메뉴 건너뛰기




Volumn 8, Issue 6, 2012, Pages 749-758

Safety and persistence of immunological response 6 months after intramuscular vaccination with an AS03-adjuvanted H1N1 2009 influenza vaccine: An open-label, randomized trial in Japanese children aged 6 months to 17 years

Author keywords

Adjuvant; H1N1; Influenza; Japanese children; Pandemic

Indexed keywords

IMMUNOLOGICAL ADJUVANT; INFLUENZA VACCINE; INFLUENZA VIRUS HEMAGGLUTININ; NEUTRALIZING ANTIBODY;

EID: 84863672960     PISSN: None     EISSN: 2164554X     Source Type: Journal    
DOI: 10.4161/hv.19684     Document Type: Article
Times cited : (9)

References (36)
  • 1
    • 67449110743 scopus 로고    scopus 로고
    • Emergence of a novel swine-origin influenza A (H1N1) virus in humans
    • Novel Swine-Origin Influenza A (H1N1) Virus Investigation Team. PMID:19423869
    • Dawood FS, Jain S, Finelli L, Shaw MW, Lindstrom S, Garten RJ, et al.; Novel Swine-Origin Influenza A (H1N1) Virus Investigation Team. Emergence of a novel swine-origin influenza A (H1N1) virus in humans. N Engl J Med 2009; 360:2605-15; PMID:19423869; http://dx.doi.org/10.1056/NEJMoa0903810.
    • (2009) N Engl J Med , vol.360 , pp. 2605-2615
    • Dawood, F.S.1    Jain, S.2    Finelli, L.3    Shaw, M.W.4    Lindstrom, S.5    Garten, R.J.6
  • 2
    • 71149117904 scopus 로고    scopus 로고
    • Geneva: World Health Organization, August 06, Available at: Accessed October 26, 2011
    • Pandemic (H1N1) 2009-update 112. Geneva: World Health Organization, August 06, 2010. Available at: http://www.who.int/csr/don/2010-08-06/en/index. html. Accessed October 26, 2011.
    • (2010) Pandemic (H1N1) 2009-update 112
  • 4
    • 33745713001 scopus 로고    scopus 로고
    • Influenza-related hospitalizations in children younger than three years of age
    • PMID:16804428
    • Rojo JC, Ruiz-Contreras J, Fernández MB, Marín MA, Folgueira L. Influenza-related hospitalizations in children younger than three years of age. Pediatr Infect Dis J 2006; 25:596-601; PMID:16804428; http://dx.doi.org/10.1097/01.inf.0000220208.59965.95.
    • (2006) Pediatr Infect Dis J , vol.25 , pp. 596-601
    • Rojo, J.C.1    Ruiz-Contreras, J.2    Fernández, M.B.3    Marín, M.A.4    Folgueira, L.5
  • 5
    • 69249206858 scopus 로고    scopus 로고
    • 2009 Pandemic influenza A (H1N1) virus infections-Chicago, Illinois, April-July 2009
    • Centers for Disease Control and Prevention (CDC). PMID:19713879
    • Centers for Disease Control and Prevention (CDC). 2009 pandemic influenza A (H1N1) virus infections-Chicago, Illinois, April-July 2009. MMWR Morb Mortal Wkly Rep 2009; 58:913-8; PMID:19713879.
    • (2009) MMWR Morb Mortal Wkly Rep , vol.58 , pp. 913-918
  • 6
    • 84873091271 scopus 로고    scopus 로고
    • Press Release February 05, Available at: Accessed October 26, 2011. Japanese
    • Ministry of Health. Labour and Welfare (MHLW); Press Release (February 05, 2010). Available at: http://www.mhlw.go.jp/kinkyu/kenkou/influenza/houdou/ 2010/02/dl/infuh0205-05.pdf. Accessed October 26, 2011. Japanese.
