Background Rotavirus is the most common cause of acute childhood gastroenteritis.
Vaccination with live oral heterologous rotavirus vaccines may prevent rotavirus gastroenteritis.
We assessed the efficacy of rhesus-human reassortant rotavirus tetravalent vaccine (RRV-TV) against severe rotavirus gastroenteritis in Finnish children in a randomised placebocontrolled double-blind trial.
Methods Placebo or RRV-TV (titre 4X105 plaque-forming units) was given to infants at ages 2,3, and 5 months.
The children were followed up for one or two rotavirus epidemic seasons.
The main outcome measure was protection against severe rotavirus gastroenteritis (score =11 on a 20-point severity scale). 2398 children were enrolled and received at least one dose of RRV-TV (n=1191) or placebo (n=1207).
The primary efficacy analysis was based on children who received three doses of RRV-TV (n=1128) or placebo (n=1145).
Findings 256 episodes of rotavirus gastroenteritis occurred at any time during the study ; 65 were among 1191 RRV-TV recipients, and 191 among 1207 placebo recipients (vaccine efficacy 66% [95% Cl 55-74] ; intention-to-treat analysis). 226 episodes were included in the primary efficacy analysis of fully vaccinated children (54 among 1128 RRV-TV recipients, 172 among 1145 placebo recipients ; vaccine efficacy 68% [57-76]). 100 episodes were severe, eight in RRV-TV recipients and 92 in placebo recipients (vaccine efficacy 91% [82-96]). (...)
Mots-clés Pascal : Gastroentérite, Rotavirus, Reoviridae, Virus, Randomisation, Vaccin polyvalent, Essai thérapeutique contrôlé, Enfant, Homme, Prévention, Epidémiologie, Finlande, Europe, Appareil digestif pathologie, Estomac pathologie, Intestin pathologie, Immunoprophylaxie, Vaccin tetravalent rotavirus rhesus humain
Mots-clés Pascal anglais : Gastroenteritis, Rotavirus, Reoviridae, Virus, Randomization, Polyvalent vaccine, Controlled therapeutic trial, Child, Human, Prevention, Epidemiology, Finland, Europe, Digestive diseases, Gastric disease, Intestinal disease, Immunoprophylaxis
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Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 97-0534559
Code Inist : 002B05A02. Création : 13/02/1998.