Subject-Level Analysis Dataset

NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER

Reason for Discontinuation from Study
Withdrawal of Consent (COVID-19 Non-Infection Related)

Reason Spec for Discont from Study
SUBJECT REQUESTED TO BE UNBLINDED AS SHE IS SCHEDULED TO RECEIVE EUA COVID-19 VACCINE THROUGH HER WORK. PI UNBLINDED AND SUBJECT WAS WITHDRAWN FROM STUDY.
PT RECEIVED PFIZER COVID-19 VACCINE UNDER EUA, OUTSIDE OF STUDY. WITHDRAWN, PER SPONSOR INSTRUCTIONS.
SUBJECT BEGAN TAKING HYDROXYCHLOROQUINE FOR COVID-19 PREVENTION. IMMUNOSUPPRESSANT DRUGS ARE EXCLUSIONARY FOR THIS STUDY. SUBJECT HAS BEEN WITHDRAWN.
SUBJECT RECEIVED COVID-19 VACCINE UNDER EUA, OUTSIDE OF THE STUDY. WITHDRAWN PER SPONSOR INSTRUCTION.
SUBJECT MOVED OUT OF STATE. PER PI, UNABLE TO PROPERLY FOLLOW COMPLIANCE REQUIREMENTS.
PT RECEIVED J & J COVID 19 VACCINE OUTSIDE OF STUDY ON 03/06/2021
SUBJECT IS UNABLE TO PARTICIPATE IN DECISION VISIT
EUA COVID-19 VACCINE "REQUEST TO UNBLIND"
REQUEST TO UNBLIND/ EUA COVID-19 VACCINE
SUBJECT RECEIVING VACCINE OUTSIDE OF THE STUDY (EUA)
REQUEST TO UNBLIND / EUA COVID-19 VACCINE
VACCINATION OUTSIDE OF THE STUDY AND PROTOCOL DEVIATION
SUBJECT RECEIVED A COVID VACCINE THROUGH THEIR WORKPLACE.
SUBJECT RECIEVED A VACCINATION FROM THEIR PLACE FO WORK
PATIENT WITHDREW FROM STUDY- DID NOT WANT TO PROCEED.
WILL RECEIVE VACCINE AT HER JOB ON 01/19/2021
SUBJECT RECEIVED COVID VACCINE THROUGH OUTSIDE VENDOR WHILE PARTICIPATING IN THE TRIAL
PATIENT UNBLINDED, DISENROLLED DUE TO PATIENT DESIRE TO RECEIVE OUTSIDE VACCINE OF ANOTHER MANUFACTURER.
DR. WILLIAMS DOES NOT FEEL THAT SUBJECT SHOULD RECEIVE ANOTHER DOSE OF STUDY VACCINE DUE TO SAES. DR. WILLIAMS DETERMINED IT WAS IN THE SUBJECT'S BEST INTEREST TO NO LONGER PARTICIPATE.

Reason for Discontinuation of Treatment
Withdrawal of Consent (COVID-19 Non-Infection Related)

Reason Specify for Discont of Treatment
FALSE POSITIVE COVID RESULT REPORTED FROM CENTRAL LAB
FALSE POSITIVE COVID INFECTION RESULTED BY CENTRAL LAB
DID NOT WANT TO PROCEED- PATIENT WITHDREW FROM STUDY
PER CRA, POSITIVE COVID SWAB WAS REPORTED IN ERROR BY PPD LABS. PATIENT IS NO LONGER WITHIN WINDOW TO RECEIVE 2ND DOSE.

Reason for 1st Solicited Safety Set Exc
Did not contribute any solicited AR data for Vaccination #1

Reason for BAB Full Analysis Set Exc
There were no immunogenicity results at baseline and at least one post-vaccination

Reason for NAB Full Analysis Set Exc
There were no immunogenicity results at baseline and at least one post-vaccination

Reason for BAB Per-Protocol Set Exc
There was no immunogenicity result at corresponding visit; Not in Full Analysis Set
Did not receive Vaccination #2; There was no immunogenicity result at corresponding visit; Serum collection out of window; Other study deviation; Post-baseline COVID-19 infection prior to the visit
Did not receive Vaccination #2; There was no immunogenicity result at corresponding visit; Serum collection out of window; Other study deviation
Vaccination #2 out of window; There was no immunogenicity result at corresponding visit; Serum collection out of window; Other study deviation
Did not receive Vaccination #2; There was no immunogenicity result at corresponding visit; Not in Full Analysis Set
Did not receive Vaccination #2; There was no immunogenicity result at corresponding visit; Not in Full Analysis Set; Other study deviation
Did not receive Vaccination #2; There was no immunogenicity result at corresponding visit
Dosing error; There was no immunogenicity result at corresponding visit; Serum collection out of window; Other study deviation
Dosing error; There was no immunogenicity result at corresponding visit
Vaccination #2 out of window; There was no immunogenicity result at corresponding visit; Serum collection out of window; Other study deviation; Post-baseline COVID-19 infection prior to the visit
There was no immunogenicity result at corresponding visit; Serum collection out of window; Other study deviation
There was no immunogenicity result at corresponding visit; Not in Full Analysis Set; Other study deviation
There was no immunogenicity result at corresponding visit; Other study deviation
Vaccination #2 out of window; There was no immunogenicity result at corresponding visit; Other study deviation