    • (2010)
  • 7
    • 84873088530 scopus 로고    scopus 로고
    • Press Release August 11, Available at: Accessed October 26, 2011. Japanese
    • Ministry of Health. Labour and Welfare (MHLW); Press Release (August 11, 2010). Available at: http://www.mhlw.go.jp/kinkyu/kenkou/influenza/houdou/2010/ 08/dl/infuh0811-01.pdf. Accessed October 26, 2011. Japanese.
    • (2010)
  • 8
    • 77949824961 scopus 로고    scopus 로고
    • Incidence of 2009 pandemic influenza A H1N1 infection in England: A cross-sectional serological study
    • PMID:20096450
    • Miller E, Hoschler K, Hardelid P, Stanford E, Andrews N, Zambon M. Incidence of 2009 pandemic influenza A H1N1 infection in England: a cross-sectional serological study. Lancet 2010; 375:1100-8; PMID:20096450; http://dx.doi.org/10.1016/S0140-6736(09)62126-7.
    • (2010) Lancet , vol.375 , pp. 1100-1108
    • Miller, E.1    Hoschler, K.2    Hardelid, P.3    Stanford, E.4    Andrews, N.5    Zambon, M.6
  • 9
    • 67449110743 scopus 로고    scopus 로고
    • Emergence of a novel swine-origin influenza A (H1N1) virus in humans
    • Novel Swine-Origin Influenza A (H1N1) Virus Investigation Team. [Erratum in: N Engl J Med 2009; 361:102]. PMID:19423869
    • Dawood FS, Jain S, Finelli L, Shaw MW, Lindstrom S, Garten RJ, et al.; Novel Swine-Origin Influenza A (H1N1) Virus Investigation Team. Emergence of a novel swine-origin influenza A (H1N1) virus in humans. [Erratum in: N Engl J Med 2009; 361:102]. N Engl J Med 2009; 360:2605-15; PMID:19423869; http://dx.doi.org/10.1056/NEJMoa0903810.
    • (2009) N Engl J Med , vol.360 , pp. 2605-2615
    • Dawood, F.S.1    Jain, S.2    Finelli, L.3    Shaw, M.W.4    Lindstrom, S.5    Garten, R.J.6
  • 10
    • 80053130921 scopus 로고    scopus 로고
    • Epidemiological characteristics and low case fatality rate of pandemic (H1N1) 2009 in Japan
    • December 20: Available at: Accessed October 26, 2011
    • Kamigaki T, Oshitani H. Epidemiological characteristics and low case fatality rate of pandemic (H1N1) 2009 in Japan. PLoS Curr Influenza 2009; December 20: RRN1139. Available at: http://knol.google.com/k/taro-kamigaki/ epidemiological-characteristics-and-low/38epug6fmizmk/1#. Accessed October 26, 2011.
    • (2009) PLoS Curr Influenza
    • Kamigaki, T.1    Oshitani, H.2
  • 11
    • 72449127030 scopus 로고    scopus 로고
    • Trial of 2009 influenza A (H1N1) monovalent MF59-adjuvanted vaccine
    • PMID:19745215
    • Clark TW, Pareek M, Hoschler K, Dillon H, Nicholson KG, Groth N, et al. Trial of 2009 influenza A (H1N1) monovalent MF59-adjuvanted vaccine. N Engl J Med 2009; 361:2424-35; PMID:19745215; http://dx.doi.org/10.1056/NEJMoa0907650.
    • (2009) N Engl J Med , vol.361 , pp. 2424-2435
    • Clark, T.W.1    Pareek, M.2    Hoschler, K.3    Dillon, H.4    Nicholson, K.G.5    Groth, N.6
  • 12
    • 72949104686 scopus 로고    scopus 로고
    • Safety and immunogenicity of 2009 pandemic influenza A H1N1 vaccines in China: A multicentre, double-blind, randomised, placebo-controlled trial
    • PMID:20018364
    • Liang XF, Wang HQ, Wang JZ, Fang HH, Wu J, Zhu FC, et al. Safety and immunogenicity of 2009 pandemic influenza A H1N1 vaccines in China: a multicentre, double-blind, randomised, placebo-controlled trial. Lancet 2010; 375:56-66; PMID:20018364; http://dx.doi.org/10.1016/S0140-6736(09)62003-1.
