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Rotavirus Vaccine RIX4414 (Rotarix™)

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Abstract

  • ▲ RIX4414 is a human, live attenuated rotavirus vaccine containing a rotavirus strain of G1P[8] specificity; it is administered orally using a two-dose schedule.

  • ▲ RIX4414 showed good immunogenicity in healthy infants in several well designed trials in terms of both seroconversion rates and vaccine take. Moreover, RIX4414 did not impair the immune response of infants to other vaccines.

  • ▲ RIX4414 provided significant protection against severe rotavirus gastroenteritis. In a subgroup analysis (n = 20 169) of a large (n = 63 225), well designed, placebo-controlled, phase III trial (conducted in Latin America and Finland), the efficacy of RIX4414 against severe rotavirus gastroenteritis was 85% in healthy infants, with an efficacy against hospitalization for severe rotavirus gastroenteritis of 85%. RIX4414 provided cross-protection against non-G1 serotypes containing the P[8] antigen.

  • ▲ Moreover, in this trial, RIX4414 had a protective efficacy against severe gastroenteritis of any cause of 40%, with an efficacy against hospitalization because of severe gastroenteritis of any cause of 42%.

  • ▲ In another well designed, placebo-controlled, phase III trial (conducted in Europe; n = 3874), RIX4414 had an efficacy against rotavirus gastroenteritis of any severity of 87%, an efficacy against severe rotavirus gastroenteritis of 96%, and an efficacy against hospitalization because of rotavirus gastroenteritis of 100%. RIX4414 protected against rotavirus gastroenteritis from the first dose onwards.

  • ▲ A meta-analysis revealed that RIX4414 had a protective efficacy against rotavirus gastroenteritis of any severity caused by the G2P[4] serotype of 81% and against severe rotavirus gastroenteritis caused by the G2P[4] serotype of 71%.

  • ▲ RIX4414 was generally well tolerated in healthy infants. The vaccine did not appear to be associated with an increased risk of intussusception.

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Notes

  1. The use of trade names is for product identification purposes only and does not imply endorsement.

References

  1. Sabin Vaccine Institute. Proceedings of the Sixth International Rotavirus Symposium; 2004 Jul 7–9; Mexico City [online]. Available from URL: http://www.sabin.org/PDF/rotavirusengweb.pdf [Accessed 2005 Jun 10]

  2. Widdowson M-A, Bresee JS, Gentsch JR, et al. Rotavirus disease and its prevention. Curr Opin Gastroenterol 2005; 21: 26–31

    PubMed  Google Scholar 

  3. Soriano-Gabarró M, Mrukowicz J, Vesikari T, et al. Burden of rotavirus disease in European Union countries. Pediatr Infect Dis J 2006 Jan; 25(1 Suppl.): S7–11

    PubMed  Google Scholar 

  4. Glass RI, Bresee JS, Parashar UD, et al. The future of rotavirus vaccines: a major setback leads to new opportunities. Lancet 2004 May 8; 363(9420): 1547–50

    Article  PubMed  Google Scholar 

  5. De Vos B, Vesikari T, Linhares AC, et al. A rotavirus vaccine for prophylaxis of infants against rotavirus gastroenteritis. Pediatr Infect Dis J 2004 Oct; 23(10 Suppl.): S179–82

    PubMed  Google Scholar 

  6. GlaxoSmithKline. Rotarix: first vaccine against rotavirus available in Europe [media release]. Available from URL: http://www.gsk.com [Accessed 2006 Mar 8]

  7. Bernstein DI, Smith VE, Sherwood JR, et al. Safety and immunogenicity of live, attenuated human rotavirus vaccine 89-12. Vaccine 1998 Feb; 16(4): 381–7

    Article  PubMed  CAS  Google Scholar 

  8. Bernstein DI, Sack DA, Rothstein E, et al. Efficacy of live, attenuated, human rotavirus vaccine 89-12 in infants: a randomised placebo-controlled trial. Lancet 1999 Jul 24; 354(9174): 287–90

    Article  PubMed  CAS  Google Scholar 

  9. Bernstein DI, Sack DA, Reisinger K, et al. Second-year follow-up evaluation of live, attenuated human rotavirus vaccine 89-12 in healthy infants. J Infect Dis 2002 Nov 15; 186: 1487–9

    Article  PubMed  Google Scholar 

  10. European Medicines Agency. Rotarix: summary of product characteristics [online]. Available from URL: http://www.emea.eu.int [Accessed 2006 Sep 13]

  11. Vesikari T, Karvonen A, Korhonen T, et al. Safety and immunogenicity of RIX4414 live attenuated human rotavirus vaccine in adults, toddlers and previously uninfected infants. Vaccine 2004 Jul 29; 22: 2836–42

    Article  PubMed  CAS  Google Scholar 

  12. Vesikari T, Karvonen A, Puustinen L, et al. Efficacy of RIX4414 live attenuated human rotavirus vaccine in Finnish infants. Pediatr Infect Dis J 2004 Oct; 23(10): 937–43

