ID
35694
Description
Study ID: 100565 Clinical Study ID: 100565 Study Title: An open study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' commercially available combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) containing 720 ELISA units of hepatitis A antigen and 20 µg of hepatitis B surface antigen, administered following a two-dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B
Keywords
Versions (2)
- 3/12/19 3/12/19 -
- 3/15/19 3/15/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
March 15, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565)
Visit 1 - Demographics; General Medical History; Laboratory Tests; Baseline Assessment; General Symptoms Observed Just Before Injection
Description
Demographics
Alias
- UMLS CUI-1
- C1704791
Description
Subject initials - First name
Data type
text
Alias
- UMLS CUI [1,1]
- C1997894
- UMLS CUI [1,2]
- C2986440
- UMLS CUI [2]
- C1443235
Description
Subject initials - Family Name
Data type
text
Alias
- UMLS CUI [1,1]
- C1997894
- UMLS CUI [1,2]
- C2986440
- UMLS CUI [2]
- C1301584
Description
Date of birth
Data type
date
Alias
- UMLS CUI [1]
- C0421451
Description
Gender
Data type
text
Description
Race
Data type
text
Alias
- UMLS CUI [1]
- C0034510
Description
If other race, please specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0034510
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Description
Height
Data type
integer
Measurement units
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
Weight
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Eligibility
Alias
- UMLS CUI-1
- C0013893
Description
If no, please give the corresponding criterion number(s)
Data type
boolean
Alias
- UMLS CUI [1]
- C0013893
Description
Corresponding criterion number(s)
Data type
text
Alias
- UMLS CUI [1,1]
- C1516637
- UMLS CUI [1,2]
- C0237753
Description
Investigator Signature
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
General Medical History / Physical Examination
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0031809
Description
Medical Condition
Alias
- UMLS CUI-1
- C0012634
Description
Diagnosis
Data type
integer
Alias
- UMLS CUI [1]
- C0011900
Description
Status
Data type
integer
Alias
- UMLS CUI [1]
- C0449438
Description
Medical Condition
Data type
text
Alias
- UMLS CUI [1]
- C0012634
Description
Laboratory Tests
Alias
- UMLS CUI-1
- C0022885
Description
Baseline Temperature
Alias
- UMLS CUI-1
- C0005903
- UMLS CUI-2
- C1442488
Description
Baseline Assessment - General Symptoms
Alias
- UMLS CUI-1
- C1442488
- UMLS CUI-2
- C1516048
- UMLS CUI-3
- C0159028
Description
Does the subject experience any of the following general solicited signs or symptoms just before injection
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C1533685
- UMLS CUI [1,3]
- C0332152
Description
General Symptoms Observed Just Before Injection
Alias
- UMLS CUI-1
- C0159028
- UMLS CUI-2
- C1533685
- UMLS CUI-3
- C0332152
Description
General Symptoms Observed Just Before Injection
Alias
- UMLS CUI-1
- C0159028
- UMLS CUI-2
- C1533685
- UMLS CUI-3
- C0332152
Similar models
Visit 1 - Demographics; General Medical History; Laboratory Tests; Baseline Assessment; General Symptoms Observed Just Before Injection
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C2986440 (UMLS CUI [1,2])
C1443235 (UMLS CUI [2])
C2986440 (UMLS CUI [1,2])
C1301584 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,2])
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C0159028 (UMLS CUI-3)
C1533685 (UMLS CUI [1,2])
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C1533685 (UMLS CUI-2)
C0332152 (UMLS CUI-3)