Page 32 - pfizervax

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

Visit Number 1 2 3 4 5 6 Unplanned Unplanned
Visit Description Vaccination 1 Vaccination 2 1-Month 6-Month 12-Month 24-Month Potential Potential
Follow-up Follow-up Follow-up Follow-up COVID-19 COVID-19
a
Visit Visit Visit Visit Illness Visit Convalescent
Visit
Visit Window (Days) Day 1 19 to 23 Days 28 to 35 Days 175 to 189 350 to 378 714 to 742 Optimally 28 to 35 Days
b
After Visit 1 After Visit 2 Days After Days After Days After Within 3 After
Visit 2 Visit 2 Visit 2 Days After Potential
Potential COVID-19
COVID-19 Illness Visit
Illness Onset
Collection of COVID-19–related clinical and X X
laboratory information (including local diagnosis)
Abbreviations: HIV = human immunodeficiency virus; e-diary = electronic diary.
a. The COVID-19 illness visit may be conducted as an in-person or telehealth visit.
b. The visit may be conducted across 2 consecutive days; if so, all steps from assessing the inclusion and exclusion criteria onwards must be conducted on the
same day.
c. Including, if indicated, a physical examination.
d. 20 mL is to be collected from participants ≥16 years of age; 10 mL is to be collected from participants 12 to 15 years of age.
e. Reactogenicity subset participants only.
f. Any AEs occurring up to 48 hours after the blood draw must be recorded (see Section 8.3.1).

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