23 8 2 HA TFHA HA 22 4 28 23 8 1 4
23 7 20 HA TF HA HA 22 4 28 1 A B HA A B HA A B 6
23 7 20 HA TF HA HA 22 4 28 6 3 0.25mL 3 13 0.5mL 2 4 2 13 0.5mL 1 1 4 2 2
1 23 6 17 HA TF HA HA 22 4 28 1 A B HA A B HA A B 3 0.25mL 1 4 2 3 13 0.5mL 1 4 2 13 0.5mL 1 1 4 2 1 A B C A Hemagglutinin HANeuraminidase NAH1 H16 N1 N9 3
2011 A H1N1 2009 1 A H3N2 B MMWR Recomm Rep, 58: 1-52, 2009 Wkly Epidemiol Rec, 80: 279-287, 2005, 5: 49-55, 2004, 59: 59-66, 2009, 10: 33-39, 2009 Influenza A(H1N1) virus resistance to oseltamivir- 2008/2009 influenza season, northern hemisphere http://www.who.int/csr/disease/influenza/h1n1_table/en/index.html IASR, 30: 101-106, 2009 3 HA HA 4 1 HA 12, p227,, 2008 1972 HA 1 HA WHO WHO a / a / 1 0.1mL 2 / 0.25mL 1 2 c / 1 3 0.2mL 2 / 3 6 0.5mL 1 2 c / 6 9 0.3mL 2 / 9 13 0.5mL 1 / 13 0.5mL 1 2 b / a) 1 0.5mL HA 1 15 g b) 1 1 4 2 c) 1 2 WHO 6 36 Wkly Epidemiol Rec, 80: 279-287, 2005 2011 1 2009 4 A H1N1 2009 2011 3 1977 A H1N1 A H1N1 2009 4
6 36 0.25mL/36 0.5mL/ WHO HA 1 WHO, 105: 990-991, 2001, 6: 325-330, 2005 Vaccine, 22: 3404-3410, 2004 5 17 2 2 http://www.mhlw.go.jp/shingi/2005/02/txt/s0202-5.txt HA 17 3 http://www.mhlw.go.jp/houdou/2005/03/dl/h0331-7a.pdf HA 1 WHO HI 2. 2 2 WHO HA HA TF HA HA WHO KD-PEDFLU-1 A H1N1 2009 1 HA TF A H1N1 2009 A HA H1N1 A H1N1 2009 2010 4 28 6 1 2 20 KD-PEDFLU-2 HA WHO 23 6 16 2. KD-PEDFLU-1 5
KD-PEDFLU-2 2 1 / KD-PEDFLU-1 20 20 6 13 80 40 A H1N1 2009 WHO 2 KD-PEDFLU-1 2009 2010 A H1N1 A/Brisbane/59/2007 H1N1A H3N2 A/Uruguay/716/2007 H3N2 B B/Brisbane/60/2008 0.5mL 1 HA 15 g A H1N1 2009 2009 4 HA NA A H1N1 2009 A/California/7/2009 H1N1 v-like strain X-179A 0.5mL HA 15 g WHO A H1N1 2009 WHO A H1N1 2009 2 2 WHO WHO / / 6 3 0.25mL/2 / A H1N1 2009 0.25mL/2 / A H1N1 2009 3 13 0.5mL/2 / 0.5mL/2 / A H1N1 2009 A H1N1 2009 WHO 21 7 2 80 WHO 40 6 3 20 3 13 20 WHO 40 6 3 20 3 13 20 1 WHO 6 3 79 FAS Full analysis setfas WHO 40 6 3 20 3 13 20 WHO 39 6 3 19 3 13 20 A H1N1 2009 1 2 21 7 HI HI A H1N1 2009 A H1N1 2009 2 6