    • (2010) Lancet , vol.375 , pp. 56-66
    • Liang, X.F.1    Wang, H.Q.2    Wang, J.Z.3    Fang, H.H.4    Wu, J.5    Zhu, F.C.6
  • 13
    • 77953725648 scopus 로고    scopus 로고
    • Strategic Advisory Group of Experts on Immunization. 7 July Available at: Accessed October 26, 2011
    • Strategic Advisory Group of Experts on Immunization. Report of the extraordinary meeting on the influenza A (H1N1) 2009 pandemic, 7 July 2009. Available at: www.who.int/wer/2009/wer8430.pdf. Accessed October 26, 2011.
    • (2009) Report of the Extraordinary Meeting on the Influenza A (H1N1) 2009 Pandemic
  • 14
    • 70349861815 scopus 로고    scopus 로고
    • Immunogenicity and tolerability of an AS03(A)-adjuvanted prepandemic influenza vaccine: A phase III study in a large population of Asian adults
    • H5N1 Flu Study Group for Hong Kong, Singapore, Taiwan and Thailand. PMID:19683087
    • Chu DWS, Hwang SJ, Lim FS, Oh HM, Thongcharoen P, Yang PC, et al.; H5N1 Flu Study Group for Hong Kong, Singapore, Taiwan and Thailand. Immunogenicity and tolerability of an AS03(A)-adjuvanted prepandemic influenza vaccine: a phase III study in a large population of Asian adults. Vaccine 2009; 27:7428-35; PMID:19683087; http://dx.doi.org/10.1016/j.vaccine.2009.07.102.
    • (2009) Vaccine , vol.27 , pp. 7428-7435
    • Chu, D.W.S.1    Hwang, S.J.2    Lim, F.S.3    Oh, H.M.4    Thongcharoen, P.5    Yang, P.C.6
  • 15
    • 78649327318 scopus 로고    scopus 로고
    • A phase II, open-label, multicentre study to evaluate the immunogenicity and safety of an adjuvanted prepandemic (H5N1) influenza vaccine in healthy Japanese adults
    • PMID:21108818
    • Nagai H, Ikematsu H, Tenjinbaru K, Maeda A, DraméM, Roman FP. A phase II, open-label, multicentre study to evaluate the immunogenicity and safety of an adjuvanted prepandemic (H5N1) influenza vaccine in healthy Japanese adults. BMC Infect Dis 2010; 10:338; PMID:21108818; http://dx.doi.org/10.1186/ 1471-2334-10-338.
    • (2010) BMC Infect Dis , vol.10 , pp. 338
    • Nagai, H.1    Ikematsu, H.2    Tenjinbaru, K.3    Maeda, A.4    Dramé, M.5    Roman, F.P.6
  • 16
    • 34547837401 scopus 로고    scopus 로고
    • Antigen sparing and cross-reactive immunity with an adjuvanted rH5N1 prototype pandemic influenza vaccine: A randomised controlled trial
    • PMID:17707753
    • Leroux-Roels I, Borkowski A, Vanwolleghem T, Dramé M, Clement F, Hons E, et al. Antigen sparing and cross-reactive immunity with an adjuvanted rH5N1 prototype pandemic influenza vaccine: a randomised controlled trial. Lancet 2007; 370:580-9; PMID:17707753; http://dx.doi.org/10.1016/S0140-6736(07) 61297-5.
