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  1. Prescribing Information for ROTARIX.
  2. Centers for Disease Control and Prevention. Prevention of rotavirus gastroenteritis among infants and children. MMWR. 2006;55(RR-12):1-13.
  3. Vesikari T, Karvonen A, Prymula R, et al. Efficacy of human rotavirus vaccine against rotavirus gastroenteritis during the first 2 years of life in European infants: randomised, double-blind controlled study. Lancet. 2007;370:1757-1763.
  4. Centers for Disease Control and Prevention. Recommended immunization schedule for persons 0–18 years—United States, 2008.MMWR. 2008;57(01):Q1-Q4.
  5. Ruiz-Palacios GM, Perez-Schael I, Velazquez FR, et al. Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis. N Engl J Med. 2006;354:11-22.
  6. Charles MD, Holman RC, Curns AT, et al. Hospitalizations associated with rotavirus gastroenteritis in the United States, 1993-2002. Pediatr Infect Dis J. 2006;25:489-493.
  7. Chang HG, Glass RI, Smith PF, Cicirello HG, Holman RC, Morse DL. Disease burden and risk factors for hospitalizations associated with rotavirus infection among children in New York State, 1989 through 2000. Pediatr Infect Dis J. 2003;22:808-814.
  8. Griffin DD, Kirkwood CD, Parashar UD, et al and the National Rotavirus Strain Surveillance System Collaborating Laboratories. Surveillance of rotavirus strains in the United States: identification of unusual strains. J Clin Microbiol. 2000;38:2784-2787.
  9. Data on file, DOF1887_001. GlaxoSmithKline.
  10. Ramachandran M, Kirkwood CD, Unicomb L, et al. Molecular characterization of serotype G9 rotavirus strains from a global collection. Virology. 2000;278:436-444.
  11. Linhares AC, Verstraeten T,Wolleswinkel-van den Bosch J, Clemens R, Breuer T. Rotavirus serotype G9 is associated with more-severe disease in Latin America. Clin Infect Dis. 2006;43:312-314.
  12. Clark HF, Lawley DA, Schaffer A, et al. Assessment of the epidemic potential of a new strain of rotavirus associated with the novel G9 serotype which caused an outbreak in the United States for the first time in the 1995-1996 season. J Clin Microbiol. 2004;42:1434–1438.
  13. Rahman M, Matthijnssens J, Goegebuer T, et al. Predominance of rotavirus G9 genotype in children hospitalized for rotavirus gastroenteritis in Belgium during 1999-2003. J Clin Virol. 2005;33:1-6.
  14. Raebel MA, Ou BS. Rotavirus Disease and Its Prevention in Infants and Children. Pharmacotherapy 1999.19(11):1279-1295.
  15. Parashar UD, Bresse JS, Gentsch JR, Glass RI. Rotavirus. Emerg Infect Dis. 1998;4:561-570.
  16. Staat MA, Azimi PH, Berke T. Clinical presentations of rotavirus infection among hospitalized children. Pediatr Infect Dis J. 2002;21:221-7.
  17. Glass RI. New hope for defeating rotavirus. Sci Am. 2006;294:46-51, 54-55.
  18. Rodriguez WJ, Kim HW, Arrobio JO, et al. Clinical features of acute gastroenteritis associated with human reovirus-like agent in infants and young children. J Pediatr. 1977:91;188-93.
  19. Glass RI, Parashar UD, Bresee JS et al. Rotavirus vaccines: current prospects and future challenges. Lancet. 2006; 368:323-332.
  20. Tcheremenskaia O, Marucci G, De Petris S et al; Rotavirus Study Group. Molecular epidemiology of rotavirus in Central and Southeastern Europe. J Clin Microbiol. 2007;45:2197-2204.
  21. Begue RE, Dennehy PH, Huang J, Martin P. Serotype variation of group A rotaviruses over nine winter epidemics in southeastern New England. J Clin Microbiol. 1992;30:1592-1594.
  22. Ramachandran M, Gentsch JR, Parashar UD, et al. Detection and characterization of novel rotavirus strains in the United States. J Clin Microbiol. 1998;36:3223-3229.
  23. Barril PA, Martinez LC, Giordano MO, et al. Detection of group a human rotavirus G9 genotype circulating in Córdoba, Argentina, as early as 1980. J Med Virol. 2006;78:1113-1118.
  24. Rahman M, Sultana R, Ahmed G, et al. Prevalence of G2P[4] and G12P[6] rotavirus, Bangladesh. Emerg Infect Dis. 2007;13:18-24.
  25. Kirkwood CD, Bogdanovic-Sakran N, Clark R, Bishop RF, Barnes GL. Report of the Australian rotavirus surveillance program 2001-2002. Commun Dis Intell. 2002;26:537-540.
  26. Bishop RF, Barnes GL, Cipriani E, Lund JS. Clinical immunity after neonatal rotavirus infection. NEJM. 1983;309:72-6.
  27. Velázquez FR, Matson DO, Calva JJ, et al. Rotavirus infections in infants as protection against subsequent infections. N Engl J Med. 1996;335:1022-1028.
  28. Bernstein DI, Sack DA, Rothstein E, et al. Efficacy of live, attenuated, human rotavirus vaccine 89-12 in infants: a randomized placebo-controlled trial. Lancet. 1999;354:287-90.
  29. Ward RL, Clemens JD, Knowlton DR, et al. Evidence that protection against rotavirus diarrhea after natural infection is not dependent on serotype-specific neutralizing antibody. J Infect Dis. 1992;166:1251-1257.
 

Indications and Usage

ROTARIX is indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) when administered as a 2-dose series in infants and children.

 

Important Safety Information

  • In clinical studies, common adverse events were fussiness/irritability, cough/runny nose, fever, loss of appetite, and vomiting.
  • History of uncorrected congenital malformation of the gastrointestinal tract is a contraindication.
  • Previous hypersensitivity to any component of ROTARIX, including latex rubber, should be reviewed prior to administration.
  • Administration in infants suffering from acute diarrhea or vomiting should be delayed.
  • Safety and effectiveness in infants with chronic gastrointestinal disorders, or with known primary or secondary immunodeficiencies, have not been evaluated.

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