Background Influenzavirus vaccine is used infrequently in healthy children, even though the rates of influenza in this group are high.
We conducted a multicenter, double-blind, placebo-controlled trial of a live attenuated, cold-adapted, trivalent influenzavirus vaccine in children 15 to 71 months old.
Methods Two hundred eighty-eight children were assigned to receive one dose of vaccine or placebo given by intranasal spray, and 1314 were assigned to receive two doses approximately 60 days apart.
The strains included in the vaccine were antigenically equivalent to those in the inactivated influenzavirus vaccine in use at the time.
The subjects were monitored with viral cultures for influenza during the subsequent influenza season.
A case of influenza was defined as an illness associated with the isolation of wild-type influenzavirus from respiratory secretions.
Results The intranasal vaccine was accepted and well tolerated.
Among children who were initially seronegative, antibody titers increased by a factor of four in 61 to 96 percent, depending on the influenza strain.
Culture-positive influenza was significantly less common in the vaccine group (14 cases among 1070 subjects) than the placebo group (95 cases among 532 subjects).
The vaccine efficacy was 93 percent (95 percent confidence interval, 88 to 96 percent) against culture-confirmed influenza. (...)
Mots-clés Pascal : Vaccination, Influenzavirus, Orthomyxoviridae, Virus, Voie intranasale, Prévention, Efficacité, Enfant, Homme, Etude multicentrique, Etude double insu, Etats Unis, Amérique du Nord, Amérique
Mots-clés Pascal anglais : Vaccination, Influenzavirus, Orthomyxoviridae, Virus, Intranasal administration, Prevention, Efficiency, Child, Human, Multicenter study, Double blind study, United States, North America, America
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Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 98-0260670
Code Inist : 002B05A02. Création : 11/09/1998.