Subject-Level Analysis Dataset
Study Identifier
Unique Subject Identifier
Subject Identifier for the Study
Study Site Identifier
Age Units
Sex (N)
Race (N)
Ethnicity
Ethnicity (N)
Racial Designation
Racial Designation (N)
Safety Population Flag
Randomized Population Flag
Enrolled Population Flag
Subject Death Flag
Description of Planned Arm
Planned Arm Code
Description of Actual Arm
Actual Arm Code
Planned Treatment for Period 01
Planned Treatment for Period 01 (N)
Planned Treatment for Period 02
Planned Treatment for Period 02 (N)
Actual Treatment for Period 01
Actual Treatment for Period 01 (N)
Actual Treatment for Period 02
Actual Treatment for Period 02 (N)
Planned Sequence of Treatments
Actual Sequence of Treatments
Date of Birth
Date of Birth Imput. Flag
Date/Time of Death
Date of Death
Date of Death Imputation Flag
Date of Randomization
Randomization Number
Subject Reference Start Date
Subject Reference Start Time
Subject Reference End Date
Subject Reference End Time
Date of End of Participation
Date of Informed Consent
Date of First Exposure to Treatment
Time of First Exposure to Treatment
Date of Last Exposure to Treatment
Time of Last Exposure to Treatment
Date of First Exposure in Period 01
Time of First Exposure in Period 01
Date of Last Exposure in Period 01
Time of Last Exposure in Period 01
Date of First Exposure in Period 02
Time of First Exposure in Period 02
Date of Last Exposure in Period 02
Time of Last Exposure in Period 02
Datetime of First Exposure to Treatment
Datetime of Last Exposure to Treatment
Datetime of First Exposure in Period 01
Datetime of Last Exposure in Period 01
Datetime of First Exposure in Period 02
Datetime of Last Exposure in Period 02
Vaccination Date 01
Vaccination Date 02
Vaccination Date 03
Vaccination Date 04
Age at Vaccination 01
Age Units at Vaccination 01
Age at Vaccination 03
Age Units at Vaccination 03
Pooled Age Group 1
Pooled Age Group 1 (N)
Analysis Race
Analysis Race (N)
Pooled Race Group 1
Pooled Race Group 1 (N)
End Of Study Discontinuation Date
End Of Study Discontinuation Reason
End Of Treatment Discontinuation Date
End Of Treatment Discontinuation Reason
Adjusted Treatment for Rel. Efficacy
Adjusted Treatment for Rel. Efficacy (N)
Evaluable Efficacy Pop Flag - Asympt
Evaluable Efficacy Pop Flag - Seroconv
Exclusion Flag 17
No PD prior to 1st N-Binding test PD2
Exclusion Flag 18
Exclusion Criterion 18
Have valid immuno within timeframe 2
Have N-Binding result PD2
Exclusion Flag 4
Exclusion Flag 9
Asymptomatic Surveillance Consented Date
Vaccination 04
Vaccination Date Unplanned
Vaccination Date Unplanned in Period 02
Vaccination Unplanned
Vaccination Unplanned in Period 02
Vaccination Time 01
Vaccination Time 02
Vaccination Time Unplanned
Vaccination Time 03
Vaccination Time 04
Vaccination Time Unplanned in Period 02
Investigator Identifier
Investigator Name
Actual Dosing Level
Planned Dosing Level
Planned Dosing Level (N)
Actual Dosing Level (N)
Reactogenicity Population Flag
Cohort Group
Cohort Group (N)
Study Phase (N)
Study Phase
Pooled Age Group 2
Pooled Age Group 3
Pooled Age Group 4
Pooled Age Group 4 (N)
Pooled Age Group 2 (N)
Pooled Age Group 3 (N)
Age Group at Vaccination 03
Age Group at Vaccination 03 (N)
Vaccination 01
Vaccination 02