i) 1 20 1 4 ii) 1 40 1 4 3 4 3 WHO HI KD-PEDFLU-1 FAS 1 2 1 2 [95%CI] [95%CI] [95%CI] [95%CI] 6 3 N 20 10 50.0 17 85.0 x7 35.0 16 80.0 A H1N1 [27.2, 72.8] [62.1, 96.8] [15.4, 59.2] [56.3, 94.3] 3 13 N 20 11 55.0 x9 45.0 11 55.0 x9 45.0 [31.5, 76.9] [23.1, 68.5] [31.5, 76.9] [23.1, 68.5] 6 3 N 20 14 70.0 x20 100.0 10 50.0 20 100.0 A H3N2 [45.7, 88.1] [83.2, 100.0] [27.2, 72.8] [83.2, 100.0] 3 13 N 20 13 65.0 17 85.0 11 55.0 15 75.0 [40.8, 84.6] [62.1, 96.8] [31.5, 76.9] [50.9, 91.3] B 6 3 N 20 x4 20.0 15 75.0 x0 x0.0 x7 35.0 [5.7, 43.7] [50.9, 91.3] [0.0, 16.8] [15.4, 59.2] 3 13 N 20 x8 40.0 18 90.0 x7 35.0 11 55.0 [19.1, 63.9] [68.3, 98.8] [15.4, 59.2] [31.5, 76.9] N95 CI 95 4 A H1N1 2009 HI KD-PEDFLU-1 FAS HI HI 1 2 1 2 1 2 1 2 [95 CI] [95 CI] [95 CI] [95 CI] [95 CI] [95 CI] [95 CI] [95 CI] 6 3 WHO N 20 x6 30.0 18 90.0 10 50.0 20 100.0 x1 5.0 13 65.0 x8 40.0 20 100.0 [11.9, 54.3] [68.3, 98.8] [27.2, 72.8] [83.2, 100.0] [0.1, 24.9] [40.8, 84.6] [19.1, 63.9] [83.2, 100.0] WHO N 19 x5 26.3 [9.1, 51.2] 3 13 WHO N 20 15 75.0 [50.9, 91.3] WHO N 20 14 70.0 [45.7, 88.1] 17 89.5 [66.9, 98.7] 12 63.2 [38.4, 83.7] 18 90.0 [68.3, 98.8] 18 90.0 [68.3, 98.8] 18 90.0 17 85.0 [68.3, 98.8] [62.1, 96.8] 19 100.0 [82.4, 100.0] 19 95.0 [75.1, 99.9] 20 100.0 [83.2, 100.0] x2 10.5 [1.3, 33.1] 14 73.7 [48.8, 90.9] x9 47.4 [24.4, 71.1] 14 70.0 17 85.0 18 90.0 [45.7, 88.1] [62.1, 96.8] [68.3, 98.8] 10 50.0 14 70.0 15 75.0 [27.2, 72.8] [45.7, 88.1] [50.9, 91.3] 19 100.0 [82.4, 100.0] 18 90.0 [68.3, 98.8] 20 100.0 [83.2, 100.0] HI European Medicines Agency EMA Note for guidance on harmonisation of requirements for influenza vaccines. CPMP/BWP/214/96 EMA EMA 18 60 3 5 i) 1 1 10 1 40 1 7
ii) iii) 1 10 4 40 GMT 1 GMT 2.5 1 40 70 6 3 0.25mL 3 13 0.5mL 5 HI EMA KD-PEDFLU-1 FAS 1 2 1 2 HI HI A H1N1 2009 A H1N1 WHO A H3N2 B WHO A H1N1 2009 N 20 19 1 5.0 7 35.0 10 50.0 0 0.0 2 10.5 GMT 2.0 3.9 5.7 1.6 2.1 1 5.0 9 45.0 10 50.0 0 0.0 2 10.5 13 65.0 16 80.0 20 100.0 7 35.0 14 73.7 GMT 8.6 10.9 14.0 4.3 12.4 13 65.0 18 90.0 20 100.0 7 35.0 14 73.7 N 20 20 14 70.0 11 55.0 11 55.0 7 35.0 10 50.0 GMT 12.7 3.6 5.1 2.6 6.5 15 75.0 20 100.0 15 75.0 8 40.0 10 50.0 17 85.0 9 45.0 15 75.0 11 55.0 14 70.0 GMT 32.3 3.3 7.5 4.8 17.3 18 90.0 20 100.0 18 90.0 12 60.0 14 70.0 KD-PEDFLU-1 EMA 1 2 21 7 6 3 WHO 14/20 70.0 9/20 45.0WHO 17/20 85.0 7/20 35.0 3 13 WHO 19/20 95.0 15/20 75.0WHO 15/20 75.0 9/20 45.0 A H1N1 2009 6 Grade 1 Grade 4 Grade 3 39.0 1 Grade 4 39.0 2 Grade 3 6 3 WHO 1/20 5.0WHO 2/20 10.03 13 WHO 3/20 15.0 1 WHO 2/20 10.0 8
