Disposition

Reported Term for the Disposition Event
ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
receipt of non-study COVID vaccine prior to study end
OTHER-subject request due to receipt of non-study COVID vaccine
Receipt of non-study COVID vaccine prior to study end
Participant had COVID-19 prior to second vaccine
Pfizer vaccine outside of study, participant verbalized wanting to withdrawal from the study
requested unblinding 5/12, withdrew consent 5/13
OTHER-requested unblinding 5/12, then 5/13 withdrew consent to be vaccinated outside study
OTHER-requested unblinding 5/12, then parent withdrew consent 5/13
2nd vax not given due to confirmed covid illness prior to vax #2
the participant is willing/eligible to receive Vaccination 3
Wanted to get vaccine closer to home and now able to do so.
Mother wanted unblinded did not want to continue in study; wanted vaccine in community.
Subject no longer able to make appointments due to drive.
Subject received first dose in community.
Subject wanted to get vaccine closer to home.
Subject could not make the time commitment with 2 hour drive.
Unable to make further appointments - vaccinated in community.
Parent/guardian contacted the site to advise that her daughter is no longer interested in continuing
UNABLE TO DRIVE TO JACKSONVILLE FOR STUDY VISITS
father stated just didn't want daughter participating at this time. no other reason disclosed
mother stated she didn't want him to do it anymore
no longer interested in revax V101, no longer interested in study participation
subject unblinded for vax 3 per protocol
Subject recieved covid-19 vaccine outside study and is moving. Does not wish to continue in followup
Subject withdrew consent prior to blood draw.
subject received vaccine outside of study.
Subject received outside Pfizer Vaccine 14May2021
Subject was rescreened under #1462. Subject randomized in error.
Patient moved from the area and cannot be present for scheduled visits
Pt requested to be dropped from the study and refused to elaborate
Could not reach patient via telephone to schedule vaccination
Patient lost to follow up due to inability to be present for appointments.
Subject no-showed for V4, and site staff was unable to contact them to reschedule
Patient requested to be out of the study, did not want to participate in crossover.
Subject no showed for V4, staff could not contact subject
Inability to contact patient regarding reported symptoms on illness diary
Patient did not want to participate in the crossover and requested to be dropped from the study.
Patient requested to be dropped because they did not want to come into clinic for any more visits
Subject no longer wanted to participate in the crossover
Subject requested withdrawal from study due to fears of blood collection.
Patient consistently no-showed for V102.
Patient is Lost toFollow-up as of June 21, 2021
Multiple phone attempts made, certified letter sent. Subject did not complete Visit 101
Subject does not wish to continue in study
Several voicemails left and Certified letter sent on 7/9
Certified letter sent after multiple attempts to contact for potential revax contact
Subject did not receive 2nd vaccine due to Covid 19 disease.
Subject's decided to withdraw and receive vaccine elsewhere
Subject decided to receive 2nd dose elsewhere and wanted to withdraw.
SUBJECT TO BE DISCONTINUED DUE TO UNABLE TO OBTAIN SPECIMEN
OTHER-withdrew consent due to moving out of state and unable to continue.
Treatment discontinued due to COVID Illness "exclusion 5"
Subject does not want to complete mandatory nasal swabs required at revaccination visits 101 and 102
Subject no longer willing to comply with study requirements.
Subject moved out of state. Pfizer could not provide transfer site.
To participate in the C4591031 Booster Study
Received nonstudy COVID-19 vaccine, withdrawn from study.
SUBJECT CAN NOT BE REACHED VIA PHONE. CERTIFIED LETTER SENT. SUBJECT CONTINUES TO COMPLETE eDIARY.
SUBJECT AND FATHER STATED THAT THEY NO LONGER WISHED TO PARTICIPATE IN THE TRIAL.
OTHER-PARENT WANTED TO CONFIRM THAT PARTICIPANT HAD RECEIVED PLACEBO.
SUBJECT NO LONGER MEETS ELIGIBILITY BECAUSE THEY RECEIVED VACCINE OUTSIDE OF STUDY.
Subject declines to participate in further study activities.
EC#55: Participant had a positive local COVID-19 test before Vx2, symptomatic with test