ID
43669
Description
Study ID: 100551 (EXT Y11) Clinical Study ID: 100551 Study Title: A double blind randomised, comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B vaccine when administered in healthy adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289770 Sponsor: GlaxoSmithKline Collaborators: N/A 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 (3)
- 6/26/17 6/26/17 -
- 9/26/17 9/26/17 -
- 9/20/21 9/20/21 -
Uploaded on
September 20, 2021
DOI
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License
Creative Commons BY-NC 3.0
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Comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B (Visit 21 Year 14)
Comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B (Visit 21 Year 14)
Description
General Information
Alias
- UMLS CUI-1
- C1508263
Description
Date of visit
Data type
date
Alias
- UMLS CUI [1]
- C1320303
Description
Subject Number
Data type
integer
Alias
- UMLS CUI [1]
- C2348585
Description
I certify that Informed Consent has been obtained prior to any study procedure.
Data type
date
Alias
- UMLS CUI [1]
- C0021430
Description
Demographics
Alias
- UMLS CUI-1
- C1704791
Description
Center number
Data type
integer
Alias
- UMLS CUI [1,1]
- C1301943
- UMLS CUI [1,2]
- C0600091
Description
Date of birth
Data type
date
Alias
- UMLS CUI [1]
- C0421451
Description
Gender
Data type
text
Alias
- UMLS CUI [1]
- C0079399
Description
Race
Data type
text
Alias
- UMLS CUI [1]
- C0034510
Description
Race: Specification
Data type
text
Alias
- UMLS CUI [1,1]
- C0034510
- UMLS CUI [1,2]
- C2348235
Description
Laboratory tests
Alias
- UMLS CUI-1
- C0022885
Description
Anti-HAV and anti-HBs antibodies
Data type
text
Alias
- UMLS CUI [1]
- C0201473
- UMLS CUI [2]
- C0201478
Description
Collection Date
Data type
date
Alias
- UMLS CUI [1]
- C1317250
Description
Hepatitis A or Hepatitis B vaccine
Data type
text
Alias
- UMLS CUI [1,1]
- C0170300
- UMLS CUI [1,2]
- C2240392
Description
Hepatitis A or Hepatitis B vaccine: Specification
Data type
text
Alias
- UMLS CUI [1,1]
- C0170300
- UMLS CUI [1,2]
- C2348235
- UMLS CUI [2,1]
- C2240392
- UMLS CUI [2,2]
- C2348235
Description
Hepatitis A or Hepatitis B immunoglobulins
Data type
text
Alias
- UMLS CUI [1]
- C3652495
- UMLS CUI [2]
- C0062525
Description
Specification of Hepatitis A or Hepatitis B immunoglobulins
Data type
text
Alias
- UMLS CUI [1,1]
- C3652495
- UMLS CUI [1,2]
- C2348235
- UMLS CUI [2,1]
- C0062525
- UMLS CUI [2,2]
- C2348235
Description
Hepatitis A or B infection
Data type
boolean
Alias
- UMLS CUI [1]
- C0019159
- UMLS CUI [2]
- C0019163
Description
Serology conclusion before booster
Alias
- UMLS CUI-1
- C0036743
Description
Please complete this section only after receipt of the serology results related to the assessment done at visit 21.
Data type
boolean
Alias
- UMLS CUI [1]
- C0201478
Description
If YES to any of above, subject will receive either ENGERIX™, HAVRIX™ or TWINRIX™ ADULT as appropriate. Please complete the entire Case Report Form. If NO to both questions, please complete the study conclusion section only.
Data type
boolean
Alias
- UMLS CUI [1]
- C0062524
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Comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B (Visit 21 Year 14)
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