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PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines)
Protocol C4591001
It is anticipated that the procedures below will be conducted in a stepwise manner; however,
the visit can occur over more than 1 day.
• Assign a single participant number using the IRT system.
• Obtain the participant’s demography (including date of birth, sex, race, and ethnicity).
The full date of birth will be collected to critically evaluate the immune response and
safety profile by age.
• Obtain any medical history of clinical significance.
• Obtain details of any medications currently taken.
• Perform physical examination including vital signs (weight, height, body temperature,
pulse rate, and seated blood pressure), 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 20 mL) for potential future serological
assessment and to perform a rapid test for prior COVID-19 infection.
• Collect a blood sample (approximately 10 mL) for hematology and chemistry
laboratory tests as described in Section 10.2.
• Collect a blood sample (approximately 10 mL) for HIV, HBsAg, HBc Ab, and HCV
Ab tests.
• Perform urine pregnancy test on WOCBP as described in Section 8.2.6.
• Discuss contraceptive use as described in Section 10.4.
• Record nonstudy vaccinations as described in Section 6.5.
• Ensure and document that all of the inclusion criteria and none of the exclusion
criteria are met.
• Record AEs as described in Section 8.3. AEs that occur prior to dosing should be
noted on the Medical History CRF.
• Ask the participant to contact the site staff or investigator immediately if any
significant illness or hospitalization occurs.
• Ask the participant to contact the site staff or investigator 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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