Page 23 - pfizervax

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

Visit Number Screening 1 2 3 4 5 6 7 8 9 10 Unplanned Unplanned
Visit Description Screening Vax 1 Next- 1-Week Vax 2 1-Week 2-Week 1-Month 6-Month 12- 24- Potential Potential
Day Follow- Follow- Follow- Follow- Follow- Month Month COVID-19 COVID-19
Follow- up Visit up Visit up Visit up Visit up Visit Follow- Follow- Illness Convalescent
a
up Visit (Vax 1) (Vax 2) (Vax 2) up Visit up Visit Visit Visit
(Vax 1)
Visit Window (Days) 0 to 28 Day 1 1 to 3 6 to 8 19 to 23 6 to 8 12 to 16 28 to 35 175 to 350 to 714 to Optimally 28 to 35 Days
Days Days Days Days Days Days Days 189 Days 378 Days 742 Days Within 3 After
Before After After After After After After After After After Days After Potential
Visit 1 Visit 1 Visit 1 Visit 1 Visit 4 Visit 4 Visit 4 Visit 4 Visit 4 Visit 4 Potential COVID-19
COVID-19 Illness Visit
Illness
Onset
Obtain randomization number X
and study intervention
allocation
Collect blood sample for ~50 mL ~50 mL ~50 mL ~50 mL ~50 mL ~50 mL ~20 mL ~20 mL ~20 mL ~20 mL
immunogenicity assessment + + +
e
e
e
optional optional optional
~170 mL ~170 mL ~170 mL
Administer study intervention X X
Assess acute reactions for at X X
least 30 minutes after study
intervention administration
d
Explain participant X
communication methods
(including for e-diary
completion), assist the
participant with downloading
the app, or issue provisioned
device, if required
Provide thermometer and X X
measuring device

Review reactogenicity e-diary
data (daily review is optimal
during the active diary period)
Review ongoing X X
reactogenicity e-diary

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