Associations of the correlates of protection and implication on the statistical power for demonstrating non-inferiority: application of a re-sampling method on a large phase III influenza vaccine clinical trial.

Bugarini, R; Casula, D; Groth, N; Lattanzi, M; Holmes, S; Podda, A

Bugarini, R; Casula, D; Groth, N; Lattanzi, M; Holmes, S; Podda, A.

Affiliation

Bugarini R; Novartis Vaccines, Global Clinical Research and Development, Via Fiorentina 1, 53100 Siena, Italy. roberto.bugarini@novartis.com

Vaccine ; 28(46): 7401-6, 2010 Oct 28.

Article in En | MEDLINE | ID: mdl-20850533

Subject(s)

Endpoint Determination/statistics & numerical data; Influenza Vaccines/immunology; Influenza, Human/prevention & control; Clinical Trials, Phase III as Topic; Endpoint Determination/methods; Humans; Influenza, Human/immunology; Randomized Controlled Trials as Topic; Statistics as Topic

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Full text: 1 Collection: 01-internacional Health context: 1_ASSA2030 / 2_ODS3 Database: MEDLINE Main subject: Influenza Vaccines / Endpoint Determination / Influenza, Human Type of study: Clinical_trials / Guideline / Prognostic_studies / Risk_factors_studies Limits: Humans Language: En Journal: Vaccine Year: 2010 Document type: Article

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