6 51 KD-PEDFLU-1 6 3 3 13 WHO N=20 WHO N=20 8 40.0 8 40.0 5 25.0 5 25.0 4 20.0 4 20.0 3 15.0 3 15.0 3 15.0 3 15.0 1 5.0 1 5.0 1 5.0 1 5.0 1 5.0 1 5.0 1 5.0 1 5.0 0 0.0 0 0.0 0 0.0 0 0.0 1 5.0 1 5.0 8 40.0 0 0.0 8 40.0 0 0.0 4 20.0 0 0.0 6 30.0 1 5.0 4 20.0 0 0.0 4 20.0 0 0.0 4 20.0 0 0.0 4 20.0 0 0.0 1 5.0 1 5.0 3 15.0 1 5.0 1 5.0 0 0.0 2 10.0 0 0.0 1 5.0 1 5.0 0 0.0 0 0.0 1 5.0 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 1 5.0 0 0.0 0 0.0 0 0.0 1 5.0 0 0.0 0 0.0 0 0.0 1 5.0 0 0.0 0 0.0 0 0.0 1 5.0 0 0.0 0 0.0 0 0.0 1 5.0 1 5.0 0 0.0 0 0.0 1 5.0 0 0.0 11 55.0 11 55.0 8 40.0 8 40.0 11 55.0 11 55.0 6 30.0 6 30.0 10 50.0 10 50.0 7 35.0 7 35.0 10 50.0 10 50.0 6 30.0 6 30.0 7 35.0 7 35.0 6 30.0 6 30.0 1 5.0 1 5.0 2 10.0 2 10.0 9 45.0 0 0.0 2 10.0 0 0.0 7 35.0 0 0.0 6 30.0 0 0.0 7 35.0 2 10.0 3 15.0 3 15.0 5 25.0 0 0.0 1 5.0 0 0.0 4 20.0 0 0.0 2 10.0 0 0.0 3 15.0 0 0.0 2 10.0 0 0.0 3 15.0 0 0.0 0 0.0 0 0.0 2 10.0 0 0.0 1 5.0 0 0.0 2 10.0 0 0.0 0 0.0 0 0.0 1 5.0 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 1 5.0 0 0.0 0 0.0 0 0.0 1 5.0 0 0.0 0 0.0 0 0.0 1 5.0 0 0.0 2 / KD-PEDFLU-2 20 20 6 13 40 10 WHO 9
3 KD-PEDFLU-2 2010 2011 A H1N1 2009 A/California/7/2009 H1N1 pdm A H3N2 A/Victoria/210/2009 H3N2 B B/Brisbane/60/2008 0.5mL 1 HA 15 g WHO 1 21 7 2 66 6 1 23 1 3 15 3 6 18 6 13 10 FAS FAS 1 2 21 7 HI EMA 3 i iii 1 i) 1 1 10 1 40 1 1 10 4 40 ii) GMT GMT 1 2.5 iii) 1 40 70 7 KD-PEDFLU-2 1 1 10 1 40 1 1 10 4 0.25mL 1 A H1N1 2009 B EMA 2 3 EMA 0.5mL 1 3 EMA 56/66 84.8 32/66 48.51 2 21 7 5 8 Grade 3 0.25mL 1 1 1 24 10