    • (2007) Lancet , vol.370 , pp. 580-589
    • Leroux-Roels, I.1    Borkowski, A.2    Vanwolleghem, T.3    Dramé, M.4    Clement, F.5    Hons, E.6
  • 17
    • 43049097919 scopus 로고    scopus 로고
    • Broad Clade 2 cross-reactive immunity induced by an adjuvanted clade 1 rH5N1 pandemic influenza vaccine
    • PMID:18301743
    • Leroux-Roels I, Bernhard R, Gérard P, Dramé M, Hanon E, Leroux-Roels G. Broad Clade 2 cross-reactive immunity induced by an adjuvanted clade 1 rH5N1 pandemic influenza vaccine. PLoS One 2008; 3:1665; PMID:18301743; http://dx.doi.org/10.1371/journal.pone.0001665.
    • (2008) PLoS One , vol.3 , pp. 1665
    • Leroux-Roels, I.1    Bernhard, R.2    Gérard, P.3    Dramé, M.4    Hanon, E.5    Leroux-Roels, G.6
  • 18
    • 75249101993 scopus 로고    scopus 로고
    • Immunogenicity and safety in adults of one dose of influenza A H1N1v 2009 vaccine formulated with and without AS03A-adjuvant: Preliminary report of an observer-blind, randomised trial
    • PMID:20034605
    • Roman F, Vaman T, Gerlach B, Markendorf A, Gillard P, Devaster JM. Immunogenicity and safety in adults of one dose of influenza A H1N1v 2009 vaccine formulated with and without AS03A-adjuvant: preliminary report of an observer-blind, randomised trial. Vaccine 2010; 28:1740-5; PMID:20034605; http://dx.doi.org/10.1016/j.vaccine.2009.12.014.
    • (2010) Vaccine , vol.28 , pp. 1740-1745
    • Roman, F.1    Vaman, T.2    Gerlach, B.3    Markendorf, A.4    Gillard, P.5    Devaster, J.M.6
  • 19
    • 77955560311 scopus 로고    scopus 로고
    • Immunogenicity and safety of AS03-adjuvanted 2009 influenza A H1N1 vaccine in children 6-35 months
    • PMID:20600478
    • Carmona A, Omeñaca F, Tejedor JC, Merino JM, Vaman T, Dieussaert I, et al. Immunogenicity and safety of AS03-adjuvanted 2009 influenza A H1N1 vaccine in children 6-35 months. Vaccine 2010; 28:5837-44; PMID:20600478; http://dx.doi.org/10.1016/j.vaccine.2010.06.065.
    • (2010) Vaccine , vol.28 , pp. 5837-5844
    • Carmona, A.1    Omeñaca, F.2    Tejedor, J.C.3    Merino, J.M.4    Vaman, T.5    Dieussaert, I.6
  • 20
    • 78649385920 scopus 로고    scopus 로고
    • Immunogenicity and safety of a novel AS03(A)-adjuvanted H1N1 2009 pandemic influenza vaccine in adults in Japan
    • PMID:20980795
    • Ikematsu H, Nagai H, Kawashima M, Kawakami Y, Tenjinbaru K, Maeda A, et al. Immunogenicity and safety of a novel AS03(A)-adjuvanted H1N1 2009 pandemic influenza vaccine in adults in Japan. Hum Vaccin 2010; 6:888-93; PMID:20980795; http://dx.doi.org/10.4161/hv.6.11.12851.
    • (2010) Hum Vaccin , vol.6 , pp. 888-893
    • Ikematsu, H.1    Nagai, H.2    Kawashima, M.3    Kawakami, Y.4    Tenjinbaru, K.5    Maeda, A.6
  • 21
    • 84863675227 scopus 로고    scopus 로고
    • Clinical evaluation of an AS03-adjuvanted pandemic influenza H1N1 2009 vaccine in children (Preliminary report)
    • Japanese
    • Saitoh A, Tamura S, Nagai A, Tsuchida N, Sako M, Maekawa T, et al. Clinical evaluation of an AS03-adjuvanted pandemic influenza H1N1 2009 vaccine in children (Preliminary report). [Japanese]. J Jap Pediatr Soc 2011; 115:578-84.
