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PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines)
Protocol C4591001
8.12. Unscheduled Visit for a Grade 3 or Suspected Grade 4 Reaction ........................92
8.13. COVID-19 Surveillance (All Participants) ...........................................................93
8.13.1. Potential COVID-19 Illness Visit: (Optimally Within 3 Days After
Potential COVID-19 Illness Onset) .................................................................95
8.13.2. Potential COVID-19 Convalescent Visit: (28 to 35 Days After
Potential COVID-19 Illness Visit) ..................................................................96
8.14. Communication and Use of Technology ...............................................................96
8.15. SARS-CoV-2 NAAT Results From Visits 1 and 2 and Potential COVID-19
Illness Visits ..............................................................................................................97
9. STATISTICAL CONSIDERATIONS ................................................................................98
9.1. Estimands and Statistical Hypotheses .....................................................................98
9.1.1. Estimands ....................................................................................................98
9.1.2. Statistical Hypotheses .................................................................................99
9.1.2.1. Statistical Hypothesis Evaluation for Efficacy ..........................99
9.1.2.2. Statistical Hypothesis Evaluation for Immunogenicity .............99
9.2. Sample Size Determination .....................................................................................99
9.3. Analysis Sets .........................................................................................................101
9.4. Statistical Analyses ...............................................................................................102
9.4.1. Immunogenicity Analyses ........................................................................102
9.4.2. Efficacy Analyses .....................................................................................107
9.4.3. Safety Analyses ........................................................................................109
9.4.4. Other Analyses ..........................................................................................110
9.5. Interim Analyses ...................................................................................................111
9.5.1. Analysis Timing........................................................................................114
9.6. Data Monitoring Committee or Other Independent Oversight Committee ...........114
10. SUPPORTING DOCUMENTATION AND OPERATIONAL
CONSIDERATIONS ........................................................................................................116
10.1. Appendix 1: Regulatory, Ethical, and Study Oversight Considerations .............116
10.1.1. Regulatory and Ethical Considerations ..................................................116
10.1.1.1. Reporting of Safety Issues and Serious Breaches of the
Protocol or ICH GCP .......................................................................116
10.1.2. Informed Consent Process ......................................................................117
10.1.3. Data Protection .......................................................................................118
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