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Effectiveness of Trivalent Inactivated Influenza Vaccine in Children Estimated by a Test-Negative Case-Control Design Study Based on Influenza Rapid Diagnostic Test Results
Authors:Masayoshi Shinjoh  Norio Sugaya  Yoshio Yamaguchi  Yuka Tomidokoro  Shinichiro Sekiguchi  Keiko Mitamura  Motoko Fujino  Hiroyuki Shiro  Osamu Komiyama  Nobuhiko Taguchi  Yuji Nakata  Naoko Yoshida  Atsushi Narabayashi  Michiko Myokai  Masanori Sato  Munehiro Furuichi  Hiroaki Baba  Hisayo Fujita  Akihiro Sato  Ichiro Ookawara  Kenichiro Tsunematsu  Makoto Yoshida  Mio Kono  Fumie Tanaka  Chiharu Kawakami  Takahisa Kimiya  Takao Takahashi  Satoshi Iwata  Keio Pediatric Influenza Research Group
Abstract:We assessed vaccine effectiveness (VE) against medically attended, laboratory-confirmed influenza in children 6 months to 15 years of age in 22 hospitals in Japan during the 2013–14 season. Our study was conducted according to a test-negative case-control design based on influenza rapid diagnostic test (IRDT) results. Outpatients who came to our clinics with a fever of 38°C or over and had undergone an IRDT were enrolled in this study. Patients with positive IRDT results were recorded as cases, and patients with negative results were recorded as controls. Between November 2013 and March 2014, a total of 4727 pediatric patients (6 months to 15 years of age) were enrolled: 876 were positive for influenza A, 66 for A(H1N1)pdm09 and in the other 810 the subtype was unknown; 1405 were positive for influenza B; and 2445 were negative for influenza. Overall VE was 46% (95% confidence interval [CI], 39–52). Adjusted VE against influenza A, influenza A(H1N1)pdm09, and influenza B was 63% (95% CI, 56–69), 77% (95% CI, 59–87), and 26% (95% CI, 14–36), respectively. Influenza vaccine was not effective against either influenza A or influenza B in infants 6 to 11 months of age. Two doses of influenza vaccine provided better protection against influenza A infection than a single dose did. VE against hospitalization influenza A infection was 76%. Influenza vaccine was effective against influenza A, especially against influenza A(H1N1)pdm09, but was much less effective against influenza B.
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