ID
25679
Description
Visit 4, Concomitant vaccination, medication and study conclusion- 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
Mots-clés
Versions (1)
- 09/09/2017 09/09/2017 -
Détendeur de droits
glaxoSmithKline
Téléchargé le
9 septembre 2017
DOI
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Licence
Creative Commons BY-NC 3.0
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Visit 4, Concomitant vaccination, medication and study conclusion- GSK Study: Hepatitis A & B Vaccine vs. monovalent Hep. A and Hep. B vaccines and risk factors likely to influence their immunogenicity NCT00289731
Visit 4, Concomitant vaccination, medication and study conclusion- GSK Study: Hepatitis A & B Vaccine vs. monovalent Hep. A and Hep. B vaccines and risk factors likely to influence their immunogenicity NCT00289731
Description
Blood sample
Alias
- UMLS CUI-1
- C0005834
Description
Concomitant vaccination
Alias
- UMLS CUI-1
- C0042196
- UMLS CUI-2
- C2347852
Description
Concomitant vaccination
Alias
- UMLS CUI-1
- C0042196
- UMLS CUI-2
- C2347852
Description
Trade name
Type de données
text
Alias
- UMLS CUI [1,1]
- C0592503
- UMLS CUI [1,2]
- C0042210
Description
Route of vaccine administration
Type de données
text
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C0449444
Description
Date of vaccine administration
Type de données
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C2368628
Description
Medication
Alias
- UMLS CUI-1
- C0013227
Description
Medication
Alias
- UMLS CUI-1
- C0013227
Description
Trade / Generic Name of medication
Type de données
text
Alias
- UMLS CUI [1,1]
- C0592503
- UMLS CUI [1,2]
- C0013227
Description
Medical Indication for medication
Type de données
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C3146298
Description
Prophylactic medication
Type de données
boolean
Alias
- UMLS CUI [1]
- C0420172
Description
Total daily dose of medication
Type de données
float
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C2348070
Description
Drug administration route
Type de données
text
Alias
- UMLS CUI [1]
- C0013153
Description
Start date of medication
Type de données
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Description
End date of medication
Type de données
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Description
Medication continuous
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0549178
Description
Medical status at study end (Month 7)
Alias
- UMLS CUI-1
- C3899485
Description
Disease
Alias
- UMLS CUI-1
- C0012634
Description
Disease
Type de données
text
Alias
- UMLS CUI [1]
- C0012634
Description
Start date of disease
Type de données
date
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0808070
Description
If 'yes', please complete the medication section.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0332121
Description
Follow-up- Studies
Alias
- UMLS CUI-1
- C0016441
- UMLS CUI-2
- C0042210
Description
If "No", please specify the most appropriate reason.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0016441
- UMLS CUI [1,2]
- C2348568
Description
Reason for non participation in follow-up
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0016441
- UMLS CUI [1,2]
- C2348568
- UMLS CUI [1,3]
- C0566251
Description
specify Adverse Events
Type de données
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
Type de données
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
Serious adverse event
Type de données
boolean
Alias
- UMLS CUI [1]
- C1519255
Description
Number of SAE
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0449788
- UMLS CUI [1,2]
- C1519255
Description
Pregnancy information
Alias
- UMLS CUI-1
- C0032961
Description
Elimination criteria
Alias
- UMLS CUI-1
- C0680251
Description
Elimination criteria
Type de données
boolean
Alias
- UMLS CUI [1]
- C0680251
Description
specify elimination criteria
Type de données
text
Alias
- UMLS CUI [1,1]
- C0680251
- UMLS CUI [1,2]
- C1521902
Description
Study conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Description
Withdrawn from study
Type de données
boolean
Alias
- UMLS CUI [1]
- C2348568
Description
Reason for withdrawal from study
Type de données
text
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0392360
Description
Number of SAE
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0449788
- UMLS CUI [1,2]
- C1519255
Description
specify protocol violation
Type de données
text
Alias
- UMLS CUI [1,1]
- C1709750
- UMLS CUI [1,2]
- C1521902
Description
specify other reason
Type de données
text
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C1521902
- UMLS CUI [1,3]
- C2348568
Description
decision study participation
Type de données
integer
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0679006
Description
Date of last contact
Type de données
date
Alias
- UMLS CUI [1]
- C0805839
Description
Medical status
Type de données
integer
Alias
- UMLS CUI [1]
- C3899485
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.
Type de données
text
Alias
- UMLS CUI [1]
- C2346576
Description
Printed Investigator's name
Type de données
text
Alias
- UMLS CUI [1]
- C2826892
Description
Date of investigator's signature
Type de données
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Similar models
Visit 4, Concomitant vaccination, medication and study conclusion- GSK Study: Hepatitis A & B Vaccine vs. monovalent Hep. A and Hep. B vaccines and risk factors likely to influence their immunogenicity NCT00289731
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0679006 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C2347852 (UMLS CUI-2)
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI-2)
C0042210 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,2])
C2348070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0332121 (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])
C0392360 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0679006 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])