Effectiveness of the monovalent G1P[8] human rotavirus vaccine against hospitalization for severe G2P[4] rotavirus gastroenteritis in Belém, Brazil

Pediatric Infectious Disease Journal

Volumn 30, Issue 5, 2011, Pages 396-401

  Justino, Maria Cleonice A ^a   Linhares, Alexandre C ^a   Lanzieri, Tatiana M ^b   Miranda, Yllen ^a   Mascarenhas, Joana D'Arc P ^a   Abreu, Erika ^a   Guerra, Sylvia F S ^a   Oliveira, Alessilva S L ^a   Da Silva, Veronilce B ^a   Sanchez, Nervo ^b   Meyer, Nadia ^c   Shafi, Fakrudeen ^d   Ortega Barria, Eduardo ^b   Soriano Gabarró, Montse ^c,e   Colindres, Romulo E ^b  

^a INSTITUTO EVANDRO CHAGAS   (Brazil)

^b Estrada dos Bandeirantes   (Brazil)

^c GLAXOSMITHKLINE BIOLOGICALS   (Belgium)

^d GlaxoSmithKline Pharmaceuticals Ltd   (India)

^e BAYER PHARMA AG   (Germany)

Author keywords

Brazil; gastroenteritis; hospitalizations; human rotavirus vaccine; rotavirus

Indexed keywords

ROTAVIRUS VACCINE;

ARTICLE; BRAZIL; CASE CONTROL STUDY; CHILD; CONTROLLED STUDY; DRUG EFFICACY; FEMALE; GASTROENTERITIS; HOSPITALIZATION; HUMAN; INFANT; INFECTION PREVENTION; MAJOR CLINICAL STUDY; MALE; PRESCHOOL CHILD; PRIORITY JOURNAL; ROTAVIRUS INFECTION; VACCINATION;

EID: 79954726795     PISSN: 08913668     EISSN: 15320987     Source Type: Journal    
DOI: 10.1097/INF.0b013e3182055cc2     Document Type: Article

References (43)

