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
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 98-0511761
Code Inist : 002B05B02E. Création : 23/03/1999.