AAP. Committee on Infectious Diseases. Havrix (GlaxoSmithKline Rixensart ) Vaqta (Merck & Co Inc Whitehouse Station NJ)

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1 AAP Committee on Infectious Diseases 1995 () (FDA) Havrix (GlaxoSmithKline Rixensart) Vaqta (Merck & Co Inc Whitehouse Station NJ) 1 d 5 (hepatitis A); (immunization); (prevention); (epidemiology); (child) FDA = Food and Drug Administration CDC = Centers for Disease Control and Prevention ELU = enzyme-linked immunosorbent assay units VAERS = Vaccine Adverse Event Reporting System QALY = quality-adjusted lifeyear 188 AMERICAN ACADEMY OF PEDIATRICS

2 ( ) 15 y ( ) () [1] / y [1] (FDA) 1995Havrix (GlaxoSmithKline Rixensart ) 1996Vaqta (Merck & Co Inc Whitehouse Station NJ) (CDC) [2, 3] 2 [2] ( 1) 1999 CDC [4] 11 2 ( 20 / ) 2 6 (10 20 / ) [4] 1999 ( 2 3) () [6] y 90% [7] FDA 12 CDC 12 [8] / ACIP 1999 ACIP % ( 1) [5] / ( 2 3) [5] ACIP (Advisory Committee on Immunization Practices) ( CDC) PEDIATRICS

3 [9] 10 y [10 12] y y [5, 13] / 2006 [5] 10 y [5, 14] [15, 16] 2002 (PCR) [17] [12] [18, 19] ( ) ( ) [20] [12, 13, 21] d 8d [22] 3 mo PCR RNA [23] 10 wk [24] 10% 15% [25, 26] [15] 4 30 / [27] / y 5 14 y y y 40 y ( ) 190 AMERICAN ACADEMY OF PEDIATRICS

4 25% [28] 2wk [38] [39] RNA ( ) 6 90% 2/3 [29] [30] 28 d ( d) [31] 1 7d [32, 33] 2 3wk 3 4wk 2 [34, 35] [36] [37] 10% 15% 6mo 20% [25, 40] [25, 26] [26, 41] [42] % 2% 50 [43] [44 46] / / / ( ) PEDIATRICS

5 [47, 48] 30% 60% Vaqta [49] Havrix [50] / Twinrix (Glaxo SmithKline) [51] Havrix Twinrix () Vaqta Havrix (ELU) Vaqta (U) Havrix / (12 18 ) 0.5 ml 720 ELU 1mL ELU Vaqta Twinrix (720 ELU) (20 µg)0 1 6 mo 3 Twinrix 18 3 Twinrix [52] 1mo 97% 95% 2 100% [53] (DtaP) () b (Hib) (MMR) [54] Prevnar (Wyeth Pharmaceuticals Madison NJ) [55] [56] (Havrix 360 ELU / ) 2 1 mo [57] 21 d 1 mo97% 1y 94% (95% CI 79% 99%) [57] [58] 1 Vaqta 100% (95% CI 87%) [58] 192 AMERICAN ACADEMY OF PEDIATRICS

6 2 25 y [59] Butte [60] (66%) y 94% 98% [60] (Catalonia) / / % [61] Havrix Vaqta 1d [57] 10% 15% Havrix Vaqta Havrix [57] 1995 (Beth Bell MD CDC 2006 ) Vaqta 18 mo 1mo ( ) [62] (VAERS) 871 VAERS Vaqta Havrix [63] / / (QALY) 1 (societal cost) /QALY [64] QALY 10% ( 1.5 [65] )2Vaqta Havrix 12 2 Havrix mo Vaqta mo Twinrixis 0 1 6mo 3 [66] 2 8 (36 46 ) 37 (98 ) 1 wk Vaqta Havrix [67] PEDIATRICS

7 1. 1 (12 23 ) 2 ( 1) Havrix Vaqta 2 [68] / y () / ml /mo 1 18 y Vaqta (Merck) 25 U Havrix (GlaxoSmithKline) 720 ELU y Vaqta (Merck) 50 U Havrix (GlaxoSmithKline) ELU Twinrix (GlaxoSmithKline) 720 ELU () 20 µg () 1. www. cdc.gov/travel/vaccinat.htm 4 wk 2wk VAERS VAERS vaers/vaers.htm VAERS [5] 194 AMERICAN ACADEMY OF PEDIATRICS

8 3 (Third National Health and Nutrition Examination Survey) [69] (National Notifiable Diseases Surveillance System) [6, 7, 70] 6 90% 10 y 10 y [71] 25 y [59] [71] [54] % 1 [72] 1% 1 1 Armstrong GL, et al. Pediatrics 2002;109: Centers for Disease Control and Prevention. MMWR Recomm Rep 1996;45(RR-15): American Academy of Pediatrics, et al. Pediatrics 1996;98: PEDIATRICS