Reason for nAb Per-Protocol Set Exc
There was no immunogenicity result at corresponding visit; Not in Full Analysis Set
Did not receive Vaccination #2; There was no immunogenicity result at corresponding visit; Not in Full Analysis Set; Other study deviation; Post-baseline COVID-19 infection prior to the visit
Did not receive Vaccination #2; There was no immunogenicity result at corresponding visit; Serum collection out of window; Other study deviation
Vaccination #2 out of window; There was no immunogenicity result at corresponding visit; Serum collection out of window; Other study deviation
Did not receive Vaccination #2; There was no immunogenicity result at corresponding visit; Not in Full Analysis Set
Did not receive Vaccination #2; There was no immunogenicity result at corresponding visit; Not in Full Analysis Set; Other study deviation
Did not receive Vaccination #2; There was no immunogenicity result at corresponding visit
Dosing error; There was no immunogenicity result at corresponding visit; Serum collection out of window; Other study deviation
Dosing error; There was no immunogenicity result at corresponding visit
Vaccination #2 out of window; There was no immunogenicity result at corresponding visit; Serum collection out of window; Other study deviation; Post-baseline COVID-19 infection prior to the visit
There was no immunogenicity result at corresponding visit; Serum collection out of window; Other study deviation
There was no immunogenicity result at corresponding visit; Other study deviation
Vaccination #2 out of window; There was no immunogenicity result at corresponding visit; Other study deviation
Did not receive Vaccination #2; There was no immunogenicity result at corresponding visit; Serum collection out of window; Other study deviation; Post-baseline COVID-19 infection prior to the visit
There was no immunogenicity result at corresponding visit; Serum collection out of window; Not in Full Analysis Set; Other study deviation

Reason for bAb Per-Protocol Day 29 Exc
There was no immunogenicity result at corresponding visit
Did not receive Vaccination #2; There was no immunogenicity result at corresponding visit; Other study deviation
Post-baseline COVID-19 infection prior to the visit
Vaccination #2 out of window; Serum collection out of window; Other study deviation
Did not receive Vaccination #2; There was no immunogenicity result at corresponding visit; Not in Full Analysis Set
Did not receive Vaccination #2; There was no immunogenicity result at corresponding visit; Not in Full Analysis Set; Other study deviation
Did not receive Vaccination #2; Other study deviation
Not in Full Analysis Set; Other study deviation
Vaccination #2 out of window; There was no immunogenicity result at corresponding visit; Other study deviation
There was no immunogenicity result at corresponding visit; Other study deviation
Did not receive Vaccination #2; Serum collection out of window; Other study deviation

Reason for bAb Per-Protocol Day 57 Exc
Did not receive Vaccination #2; There was no immunogenicity result at corresponding visit; Other study deviation
Serum collection out of window; Other study deviation; Post-baseline COVID-19 infection prior to the visit
Did not receive Vaccination #2; Serum collection out of window; Other study deviation
Vaccination #2 out of window; Other study deviation
Did not receive Vaccination #2; There was no immunogenicity result at corresponding visit; Not in Full Analysis Set
Post-baseline COVID-19 infection prior to the visit
Serum collection out of window; Other study deviation
Did not receive Vaccination #2; There was no immunogenicity result at corresponding visit; Not in Full Analysis Set; Other study deviation
Vaccination #2 out of window; There was no immunogenicity result at corresponding visit; Other study deviation
Vaccination #2 out of window; Serum collection out of window; Other study deviation
Did not receive Vaccination #2; There was no immunogenicity result at corresponding visit
Not in Full Analysis Set; Other study deviation
There was no immunogenicity result at corresponding visit; Other study deviation
Did not receive Vaccination #2; Serum collection out of window; Other study deviation; Post-baseline COVID-19 infection prior to the visit