1. Parashar UD, Gibson CJ, Bresse JS, et al. Rotavirus and severe childhood diarrhea. Emerg Infect Dis. 2006;12:304-330.
2. World Health Organization. Rotavirusvaccines. WHO positionpaper. Wkly Epidemiol Rec. 2007;82:285-396.
3. Rotavirus Surveillance\Worldwide, 2001-2008. Morb Mortal Wkly Rep. 2008;57:1255-1257.
4. Parashar UD, Burton A, Lanata C, et al. Global mortality associated with rotavirus disease among children in 2004. JInfect Dis. 2009;200:S9-S15.
5. Meeting ofthe immunization Strategic Advisory Group of Experts April 2009-conclusions and recommendations. Wkly Epidemiol Rec. 2009; 84: 220-236.
6. Danchin MH, Bines JE. Defeating rotavirus? The global recommendation for rotavirus vaccination. New Engl J Med. 2009;61:919-921.
7. Grimwood K, Lambert SB. Rotavirus vaccines. Opportunities and chal-lenges. Hum Vaccin. 2009;5:57-69.
8. 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;354:11-22. (Pubitemid 43048947)
9. Vesikari T, Matson DO, Dennehy P, et al. Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine. N Engl J Med. 2006;354:23-33. (Pubitemid 43048948)
10. 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. (Pubitemid 350137490)
11. Linhares AC, Velázquez FR, Pérez-Schael I, et al. Efficacy and safety of an oral live attenuated human rotavirus vaccine against rotavirus gastroenteri-tis during the first 2 years oflife in Latin American infants: a randomised, double-blind, placebo-controlled phase III study. Lancet. 2008;371:1181-1189. (Pubitemid 351458523)
12. Phua KB, Lim FS, Lau YL, et al. Safety and efficacy ofhuman rotavirus vaccine during the first 2 years of life in Asian infants: randomised, double-blind, controlled study. Vaccine. 2009;27:5936-5941.
13. Vesikari T, Itzler R, Karvonen A, et al. RotaTeq, a pentavalent rotavirus vaccine: efficacy and safety among infants in Europe. Vaccine. 2009;28: 345-351.
14. Madhi SA, Cunliffe NA, Steele D, et al. Effect ofhuman rotavirus vaccine on severe diarrhea in African infants. N Engl J Med. 2010;362:289-298.
15. O'Ryan M, Linhares AC. Update on Rotarix: an oral human rotavirus vaccine. Expert Rev Vaccines. 2009;8:1627-1641.
16. Patel M, Pedreira C, de Oliveira LH, et al. Association between pentavalent rotavirus vaccine and severe rotavirus diarrhea among children in Nicara-gua. JAMA. 2009;301:2243-2251.
17. Correia JB, Patel MM, Nakagomi O, et al. Effectiveness of monovalent rotavirus vaccine (Rotarix) against severe diarrhea caused by serotypically unrelated G2P[4] strains in Brazil. J Infect Dis. 2010;201:363-369.
18. Sartori AM, Valentim J, de Soárez PC, et al. Rotavirus morbidity and mortalityinchildren in Brazil. Rev Panam Salud Publica. 2008;23:92-100.
19. Munford V, Gilio AE, de Souza EC, et al. Rotavirus gastroenteritis in children in 4 regions in Brazil: a hospital-based surveillance study. J Infect Dis. 2009;200:S106-S113.
20. Abate H, Linhares AC, Venegas G, et al. Results of a hospital-based study on rotavirus gastroenteritis in Latin American children. In: 24th Interna-tional Congress ofPediatrics (ICP); August 15-20, 2004; Cancun, Mexico. Abstract 656.
21. World Health Organization. Generic Protocol for Monitoring Impact of Rotavirus Vaccination on Gastroenteritis Disease Burden and Viral Strains. Geneva, Switzerland: World Health Organization; 2008. Available at: http://whqlibdoc.who.int/hq/2008/WHO-IVB-08.16-eng.pdf. Accessed October 2010.
22. Patel MM, Parashar UD. Assessing the effectiveness and public health impact ofrotavirus vaccines after introduction in immunization programs. JInfect Dis. 2009;200:S291-S299.
23. Matthijnssens J, Bilcke J, Ciarlet M, et al. Rotavirus disease and vaccina-tion: impact on genotype diversity. Future Microbiol. 2009;4:1303-1316.
24. Instituto Brasileiro de Geografia e Estatística- População Residente. Available at: http://tabnet.datasus.gov.br/ cgi/deftohtm.exe?ibge/cnv/poppa.def Accessed October 2010.
25. Sistema de Informações de Nascidos Vivos. Available at: http://tabnet.datasus. gov.br/cgi/tabcgi.exe?sinascp/cnv/nvpa.def Accessed October 2010.
26. Tarone RE, Gart JJ, Hauck WW. On the asymptotic inefficiency of certain noniterative estimators of a common relative risk or odds ratio. Biometrika. 1983;70:519-522.
27. Niccolai LM, Ogden LG, Muehlenbein CE, et al. Methodological issues in design and analysis of a matched case-control study of a vaccine's effec-tiveness. J Clin Epidemiol. 2007;60:1127-1131. (Pubitemid 47552761)
28. Ruuska T, Vesikari T. Rotavirus disease in Finnish children: use of numerical scores for clinical severity ofdiarrhoeal episodes. Scand J Infect Dis. 1990;22:259-267.
29. López P, Linhares A, Pérez-Schael I, et al. Early protection against severe rotavirus gastroenteritis-RIX4414 experience in Latin America. In: 24th Annual Meeting ofthe European Society for Paediatric Infectious Diseases (ESPID); May 3-5, 2006; Basel, Switzerland. Abstract 462.
30. Kirkwood CD, Cannan D, Boniface K, et al. Australian Rotavirus Surveil-lance Group. Australian Rotavirus Surveillance Program annual report, 2007/2008. Commun Dis Intell. 2008;32:425-429.
31. Leite JP, Carvalho-Costa FA, Linhares AC. Group A rotavirus genotypes and the ongoing Brazilian experience: a review. Mem Inst Oswaldo Cruz. 2008;103:745-753.
32. Antunes H, Afonso A, Iturriza M, et al. G2P[4] the most prevalent rotavirus genotype in 2007 winter season in an European non-vaccinated population J Clin Virol. 2009;45:76-78.
33. Carvalho-Costa FA, Araújo IT, Santos de Assis RM, et al. Rotavirus genotype distribution after vaccine introduction, Rio de Janeiro, Brazil. Emerg Infect Dis. 2009;15:95-97.
34. Dey SK, Hayakawa Y, Rahman M, et al. G2 strain of rotavirus among infants and children, Bangladesh Emerg Infect Dis. 2009;15:91-94.
35. Hasing ME, Trueba G, Baquero MI, et al. Rapid changes in rotaviral genotypes in Ecuador. J Med Virol. 2009;81:2109-2113.
36. De Vos B, Han HH, Bouckenooghe A, et al. Live attenuated human rotavirus vaccine, RIX4414, provides clinical protection in infants against rotavirus strains with and without shared G and P genotypes: integrated analysis ofrandomizedcontrolledtrials. Pediatr Infect Dis J. 2009;28:261-266.
37. Gurgel RG, Bohland AK, Vieira SC, et al. Incidence of rotavirus and all-cause diarrhea in northeast Brazil following the introduction of a national vaccination program. Gastroenterology. 2009;137:1970-1975.
38. Lanzieri TM, Costa I, Shafi FA, et al. Trends in hospitalizations from all-cause gastroenteritis in children younger than 5 years of age in Brazil before and afterhumanrotavirus vaccine introduction, 1998-2007. Pediatr Infect Dis J. 2010;29:673-675.
39. Smith PG. Epidemiological methods to evaluate vaccine efficacy. Br Med Bull. 1988;44:679-690.
40. Rodrigues LC, Smith PG. Use of the case-control approach in vaccine evaluation: efficacy and adverse effects. Epidemiol Rev. 1999;21:56-72. (Pubitemid 29441985)
41. Dantas OM, Ximenes RA, de Albuquerque Mde F, et al. Selection bias: neighborhood controls and controls selected from those presenting to a Health Unit in a case control study ofefficacy ofBCG revaccination. BMC Med Res Methodol. 2007;7:11.
42. Rodewald LE, Szilagyi PG, Humiston SG, et al. Is an emergency depart-ment visit a marker for under vaccination and missed vaccination oppor-tunities among children who have access to primary care? Pediatrics. 1993;91:605-611. (Pubitemid 23065408)
43. DATASUS. Imunizações-Cobertura. Available at: http://tabnet.datasus.gov.br/cgi/tabcgi.exe?pni/CNV/CPNIPA.def Accessed October 2010