.1 (p25~32)
Background : The safety and effectiveness of influenza vaccine are well known in developed country. The influenza vaccination has been recommended as one of the tentative immunization schedule for indicated persons since 1997 in Korea. But there are still no available data about them, even though nearly 5 million doses of influenza vaccine were used in 1997-1998 season. So it is immediately needed to investigate the safety. efficacy and immunogenicity of influenza vaccine among Korean.

Methods : We studied the clinical efficacy of influenza vaccine by monitoring Occurrence of influenza-like illness in influenza risk group(vaccination ; 300, non-vaccination; 215) from December in 1997 to March in 1998. We used the split quadrivalent influenza vaccine containing 15 microgram of hemagglutinin of A/Beijing/262/95(H1N1), A/Wuhan/359/95(H3N2), B/Mie/1/93 and B/Guangdong/5/94. Hemagglutination inhibition(HAI) antibody titers were determined before immunization and 1 months after vaccination And we evaluated adverse effect of influenza vaccination at 7 days after vaccination.

Results : Influenza vaccination was associated with significant reductions in influenza-like symptoms(vaccination group; 28.35%, non-vaccination group, 35.88%, p=0.001). The preventive effect of influenza-like illness among influenza risk group was 20.97%. And immunogenicity of influenza A and B exceeded all of the European licensure criteria for immunogenicity except postvaccination proportion of titers ≥40 of B/Guangdong/5/94 strain. And the adverse effects were mainly local injection site problem and no serious adverse effect was noted.

Conclusion : Split influenza vaccine is safe, immunogenic and effective in influenza risk group in Korea.
Keywords : Influenza vaccine, Immunogenicity, Clinical efficacy, Adverse effect