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PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines)
Protocol C4591001
• Complete the source documents.
• Complete the CRF.
8.11.1.2. Visit 1 – Vaccination 1: (Day 1)
It is anticipated that the procedures below will be conducted in a stepwise manner; ensure
that procedures listed prior to administration of the vaccine are conducted prior to
vaccination.
• Record AEs as described in Section 8.3.
• 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.
• 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.
• Review screening laboratory results (hematology and chemistry, and HIV, HBsAg,
HBc Ab, and HCV Ab tests).
• Obtain 2 nasal (midturbinate) swabs (collected by site staff). One will be tested
(if possible at the site, otherwise at the central laboratory) within 24 hours and
vaccination will proceed only if it is NAAT-negative for SARS-CoV-2 genomes.
The second will be sent to the central laboratory for potential later testing.
• Ensure and document that all of the inclusion criteria and none of the exclusion
criteria are met.
• Ensure that the participant meets none of the temporary delay criteria as described in
Section 5.5.
• Obtain the participant’s randomization number and study intervention allocation
using the IRT system. Only an unblinded site staff member may obtain this
information.
• Collect a blood sample (approximately 50 mL) for immunogenicity testing.
• Unblinded site staff member(s) will dispense/administer 1 dose of study intervention
into the deltoid muscle of the preferably nondominant arm. Please refer to the IP
manual for further instruction on this process.
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