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  1. Comparative Safety of two recombinant hepatitis B vaccines in children : Data from the Vaccine Adverse Event Reporting System (VAERS) and Vaccine Safety Datalink (VSD).

    Article - En anglais

    Background 

    Preliminary review of data from the Vaccine Adverse Event Reporting System (VAERS), 1991-1994, revealed that more serious adverse events were reported in children who received a specific brand of recombinant hepatitis B (HepB) vaccine.

    Objective 

    To compare the post-marketing safety experience of the two recombinant HepB vaccines licensed for use in infants and children in the United States.

    Design 

    Review of a case series derived from passive surveillance data in the national VAERS.

    A retrospective cohort study using data from one health maintenance organization participating in Vaccine Safety Datalink (VSD), a computerized record linkage system.

    Populations Studied : U.S. children, ages birth-10 years for whom adverse events after HepB vaccine were reported to VAERS, 1991-1994.

    Children, ages birth-6 years, who received HepB vaccine at Kaiser Permanente Medical Care Program, Northern California, 1991-1994.

    Main Outcome Measures 

    VAERS reporting rates for each vaccine by manufacturer were calculated from the numbers of reported events occurring within 30 days of HepB vaccination and the number of doses distributed by the manufacturers.

    VSD event rates for each vaccine were calculated from the numbers of hospitalization or emergency room visits within 30 days of HepB vaccination and the number of vaccine doses administered to the cohort.

    Results 

    In VAERS, higher rates of serious events (i.e. (...)

    Mots-clés Pascal : Vaccin, Hépatite virale B, Virose, Infection, Protéine recombinante, Etude comparative, Enfant, Homme, Complication, Epidémiologie, Etats Unis, Amérique du Nord, Amérique, Pharmacovigilance, Chaînage donnée, Registre, Appareil digestif pathologie, Foie pathologie

    Mots-clés Pascal anglais : Vaccine, Viral hepatitis B, Viral disease, Infection, Recombinant protein, Comparative study, Child, Human, Complication, Epidemiology, United States, North America, America, Pharmacovigilance, Data link, Register, Digestive diseases, Hepatic disease

    Logo du centre Notice produite par :
    Inist-CNRS - Institut de l'Information Scientifique et Technique

    Cote : 98-0344412

    Code Inist : 002A05C07. Création : 27/11/1998.