ID
25690
Description
Visit 7 - GSK Study: Hepatitis A & B Vaccine vs. monovalent Hep. A and Hep. B vaccines and risk factors likely to influence their immunogenicity NCT00289731 Study ID: 100382 Clinical Study ID: 100382 Study Title: Evaluate the Effect of Several Risk Factors That Are Likely to Influence the Immunogenicity of GSK Biologicals’ Combined Hepatitis A & B Vaccine, vs Separately Administered Monovalent Hepatitis A and Hepatitis B Vaccines Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289731 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B
Keywords
Versions (1)
- 9/10/17 9/10/17 -
Copyright Holder
glaxoSmithKline
Uploaded on
September 10, 2017
DOI
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License
Creative Commons BY-NC 3.0
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Visit 7 - GSK Study: Hepatitis A & B Vaccine vs. monovalent Hep. A and Hep. B vaccines and risk factors likely to influence their immunogenicity NCT00289731
Visit 7 - GSK Study: Hepatitis A & B Vaccine vs. monovalent Hep. A and Hep. B vaccines and risk factors likely to influence their immunogenicity NCT00289731
Description
Demographics
Alias
- UMLS CUI-1
- C0011298
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
integer
Alias
- UMLS CUI [1]
- C0034510
Description
If you chose 'Other Race', please specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0034510
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C3845569
Description
Laboratory tests
Alias
- UMLS CUI-1
- C0022885
Description
Blood sample
Data type
boolean
Alias
- UMLS CUI [1]
- C0005834
Description
Please complete only if different from visit date
Data type
date
Alias
- UMLS CUI [1,1]
- C1277698
- UMLS CUI [1,2]
- C0011008
Description
Hepatitis A vaccine monovalent or recombined
Data type
boolean
Alias
- UMLS CUI [1]
- C0170300
Description
Specify hepatitis a vaccine
Data type
integer
Alias
- UMLS CUI [1,1]
- C0170300
- UMLS CUI [1,2]
- C1521902
Description
Follow-up- Studies
Alias
- UMLS CUI-1
- C0016441
- UMLS CUI-2
- C0042210
Description
If "No", please specify the most appropriate reason.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0016441
- UMLS CUI [1,2]
- C2348568
Description
Reason for non participation in follow-up
Data type
integer
Alias
- UMLS CUI [1,1]
- C0016441
- UMLS CUI [1,2]
- C2348568
- UMLS CUI [1,3]
- C0566251
Description
specify Adverse Events
Data type
text
Alias
- UMLS CUI [1,1]
- C0559546
- UMLS CUI [1,2]
- C1521902
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C1521902
Description
Other reason for no follow-up
Data type
text
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C3840932
- UMLS CUI [1,3]
- C1521902
Description
Occurrence of serious adverse event
Alias
- UMLS CUI-1
- C1519255
Description
Pregnancy information
Alias
- UMLS CUI-1
- C0032961
Description
Elimination criteria
Alias
- UMLS CUI-1
- C0680251
Description
Investigator's signature
Alias
- UMLS CUI-1
- C2346576
Description
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.
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Printed Investigator's name
Data type
text
Alias
- UMLS CUI [1]
- C2826892
Description
Date of investigator's signature
Data type
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Description
Reason for non participation
Alias
- UMLS CUI-1
- C0558080
- UMLS CUI-2
- C0679823
- UMLS CUI-3
- C0392360
Description
Subject number
Data type
text
Alias
- UMLS CUI [1]
- C2348585
Description
Date of Birth
Data type
date
Alias
- UMLS CUI [1]
- C0421451
Description
Reason for non participation
Data type
integer
Alias
- UMLS CUI [1,1]
- C0558080
- UMLS CUI [1,2]
- C0679823
- UMLS CUI [1,3]
- C0392360
Description
Subject not eligible? - please specify criteria that are not fullfilled:
Data type
text
Alias
- UMLS CUI [1,1]
- C1555471
- UMLS CUI [1,2]
- C1521902
Description
Only fill in, if you chose "Subject eligible but not willing to participate due to: Please specify:" before.
Data type
text
Alias
- UMLS CUI [1,1]
- C3846156
- UMLS CUI [1,2]
- C0392360
Description
Only fill in, if you chose "adverse events, or serious adverse event: please specify" before.
Data type
text
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [1,3]
- C1521902
Description
Only fill in if you chose "other" before.
Data type
text
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C1521902
- UMLS CUI [1,3]
- C2348568
Description
Only fill in, if you chose "Subject died on:" before.
Data type
date
Alias
- UMLS CUI [1]
- C1148348
Description
Date of contact
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1705415
- UMLS CUI [1,3]
- C2348568
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