Protocol Deviations

Protocol Deviation Term
Unblinding procedure for identification of participants to transition from placebo to active not conducted per protocol
Procedure not performed by a medically qualified individual at specified visits
Vaccination diary not completed at all during required 7-day post vaccination period.
Visit performed outside of protocol specified window.
Nasal swab not collected for the visit where it is required
Procedure not performed as part of vital signs.
Visit conducted when not required per protocol
Nasal swab collected at a visit where it was not required
Procedure/Test not performed per protocol
Nasal swab not collected by site staff prior to vaccination.
Participant met exclusion criterion #01 (participant having other medical or psychiatric condition)
Subject/LAR did not sign the ICD but gave verbal consent
Receipt of any other nonstudy coronavirus vaccine at any time prior to or during the study.
Procedure not recorded in source documentation as having been performed.
Subject received allowable non-study vaccine within 28 days prior to or 28 days after the administration of IP.
Revised ICD not signed at the first subject visits after the revised/approved ICD was available at site
ICD signed by subject/LAR had not received IRB/IEC approval
Assessment of acute reaction for protocol specified timeframe after study intervention administration not performed at the vaccination visits.
Incorrect serology sample volume collected
Participant entered into asymptomatic swabbing part of study after they were unblinded
Blind broken outside of IRT when not permitted per protocol
SAE report delayed or not reported to Sponsor
Subject/LAR signed a superseded/outdated version of the ICD
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
Subject was vaccinated despite the site being instructed to discontinue further vaccination
Potential COVID-19 illness visit not done when required per protocol.
ICD signed by unauthorized site personnel
Participant randomized into incorrect age stratum in Impala
IP documentation error - IRT Confirmation Report Error
IP Documentation Error - Confirmation of Treatment - Received Form errors
IP administered prior to Almac authorizing it for use
Surveillance for asymptomatic SARS-CoV-2 infection is performed after Visit-4
Subject/LAR signed consent but did not date it
IP documentation error - Confirmation of blind error
Serology sample not labeled properly and had to discarded
Subject/LAR signed and dated ICD after screen/enroll date
Visit 1 procedures not performed per protocol specified sequence with respect to randomization.
Serology sample collected after vaccination at vaccination visits.
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