Statistical Inference for Vaccine Efficacy: A Re-Randomization Procedure to Analyse Poisson Outcomes under Covariate-Adaptive Randomization

Author:

Ovbude Leroy Jide1,Grassano Luca2,Cheuvart Brigitte1,Solmi Francesca1

Affiliation:

1. GSK, Wavre, Belgium

2. GSK, Siena, Italy

Funder

GlaxoSmithKline Biologicals SA

Publisher

Informa UK Limited

Subject

Pharmaceutical Science,Statistics and Probability

Reference25 articles.

1. Inference Under Covariate-Adaptive Randomization

2. Inference under covariate-adaptive randomization: A simulation study

3. Prevention of vaccine-matched and mismatched influenza in children aged 6–35 months: a multinational randomised trial across five influenza seasons

4. EMA (2015) “Guideline on Adjustment for Baseline Covariates in Clinical Trials ” available at https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-adjustment-baseline-covariates-clinical-trials_en.pdf (accessed September 15 2021).

5. FDA (2019) “Adaptive Designs for Clinical Trials of Drugs and Biologics ” available at https://www.fda.gov/media/78495/download (accessed September 15 2021).

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