Protocol Deviations

Protocol Deviation Term
Procedure/Test not performed per protocol
Receipt of any other nonstudy coronavirus vaccine at any time prior to or during the study.
Procedure not performed as part of vital signs.
Subject was vaccinated despite meeting temporary delay criterion #1 (current febrile illness or other acute illness within 48 hrs before study intervention administration. Includes current symptoms
Nasal swab not collected for the visit where it is required
IP Documentation Error - Confirmation of Treatment - Received Form errors
Nasal swab not collected by site staff prior to vaccination.
Visit performed outside of protocol specified window.
Potential COVID-19 illness visit not done when required per protocol.
Subject received allowable non-study vaccine within 28 days prior to or 28 days after the administration of IP.
Subject/LAR signed and dated ICD after screen/enroll date
Serology sample not collected at the convalescent visit.
IP documentation error - IRT Confirmation Report Error
Participant randomized into incorrect age stratum in Impala
Unblinding procedure for identification of participants to transition from placebo to active not conducted per protocol
Blind broken outside of IRT when not permitted per protocol
Participant met exclusion criterion #19 ( Phase 1 only: any screening hematology and/or blood chemistry laboratory value that meets the definition of a >=grade 1 abnormality)
Revised ICD not signed at the first subject visits after the revised/approved ICD was available at site
Procedure not recorded in source documentation as having been performed.
Subject/LAR signed a superseded/outdated version of the ICD
SAE report delayed or not reported to Sponsor
Assessment of acute reaction for protocol specified timeframe after study intervention administration not performed at the vaccination visits.
Subject received systemic corticosteroids (>=20mg/day of prednisone or equivalent) for >=14 days is prohibited from 28 days prior to enrollment to specified visits/cohorts per protocol.
Dosing/administration error, subject did not receive correct dose of vaccine
Vaccination diary not completed at all during required 7-day post vaccination period.
Participant met exclusion criterion #11 (women who are pregnant or breastfeeding)
Subject/LAR did not sign placebo transition ICD addendum & did not give verbal consent
Nasal swab collected at a visit where it was not required
Serology sample collected at a visit where it is not required
Subject received the season influenza vaccine or the pandemic influenza vaccine within 14 days prior to or 14 days after the administration of IP.
Subject was unblinded for placebo transition and vaccinated despite being not eligible per protocol
Visit conducted when not required per protocol
Participant met exclusion criterion #16 (Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation)
Participant met exclusion criterion #01 (participant having other medical or psychiatric condition)
Subject was vaccinated despite meeting temporary delay criterion #4 (receiving short-term (<14 days) systemic corticosteroids, IP administration should be delayed untill systemic corticosteroid use
Receipt of blood/plasma products or immunoglobulins within 60 days before enrollment through conclusion of the study.
Subject was vaccinated despite meeting temporary delay criterion #2 (receiving seasonal or pandemic influenza vaccine within the previous 14 days or any other non-study vaccine within 28 days before
Incorrect serology sample volume collected
Subject/LAR signed consent but did not date it
Administration error, incorrect container, but correct IP administered
IP administered prior to Almac authorizing it for use
Incorrect vaccine allocation/assigned to subject
IP documentation error - Confirmation of blind error
ICD signed by unauthorized site personnel
Visit 1 procedures not performed per protocol specified sequence with respect to randomization.
Serology sample collected after vaccination at vaccination visits.
Participant met exclusion criterion #13 (participant receiving treatment with immunosuppressive therapy as specified in protocol)
Participant met exclusion criterion #08 (Immunocompromised individual with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination)
IP administered that was deemed not suitable for use by Almac
Subject/LAR did not sign the placebo transition ICD addendum but gave verbal consent
Subject received chronic systemic treatment with known immunosuppressant medication, or radiotherapy, within 60 days before enrollment through conclusion of the study.
Procedures for contraception counseling/contraception requirements not followed
Participant with known HIV infection whose documented viral load/CD4 count is taken outside of protocol specified window
Subjects was not dispensed a provisioned device, or did not download the app to their own device
Participant failed to meet inclusion criterion #03 (Healthy participants who are determined by medical history, physical examination and clinical judgement of the investigator to be eligible for
Participant met exclusion criterion #05 (previous clinical or microbiological diagnosis of COVID-19)
Procedure not performed by a medically qualified individual at specified visits
Subject was enrolled more than once in the study, at different sites
Nasal swab can't be analyzed due to incorrect shipping procedure
Participant met exclusion criterion #04 (receipt of medications intended to prevent COVID-19)
Subject/LAR did not sign the ICD but gave verbal consent
ICD had not undergone proper Pfizer/CRO approval
AE/SAE not recorded in clinical database
Subject was vaccinated despite meeting temporary delay criterion #3 (anticipation of receiving seasonal or pandemic influenza vaccine within 14 days or any other non-study vaccine within 28 days after
Serology samples not received by the lab
Serology sample not labeled properly and had to discarded
Impartial witness not present for consenting process when required.
Subject was vaccinated despite being ineligible
Participant failed to meet inclusion criterion #01 (Male or female participants between the ages of 18 and 55 years, inclusive, 65 and 85 years, inclusive, or 18 and 85 years, inclusive, at
Participant met exclusion criterion #02 (participant having known infection with HIV, HCV or HBV)
Subject had a vaccination diary activated, but was not part of the reactogenicity subset
Participant met exclusion criterion #22 (investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their
Incorrect IP assigned to subject due to IRT not being utilized
Participant failed to meet inclusion criterion #04 (Participants who, in the judgment of the investigator, are at risk for acquiring COVID-19)
IP destruction not done as per IP manual
Abnormal procedure/test result not followed up per protocol
ICD signed by subject/LAR had not received IRB/IEC approval
ICD not translated to subject's/LAR native language
Efficacy data considered potentially unreliable due to lack of PI oversight identified as significant quality event
Safety and efficacy data considered potentially unreliable due to lack of PI oversight identified as significant quality event.
Subject/LAR did not sign ICD & did not give verbal consent
COVID-19 Rapid test not performed at the site to determine eligibility criteria per exclusion criterion #17
Participant failed to meet inclusion criterion #02 (Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other
Study vaccine was not administered per protocol due to lack of IP supply
SAE not reported to IRB per local regulations
Nasal swab obtained for surveillance of asymptomatic infection from a participant not part of that subset