title: The European CHMP criteria for influenza vaccine immunogenicity cannot be improved by the use of confidence intervals.
abstract: In a well-know CHMP Note for Guidance criteria are given for evaluation the results of annual-update studies. Now and then it sometimes is suggested that these criteria can be improved by the use of confidence intervals. Here it is argued that this is based on a misinterpretation of what confidence intervals are. These intervals require that subjects are chosen at random from a population. In influenza studies this is never the case.
authors.affiliation: Solvay Pharmaceuticals, Clinical Development Influenza Vaccines, P.O. BOX 900, 1380 DA Weesp, The Netherlands. jos.nauta@solvay.com
authors.forename: Jozef J P
authors.initials: JJ
authors.lastname: Nauta
authors.forename: Iris A
authors.initials: IA
authors.lastname: de Bruijn
mesh_terms: D016001:Confidence Intervals; D005060:Europe; D006801:Humans; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology* / Q000592:standards; D007251:Influenza, Human / Q000453:epidemiology / Q000276:immunology / Q000517:prevention & control
chemical_list: D007252:Influenza Vaccines