7 HI EMA KD-PEDFLU-2 FAS A H1N1 2009 A H3N2 B [95 CI] [95 CI] [95 CI] 0.25mL 6 3 N 38 0.5mL 3 13 N 28 1 2 1 2 9 23.7 [11.4, 40.2] 13 34.2 [19.6, 51.4] 4 10.5 [2.9, 24.8] HI GMT 2.3 [1.4, 3.8] 4.3 [3.2, 5.7] 1.5 [1.1, 2.0] 9 23.7 [11.4, 40.2] 13 34.2 [19.6, 51.4] 4 10.5 [2.9, 24.8] 14 36.8 [21.8, 54.0] 18 47.4 [31.0, 64.2] 7 18.4 [7.7, 34.3] 23 60.5 [43.4, 76.0] 30 78.9 [62.7, 90.4] 12 31.6 [17.5, 48.7] HI GMT 6.7 [4.3, 10.3] 11.1 [8.4, 14.7] 3.2 [2.3, 4.4] 23 60.5 [43.4, 76.0] 30 78.9 [62.7, 90.4] 12 31.6 [17.5, 48.7] 31 81.6 [65.7, 92.3] 33 86.8 [71.9, 95.6] 18 47.4 [31.0, 64.2] 21 75.0 [55.1, 89.3] 17 60.7 [40.6, 78.5] 7 25.0 [10.7, 44.9] HI GMT 9.1 [4.6, 17.9] 5.8 [2.8, 12.1] 3.2 [1.9, 5.3] 24 85.7 [67.3, 96.0] 20 71.4 [51.3, 86.8] 11 39.3 [21.5, 59.4] 24 85.7 [67.3, 96.0] 21 75.0 [55.1, 89.3] 11 39.3 [21.5, 59.4] 22 78.6 [59.0, 91.7] 22 78.6 [59.0, 91.7] 11 39.3 [21.5, 59.4] HI GMT 8.4 [4.3, 16.5] 7.1 [3.5, 14.2] 4.2 [2.6, 6.8] 25 89.3 [71.8, 97.7] 25 89.3 [71.8, 97.7] 15 53.6 [33.9, 72.5] 27 96.4 [81.7, 99.9] 23 82.1 [63.1, 93.9] 11 39.3 [21.5, 59.4] EMA 8 5 KD-PEDFLU-2 0.25mL N=38 0.5mL N=28 32 84.2 14 36.8 24 85.7 18 64.3 8 21.1 8 21.1 17 60.7 17 60.7 30 78.9 6 15.8 21 75.0 2 7.1 7 18.4 7 18.4 11 39.3 11 39.3 5 13.2 5 13.2 5 17.9 5 17.9 3 7.9 3 7.9 2 7.1 2 7.1 2 5.3 2 5.3 5 17.9 5 17.9 0 0.0 0 0.0 9 32.1 9 32.1 12 31.6 0 0.0 12 42.9 0 0.0 8 21.1 3 7.9 0 0.0 0 0.0 8 21.1 0 0.0 1 3.6 0 0.0 7 18.4 0 0.0 3 10.7 0 0.0 5 13.2 0 0.0 0 0.0 0 0.0 4 10.5 3 7.9 1 3.6 1 3.6 2 5.3 2 5.3 0 0.0 0 0.0 2 5.3 1 2.6 1 3.6 0 0.0 2 5.3 0 0.0 1 3.6 0 0.0 2 5.3 0 0.0 1 3.6 0 0.0 2 5.3 0 0.0 0 0.0 0 0.0 RS 2 5.3 0 0.0 0 0.0 0 0.0 2 5.3 0 0.0 0 0.0 0 0.0 2 5.3 0 0.0 0 0.0 0 0.0 2 5.3 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 2 7.1 0 0.0 11
1 1 KD-PEDFLU-1 KD-PEDFLU-2 KD-PEDFLU-1 6 1 2 A H1N1 2009 HA 6 1 KD-PEDFLU-2 WHO KD-PEDFLU-1 A H1N1 2009 2 KD-PEDFLU-1 KD-PEDFLU-2 WHO 1 5 i) WHO WHO Vaccines 5th ed., p271, Saunders, Philadelphia, 2008 Current Topics In Microbiology and Immunology vol.333, p50, Springer-Verlag, Heidelberg, 2009 ii) WHO 2 13 WHO 2 2 WHO iii) HI KD-PEDFLU-2 EMA HA iv) WHO v) HA KD-PEDFLU-1 KD-PEDFLU-2 1. 12
WHO WHO HA HA 21 10 16 http://www.mhlw.go.jp/bunya/kenkou/kekkaku-kansenshou04/pdf/091016_01.pdf 19 19 12 http://www.mhlw. go.jp/bunya/iyakuhin/file/dl/file01_0001.pdf 22 2010 2011 1 1 22 http://www.mhlw.go.jp/bunya/kenkou/kekkaku- kansenshou04/inful_vaccine22.html 1 KD-PEDFLU-1 KD-PEDFLU-2 WHO EMA WHO KD-PEDFLU-1 KD-PEDFLU-2 WHO WHO 3 KD-PEDFLU-2 EMA Food and Drug Administration FDA Guidance for Industry Clinical data needed to support the licensure of seasonal inactivated influenza vaccines. May 2007 EMA EMA EMA 13
