ID
25689
Descripción
Visit 6 - 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
Palabras clave
Versiones (1)
- 10/9/17 10/9/17 -
Titular de derechos de autor
glaxoSmithKline
Subido en
10 de septiembre de 2017
DOI
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Licencia
Creative Commons BY-NC 3.0
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Visit 6 - GSK Study: Hepatitis A & B Vaccine vs. monovalent Hep. A and Hep. B vaccines and risk factors likely to influence their immunogenicity NCT00289731
Visit 6 - GSK Study: Hepatitis A & B Vaccine vs. monovalent Hep. A and Hep. B vaccines and risk factors likely to influence their immunogenicity NCT00289731
Descripción
Demographics
Alias
- UMLS CUI-1
- C0011298
Descripción
Date of Birth
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0421451
Descripción
Gender
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0079399
Descripción
Race
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0034510
Descripción
If you chose 'Other Race', please specify
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0034510
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C3845569
Descripción
Laboratory tests
Alias
- UMLS CUI-1
- C0022885
Descripción
Blood sample
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0005834
Descripción
Please complete only if different from visit date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C1277698
- UMLS CUI [1,2]
- C0011008
Descripción
Hepatitis A vaccine monovalent or recombined
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0170300
Descripción
Specify hepatitis a vaccine
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0170300
- UMLS CUI [1,2]
- C1521902
Descripción
Follow-up- Studies
Alias
- UMLS CUI-1
- C0016441
- UMLS CUI-2
- C0042210
Descripción
If "No", please specify the most appropriate reason.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0016441
- UMLS CUI [1,2]
- C2348568
Descripción
Reason for non participation in follow-up
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0016441
- UMLS CUI [1,2]
- C2348568
- UMLS CUI [1,3]
- C0566251
Descripción
specify Adverse Events
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0559546
- UMLS CUI [1,2]
- C1521902
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C1521902
Descripción
Other reason for no follow-up
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C3840932
- UMLS CUI [1,3]
- C1521902
Descripción
Occurrence of serious adverse event
Alias
- UMLS CUI-1
- C1519255
Descripción
Serious adverse event
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1519255
Descripción
Number of SAE
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0449788
- UMLS CUI [1,2]
- C1519255
Descripción
Pregnancy information
Alias
- UMLS CUI-1
- C0032961
Descripción
Elimination criteria
Alias
- UMLS CUI-1
- C0680251
Descripción
Investigator's signature
Alias
- UMLS CUI-1
- C2346576
Descripción
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.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2346576
Descripción
Printed Investigator's name
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826892
Descripción
Date of investigator's signature
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Descripción
Reason for non participation
Alias
- UMLS CUI-1
- C0558080
- UMLS CUI-2
- C0679823
- UMLS CUI-3
- C0392360
Descripción
Subject number
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2348585
Descripción
Date of Birth
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0421451
Descripción
Reason for non participation
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0558080
- UMLS CUI [1,2]
- C0679823
- UMLS CUI [1,3]
- C0392360
Descripción
Subject not eligible? - please specify criteria that are not fullfilled:
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1555471
- UMLS CUI [1,2]
- C1521902
Descripción
Only fill in, if you chose "Subject eligible but not willing to participate due to: Please specify:" before.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C3846156
- UMLS CUI [1,2]
- C0392360
Descripción
Only fill in, if you chose "adverse events, or serious adverse event: please specify" before.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [1,3]
- C1521902
Descripción
Only fill in if you chose "other" before.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C1521902
- UMLS CUI [1,3]
- C2348568
Descripción
Only fill in, if you chose "Subject died on:" before.
Tipo de datos
date
Alias
- UMLS CUI [1]
- C1148348
Descripción
Date of contact
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1705415
- UMLS CUI [1,3]
- C2348568
Similar models
Visit 6 - GSK Study: Hepatitis A & B Vaccine vs. monovalent Hep. A and Hep. B vaccines and risk factors likely to influence their immunogenicity NCT00289731
C0205394 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C1521902 (UMLS CUI [2,2])
C3840932 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0679823 (UMLS CUI-2)
C0392360 (UMLS CUI-3)
C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C1705415 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])