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25679
Beschrijving
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
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Versies (1)
- 09-09-17 09-09-17 -
Houder van rechten
glaxoSmithKline
Geüploaded op
9 september 2017
DOI
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Licentie
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
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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
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item
Did the subject come at visit 4?
integer
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
CL Item
Yes, please complete the following pages. (1)
CL Item
No, please complete below. (2)
Item
Please tick the ONE most appropriate reason.
text
C2348568 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
CL Item
Serious adverse event (complete the Serious Adverse Event form) (SAE)
CL Item
Other, please specify (OTH)
Number of SAE
Item
Please specify SAE N°
integer
C1519255 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
Other reason for non-participation
Item
Other, please specify
text
C2348568 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C3840932 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
Please tick who took the decision.
integer
C2348568 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,2])
CL Item
Investigator’s decision (1)
CL Item
Subject's decision (2)
Blood sample
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])
Date of Blood sample
Item
Date of Blood sample
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item Group
Concomitant vaccination
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C2347852 (UMLS CUI-2)
Item
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
integer
C0042196 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
Code List
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
CL Item
No (1)
CL Item
Yes, please record concomitant vaccination with trade name and / or generic name, route and vaccine administration date. (2)
Item Group
Concomitant vaccination
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C2347852 (UMLS CUI-2)
Trade name
Item
Trade / (Generic) Name
text
C0592503 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,2])
CL Item
Intradermal (ID)
CL Item
Inhalation (IH)
CL Item
Intramuscular (IM)
CL Item
Intravenous (IV)
CL Item
Intranasal (NA)
CL Item
Other (OTH)
CL Item
Parenteral (PE)
CL Item
Oral (PO)
CL Item
Subcutaneous (SC)
CL Item
Sublingual (SL)
CL Item
Transdermal (TD)
CL Item
Unknown (UNK)
Date of vaccine administration
Item
Administration date
date
C0011008 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,2])
Item
Have any medications/treatments been administered during study period?
integer
C2347852 (UMLS CUI [1])
Code List
Have any medications/treatments been administered during study period?
CL Item
No (1)
CL Item
Yes, please complete the following table. (2)
Trade / Generic Name of medication
Item
Trade / Generic Name
text
C0592503 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
Medical Indication for medication
Item
Medical Indication
text
C0013227 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,2])
Prophylactic medication
Item
Prophylactic
boolean
C0420172 (UMLS CUI [1])
Total daily dose of medication
Item
Total daily dose
float
C0013227 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
C2348070 (UMLS CUI [1,2])
CL Item
External (EXT)
CL Item
Intradermal (ID)
CL Item
Inhalation (IH)
CL Item
Intramuscular (IM)
CL Item
Intraarticular (IR)
CL Item
Intrathecal (IT)
CL Item
Intravenous (IV)
CL Item
Intranasal (NA)
CL Item
Other (OTH)
CL Item
Parenteral (PE)
CL Item
Oral (PO)
CL Item
Rectal (PR)
CL Item
Subcutaneous (SC)
CL Item
Sublingual (SL)
CL Item
Transdermal (TD)
CL Item
Topical (TO)
CL Item
Unknown (UNK)
CL Item
Vaginal (VA)
Start date of medication
Item
Start
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
End date of medication
Item
End
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Medication continuous
Item
Medication continuing at the end of the study?
boolean
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
medical status
Item
Is the medical condition of the subject now the same as it was at study entry?
boolean
C3899485 (UMLS CUI [1])
Disease
Item
Name of disease
text
C0012634 (UMLS CUI [1])
Start date of disease
Item
Start date
date
C0012634 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Disease requires medication
Item
Requiring medication?
boolean
C0012634 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0332121 (UMLS CUI [1,2])
willing to participate in a follow-up study
Item
Would the subject be willing to participate in a follow-up study?
boolean
C0016441 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,2])
Item
Please specify the most appropriate reason.
integer
C0016441 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
CL Item
Adverse Events, or Serious Adverse Events (1)
CL Item
Others (2)
specify Adverse Events
Item
Please specify Adverse Events, or Serious Adverse Events.
text
C0559546 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C1521902 (UMLS CUI [2,2])
C1521902 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C1521902 (UMLS CUI [2,2])
Other reason for no follow-up
Item
Specify other reason
text
C2348568 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C3840932 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Serious adverse event
Item
Did the subject experience any Serious Adverse Event during the study period?
boolean
C1519255 (UMLS CUI [1])
Number of SAE
Item
If yes, please give the total number of SAE's.
integer
C0449788 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not applicable (not of childbearing potential or male) (3)
Elimination criteria
Item
Did any elimination criteria become applicable during the study?
boolean
C0680251 (UMLS CUI [1])
specify elimination criteria
Item
Please specify elimination criteria.
text
C0680251 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
Withdrawn from study
Item
Was the subject withdrawn from study?
boolean
C2348568 (UMLS CUI [1])
Item
Please tick the ONE most appropriate category for drop out.
text
C2348568 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
Code List
Please tick the ONE most appropriate category for drop out.
CL Item
Serious adverse event (complete the Serious Adverse Event form) (SAE)
CL Item
Protocol violation (PTV)
CL Item
Consent withdrawal, not due to an adverse event. (CWS)
CL Item
Migrated / moved from the study area (MIG)
CL Item
Lost to follow-up. (LFU)
CL Item
Other (OTH)
Number of SAE
Item
Please specify SAE N°
integer
C0449788 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
specify protocol violation
Item
Please specify protocol violation.
text
C1709750 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
specify other reason
Item
Please specify other reason
text
C3840932 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
Item
Tick who took the decision for study withdrawal.
integer
C2348568 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,2])
CL Item
Investigator’s decision (1)
CL Item
Subject's decision (2)
Date of last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
Item
Compared to subject's medical condition at the beginning of the study (Day 0), is the medical condition the same at Month 7?
integer
C3899485 (UMLS CUI [1])
Code List
Compared to subject's medical condition at the beginning of the study (Day 0), is the medical condition the same at Month 7?
CL Item
Yes (1)
CL Item
No, please complete Medical Condition Questionnaire at Month 7. (2)
Investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Printed Investigator's name
Item
Printed Investigator's name
text
C2826892 (UMLS CUI [1])
Date of investigator's signature
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])