logo BDSP

Base documentaire

  1. The effect of investigator compliance (observer bias) on calculated efficacy in a pertussis vaccine trial.

    Article - En anglais


    In the course of a large pertussis vaccine efficacy trial we realized that investigator compliance could have a major impact on calculated vaccine efficacy.


    In our pertussis vaccine efficacy trial, the study investigators were to monitor illness in study families by telephone every 2 weeks.

    If a cough illness of >=7 days duration was noted, the study child was to be evaluated.

    If the cough illness persisted for<14 days, the child was to be referred to a central investigator.

    For this report we analyzed study physician evaluation rates and rates of referral to the central investigators.

    Physician practices were separated into three compliance categories : high, intermediate, and low.

    We analyzed vaccine efficacy of an acellular pertussis component DTP vaccine (DTaP) and a whole cell pertussis component DTP vaccine (DTP) by compliance category.

    Bordetella pertussis infection was documented by culture of the organism in the study child or in a household contact or by a significant antibody response to pertussis toxin determined by enzyme-linked immunosorbent assay.


    Using a clinical case definition that included both mild and typical pertussis (cough illness >=7 days duration) efficacy of DTaP vaccine was 40% (95% confidence interval [CI]=-3-65) in the high compliance category and 78% (95% CI=65-86) and 75% (95% CI=53-87) in the intermediate and low compliance groups, respectively. (...)

    Mots-clés Pascal : Bordetella pertussis, Bactérie, Nourrisson, Homme, Vaccin acellulaire, Vaccination, Etude comparative, Efficacité, Biais méthodologique, Infection, Traitement, Prévention

    Mots-clés Pascal anglais : Bordetella pertussis, Bacteria, Infant, Human, Acellular vaccine, Vaccination, Comparative study, Efficiency, Methodological bias, Infection, Treatment, Prevention

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

    Cote : 98-0511761

    Code Inist : 002B05B02E. Création : 23/03/1999.