120 infants were excluded from the according-to-protocol analysis. During the first efficacy follow-up period (mean duration 5·7 months [SD 1·2]), 24 of 2572 infants allocated RIX4414 versus 94 of 1302 given placebo had rotavirus gastroenteritis episodes of any severity, resulting in a vaccine efficacy of 87·1 % (95 % CI 79·6–92·1; p<0·0001). For the combined efficacy follow-up period, vaccine efficacy against severe rotavirus gastroenteritis was 90·4 % (85·1–94·1; p<0·0001), for admission owing to rotavirus gastroenteritis 96·0 % (83·8–99·5; p<0·0001), and for rotavirus-related medical attention 83·8 % (76·8–88·9; p<0.0001), and significant protection against severe rotavirus gastroenteritis by circulating G1, G2, G3, G4, and G9 rotavirus types was shown.
In a European setting, two doses of RIX4414 coadministered with childhood vaccines provided high protection against any and severe rotavirus gastroenteritis, with an overall reduction of admissions for gastroenteritis over two consecutive rotavirus epidemic seasons.
A short report on highlights of world Vaccine |
Vaccine, Volume 24, Issue 18, 1 May 2006, Pages 3784-3785 A.C. Linhares, G.M. Ruiz-Palacios, M.L. Guerrero, B. Salinas, I. Perez-Schael, S.A. Costa Clemens, B. Innis, J.P. Yarzabal, G. Vespa, Y. Cervantes, K. Hardt, B. De Vos Abstract An oral, human-derived monovalent (G1P1A) rotavirus vaccine, strain RIX4414, has been developed by GlaxoSmithKline, Rixensart, Belgium. The safety, immunogenicity and efficacy of this vaccine were evaluated in a randomized, double-blind, placebo-controlled, phase IIb trial conducted in Brazil, Mexico and Venezuela. Healthy infants were given two doses of vaccine (104.7, 105.2 or 105.8 ffu) or placebo at age 2 and 4 months, with routine DTPw-HBV and Hib vaccines. OPV was given separately, at least 2 weeks before or after administration of the study vaccine. A total of 2155 infants were enrolled, of whom 1618 received one of the three vaccine viral concentrations and 537 were given placebo. Analysis of efficacy included diarrheal episodes occurring from 2 weeks after second dose until one year of age. Efficacy rates against any rotavirus gastroenteritis, severe rotavirus gastroenteritis and hospitalizations for rotavirus disease were as high as 70 % (46–84 % ; 95 % CI), 86 % (63–96 % ; 95 % CI), and 93 % (54–100 % ; 95 % CI), respectively. For non-G1 (mainly G9) serotypes, RIX4414 vaccine conferred protection as high as 83 % (40–97 % ; 95 % CI) against severe gastroenteritis. A decrease was noted in the incidence of severe rotavirus-related gastroenteritis after first dose. It is demonstrated that two doses of RIX4414 are highly efficacious against severe rotavirus gastroenteritis and hospitalization, including disease caused by non-G1 strains, namely G9 serotypes. |
A short report on highlights of world Vaccine |
Vaccine, Volume 24, Issue 18, 1 May 2006, Page 3779 T. Vesikari, A. Karvonen, L. Puustinen, E.D. Szakal, S.-Q. Zeng, A. Delem, B. De Vos |
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Efficacy and safety of an oral live attenuated human rotavirus vaccine against rotavirus gastroenteritis during the first 2 years of life in Latin American infants: a randomised, double-blind, placebo-controlled phase III study