9 Centers for Disease Control and Prevention. MMWR Recomm Rep 1999;48(RR-12): Wasley A, et al. JAMA 2005;294: Samandari T, et al. Vaccine 2004;22: Dagan R, et al. JAMA 2005;294: Centers for Disease Control and Prevention. MMWR Recomm Rep 2006;55(RR-7): Shapiro CN, et al. J Hepatol 1993;18(Suppl 2):S11 S14 10 Bowden FJ, et al. Med J Aust 1994;161: Martin DJ, et al. Trans R Soc Trop Med Hyg 1994;88: Shapiro CN, et al. Vaccine 1992;10(Suppl 1):S59 S62 13 Shapiro CN, et al. Epidemiology of hepatitis A in the United States. In: Hollinger FB, et al, eds. Viral Hepatitis and Liver Disease. Baltimore, MD: Williams & Wilkins Co; 1991: Bialek SR, et al. Am J Public Health 2004;94: Lemon SM. Vox Sang 1994;67(Suppl 4):19 23; discussion Soucie JM, et al. Transfusion 1998;38: Benjamin RJ. Semin Hematol 2001;38(4 Suppl 9): Jackson LA, et al. Pediatr Infect Dis J 1996;15: Shapiro CN, et al. Pediatr Ann 1991;20: Fiore AE. Clin Infect Dis 2004;38: Bell BP, et al. J Infect Dis 1998;178: Krugman S, et al. N Engl J Med 1959;261: Yotsuyanagi H, et al. Hepatology 1996;24: Rosenblum LS, et al. J Infect Dis 1991;164: Glikson M, et al. Medicine (Baltimore) 1992;71: Sjogren MH, et al. Ann Intern Med 1987;106: Mutsch M, et al. Clin Infect Dis 2006;42: Weinberg M, et al. Pediatrics 2004;114(1). Available at: www. pediatrics.org/cgi/content/full/114/1/e68 29 Lednar WM, et al. Am J Epidemiol 1985;122: Hadler SC, et al. Rev Infect Dis 1986;8: Krugman S. Calif Med 1970;113: Koff RS. Vaccine 1992;10(Suppl 1):S15 S17 33 Yao G. Clinical spectrum and natural history of viral hepatitis A in a 1988 Shanghai epidemic. In: Hollinger FB, et al, eds. Viral Hepatitis and Liver Disease. Baltimore, MD: Williams & Wilkins Co; 1991: Leikin E, et al. Obstet Gynecol 1996;88(4 pt 2): McDuffie RS Jr, et al. Am J Obstet Gynecol 1999;180: Tong MJ, et al. Gastroenterology 1981;80: Watson JC, et al. J Infect Dis 1993;167: Tassopoulos NC, et al. J Infect Dis 1986;154: Bower WA, et al. J Infect Dis 2000;182: Cobden I, et al. J Hepatol 1986;2: Tedeschi MV, et al. Mem Inst Oswaldo Cruz 1989;84: Schiff ER. Vaccine 1992;10(Suppl 1):S18 S20 43 Lemon SM, et al. Infect Agents Dis 1994;3: Cooksley WG. What did we learn from the Shanghai hepatitis A epidemic? Viral Hepat 2000;7(Suppl 1): Keeffe E. J Viral Hepat 2000;7(Suppl 1): Vento S, et al. N Engl J Med 1998;338: Debray D, et al. Hepatology 1997;26: Shah U, et al. Pediatrics 2000;105: Vaqta [package insert]. Whitehouse Station, NJ: Merck & Co Inc; Available at: pi_circulars/v/vaqta/vaqta_pi.pdf. Accessed November 10, Havrix [package insert]. Research Triangle Park, NC: Glaxo- SmithKline; Available at: assets/us_havrix.pdf. Accessed November 10, Peetermans J. Vaccine 1992;10(Suppl 1):S99 S Ambrosch F, et al. Vaccine 1992;10(Suppl 1):S142 S Clemens R, et al. J Infect Dis 1995;171(Suppl 1):S44 S49 54 Usonis V, et al. Vaccine 2005;23: Zaaijer HL, et al. J Med Virol 1993;40: Cuthbert JA. Clin Microbiol Rev 2001;14: Innis BL, et al. JAMA 1994;271: Werzberger A, et al. N Engl J Med 1992;327: Wiedermann G, et al. Acta Trop 1998;69: Averhoff F, et al. JAMA 2001;286: Domínguez A, et al. Vaccine 2003;21: Black S, et al. Vaccine 2004;22: Rein DB, et al. Pediatrics 2007;119(1). Available at: www. pediatrics.org/cgi/content/full/119/1/e12 64 Jacobs RJ, et al. Pediatr Infect Dis J 2003;22: American Academy of Pediatrics. Vaccine administration. In: Pickering LK, et al, eds. Red Book: 2006 Report of the Committee on Infectious Diseases. Elk Grove Village, IL: American Academy of Pediatrics; 2006: Williams JL, et al. Vaccine 2003;21: Wiedermann G, et al. Vaccine 1994;12: Connor BA, et al. Clin Infect Dis 2001;32: Bell BP, et al. Vaccine 2005;23: Lopalco PL, et al. Vaccine 2000;19: Van Damme P, et al. Lancet 2003;362: Amon JJ, et al. Pediatrics 2006;117:30 33 PEDIATRICS 2007;120(1): AMERICAN ACADEMY OF PEDIATRICS

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