Efficacy of the rhesus rotavirus-based quadrivalent vaccine in infants and young children in Venezuela.
Background Rotaviruses are the principal known etiologic agents of severe diarrhea among infants and young children worldwide.
Although a rhesus rotavirus-based quadrivalent vaccine is highly effective in preventing severe diarrhea in developed countries, in developing countries its efficacy has been less impressive.
We thus conducted a catchment study in Venezuela to assess the efficacy of the vaccine against dehydrating diarrhea.
Methods In this randomized, double-blind, placebo-controlled trial, 2207 infants received three oral doses of the quadrivalent rotavirus vaccine (4X105 plaque-forming units per dose) or placebo at about two, three, and four months of age.
During approximately 19 to 20 months of passive surveillance, episodes of gastroenteritis were evaluated at the hospital.
Results The vaccine was safe, although 15 percent of the vaccinated infants had febrile episodes (rectal temperature, =38.1°C) during the six days after the first dose, as compared with 7 percent of the controls (P<0.001).
However, the vaccine gave 88 percent protection against-severe diarrhea caused by rotavirus and 75 percent protection against dehydration, and produced a 70 percent reduction in hospital admissions.
Overall, the efficacy of the vaccine against a first episode of rotavirus diarrhea was 48 percent.
Horizontal transmission of vaccine virus was demonstrated in 15 percent of the vaccine recipients and 13 percent of the placebo recipients with rotavirus-positive diarrhea. (...)
Mots-clés Pascal : Rotavirus, Reoviridae, Virus, Vaccination, Randomisation, Vaccin polyvalent, Voie orale, Etude double insu, Essai thérapeutique contrôlé, Enfant, Homme, Prévention, Venezuela, Amérique du Sud, Amérique, Virose, Infection, Organisation santé, Immunoprophylaxie
Mots-clés Pascal anglais : Rotavirus, Reoviridae, Virus, Vaccination, Randomization, Polyvalent vaccine, Oral administration, Double blind study, Controlled therapeutic trial, Child, Human, Prevention, Venezuela, South America, America, Viral disease, Infection, Public health organization, Immunoprophylaxis
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Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 97-0542884
Code Inist : 002B05A02. Création : 24/03/1998.