Study Identifier
Unique Subject Identifier
Domain Abbreviation
Subject Identifier for the Study
Study Site Identifier
Date of First Exposure to Treatment
Date of Last Exposure to Treatment
Description of Planned Arm
Planned Arm Code
Description of Actual Arm
Actual Arm Code
Planned Treatment for Period 01
Actual Treatment for Period 01
Planned Treatment for Period 01 (N)
Actual Treatment for Period 01 (N)
Pooled Age Group 1
Pooled Age Group 1 (N)
Sequence Number
Sponsor-Defined Identifier
Protocol Deviation Term
Protocol Deviation Term 1
Protocol Deviation Coded Term
Actual Site of Deviation Occurrence
Visit Designator
Confirmed Analysis Population Exclusion
Category for Protocol Deviation
Start Date/Time of Deviation
Study Day of Start of Deviation
Analysis Start Date
Pre-treatment Flag
On Treatment Flag
Randomized Population Flag
Study Phase
Study Phase (N)
Cohort Group
Cohort Group (N)
Actual Dosing Level
Actual Dosing Level (N)
Planned Dosing Level
Planned Dosing Level (N)
Phase 3 3000 Subjects Flag
Pooled Age Group 3 (N)
Pooled Age Group 3
Pooled Age Group 4 (N)
Pooled Age Group 4
HIV Positive Subjects Flag
Age at Vaccination 01
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 01
Vaccination 02
Vaccination Unplanned
Vaccination 03
Vaccination 04
Vaccination Unplanned in Period 02
Vaccination Date Unplanned in Period 02
Treatment Unblinded Date
Multiply Enrolled Subjects
Random - exclude Multi-Enrolloer