EMA Standard pediatric investigation plan for non-adjuvanted or adjuvanted pandemic influenza vaccines during a pandemic EMA/185099/2010EMA 1 50 2 50 KD-PEDFLU-2 1 30 1 50 EMA EMA KD-PEDFLU-2 WHO 0.25mL 0.5mL EMA 50 1 2 HI EMA KD-PEDFLU-2 4 Harrison s Principal of Internal Medicine 17th ed., p1085, McGraw Hill Professional, New York, 2008 4 6 9 A H1N1 3 A/Brisbane/59/2007 A/New Caledonia/20/1999 A/Solomon Islands/3/2006 HI 1 40 1 40 MMWR, 58: 521-524, 2009 4 HI KD-PEDFLU-2 HI EMA 2 WHO 2 14
WHO 2 KD-PEDFLU-2 7 1 6 3 1 0.25mL 2 3 13 1 0.5mL 2 21 7 HI EMA 1 WHO WHO 1. WHO KD-PEDFLU-1 KD-PEDFLU-2 KD-PEDFLU-2 1 WHO 0.25mL 0.5mL 2 HI 3 EMA 7 1WHO 9 1 13 2 KD-PEDFLU-1 KD-PEDFLU-2 9 2 4 2KD-PEDFLU-1 KD-PEDFLU-2 9 13 HA 0.5mL 2 3 13 96 11 HA 3 9 0.5mL 2 European Centre for Disease Prevention and Control, Technical report of the scientific panel on vaccines and immunisation. Stockholm, 2007 MMWR Recomm Rep, 58: 1-52, 20099 13 6 9 2 WHO 1 WHO 4 6 1 1 3 3 6 6 13 1 KD-PEDFLU-2 1 13 2 HI EMA 1 WHO 2 6 1 WHO 2 15
HI A H1N1 2009 A H3N2 EMA B 2 HI EMA 9 9 HI EMA KD-PEDFLU-2 FAS A H1N1 2009 A H3N2 B [95 CI] [95 CI] [95 CI] 6 1 N 23 1 3 N 15 3 6 N 18 6 13 N 10 1 2 1 2 1 2 1 2 HI 0 0.0 [0.0, 14.8] 7 30.4 [13.2, 52.9] 0 0.0 [0.0, 14.8] GMT 1.2 [1.1, 1.4] 4.1 [3.0, 5.8] 1.0 [ - ] 0 0.0 [0.0, 14.8] 7 30.4 [13.2, 52.9] 0 0.0 [0.0, 14.8] 3 13.0 [2.8, 33.6] 10 43.5 [23.2, 65.5] 0 0.0 [0.0, 14.8] HI 11 47.8 [26.8, 69.4] 21 91.3 [72.0, 98.9] 4 17.4 [5.0, 38.8] GMT 5.3 [3.3, 8.3] 13.8 [9.6, 19.8] 2.3 [1.5, 3.4] 11 47.8 [26.8, 69.4] 21 91.3 [72.0, 98.9] 4 17.4 [5.0, 38.8] 17 73.9 [51.6, 89.8] 21 91.3 [72.0, 98.9] 6 26.1 [10.2, 48.4] HI 9 60.0 [32.3, 83.7] 6 40.0 [16.3, 67.7] 4 26.7 [7.8, 55.1] GMT 6.1 [2.5, 14.9] 4.6 [2.7, 7.9] 2.9 [1.6, 5.1] 9 60.0 [32.3, 83.7] 6 40.0 [16.3, 67.7] 4 26.7 [7.8, 55.1] 11 73.3 [44.9, 92.2] 8 53.3 [26.6, 78.7] 7 46.7 [21.3, 73.4] HI 12 80.0 [51.9, 95.7] 9 60.0 [32.3, 83.7] 8 53.3 [26.6, 78.7] GMT 9.6 [4.6, 20.3] 8.0 [5.3, 12.1] 5.3 [3.2, 8.6] 12 80.0 [51.9, 95.7] 9 60.0 [32.3, 83.7] 8 53.3 [26.6, 78.7] 14 93.3 [68.1, 99.8] 12 80.0 [51.9, 95.7] 12 80.0 [51.9, 95.7] HI 13 72.2 [46.5, 90.3] 10 55.6 [30.8, 78.5] 4 22.2 [6.4, 47.6] GMT 10.1 [4.1, 24.8] 5.7 [2.2, 14.7] 3.6 [2.5, 5.1] 15 83.3 [58.6, 96.4] 11 61.1 [35.7, 82.7] 4 22.2 [6.4, 47.6] 15 83.3 [58.6, 96.4] 13 72.2 [46.5, 90.3] 6 33.3 [13.3, 59.0] HI 14 77.8 [52.4, 93.6] 14 77.8 [52.4, 93.6] 8 44.4 [21.5, 69.2] GMT 10.1 [4.3, 23.6] 7.4 [2.9, 18.6] 5.2 [3.5, 7.7] 16 88.9 [65.3, 98.6] 15 83.3 [58.6, 96.4] 8 44.4 [21.5, 69.2] 17 94.4 [72.7, 99.9] 15 83.3 [58.6, 96.4] 7 38.9 [17.3, 64.3] HI 8 80.0 [44.4, 97.5] 7 70.0 [34.8, 93.3] 3 30.0 [6.7, 65.2] GMT 7.5 [2.5, 22.3] 6.1 [1.8, 20.4] 2.6 [0.9, 8.2] 9 90.0 [55.5, 99.7] 9 90.0 [55.5, 99.7] 7 70.0 [34.8, 93.3] 9 90.0 [55.5, 99.7] 8 80.0 [44.4, 97.5] 5 50.0 [18.7, 81.3] HI 8 80.0 [44.4, 97.5] 8 80.0 [44.4, 97.5] 3 30.0 [6.7, 65.2] GMT 6.1 [1.8, 20.2] 6.5 [2.1, 19.7] 2.8 [1.0, 8.3] 9 90.0 [55.5, 99.7] 10 100.0 [69.2, 100.0] 7 70.0 [34.8, 93.3] 10 100.0 [69.2, 100.0] 8 80.0 [44.4, 97.5] 4 40.0 [12.2, 73.8] EMA B HI A H1N1 2009 A H3N2 HA A B J Infect Dis, 194: 1032-1039, 2006 Pediatr Infect Dis J, 29: 105-110, 2010 A 50 HI 1 48 B 1 12 J Hyg (Lond), 70: 767-777, 1972 B HI 16
KD-PEDFLU-2 6 1 B HI 1 1 10 2 1 10 56.5 1 20 34.8 2 B 1 13 6 1 WHO WHO 2 4 9 1 13 A B HI 1 EMA HI WHO 2 6 1 WHO 2 A 2 HI EMA HI B EMA 9 3 HA 0.5mL B Lancet Infect Dis, 11: 23-29, 2011 HA B A HA J Infect Dis, 197: 1448-1454, 2008 Pediatrics, 118: 579-585, 2006 Pediatrics, 118: 570-578, 2006 Vaccine, 25: 7656-7663, 2007 6 1 EMA B A EMA B 2 WHO B 6 1 B 2 WHO WHO 19 19, 71-79, 2008 19 20 17
20, 47-86, 2009 20 20 13 107-108, 2009 13 HI 1 WHO 1 WHO 10 11 KD-PEDFLU-2 6 3 WHO 2 A HI 7 9 10 WHO 2 HI 11 20 WHO 2 WHO 6 13 10 WHO A H1N1 a 19 d e b WHO c b WHO c 1 37/64 57.8 44/61 72.1 24/64 37.5 37/61 60.7 1 2 50/65 76.9 56/72 77.8 38/65 58.5 56/72 77.8 2 3 59/64 92.2 57/69 82.6 57/64 89.1 64/69 92.8 3 4 54/66 81.8 57/65 87.7 56/66 84.8 64/65 98.5 a) A H1N1 H1N1 HI b) 2005 2006 