    Article  PubMed  Google Scholar 

  13. Dennehy PH, Brady RC, Halperin SA, et al. Comparative evaluation of safety and immunogenicity of two dosages of an oral live attenuated human rotavirus vaccine. Pediatr Infect Dis J 2005 Jun; 24(6): 481–8

    Article  PubMed  Google Scholar 

  14. Phua KB, Quak SH, Lee BW, et al. Evaluation of RIX4414, a live, attenuated rotavirus vaccine, in a randomized, double-blind, placebo-controlled phase 2 trial involving 2464 Singaporean infants. J Infect Dis 2005 Sep 1; 192Suppl. 1: S6–16

    Article  PubMed  Google Scholar 

  15. Salinas B, Pérez Schael I, Linhares AC, et al. Evaluation of safety, immunogenicity and efficacy of an attenuated rotavirus vaccine, RIX4414: a randomized, placebo-controlled trial in Latin American infants. Pediatr Infect Dis J 2005 Sep; 24(9): 807–16

    Article  PubMed  Google Scholar 

  16. Steele AD, Tumbo JM, Armah GE, et al. Concomitant administration of a live-attenuated oral rotavirus vaccine (RIX4414) with poliovirus vaccines in African infants [abstract]. 23rd Annual Meeting of the European Society for Paediatric Infectious Diseases; 2005 May 18–20; Valencia

  17. Vesikari T, Karvonen A, Prymula R, et al. Rotarix™ (RIX4414), an oral human rotavirus vaccine, is highly immunogenic in healthy infants from 6 European countries [abstract]. 24th Annual Meeting of the European Society for Paediatric Infectious Diseases; 2006 May 3–5; Basel

  18. Schuster V, Otto W, Cohen R, et al. Rotarix™ (RIX4414), an oral human rotavirus vaccine, is highly immunogenic when co-administered with a Streptococcus pneumoniae conjugate vaccine (Prevenar™) in healthy infants from France and Germany [abstract]. 24th Annual Meeting of the European Society for Paediatric Infectious Diseases; 2006 May 3–5; Basel

  19. Tejedor JC, Díez-Delgado J, Arístegui J, et al. Rotarix™ (RIX4414), an oral human rotavirus vaccine, is highly immunogenic when co-administered with a Neisseria meningitidis serogroup C vaccine (Meningitec™) in healthy infants from Spain [abstract]. 24th Annual Meeting of the European Society for Paediatric Infectious Diseases; 2006 May 3–5; Basel

  20. Vesikari T, Prymula R, Schuster V, et al. Rotarix™ (RIX4414), an oral human rotavirus vaccine, is highly immunogenic when co-administered with diphtheria-tetanus-pertussis (DTPa)-combined vaccines in healthy infants from Europe [abstract]. 24th Annual Meeting of the European Society for Paediatric Infectious Diseases; 2006 May 3–5; Basel

  21. European Medicines Agency. Rotarix: scientific discussion [online]. Available from URL: http://www.emea.eu.int [Accessed 2006 Sep 15]

  22. Ruiz-Palacios GM, Pérez-Schael I, Velázquez FR, et al. Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis. N Engl J Med 2006 Jan 5; 354(1): 11–22

    Article  PubMed  CAS  Google Scholar 

  23. Vesikari T, Karvonen A, Prymula R, et al. Human rotavirus vaccine Rotarix™ (RIX4414) is highly efficacious in Europe [abstract]. 24th Annual Meeting of the European Society for Paediatric Infectious Diseases; 2006 May 3–5; Basel

  24. Vesikari T, Prymula R, Schuster V, et al. Early protection against rotavirus, Rotarix™ (RIX4414) experience in a European setting [abstract no. 68.021]. Int J Infect Dis 2006 Jun; 10Suppl. 1: 324

    Google Scholar 

  25. Perez-Schael I, Linhares AC, Vesikari T, et al. Two doses of the human-attenuated rotovirus vaccine RIX4414 show heterotypic protection in Latin America and Europe [abstract no. LB-12]. 45th Interscience Conference on Antimicrobial Agents and Chemotherapy; 2005 Dec 16–19; Washington, DC

  26. De Vos B, Gillard P, Cheuvart B, et al. RIX4414 vaccine efficacy against rotavirus gastroenteritis due to G2P[4] strain [abstract no. G-618]. 46th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy; 2006 Sep 27–30; San Francisco (CA)

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  1. Wolters Kluwer Health | Adis, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, Auckland, 1311, New Zealand

    Gillian M. Keating

  2. Editorial office of Wolters Kluwer Health, Conshohocken, Pennsylvania, USA

    Gillian M. Keating

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  1. Gillian M. Keating
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Keating, G.M. Rotavirus Vaccine RIX4414 (Rotarix™). Pediatr-Drugs 8, 389–395 (2006). https://doi.org/10.2165/00148581-200608060-00006

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