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

8.11.1.4. Visit 3 – 1-Week Follow-up Visit (Vaccination 1): (6 to 8 Days After Visit 1)

• Record AEs as described in Section 8.3.

• Review hematology and chemistry laboratory results and record any AEs in
accordance with Appendix 2.

• Measure vital signs (body temperature, pulse rate, and seated blood pressure), and, if
indicated by any change in the participant’s health since the previous visit, perform a
physical examination, evaluating any clinically significant abnormalities within the
following body systems: general appearance; skin; head, eyes, ears, nose, and throat;
heart; lungs; abdomen; musculoskeletal; extremities; neurological; and lymph nodes.

• Collect a blood sample (approximately 10 mL) for hematology and chemistry
laboratory tests as described in Section 10.2.

• Record nonstudy vaccinations as described in Section 6.5.

• Record details of any of the prohibited medications specified in Section 6.5.1
received by the participant if required for his or her clinical care.

• Discuss contraceptive use as described in Section 10.4.

• Collect a blood sample (approximately 50 mL) for immunogenicity testing.

• Ask the participant to contact the site staff or investigator immediately if he or she
experiences any of the following from Day 1 to Day 7 after vaccination (where Day 1
is the day of vaccination) to determine if an unscheduled reactogenicity visit is
required:

• Fever ≥39.0°C (≥102.1°F).

• Redness or swelling at the injection site measuring greater than 10 cm
(>20 measuring device units).

• Severe pain at the injection site.

• Any severe systemic event.

• Ask the participant to contact the site staff or investigator if a medically attended
event (eg, doctor’s visit, emergency room visit) or hospitalization occurs.

• Ask the participant to contact the site staff or investigator (this could be via the
COVID-19 illness e-diary) immediately if he or she experiences any respiratory
symptoms as detailed in Section 8.13.

• Schedule an appointment for the participant to return for the next study visit.

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