HA c) 2006 2007 HA WHO d) 2 HI 4 19 e) 19 11 WHO A H1N1 c 20 13 20 a WHO b 1 2/10 20.0 6/9 66.7 1 19/34 55.9 32/52 61.5 60/101 59.4 2 26/39 66.7 22/40 55.0 3 6 66/108 61.1 41/58 70.7 6 8 9/15 60.0 15/26 57.7 64/96 66.7 9 13 2/4 50.0 8/12 66.7 a) 1999 2005 HA b) 2007 2008 HA WHO c) HI 1 10 2 1 40 KD-PEDFLU-1 KD-PEDFLU-2 1 2 WHO 18
WHO HA 10 11 WHO WHO 1. EMA WHO 7 9 1 WHO 2 HI 3 EMA 4 A B 1 2 1 WHO 3 KD-PEDFLU-2 KD-PEDFLU-1 A H1N1 2009 Lancet, 374: 1339-1350, 2009 KD-PEDFLU-2 9/66 57/66 GMT 95 HI KD-PEDFLU-1 8/80 1 KD-PEDFLU-2 KD-PEDFLU-1 19
7 KD-PEDFLU-2 WHO 2 HI WHO 6 3 3 13 EMA HI 6 1 2 A HI EMA B EMA 13 WHO WHO WHO 3 1 KD-PEDFLU-2 12 WHO 2.5 6 1 6 2 1 3 6 1 KD-PEDFLU-1 6 1 2 3 6 19 3 WHO 1 WHO 2 6 1 3 6 KD-PEDFLU-2 6 1 3/23 13.0 3 6 1/18 5.6 Grade 3 KD-PEDFLU-1 Grade 3 7/80 6 3 3 3 13 4 6 1 3 6 13 WHO 20
12 KD-PEDFLU-2 6 1 1 3 3 6 6 13 56 84.8 32 48.5 25 37.9 25 37.9 66 51 77.3 8 12.1 5 7.6 4 6.1 19 82.6 6 26.1 0 0.0 0 0.0 23 19 82.6 6 26.1 3 13.0 3 13.0 13 86.7 8 53.3 8 53.3 8 53.3 15 11 73.3 0 0.0 1 6.7 0 0.0 14 77.8 9 50.0 8 44.4 8 44.4 18 12 66.7 1 5.6 1 5.6 1 5.6 10 100.0 9 90.0 9 90.0 9 90.0 10 9 90.0 1 10.0 0 0.0 0 0.0 KD-PEDFLU-2 KD-PEDFLU-1 3 WHO WHO 2.5 4 2 2 KD-PEDFLU-2 KD-PEDFLU-1 146 31 15 16 1 KD-PEDFLU-2 0.5mL KD-PEDFLU-2 15 0.25mL 8 0.5mL 7 0.25mL 7/8 87.50.5mL 4/7 57.1 21
0.25mL 2/8 25.0 0.25mL 23/30 76.70.5mL 17/21 81.0 0.25mL 4/30 13.30.5mL 2/21 9.5 KD-PEDFLU-1 16 0.25mL 5 0.5mL 11 13/16 81.30.25mL 4/5 80.00.5mL 9/11 81.8 3/16 18.8 0.25mL 1/5 20.00.5mL 2/11 18.2 2 36/64 56.3 6/64 9.4 KD-PEDFLU-2 KD-PEDFLU-1 KD-PEDFLU-1 KD-PEDFLU-2 3 WHO 3 WHO i) 4 52,008,020 0.5mL/ 149 203 15 44 72 6 5 4 3 40 ii) HA WHO 2 20 1 38.03 18/127 14.2 22
1/126 0.88/127 6.33 50/158 31.63/157 1.9 2/158 1.32 3 11/127 8.76/128 4.75/128 3.93 46/155 29.71/155 0.62/156 1.3 iii) WHO European Centre for Disease Prevention and Control, Technical report of the scientific panel on vaccines and immunisation. Stockholm, 2007 WHO WHO HA WHO WHO HA WHO KD-PEDFLU-2 KD-PEDFLU-1 WHO WHO WHO WHO 4 3 0.25mL 1 4 2 3 13 0.5mL 1 4 23
