Immunogenicity Specimen Assessments
adis_vaccineA data frame with 103 columns:
Study Identifier
Unique Subject Identifier
Subject Identifier for the Study
Study Site Identifier
Country
Domain Abbreviation
Subject Reference Start Date/Time
Subject Reference End Date/Time
Date/Time of First Study Treatment
Date/Time of Last Study Treatment
Date/Time of End of Participation
Date/Time of Death
Subject Death Flag
Geographic Region 1
Date/Time of Birth
Date/Time of Collection
Study Day of Collection
Age
Age Units
Pooled Age Group 1
Sex
Race
Pooled Race Group 1
Ethnicity
Safety Population Flag
Per-Protocol Population Flag
Description of Planned Arm
Planned Arm Code
Description of Actual Arm
Actual Arm Code
Planned Treatment
Actual Treatment
Planned Treatment for Period 01
Actual Treatment for Period 01
Planned Treatment for Period 02
Actual Treatment for Period 02
Date of First Exposure to Treatment
Datetime of First Exposure to Treatment
Date of Last Exposure to Treatment
Datetime of Last Exposure to Treatment
Period 01 Start Date
Period 01 End Date
Period 02 Start Date
Period 02 End Date
Period Start Date
Period End Date
Date/Time of Informed Consent
Analysis Date
Analysis Relative Day
Analysis Visit
Analysis Visit (N)
Analysis Timepoint
Analysis Timepoint (N)
Analysis Timepoint Reference
Period
Parameter
Parameter Code
Parameter (N)
Parameter Category 1
Analysis Value
Analysis Value Unit
Baseline Value
Baseline Category 1
Baseline Type
Change from Baseline
Ratio to Baseline
Analysis Criterion 1
Criterion 1 Evaluation Result Flag
Criterion 1 Evaluation Result Flag (N)
Derivation Type
Baseline Record Flag
Sequence Number
Immunogenicity Test/Exam Short Name
Immunogenicity Test or Examination Name
Category for Immunogenicity Test
Results or Findings in Original Units
Original Units
Character Result/Finding in Std Format
Numeric Results/Findings in Std. Units
Standard Units
Completion Status
Reason Not Done
Vendor Name
Specimen Type
Method of Test or Examination
Baseline Flag
Lower Limit of Quantitation
Visit Number
Epoch
Date/Time of Collection
Study Day of Visit/Collection/Exam
Upper Limit of Quantitation
Limit of Detection
Derivation Method
First Cutoff Value
Second Cutoff Value
Pre-vaccination seropositivity status
Pre-vaccination sero status (n)
Per-Protocol Record-Level Flag
Investigator Identifier
Investigator Name
Vaccination Date 01
Vaccination Date 02
Contains a set of 16 unique Parameter Codes and Parameters:
| PARAMCD | PARAM |
| I0019NLF | LOG10 4FOLD (I0019NT Antibody) |
| I0019NT | I0019NT Antibody |
| I0019NTF | 4FOLD (I0019NT Antibody) |
| I0019NTL | LOG10 (I0019NT Antibody) |
| J0033VLF | LOG10 4FOLD (J0033VN Antibody) |
| J0033VN | J0033VN Antibody |
| J0033VNF | 4FOLD (J0033VN Antibody) |
| J0033VNL | LOG10 (J0033VN Antibody) |
| M0019LLF | LOG10 4FOLD (M0019LN Antibody) |
| M0019LN | M0019LN Antibody |
| M0019LNF | 4FOLD (M0019LN Antibody) |
| M0019LNL | LOG10 (M0019LN Antibody) |
| R0003MA | R0003MA Antibody |
| R0003MAF | 4FOLD (R0003MA Antibody) |
| R0003MAL | LOG10 (R0003MA Antibody) |
| R0003MLF | LOG10 4FOLD (R0003MA Antibody) |
None