The European CHMP criteria for influenza vaccine immunogenicity cannot be improved by the use of confidence intervals.
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.
Nauta
Jozef J P
JJ
Solvay Pharmaceuticals, Clinical Development Influenza Vaccines, P.O. BOX 900, 1380 DA Weesp, The Netherlands. jos.nauta@solvay.com
de Bruijn
Iris A
IA
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
D007252:Influenza Vaccines