2 13 0.5mL 1 1 4 2 6 3 0.25mL 3 13 0.5mL 2 4 2 13 0.5mL 1 1 4 2 1 WHO 1 WHO Vaccines 5th ed., p271, Saunders, Philadelphia, 2008 The Australian Immunisation Handbook 9th ed., 189-190, 2008 Vaccines 5th ed., p271, Saunders, Philadelphia, 2008 EMA Note for Guidance on Harmonaisation of Requirements for Influenza Vaccines, CPMP/BWP/214/96HA HA HA 2 13 2 KD-PEDFLU-2 1 13 1 EMA 1 EMA 1 2 6 1 1 EMA 2 A 2 EMA 9 Vaccines 5th ed., p272, Saunders, Philadelphia, 20086 13 2 WHO 9 1 Wkly Epidemiol Rec, 80: 279-287, 2005 KD-PEDFLU-2 9 13 6 A H1N1 2009 1 83.3 2 100A H3N2 HI 1 50.02 24
66.7GMT 1 5.04 2 6.35 HI 1 83.32 100 B GMT 1 1.78 2 2.00 1 2 9 13 2 6 13 2 HA WHO 6 9 1 2 2 9 13 1 1 Wkly Epidemiol Rec, 80: 279-287, 2005 2 1 Vaccines 5th ed., p271, Saunders, Philadelphia, 2008 HA 6 9 2 2 KD-PEDFLU-2 6 3 1 A H1N1 2009 B HI EMA 2 3 EMA 1 7 EMA 1 2 2 3 1 6 9 2 9 13 KD-PEDFLU-2 6 WHO 2 20 HA 0.5mL 3 13 96 9 13 12 2 11 3 3 WHO HA 9 13 3 9 0.5mL 2 European Centre for Disease Prevention and Control, Technical report of the scientific panel on vaccines and immunisation. Stockholm, 2007 MMWR Recomm Rep, 58: 1-52, 2009 9 13 2 3 9 9 13 25
2 HA 9 13 0.5mL 2 3 1 4 KD-PEDFLU-2 KD-PEDFLU-1 21 7 KD-PEDFLU-2 14 18 20/66 19 23 22/66 24 28 24/66 1 4 WHO 1 2 1 Wkly Epidemiol. Rec, 80: 279-287, 2005 1 4 2 4 WHO 21 7 2 1 2 4 5 KD-PEDFLU-1KD-PEDFLU-2 WHO 3030061 1336 6134 75 26
41 951300 13 1.252.54 5 75 KD-PEDFLU-1 KD-PEDFLU-25 123 241 4 1 1 4 KD-PEDFLU-2 6 1 Grade 1 37.5 38.0 3/23 1 2 2 1 3 6 Grade 2 38.0 39.0 1/18 1 Grade 2 6 13 282 3 127 3 13 155 HA WHO Grade 2 6 3 1 1/126 0.8%2 6/128 4.7%3 13 1 3/157 1.9% 2 1/155 0.6% 20 4 Grade 2 4 29 13 2 0.5mL 2 WHO 1 27
2 GCP 5.3.5.1.1 KD-PEDFLU-1 GCP 5.3.5.1.2 KD-PEDFLU-2 GCP 1 2 GCP WHO WHO 28
2 HA TF HA HA 22 4 28 23 7 20 20 12 25 20 8 1 KD-PEDFLU-2 0.25mL 6 3 0.5mL 3 13 2 3 1 HI EMA HI 2 4 1 3 2 1 HI EMA 6 1 B HI EMA HA B HI A HA HI B 1 2.2 16 1 0.25mL 6 1 23 B 29
3 17.44 GMT 2.3 17.44 4 6 1 1 3 3 6 6 13 2 WHO 2 KD-PEDFLU-1 KD-PEDFLU-2 HA WHO WHO 4 3 21 7 2 6 13 2 2 4 4 4 Grade 2 38.0 39.0 Grade 2 0.6 4.7 1 2.5 1 95% 1 300 6 13 9 13 2 WHO 1 30
6 1 1 3 3 6 6 13 1 95 1 300 1200 9 13 WHO 150 300 6 1 23 25 2 1. 4 6 3 0.25mL 3 13 0.5mL 2 4 2 13 0.5mL 1 1 4 2 31