    • (2011) J Jap Pediatr Soc , vol.115 , pp. 578-584
    • Saitoh, A.1    Tamura, S.2    Nagai, A.3    Tsuchida, N.4    Sako, M.5    Maekawa, T.6
  • 22
    • 77953727656 scopus 로고    scopus 로고
    • Safety and immunogenicity of AS03B adjuvanted split virion versus non-adjuvanted whole virion H1N1 influenza vaccine in UK children aged 6 months-12 years: Open label, randomised, parallel group, multicentre study
    • PMID:20508026
    • Waddington CS, Walker WT, Oeser C, Reiner A, John T, Wilkins S, et al. Safety and immunogenicity of AS03B adjuvanted split virion versus non-adjuvanted whole virion H1N1 influenza vaccine in UK children aged 6 months-12 years: open label, randomised, parallel group, multicentre study. BMJ 2010; 340:2649; PMID:20508026; http://dx.doi.org/10.1136/bmj.c2649.
    • (2010) BMJ , vol.340 , pp. 2649
    • Waddington, C.S.1    Walker, W.T.2    Oeser, C.3    Reiner, A.4    John, T.5    Wilkins, S.6
  • 24
    • 78751704276 scopus 로고    scopus 로고
    • A-adjuvanted 2009 influenza A (H1N1) vaccines: A randomised, multicentre, age-stratified, head-to-head trial
    • PMID:21168369
    • A-adjuvanted 2009 influenza A (H1N1) vaccines: a randomised, multicentre, age-stratified, head-to-head trial. Lancet Infect Dis 2011; 11:91-101; PMID:21168369; http://dx.doi.org/10.1016/S1473-3099(10)70296-6.
    • (2011) Lancet Infect Dis , vol.11 , pp. 91-101
    • Nicholson, K.G.1    Abrams, K.R.2    Batham, S.3    Clark, T.W.4    Hoschler, K.5    Lim, W.S.6
  • 25
    • 78649690134 scopus 로고    scopus 로고
    • An adjuvanted pandemic influenza H1N1 vaccine provides early and long term protection in health care workers
    • PMID:21034828
    • Madhun AS, Akselsen PE, Sjursen H, Pedersen G, Svindland S, Nøstbakken JK, et al. An adjuvanted pandemic influenza H1N1 vaccine provides early and long term protection in health care workers. Vaccine 2010; 29:266-73; PMID:21034828; http://dx.doi.org/10.1016/j.vaccine.2010.10.038.
    • (2010) Vaccine , vol.29 , pp. 266-273
    • Madhun, A.S.1    Akselsen, P.E.2    Sjursen, H.3    Pedersen, G.4    Svindland, S.5    Nøstbakken, J.K.6
  • 28
    • 77957282684 scopus 로고    scopus 로고
    • A Phase III evaluation of immunogenicity and safety of two trivalent inactivated seasonal influenza vaccines in US children
    • PMID:20431425
    • Baxter R, Jeanfreau R, Block SL, Blatter M, Pichichero M, Jain VK, et al. A Phase III evaluation of immunogenicity and safety of two trivalent inactivated seasonal influenza vaccines in US children. Pediatr Infect Dis J 2010; 29:924-30; PMID:20431425; http://dx.doi.org/10.1097/INF.0b013e3181e075be.
    • (2010) Pediatr Infect Dis J , vol.29 , pp. 924-930
    • Baxter, R.1    Jeanfreau, R.2    Block, S.L.3    Blatter, M.4    Pichichero, M.5    Jain, V.K.6
  • 29
    • 36749040950 scopus 로고    scopus 로고
    • Immunogenicity and reactogenicity of a trivalent influenza split vaccine in previously unvaccinated children aged 6-9 and 10-13 years
    • PMID:18022736
    • Schmidt-Ott R, Schwarz T, Haase R, Sander H, Walther U, Fourneau M, et al. Immunogenicity and reactogenicity of a trivalent influenza split vaccine in previously unvaccinated children aged 6-9 and 10-13 years. Vaccine 2007; 26:32-40; PMID:18022736; http://dx.doi.org/10.1016/j.vaccine.2007.10.049.30. sdsd.
