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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.
8.11.2.6. Visit 6 – 24-Month Follow-up Visit: (714 to 742 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 5 (if any).
• 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.
8.12. Unscheduled Visit for a Grade 3 or Suspected Grade 4 Reaction
If a Grade 3 local reaction (Section 8.2.2.2), systemic event (Section 8.2.2.3), or fever
(Section 8.2.2.4) is reported in the reactogenicity e-diary, a telephone contact should occur to
ascertain further details and determine whether a site visit is clinically indicated. If suspected
Grade 4 local reaction (Section 8.2.2.2), systemic event (Section 8.2.2.3), or fever
(Section 8.2.2.4) is reported in the reactogenicity e-diary, a telephone contact or site visit
should occur to confirm whether the event meets the criteria for Grade 4.
A site visit must be scheduled as soon as possible to assess the participant unless any of the
following is true:
• The participant is unable to attend the unscheduled visit.
• The local reaction/systemic event is no longer present at the time of the telephone
contact.
• The participant or his/her parent(s)/legal guardian, as appropriate, recorded an
incorrect value in the reactogenicity e-diary (confirmation of a reactogenicity e-diary
data entry error).
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