Efficacy of RIX4414 live attenuated human rotavirus vaccine in Finnish infants

Pediatric Infectious Disease Journal

Volumn 23, Issue 10, 2004, Pages 937-943

  Vesikari, Timo ^a   Karvonen, Aino ^a   Puustinen, Leena ^a   Zeng, Shang Qin ^a   Szakal, Evelyn Dora ^a   Delem, Andrée ^b   De Vos, Beatrice ^b  

^a UNIVERSITY OF TAMPERE MEDICAL SCHOOL   (Finland)

^b GLAXOSMITHKLINE BIOLOGICALS   (Belgium)

Author keywords

Diarrhea; Efficacy; Rotavirus; Vaccine

Indexed keywords

PLACEBO; ROTAVIRUS VACCINE; LIVE VACCINE;

ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; ENZYME LINKED IMMUNOSORBENT ASSAY; FECES ANALYSIS; FINLAND; GASTROENTERITIS; HUMAN; IMMUNOGENICITY; INFANT; MAJOR CLINICAL STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION; ROTAVIRUS; SEROCONVERSION; SEROTYPE; VIRUS INFECTION; FEMALE; IMMUNOLOGY; MALE; ORAL DRUG ADMINISTRATION; VIROLOGY;

ADMINISTRATION, ORAL; DOUBLE-BLIND METHOD; FEMALE; FINLAND; GASTROENTERITIS; HUMANS; INFANT; MALE; ROTAVIRUS INFECTIONS; ROTAVIRUS VACCINES; VACCINES, ATTENUATED;

EID: 16544366154     PISSN: 08913668     EISSN: None     Source Type: Journal    
DOI: 10.1097/01.inf.0000141722.10130.50     Document Type: Article

References (26)

1. Parashar UD, Hummelman EG, Bresee JS, Miller MA, Glass RI. Global illness and deaths caused by rotavirus disease in children. Emerg Infect Dis. 2003;9:565-572.
2. Vesikari T, Rautanen T, von Bonsdorff C-H. Rotavirus gastroenteritis in Finland: burden of disease and epidemiological features. Acta Paediatr Suppl. 1999;426:24-30.
3. Ryan M, Ramsay M, Brown D, Gay NJ, Farrington CP, Wall PG. Hospital admissions attributable to rotavirus infection in England and Wales. J Infect Dis. 1996;174(suppl. 1):S12-S18.
4. Glass RI, Bresee JS, Parashar UD, Holman RC, Gentsch JR. First rotavirus vaccine licensed: is there really a need? Acta Paediatr Suppl. 1999;426:2-8.
5. Rennels MB, Glass RI, Dennehy PH, et al. Safety and efficacy of high-dose rhesus-human reassortant rotavirus vaccines: report of the National Multicenter Trial. Paediatrics. 1996;97:7-13.
6. Joensuu J, Koskenniemi E, Pang X-L, Vesikari T. Randomised placebo-controlled trial of rhesus-human reassortant rotavirus vaccine for prevention of severe rotavirus gastroenteritis. Lancet. 1997;350:1205-1209.
7. Murphy BR, Morens DM, Simonsen L, Chanock RM, La Montagne JR, Kapikian AZ. Reappraisal of the association of intussusception with the licensed live rotavirus vaccine challenges initial conclusions. J Infect Dis. 2003;187:1301-1308.
8. American Academy of Pediatrics. Possible association of intussusception with rotavirus vaccination. Pediatrics. 1999;104:575.
9. CDC. Withdrawal of rotavirus vaccine recommendation. MMWR. 1999; 48:1007.
10. Bernstein DI, Smith VE, Sherwood JR, et al. Safety and immunogenicity of a live attenuated human rotavirus 89-12 vaccine. Vaccine. 1998;16: 381-387.
11. 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;354:287-290.
12. 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;22:2836-2842.
13. Ruuska T, Vesikari T. Rotavirus disease in Finnish children: use of numerical scores for severity of diarrheal episodes. Scand J Infect Dis. 1990;22:259-267.
14. Vesikari T. Clinical trials of live oral rotavirus vaccines: the Finnish experience. Vaccine. 1993;11:255-261.
15. Pang X-L, 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 of vaccine efficacy analysis. J Clin Virol. 1999;13:9-16.
16. Gouvea V, Glass RI, Woods P, et al. Polymerase chain reaction amplification and typing of rotavirus nucleic acids from stool specimens. J Clin Microbiol. 1990;28:276-282.
17. Bernstein DI, Sack DA, Reisinger K, Rothstein E, Ward RL. Second year follow-up evaluation of live attenuated human rotavirus vaccine 89-12 in healthy infants. J Infect Dis. 2002;186:1487-1489.
18. Ward RL. Mechanisms of protection against rotavirus in humans and mice. J Infect Dis. 1996;174(suppl. 1):S51-S58.
19. Velasquez FR, Maison DO, Guerrero ML, et al. Serum antibody as a marker of protection against natural rotavirus infection and disease. J Infect Dis. 2000;182:1602-1609.
20. Vesikari T, Isolauri E, D'Hondt E, Delem A, Zissis G. Protection of infants against rotavirus diarrhoea by RIT 4237 attenuated bovine rotavirus strain vaccine. Lancet. 1984;1:977-981.
21. Linhares AC, Guerrero ML, Ruiz-Palacios G, Clemens SA, Jacquet J, De Vos B. Protective efficacy of an oral human rotavirus (HRV) vaccine in Latin American infants. In: 42nd Interscience Conference on Antimicrobial Agents and Chemotherapy, September 27-30, 2002, San Diego, CA. Washington, DC: American Society for Microbiology, 2002.
22. Joensuu J, Koskenniemi E, Vesikari T. Symptoms associated with rhesus-human reassortant rotavirus vaccine in infants. Pediatr Infect Dis J. 1998;17:334-340.
23. Chang HG, Smith PF, Ackelsberg J, Morse DL, Glass RI. Intussusception, rotavirus diarrhea, and rotavirus vaccine use among children in New York state. Pediatrics. 2001;108:54-60.
24. Vesikari T, Karvonen A, Espo M, Karvonen T, Delem A, De Vos B. Efficacy of an oral human rotavirus (HRV) vaccine in previously uninfected Finnish infants. In: 42nd Interscience Conference on Antimicrobial Agents and Chemotherapy, September 27-30, 2002, San Diego, CA. Washington, DC: American Society for Microbiology, 2002.
25. Vesikari T, Karvonen A, Schildt L, Delem A, De Vos B. Efficacy of the oral human rotavirus (HRV) vaccine in healthy infants during two consecutive rotavirus seasons. Presented at the meeting of the European Society for Paediatric Infectious Diseases, April 9-11, 2003, Sicily.
26. Vesikari T, Karvonen A, Puustinen L, et al. Efficacy of oral human rotavirus vaccine in infants against acute rotavirus gastroenteritis in the community determined with rotavirus antigen detection by EIA and rotavirus RT-PCR as end points. Presented at the meeting of the European Society for Clinical Virology, August 24-27, Lyon, France, 2003.