title: A multi-criteria decision making approach to identify a vaccine formulation.
abstract: This article illustrates the use of a multi-criteria decision making approach, based on desirability functions, to identify an appropriate adjuvant composition for an influenza vaccine to be used in elderly. The proposed adjuvant system contained two main elements: monophosphoryl lipid and α-tocopherol with squalene in an oil/water emulsion. The objective was to elicit a stronger immune response while maintaining an acceptable reactogenicity and safety profile. The study design, the statistical models, the choice of the desirability functions, the computation of the overall desirability index, and the assessment of the robustness of the ranking are all detailed in this manuscript.
authors.affiliation: a Biostatistics, GlaxoSmithKline Vaccines , Rixensart , Belgium.
authors.forename: Walthère
authors.initials: W
authors.lastname: Dewé
authors.affiliation: a Biostatistics, GlaxoSmithKline Vaccines , Rixensart , Belgium.
authors.forename: Christelle
authors.initials: C
authors.lastname: Durand
authors.affiliation: b Clinical R&D, 4Clinics , Waterloo , Belgium.
authors.forename: Sandie
authors.initials: S
authors.lastname: Marion
authors.affiliation: a Biostatistics, GlaxoSmithKline Vaccines , Rixensart , Belgium.
authors.forename: Lidia
authors.initials: L
authors.lastname: Oostvogels
authors.affiliation: a Biostatistics, GlaxoSmithKline Vaccines , Rixensart , Belgium.
authors.forename: Jeanne-Marie
authors.initials: JM
authors.lastname: Devaster
authors.affiliation: a Biostatistics, GlaxoSmithKline Vaccines , Rixensart , Belgium.
authors.forename: Marc
authors.initials: M
authors.lastname: Fourneau
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000009:adverse effects / Q000737:chemistry*; D000368:Aged; D017322:Clinical Trials, Phase II as Topic / Q000379:methods / Q000706:statistics & numerical data; D003657:Decision Making; D004305:Dose-Response Relationship, Drug; D004339:Drug Compounding / Q000706:statistics & numerical data; D023381:Endpoint Determination; D006801:Humans; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000737:chemistry* / Q000276:immunology*; D007251:Influenza, Human / Q000276:immunology / Q000517:prevention & control; D015233:Models, Statistical; D012107:Research Design / Q000706:statistics & numerical data
chemical_list: D000276:Adjuvants, Immunologic; D007252:Influenza Vaccines
keywords: Desirability index; formulation; multi-criteria decision-making approach; optimization; vaccine