Reason for bAb Per-Protocol Day 209 Exc
There was no immunogenicity result at corresponding visit; Other study deviation
Non study COVID-19 vaccine prior to the visit
There was no immunogenicity result at corresponding visit
Post-baseline COVID-19 infection prior to the visit
Post-baseline COVID-19 infection prior to the visit; COVID-19 related prohibited med prior to the visit
Did not receive Vaccination #2; Serum collection out of window; Other study deviation; Post-baseline COVID-19 infection prior to the visit
Did not receive Vaccination #2; Serum collection out of window; Other study deviation
Vaccination #2 out of window; There was no immunogenicity result at corresponding visit; Other study deviation
Vaccination #2 out of window; Other study deviation
Serum collection out of window; Post-baseline COVID-19 infection prior to the visit
Did not receive Vaccination #2; There was no immunogenicity result at corresponding visit; Not in Full Analysis Set
There was no immunogenicity result at corresponding visit; Post-baseline COVID-19 infection prior to the visit
Did not receive Vaccination #2; There was no immunogenicity result at corresponding visit; Not in Full Analysis Set; Other study deviation
Did not receive Vaccination #2; There was no immunogenicity result at corresponding visit
Vaccination #2 out of window; Other study deviation; Post-baseline COVID-19 infection prior to the visit
Not in Full Analysis Set; Other study deviation
Vaccination #2 out of window; Serum collection out of window; Other study deviation

Reason for nAb Per-Protocol Day 29 Exc
There was no immunogenicity result at corresponding visit
There was no immunogenicity result at corresponding visit; Not in Full Analysis Set
Did not receive Vaccination #2; There was no immunogenicity result at corresponding visit; Not in Full Analysis Set; Other study deviation
Post-baseline COVID-19 infection prior to the visit
Did not receive Vaccination #2; There was no immunogenicity result at corresponding visit; Other study deviation
Vaccination #2 out of window; Serum collection out of window; Other study deviation
Did not receive Vaccination #2; There was no immunogenicity result at corresponding visit; Not in Full Analysis Set
Did not receive Vaccination #2; Other study deviation
Vaccination #2 out of window; There was no immunogenicity result at corresponding visit; Other study deviation
There was no immunogenicity result at corresponding visit; Other study deviation
Did not receive Vaccination #2; Serum collection out of window; Other study deviation

Reason for nAb Per-Protocol Day 57 Exc
There was no immunogenicity result at corresponding visit
There was no immunogenicity result at corresponding visit; Not in Full Analysis Set
Did not receive Vaccination #2; There was no immunogenicity result at corresponding visit; Not in Full Analysis Set; Other study deviation
Serum collection out of window; Other study deviation; Post-baseline COVID-19 infection prior to the visit
Did not receive Vaccination #2; Serum collection out of window; Other study deviation
Vaccination #2 out of window; Other study deviation
Did not receive Vaccination #2; There was no immunogenicity result at corresponding visit; Not in Full Analysis Set
Post-baseline COVID-19 infection prior to the visit
Serum collection out of window; Other study deviation
Vaccination #2 out of window; There was no immunogenicity result at corresponding visit; Other study deviation
Vaccination #2 out of window; Serum collection out of window; Other study deviation
Did not receive Vaccination #2; There was no immunogenicity result at corresponding visit; Other study deviation
Did not receive Vaccination #2; There was no immunogenicity result at corresponding visit
There was no immunogenicity result at corresponding visit; Other study deviation
Did not receive Vaccination #2; Serum collection out of window; Other study deviation; Post-baseline COVID-19 infection prior to the visit
Serum collection out of window; Not in Full Analysis Set; Other study deviation

Reason for nAb Per-Protocol Day 209 Exc
There was no immunogenicity result at corresponding visit
There was no immunogenicity result at corresponding visit; Other study deviation
There was no immunogenicity result at corresponding visit; Non study COVID-19 vaccine prior to the visit
There was no immunogenicity result at corresponding visit; Not in Full Analysis Set
There was no immunogenicity result at corresponding visit; Post-baseline COVID-19 infection prior to the visit
There was no immunogenicity result at corresponding visit; Post-baseline COVID-19 infection prior to the visit; COVID-19 related prohibited med prior to the visit
Did not receive Vaccination #2; There was no immunogenicity result at corresponding visit; Not in Full Analysis Set; Other study deviation; Post-baseline COVID-19 infection prior to the visit
Did not receive Vaccination #2; There was no immunogenicity result at corresponding visit; Other study deviation
Vaccination #2 out of window; There was no immunogenicity result at corresponding visit; Other study deviation
Did not receive Vaccination #2; There was no immunogenicity result at corresponding visit; Not in Full Analysis Set
Did not receive Vaccination #2; There was no immunogenicity result at corresponding visit; Not in Full Analysis Set; Other study deviation
Did not receive Vaccination #2; There was no immunogenicity result at corresponding visit
Dosing error; There was no immunogenicity result at corresponding visit
Vaccination #2 out of window; There was no immunogenicity result at corresponding visit; Other study deviation; Post-baseline COVID-19 infection prior to the visit
Did not receive Vaccination #2; There was no immunogenicity result at corresponding visit; Other study deviation; Post-baseline COVID-19 infection prior to the visit

