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PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines)
Protocol C4591001
• 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.
• If not collected at Visit 5, and the participant (select participants only, details will be
provided by the sponsor) consents, collect an additional 170-mL blood sample for
exploratory COVID-19 research.
• 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 immediately (this could be
via the COVID-19 illness e-diary) 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.
• Complete the source documents.
• The investigator or an authorized designee completes the CRFs.
8.11.1.8. Visit 7 – 1-Month Follow-up Visit: (28 to 35 Days After Visit 4)
• Record AEs as described in Section 8.3.
• 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.
• If not collected at Visit 5 or 6, and the participant (select participants only, details will
be provided by the sponsor) consents, collect an additional 170-mL blood sample for
exploratory COVID-19 research.
• 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.
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