Subject-Level Analysis Dataset

NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER

Analysis Race
NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER

Exclusion Criterion 18
had important protocol deviation(s) as determined by the clinician for Efficacy (prior to the first post(*ESC*){unicode 2013}Dose 2 N-binding antibody test) Population

Exclusion Criterion 1
not eligible for the study at randomization

Exclusion Criterion 6
had important protocol deviation(s) as determined by the clinician for Immunogenicity (on or before 3 weeks post Dose 1) Population(s)
had important protocol deviation(s) as determined by the clinician for Efficacy (within 7 days post Dose 2), Immunogenicity (on or before 3 weeks post Dose 1) Population(s)
had important protocol deviation(s) as determined by the clinician for Immunogenicity (on or before 1 month post Dose 2) Population(s)

Exclusion Criterion 7
did not receive all vaccination(s) as randomized or did not receive Dose 2 within the predefined window (19-42 days after Dose 1)

Exclusion Criterion 8
did not have at least 1 valid and determinate immunogenicity result after Dose 2

Exclusion Criterion 9
did not have at least 1 valid and determinate immunogenicity result within 28-42 days after Dose 2

Exclusion Criterion 10
unblinded on or after 14 days but no later than 1 month post Dose 2 visit
unblinded on or after 7 days but prior to 14 days post Dose 2

Exclusion Criterion 17
did not have N-binding test result at a post(*ESC*){unicode 2013}Dose 2 visit