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Updated: Aug 7, 2026

A Method to Assess Fc-mediated Effector Functions Induced by Influenza Hemagglutinin Specific Antibodies
Published on: February 23, 2018
The European CHMP criteria for influenza vaccine immunogenicity cannot be improved by the use of confidence intervals
Jozef J P Nauta1, Iris A de Bruijn
1Solvay Pharmaceuticals, Clinical Development Influenza Vaccines, P.O. BOX 900, 1380 DA Weesp, The Netherlands. jos.nauta@solvay.com
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.

