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
PATIENT WITHDREW FROM STUDY- DID NOT WANT TO PROCEED.

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

Reason Specify for Discont of Treatment
DID NOT WANT TO PROCEED- PATIENT WITHDREW FROM STUDY
FALSE POSITIVE COVID RESULT REPORTED FROM CENTRAL LAB
FALSE POSITIVE COVID INFECTION RESULTED BY CENTRAL LAB
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
Vaccination #2 out of window; 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
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
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; Other study deviation
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; Other study deviation
Did not receive Vaccination #2; There was no immunogenicity result at corresponding visit; Not in Full Analysis Set
Dosing error; 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; Serum collection out of window; Post-baseline COVID-19 infection prior to the visit
There was no immunogenicity result at corresponding visit; Not in Full Analysis Set; Other study deviation
Dosing error; There was no immunogenicity result at corresponding visit

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

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

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

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

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

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

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

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