Page 85 - pfizervax

PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines)
Protocol C4591001

• The first 5 participants vaccinated in each group must be observed by blinded site
staff for any acute reactions for at least 4 hours after vaccination. For participants
enrolled thereafter, blinded site staff must observe the participant for at least 30
minutes after study intervention administration for any acute reactions. Record any
acute reactions (including time of onset) in the participant’s source documents and on
the AE page of the CRF, and on an SAE form as applicable.

• Issue a measuring device to measure local reactions at the injection site and a
thermometer for recording daily temperatures and provide instructions on their use.

• Explain the e-diary technologies available for this study (see Section 8.14), and assist
the participant in downloading the study application onto the participant’s own device
or issue a provisioned device if required. Provide instructions on e-diary completion
and ask the participant to complete the reactogenicity e-diary from Day 1 to Day 7,
with Day 1 being the day of vaccination and, if utilized, the COVID-19 illness e-diary
(to be completed if the participant is diagnosed with COVID-19 or has possible new
or increased symptoms, and when he/she receives a reminder, at least weekly).

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