    • (2007) Vaccine , vol.26 , pp. 32-40
    • Schmidt-Ott, R.1    Schwarz, T.2    Haase, R.3    Sander, H.4    Walther, U.5    Fourneau, M.6
  • 30
    • 79251583146 scopus 로고    scopus 로고
    • Structural basis of influenza virus neutralization
    • PMID:21251008
    • Han T, Marasco WA. Structural basis of influenza virus neutralization. Ann NY Acad Sci 2011; 1217:178-90; http://dx.doi.org/10.1111/j.1749-6632.2010. 05829.x; PMID:21251008.
    • (2011) Ann NY Acad Sci , vol.1217 , pp. 178-190
    • Han, T.1    Marasco, W.A.2
  • 31
    • 0033035523 scopus 로고    scopus 로고
    • Influenza virus: A novel method to assess viral and neutralizing antibody titers in vitro
    • PMID:10365787
    • Bachmann MF, Ecabert B, Kopf M. Influenza virus: a novel method to assess viral and neutralizing antibody titers in vitro. J Immunol Methods 1999; 225:105-11; PMID:10365787; http://dx.doi.org/10.1016/S0022-1759(99)00034-4.
    • (1999) J Immunol Methods , vol.225 , pp. 105-111
    • Bachmann, M.F.1    Ecabert, B.2    Kopf, M.3
  • 32
    • 84863657859 scopus 로고
    • A report of muscular contracture
    • Japan Pediatric Society Committee on Muscular Contracture
    • Japan Pediatric Society Committee on Muscular Contracture. A report of muscular contracture. J Jpn Pediatr Soc 1983; 87:1067-105.
    • (1983) J Jpn Pediatr Soc , vol.87 , pp. 1067-1105
  • 34
    • 79952362612 scopus 로고    scopus 로고
    • Adjuvant System AS03 containing α-tocopherol modulates innate immune response and leads to improved adaptive immunity
    • PMID:21256188
    • Morel S, Didierlaurent A, Bourguignon P, Delhaye S, Baras B, Jacob V, et al. Adjuvant System AS03 containing α-tocopherol modulates innate immune response and leads to improved adaptive immunity. Vaccine 2011; 29:2461-73; PMID:21256188; http://dx.doi.org/10.1016/j.vaccine.2011.01.011.
    • (2011) Vaccine , vol.29 , pp. 2461-2473
    • Morel, S.1    Didierlaurent, A.2    Bourguignon, P.3    Delhaye, S.4    Baras, B.5    Jacob, V.6
  • 35
    • 0036440489 scopus 로고    scopus 로고
    • Ten years of experience with the trivalent split-influenza vaccine, Fluarix™
    • Hehme NW, Künzel W, Petschke F, Türk G, Raderecht C, van Hoecke C, et al. Ten years of experience with the trivalent split-influenza vaccine, Fluarix™. Clin Drug Investig 2002; 22:751-69; http://dx.doi.org/10.2165/ 00044011-200222110-00004.
    • (2002) Clin Drug Investig , vol.22 , pp. 751-769
    • Hehme, N.W.1    Künzel, W.2    Petschke, F.3    Türk, G.4    Raderecht, C.5    Van Hoecke, C.6
  • 36
    • 33745158157 scopus 로고
    • A simple method of calculating fifty percent end point
    • Reed LT, Muench H. A simple method of calculating fifty percent end point. Am J Hyg 1938; 27:493-8.
    • (1938) Am J Hyg , vol.27 , pp. 493-498
    • Reed, L.T.1    Muench, H.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.