Safety, immunogenicity, and protective efficacy of two doses of RIX4414 live attenuated human rotavirus vaccine in healthy Brazilian infants;Segurança, imunogenicidade e eficácia protetora de duas doses da vacina RIX4414 contendo rotavírus atenuado de origem humana

Jornal de Pediatria

Volumn 83, Issue 3, 2007, Pages 217-224

  Araujo, Eliete C ^a,b   Clemens, Sue Ann C ^c,d   Oliveira, Consuelo S ^a,e   Justino, Maria Cleonice A ^a   Rubio, Pilar ^c   Gabbay, Yvone B ^a   Da Silva, Veronilce B ^a,f   Mascarenhas, Joana D P ^a   Noronha, Vânia L ^e   Clemens, Ralf ^c,d   Gusmão, Rosa Helena P ^e   Sanchez, Nervo ^c   Monteiro, Talita Antônia F ^a   Linhares, Alexandre C ^a  

^a INSTITUTO EVANDRO CHAGAS   (Brazil)

^b FEDERAL UNIVERSITY OF PARÁ   (Brazil)

^c Estrada dos Bandeirantes   (Brazil)

^d Instituto Carlos Chagas   (Brazil)

^e UNIVERSIDADE DO ESTADO DO PARÁ   (Brazil)

^f Zoonoses Control Center   (Brazil)

Author keywords

Efficacy; Gastroenteritis; Rotavirus; Vaccine

Indexed keywords

DIPHTHERIA PERTUSSIS TETANUS VACCINE; HAEMOPHILUS INFLUENZAE TYPE B VACCINE; HEPATITIS B VACCINE; IMMUNOGLOBULIN A; PLACEBO; RIX 4414; ROTAVIRUS VACCINE; UNCLASSIFIED DRUG; VIRUS ANTIBODY;

ANTIBODY RESPONSE; ARTICLE; BRAZIL; CLINICAL TRIAL; COLONY FORMING UNIT; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; GASTROENTERITIS; HUMAN; IMMUNOGENICITY; INFANT; MAJOR CLINICAL STUDY; MULTICENTER STUDY; PROTECTION; RANDOMIZED CONTROLLED TRIAL; SCORING SYSTEM; TREATMENT OUTCOME; VACCINATION; VIRUS INFECTION; VIRUS TITRATION;

ANTIBODIES, VIRAL; BRAZIL; DOUBLE-BLIND METHOD; GASTROENTERITIS; HUMANS; INFANT; MEXICO; ROTAVIRUS; ROTAVIRUS INFECTIONS; SEVERITY OF ILLNESS INDEX; VACCINES, ATTENUATED; VENEZUELA;

EID: 34250001763     PISSN: 00217557     EISSN: None     Source Type: Journal    
DOI: 10.2223/JPED.1600     Document Type: Article

References (20)

1. Parashar UD, Gibson CJ, Bresee JS, Glass RI. Rotavirus and severe childhood diarrhea. Emerg Infect Dis. 2006;12:304-6.
2. Linhares AC, Bresee JS. Rotavirus vaccines and vaccination in Latin America. Rev Panam Salud Publica. 2000;8:305-31.
3. Pan American Health Organization, World Health Organization. Regional Meeting on the Implementation of Rotavirus Epidemiological Surveillance. Final Report; 2003 Sep 4-5; Lima, Peru.
4. Linhares AC. Population-based surveillance of Rotavirus in Brazil [abstract]. In: International RV Symposium 6; 2004 Jul 7-9; Mexico City, Mexico.
5. Linhares AC. Epidemiologia das infecções por rotavírus no Brasil e os desafios para o seu controle. Cad Saude Publica. 2000;16:629-46.
6. Leite JP, Alfieri AA, Woods PA, Glass RI, Gentsch JR. Rotavirus G and P types circulating in Brazil: characterization by RT-PCR, probe hybridization, and sequence analysis. Arch Virol. 1996;141:2365-74.
7. Costa PS, Cardoso DD, Grisi SJ, Silva PA, Fiaccadori F, Souza MB, et al. Rotavirus A infections and reinfections: genotyping and vaccine implications. J Pediatr (Rio J). 2004;80:119-22.
8. Centers for Disease Control and Prevention. Withdrawal of Rotavirus vaccine recommendation. MMWR Morb Mortal Wkly Rep. 1999;48:1007.
9. Bernstein DI, Smith VE, Sherwood JR, Schiff GM, Sander DS, DeFeudis D, et al. Safety and immunogenicity of live, attenuated human Rotavirus vaccine 89-12. Vaccine. 1998;16:381-7.
10. Vesikari T, Karvonen A, Korhonen T, Espo M, Lebacq E, Forster J, et al. Safety and immunogenicity of RIX4414 live attenuated human Rotavirus vaccine in adults, toddlers and previously uninfected infants. Vaccine. 2004;22:2836-42.
11. De Vos B, Vesikari T, Linhares AC, Salinas B, Pérez-Schael I, Ruiz-Palacios GM, et al. A rotavirus vaccine for prophylaxis of infants against rotavirus gastroenteritis. Pediatr Infect Dis J. 2004;23(10 Suppl):S179-82.
12. Vesikari T, Karvonen A, Puustinen L, Zeng SQ, Szakal ED, Delem A, et al. Efficacy of RIX4414 live attenuated human rotavirus vaccine in Finnish infants. Pediatr Infect Dis J. 2004;23:937-43.
13. Pang XL, Joensuu J, Hoshino Y, Kapikian AZ, Vesikari T. Rotaviruses detected by reverse transcription polymerase chain reaction in acute gastroenteritis during a trial of rhesus-human reassortant rotavirus tetravalent vaccine: implications for vaccine efficacy analysis. J Clin Virol. 1999;13:9-16.
14. Ruuska T, Vesikari T. Rotavirus disease in Finnish children: use of numerical scores for clinical severity of diarrhoeal episodes. Scand J Infect Dis. 1990;22:259-67.
15. Salinas B, Pérez-Schael I, Linhares AC, Ruiz-Palacios GM, Guerrero ML, Yarzábal JP, 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;24:807-16.
16. Ruiz-Palacios GM, Pérez-Schael I, Velázquez FR, Abate H, Breuer T, Clemens SC, et al. Safety and efficacy of an attenuated vaccine against severe rotavirus grastroenteritis. N Engl J Med. 2006;354:11-22.
17. Steele AD, Tumbo J, Armah G, Reynders J, Scholtz F, Bos P, et al. Immunogenicity and reactogenicity of a new live attenuated oral rotavirus vaccine (RIX4414) when administered concurrently with poliovirus vaccines in African infants. In: International Congress of Pediatric; 2004 Aug 15-20; Cancun, Mexico.
18. Santos N, Hoshino Y. Global distribution of rotavirus serotypes/genotypes and its implication for the development and implementation of an effective rotavirus vaccine. Rev Med Virol. 2005;15:29-56.
19. 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;43:312-4.
20. Laird AR, Ibarra V, Ruiz-Palacios G, Guerrero ML, Glass RI, Gentsch JR. Unexpected detection of animal VP7 genes among common rotavirus strains isolated from children in Mexico. J Clin Microbiol. 2003;41:4400-3.