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PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines)
Protocol C4591001

TABLE OF CONTENTS

LIST OF TABLES .....................................................................................................................8
1. PROTOCOL SUMMARY .....................................................................................................9
1.1. Synopsis ....................................................................................................................9

1.2. Schema ....................................................................................................................17
1.3. Schedule of Activities .............................................................................................18

1.3.1. Phase 1 ........................................................................................................18
1.3.2. Phase 2/3 .....................................................................................................23

2. INTRODUCTION ...............................................................................................................26
2.1. Study Rationale .......................................................................................................26

2.2. Background .............................................................................................................26
2.2.1. Clinical Overview .......................................................................................27

2.3. Benefit/Risk Assessment .........................................................................................27
2.3.1. Risk Assessment .........................................................................................29

2.3.2. Benefit Assessment .....................................................................................31
2.3.3. Overall Benefit/Risk Conclusion ................................................................31

3. OBJECTIVES, ESTIMANDS, AND ENDPOINTS ...........................................................31
3.1. For Phase 1 ..............................................................................................................31

3.2. For Phase 2/3 ...........................................................................................................33
4. STUDY DESIGN.................................................................................................................36

4.1. Overall Design .........................................................................................................36
4.1.1. Phase 1 ........................................................................................................36

4.1.2. Phase 2/3 .....................................................................................................37
4.2. Scientific Rationale for Study Design .....................................................................39
4.3. Justification for Dose ..............................................................................................39

4.4. End of Study Definition ..........................................................................................40
5. STUDY POPULATION ......................................................................................................40

5.1. Inclusion Criteria .....................................................................................................40
5.2. Exclusion Criteria ....................................................................................................41

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