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PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines)
Protocol C4591001
• 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.
8.11.1.9. Visit 8 – 6-Month Follow-up Visit: (175 to 189 Days After Visit 4)
• Record SAEs 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.
• Collect a blood sample (approximately 20 mL) for immunogenicity testing.
• 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.
• Complete the source documents.
• The investigator or an authorized designee completes the CRFs.
• Record any AEs that occur within the 48 hours after the blood draw as described in
Section 8.3.
8.11.1.10. Visit 9 – 12-Month Follow-up Visit: (350 to 378 Days After Visit 4)
• Collect a blood sample (approximately 20 mL) for immunogenicity testing.
• 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.
• 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.
• Complete the source documents.
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