Reason for nAb 2 Per-Protocol Set Exc
There was no immunogenicity result at corresponding visit; Not in Full Analysis Set
Did not receive Vaccination #2; There was no immunogenicity result at corresponding visit; Serum collection out of window; Other study deviation; Post-baseline COVID-19 infection prior to the visit
Did not receive Vaccination #2; There was no immunogenicity result at corresponding visit; Serum collection out of window; Other study deviation
Vaccination #2 out of window; There was no immunogenicity result at corresponding visit; Serum collection out of window; Other study deviation
Did not receive Vaccination #2; There was no immunogenicity result at corresponding visit; Not in Full Analysis Set
Vaccination #2 out of window; There was no immunogenicity result at corresponding visit; Serum collection out of window; Other study deviation; Post-baseline COVID-19 infection prior to the visit
Did not receive Vaccination #2; There was no immunogenicity result at corresponding visit; Not in Full Analysis Set; Other study deviation
Did not receive Vaccination #2; There was no immunogenicity result at corresponding visit
Dosing error; There was no immunogenicity result at corresponding visit; Serum collection out of window; Other study deviation
Dosing error; There was no immunogenicity result at corresponding visit
There was no immunogenicity result at corresponding visit; Serum collection out of window; Other study deviation
There was no immunogenicity result at corresponding visit; Other study deviation
Vaccination #2 out of window; There was no immunogenicity result at corresponding visit; Other study deviation

Reason for nAb 2 PP Day 29 Exc
There was no immunogenicity result at corresponding visit
Did not receive Vaccination #2; There was no immunogenicity result at corresponding visit; Other study deviation
Post-baseline COVID-19 infection prior to the visit
Vaccination #2 out of window; Serum collection out of window; Other study deviation
Did not receive Vaccination #2; There was no immunogenicity result at corresponding visit; Not in Full Analysis Set
Did not receive Vaccination #2; There was no immunogenicity result at corresponding visit; Not in Full Analysis Set; Other study deviation
Did not receive Vaccination #2; Other study deviation
Vaccination #2 out of window; There was no immunogenicity result at corresponding visit; Other study deviation
There was no immunogenicity result at corresponding visit; Other study deviation
Did not receive Vaccination #2; Serum collection out of window; Other study deviation

Reason for nAb 2 PP Day 57 Exc
Did not receive Vaccination #2; There was no immunogenicity result at corresponding visit; Other study deviation
Serum collection out of window; Other study deviation; Post-baseline COVID-19 infection prior to the visit
Did not receive Vaccination #2; Serum collection out of window; Other study deviation
Vaccination #2 out of window; Other study deviation
Did not receive Vaccination #2; There was no immunogenicity result at corresponding visit; Not in Full Analysis Set
Post-baseline COVID-19 infection prior to the visit
Serum collection out of window; Other study deviation
Did not receive Vaccination #2; There was no immunogenicity result at corresponding visit; Not in Full Analysis Set; Other study deviation
Vaccination #2 out of window; There was no immunogenicity result at corresponding visit; Other study deviation
Vaccination #2 out of window; Serum collection out of window; Other study deviation
Did not receive Vaccination #2; There was no immunogenicity result at corresponding visit
There was no immunogenicity result at corresponding visit; Other study deviation
Did not receive Vaccination #2; Serum collection out of window; Other study deviation; Post-baseline COVID-19 infection prior to the visit

Reason for nAb 2 PP Day 209 Exc
There was no immunogenicity result at corresponding visit; Other study deviation
Non study COVID-19 vaccine prior to the visit
There was no immunogenicity result at corresponding visit
Post-baseline COVID-19 infection prior to the visit
Post-baseline COVID-19 infection prior to the visit; COVID-19 related prohibited med prior to the visit
Did not receive Vaccination #2; Serum collection out of window; Other study deviation; Post-baseline COVID-19 infection prior to the visit
Did not receive Vaccination #2; Serum collection out of window; Other study deviation
Vaccination #2 out of window; There was no immunogenicity result at corresponding visit; Other study deviation
Vaccination #2 out of window; Other study deviation
Serum collection out of window; Post-baseline COVID-19 infection prior to the visit
Did not receive Vaccination #2; There was no immunogenicity result at corresponding visit; Not in Full Analysis Set
Vaccination #2 out of window; Serum collection out of window; Other study deviation; Post-baseline COVID-19 infection prior to the visit
There was no immunogenicity result at corresponding visit; Post-baseline COVID-19 infection prior to the visit
Did not receive Vaccination #2; There was no immunogenicity result at corresponding visit; Not in Full Analysis Set; Other study deviation
Did not receive Vaccination #2; There was no immunogenicity result at corresponding visit
Vaccination #2 out of window; Other study deviation; Post-baseline COVID-19 infection prior to the visit
Vaccination #2 out of window; Serum collection out of window; Other study deviation