Vaccination 03
Treatment Unblinded Date
Re-Informed Consent Date
End Of Open Label Treatment D/C Date
End Of Open Label Treatment D/C Reason
Baseline BMI Category
Baseline BMI Category (N)
Obese Flag for Adolescent
Flag for Comorbodities
N-binding Antibody Neg at Visit 1 Flag
NAAT Negative at Visit 1 Flag
Baseline SARS-CoV-2 Status
Date of Unblinding or Visit at 1MPD2
Date of Unblinding or Visit at 6MPD2
Date of Dose 3 or Visit at 6MPD2
Date of Visit at 1M after Vax3/4
Date of Visit at 6M after Vax3/4
C19NIG Result at Visit 3
Start Date of Important PD
First PD date for safety
First PD date for efficacy
First PD date for immunogenicity
Blood Sample Drawn before Vax 1
Blood Sample Drawn 1 Week after Vax 1
Blood Sample Drawn before Vax 2
Blood Sample Drawn 1 Week after Vax 2
Blood Sample Drawn 2 Weeks after Vax 2
Blood Sample Drawn 1 Month after Vax 2
Blood Sample Drawn 6 Months after Vax 2
Blood Sample Date before Vax 1
Blood Sample Date 1 Week after Vax 1
Additional Bld Sample Date 3W after Vax1
Additional Bld Sample Date 4W after Vax1
Additional Bld Sample Date 5W after Vax1
Additional Bld Sample Date 7W after Vax1
Blood Sample Date before Vax 2
Blood Sample Date 1 Week after Vax 2
Blood Sample Date 2 Weeks after Vax 2
Blood Sample Date 1 Month after Vax 2
Blood Sample Date 6 Months after Vax 2
Are eligible for the study at rand
Have received Vax 1 as randomized
Have valid and DTM immuno result 1
No important PD determined by clinician
Received 2 doses as rand within window
Have valid and DTM immuno result 3
Unblinded after 1M post Dose 2 visit
Exclusion Flag 1
Exclusion Criterion 1
Exclusion Flag 2
Exclusion Criterion 2
Exclusion Flag 3
Exclusion Criterion 3
Exclusion Criterion 4
Exclusion Flag 6
Exclusion Criterion 6
Reason for Exclusion from Safety Pop
Exclusion Flag 7
Exclusion Criterion 7
Exclusion Flag 8
Exclusion Criterion 8
Exclusion Criterion 9
Exclusion Flag 10
Exclusion Criterion 10
Exclusion Criterion 17
Dose 1 all-available Immun Popu Flag
Dose 2 all-available Immun Popu Flag
Evaluable Efficacy Popu Flag
Evaluable Efficacy Popu Flag - 14 days
Dose 1 all-available Efficacy Popu Flag
Dose 2 all-available Efficacy Popu Flag
Dose 2 all-available Asympt Popu Flag
Dose 2 evaluable Immun Popu Flag
Have valid immuno within timeframe 1
Dose 1 evaluable Immun Popu Flag
Screening
FU to 6MPD2
Phase 3 30k Subjects Flag
Subjects Received Placebo & unblinded
Japanese Subject Flag
Phase 2/3 Pop for 12-25 Reacto Subset
Pop for Non-inferiority Assessement
HIV Positive Subjects Flag
Subject without Evidence 1MPD2
Double Blinded Follow-up Censor Date
Crossover Dose1 Censor Date
Study Censor Date
PD2 FU Time in Days: to Cutoff
PD2 FU Time in Days: to Unblinding
Post Xover D1 FUTM in Days: to Cutoff
Unblinding FUTM in Days: to Cutoff
PD1 FU Time in Days: to Cutoff
PD1 FU Time in Days: to Unblinding
PD2 FU Time Cat 1: to Cutoff
PD2 FU Time Cat 1 (N): to Cutoff
PD2 FU Time Cat 2: to Unblinding
PD2 FU Time Cat 2 (N): to Unblinding
Post Xover D1 FUTM Cat 1: to Cutoff
Post Xover D1 FUTM Cat 1 (N): to Cutoff
PD1 FU Time Cat 1: to Cutoff
PD1 FU Time Cat 1 (N): to Cutoff
HIV RNA Category
HIV RNA Category (N)
CD4 Category for HIV-positive
CD4 Category for HIV-positive (N)
Date of Completion
Post-dose Positive Swab Result Date