ID
43666
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
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B (Visit 17 Year 11)
Comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B (Visit 17 Year 11)
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
Informed consent
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]
- C0419735
- UMLS CUI [2]
- C0474232
Beschrijving
Specification of received Hepatitis A or Hepatitis B vaccine
Datatype
text
Alias
- UMLS CUI [1,1]
- C0419735
- UMLS CUI [1,2]
- C2348235
- UMLS CUI [2,1]
- C0474232
- 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
Study Conclusion
Alias
- UMLS CUI-1
- C1707478
Beschrijving
Follow-up studies
Datatype
text
Alias
- UMLS CUI [1]
- C0016441
Beschrijving
Compliance
Datatype
text
Alias
- UMLS CUI [1]
- C1321605
Beschrijving
Adverse Events or Serious Adverse Events
Datatype
text
Alias
- UMLS CUI [1]
- C0877248
- UMLS CUI [2]
- C1519255
Beschrijving
Compliance: Specification
Datatype
text
Alias
- UMLS CUI [1,1]
- C1321605
- UMLS CUI [1,2]
- C2348235
Beschrijving
Serious Adverse Event
Alias
- UMLS CUI-1
- C1519255
Beschrijving
Occurence of Serious Adverse Event
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2745955
Beschrijving
Pregnancy
Datatype
text
Alias
- UMLS CUI [1]
- C0032961
Beschrijving
Investigator´s signature
Alias
- UMLS CUI-1
- C2346576
Beschrijving
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below
Datatype
text
Beschrijving
Date
Datatype
date
Alias
- UMLS CUI [1]
- C0011008
Beschrijving
Investigator´s name
Datatype
text
Alias
- UMLS CUI [1]
- C2826892
Beschrijving
Tracking Document - Reason for non participation
Alias
- UMLS CUI-1
- C3889409
Beschrijving
Previous Subject Number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2348585
- UMLS CUI [1,2]
- C0205156
Beschrijving
Date of Birth
Datatype
date
Alias
- UMLS CUI [1]
- C0421451
Beschrijving
Reason for non participation
Datatype
integer
Alias
- UMLS CUI [1]
- C3166257
Beschrijving
Eligibility
Datatype
text
Alias
- UMLS CUI [1]
- C0013893
Beschrijving
Adverse event or serious adverse event: Specification
Datatype
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C2348235
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C2348235
Beschrijving
Study Participation Status
Datatype
text
Alias
- UMLS CUI [1]
- C2348568
Similar models
Comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B (Visit 17 Year 11)
C0600091 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0201478 (UMLS CUI [2])
C0474232 (UMLS CUI [2])
C2348235 (UMLS CUI [1,2])
C0474232 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
C0062525 (UMLS CUI [2])
C2348235 (UMLS CUI [1,2])
C0062525 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
C1519255 (UMLS CUI [2])
C2348235 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])