ID
43669
Beschrijving
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
Trefwoorden
Versies (3)
- 26-06-17 26-06-17 -
- 26-09-17 26-09-17 -
- 20-09-21 20-09-21 -
Geüploaded op
20 september 2021
DOI
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Licentie
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)
Beschrijving
General Information
Alias
- UMLS CUI-1
- C1508263
Beschrijving
Date of visit
Datatype
date
Alias
- UMLS CUI [1]
- C1320303
Beschrijving
Subject Number
Datatype
integer
Alias
- UMLS CUI [1]
- C2348585
Beschrijving
I certify that Informed Consent has been obtained prior to any study procedure.
Datatype
date
Alias
- UMLS CUI [1]
- C0021430
Beschrijving
Demographics
Alias
- UMLS CUI-1
- C1704791
Beschrijving
Center number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1301943
- UMLS CUI [1,2]
- C0600091
Beschrijving
Date of birth
Datatype
date
Alias
- UMLS CUI [1]
- C0421451
Beschrijving
Gender
Datatype
text
Alias
- UMLS CUI [1]
- C0079399
Beschrijving
Race
Datatype
text
Alias
- UMLS CUI [1]
- C0034510
Beschrijving
Race: Specification
Datatype
text
Alias
- UMLS CUI [1,1]
- C0034510
- UMLS CUI [1,2]
- C2348235
Beschrijving
Laboratory tests
Alias
- UMLS CUI-1
- C0022885
Beschrijving
Anti-HAV and anti-HBs antibodies
Datatype
text
Alias
- UMLS CUI [1]
- C0201473
- UMLS CUI [2]
- C0201478
Beschrijving
Collection Date
Datatype
date
Alias
- UMLS CUI [1]
- C1317250
Beschrijving
Hepatitis A or Hepatitis B vaccine
Datatype
text
Alias
- UMLS CUI [1,1]
- C0170300
- UMLS CUI [1,2]
- C2240392
Beschrijving
Hepatitis A or Hepatitis B vaccine: Specification
Datatype
text
Alias
- UMLS CUI [1,1]
- C0170300
- UMLS CUI [1,2]
- C2348235
- UMLS CUI [2,1]
- C2240392
- UMLS CUI [2,2]
- C2348235
Beschrijving
Hepatitis A or Hepatitis B immunoglobulins
Datatype
text
Alias
- UMLS CUI [1]
- C3652495
- UMLS CUI [2]
- C0062525
Beschrijving
Specification of Hepatitis A or Hepatitis B immunoglobulins
Datatype
text
Alias
- UMLS CUI [1,1]
- C3652495
- UMLS CUI [1,2]
- C2348235
- UMLS CUI [2,1]
- C0062525
- UMLS CUI [2,2]
- C2348235
Beschrijving
Hepatitis A or B infection
Datatype
boolean
Alias
- UMLS CUI [1]
- C0019159
- UMLS CUI [2]
- C0019163
Beschrijving
Serology conclusion before booster
Alias
- UMLS CUI-1
- C0036743
Beschrijving
Please complete this section only after receipt of the serology results related to the assessment done at visit 21.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0201478
Beschrijving
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.
Datatype
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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