Page 95 - pfizervax
P. 95
PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines)
Protocol C4591001
• 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.
8.11.1.11. Visit 10 – 24-Month Follow-up Visit: (714 to 742 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.
• Collect the participant’s e-diary or assist the participant to remove the study
application from his or her own personal device.
• 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. Phase 2/3
8.11.2.1. Visit 1 – Vaccination 1: (Day 1)
Before enrollment and before any study-related procedures are performed, voluntary, written,
study-specific informed consent will be obtained from the participant or his/her
parent(s)/legal guardian, as appropriate. Each signature on the ICD must be personally dated
by the signatory. The investigator or his or her designee will also sign the ICD. A copy of
the signed and dated ICD must be given to the participant/participant’s parent(s)/legal
guardian. The source data must reflect that the informed consent was obtained before
participation in the study.
It is anticipated that the procedures below will be conducted in a stepwise manner. The visit
may be conducted across 2 consecutive days; if so, all steps from assessing the inclusion and
exclusion criteria onwards must be conducted on the same 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. For participants who are
HIV-positive, record HIV viral load and CD4 count results from the most recent test
performed in the previous 6 months.
Page 85
