Analysis Plan of Year 2 Component D Clause Samples

Analysis Plan of Year 2 Component D. ‌ HAI antibody titers will be compared between groups receiving the mRNA COVID-19 and ccIIV4 influenza vaccines concomitantly or sequentially for each of the four influenza vaccine strains contained in the respective vaccines for that season as well as circulating influenza viruses and SARS-CoV-2 variants. Specifically, we will assess the following objectives: Primary Objective 1a: Compare the proportion of participants in each vaccination group with a seroprotective HAI titer (≥1:40) pre- and post-ccIIV4 immunization for each ccIIV4 antigen. These proportions will be compared between vaccination groups using an exact Mantel-Haenszel statistic. Primary Objective 1b: Compare the proportion of participants in each vaccination group achieving seroconversion following ccIIV4 (an HAI titer ≥1:40 following ccIIV4 immunization if the baseline titer is <1:10 or a four-fold rise in HAI titer if the baseline titer is >1:10) for each ccIIV4 antigen. These proportions will be compared between vaccination groups using an exact Mantel-Haenszel statistic. Primary Objective 1c: Compare the GMT for each ccIIV4 antigen and circulating influenza viruses pre- and post-ccIIV4 immunization in each vaccination group. GMT will be compared between vaccination groups using a regression model. Primary Objective 1d: Compare the GMFR in HAI titer for each vaccination group. GMFR will be compared between vaccination groups using a mixed effects regression model with a random intercept. Exploratory objectives will be assessed using exact Mantel-Haenszel statistics to compare proportions between vaccination groups, regression models to compare GMT, and mixed effects regression models to compare GMFR. Tables will be provided summarizing counts and proportions for categorical outcomes or summary statistics and confidence intervals for continuous outcomes. The statistical analysis of each exploratory objective will be fully described in the statistical analysis plan (SAP). HAI titers will be log transformed prior to analysis and back transformed to estimate GMT and GMFR. The same analysis plan for HAI titers will be repeated for MN titers. Data analysis will be performed using SAS version 9.4 software (SAS Institute Inc., Cary, NC) or R software (R Core Team, Vienna, Austria). REFERENCES‌ 1. ▇▇▇▇▇▇▇▇▇ ▇▇, ▇▇▇▇▇▇▇ M, ▇▇▇▇▇▇▇ M, et al. Interim recommendations for the advisory committee on immunization practices for the use of bivalent booster doses of COVID-19 vaccines - United States, October...
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