Statistical Analysis: Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: a randomised, double-blind, placebo-controlled, phase 2 trial
At the start of this study, phase 1 clinical trial data was not yet available; thus, the sample size was determined based on minimum requirements outlined by the National Medical Products Administration of China and expert opinion. Power calculations were performed using PASS software once phase 1 data became accessible, confirming a power of at least 90%. Correlation analysis was conducted for specific and neutralizing antibodies to calculate a Pearson correlation coefficient. ANOVA was used for log-transformed antibody titers, the Wilcoxon rank-sum test for non-normally distributed data, and Fisher's exact test for categorical data.
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Study design and participants: Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: a randomised, double-blind, placebo-controlled, phase 2 trial
Statistical Analysis: Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: a randomised, double-blind, placebo-controlled, phase 2 trial
Procedures: Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: a randomised, double-blind, placebo-controlled, phase 2 trial