Quote:
Originally Posted by coffeebean
How can a trial be conducted and not all participants be tested at the end of the trial? I find that to be negligent on the part of the people conducting the trial. Hope this information you read about is totally wrong about not testing all participants. Actually, that just makes no sense at all.
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Participants are requested to report in weekly and for any symptoms or positive test results throughout the study.
Antibodies are rechecked at 6, 12 and 24 months.
Full protocol here:
https://pfe-pfizercom-d8-prod.s3.ama...l_Protocol.pdf
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).
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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 8.3.
• 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.