Page 101 - pfizervax
P. 101
PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines)
Protocol C4591001
8.11.2.4. Visit 4 – 6-Month Follow-up Visit: (175 to 189 Days After Visit 2)
• Record SAEs as described in Section 8.3.
• Record nonstudy vaccinations as described in Section 6.5.
• For participants who are HIV-positive, record HIV viral load and CD4 count results
from the most recent test performed since Visit 3 (if any).
• Collect a blood sample (approximately 20 mL for participants ≥16 years of age and
approximately 10 mL for participants in the 12- to 15-year age stratum) 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 or his/her parent(s)/legal guardian, as appropriate, to contact the
site staff or investigator (this could be via the COVID-19 illness e-diary) immediately
if the participant experiences any respiratory symptoms as detailed in Section 8.3.
• 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.
8.11.2.5. Visit 5 – 12-Month Follow-up Visit: (350 to 378 Days After Visit 2)
• Collect a blood sample (approximately 20 mL for participants ≥16 years of age and
approximately 10 mL for participants in the 12- to 15-year age stratum) 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.
• For participants who are HIV-positive, record HIV viral load and CD4 count results
from the most recent test performed since Visit 4 (if any).
• Ask the participant or his/her parent(s)/legal guardian, as appropriate, to contact the
site staff or investigator (this could be via the COVID-19 illness e-diary) immediately
if the participant 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.
Page 91
