Page 5 - pfizervax

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

8.7. Genetics ...................................................................................................................72
8.8. Biomarkers ..............................................................................................................72

8.9. Immunogenicity Assessments .................................................................................72
8.10. Health Economics .................................................................................................72
8.11. Study Procedures ...................................................................................................72

8.11.1. Phase 1 ......................................................................................................72

8.11.1.1. Screening: (0 to 28 Days Before Visit 1) ................................72
8.11.1.2. Visit 1 – Vaccination 1: (Day 1) .............................................74
8.11.1.3. Visit 2 – Next-Day Follow-up Visit (Vaccination 1): (1
to 3 Days After Visit 1) .....................................................................76
8.11.1.4. Visit 3 – 1-Week Follow-up Visit (Vaccination 1): (6 to
8 Days After Visit 1) .........................................................................78

8.11.1.5. Visit 4 – Vaccination 2: (19 to 23 Days After Visit 1) ...........79
8.11.1.6. Visit 5 – 1-Week Follow-up Visit (Vaccination 2): (6 to
8 Days After Visit 4) .........................................................................81
8.11.1.7. Visit 6 – 2-Week Follow-up Visit (Vaccination 2): (12 to
16 Days After Visit 4) .......................................................................82

8.11.1.8. Visit 7 – 1-Month Follow-up Visit: (28 to 35 Days After
Visit 4) ...............................................................................................83

8.11.1.9. Visit 8 – 6-Month Follow-up Visit: (175 to 189 Days
After Visit 4) ......................................................................................84
8.11.1.10. Visit 9 – 12-Month Follow-up Visit: (350 to 378 Days
After Visit 4) ......................................................................................84
8.11.1.11. Visit 10 – 24-Month Follow-up Visit: (714 to 742 Days
After Visit 4) ......................................................................................85
8.11.2. Phase 2/3 ...................................................................................................85

8.11.2.1. Visit 1 – Vaccination 1: (Day 1) .............................................85

8.11.2.2. Visit 2 – Vaccination 2: (19 to 23 Days After Visit 1) ...........88
8.11.2.3. Visit 3 – 1-Month Follow-up Visit (After Vaccination 2):
(28 to 35 Days After Visit 2) .............................................................90
8.11.2.4. Visit 4 – 6-Month Follow-up Visit: (175 to 189 Days
After Visit 2) ......................................................................................91
8.11.2.5. Visit 5 – 12-Month Follow-up Visit: (350 to 378 Days
After Visit 2) ......................................................................................91
8.11.2.6. Visit 6 – 24-Month Follow-up Visit: (714 to 742 Days
After Visit 2) ......................................................................................92

Page 5