A short report on highlights of world-wide development of RIX4414: a latin american experience

xmlui.dri2xhtml.METS-1.0.item-date
2006xmlui.dri2xhtml.METS-1.0.item-files-viewOpen
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http://patua.iec.gov.br/handle/iec/1073xmlui.dri2xhtml.METS-1.0.item-author
Linhares, Alexandre da Costa
Ruiz-Palacios, G. M
Guerrero, M. L
Salinas, B
Perez-Schael, I
Clemens, S. A. Costa
Innis, B
Yarzabal, J. P
Vespa, G
Cervantes, Y
Hardt, K
De Vos, B
xmlui.dri2xhtml.METS-1.0.item-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.
xmlui.dri2xhtml.METS-1.0.item-citation
LINHARES, Alexandre da Costa et al. A short report on highlights of world-wide development of RIX4414: a latin american experience. Vaccine, v. 24, n. 18, p. 3784-3785, 2006xmlui.dri2xhtml.METS-1.0.item-decsPrimary
RotavirusVacinas contra Rotavirus / análise
Vacinas contra Rotavirus / uso terapêutico
América Latina