RESUMEN
WHO UNIVERSAL TRIAL NUMBERS (UTNS): U1111-1174-4615 and U1111-1174-4698. CLINICALTRIALS.GOV: NCT04210349 and NCT03430089.
Asunto(s)
Vacunas contra la Influenza , Gripe Humana , Humanos , Anticuerpos Antivirales , Pruebas de Inhibición de Hemaglutinación , Inmunogenicidad Vacunal , Virus de la Influenza B , Vacunas contra la Influenza/efectos adversos , Gripe Humana/prevención & control , Vacunas Combinadas , Vacunas de Productos Inactivados/efectos adversosRESUMEN
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.
Asunto(s)
Intervalos de Confianza , Vacunas contra la Influenza/inmunología , Europa (Continente) , Humanos , Vacunas contra la Influenza/administración & dosificación , Vacunas contra la Influenza/efectos adversos , Vacunas contra la Influenza/normas , Gripe Humana/epidemiología , Gripe Humana/inmunología , Gripe Humana/prevención & controlRESUMEN
HI titers measure anti-HA antibody concentrations in sera. By the way they are defined standard titers underestimate the true amounts of antibody. A new definition is proposed, the mid-value definition. Under mild conditions mid-value titers are on average closer to the true value than standard titers.