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25679

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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 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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  1. 09-09-17 09-09-17 -
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glaxoSmithKline

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9 september 2017

DOI

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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

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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

    1 Formulieren  
    Check for study continuation
    Beschrijving

    Check for study continuation

    Alias
    UMLS CUI-1
    C2348568
    Did the subject come at visit 4?
    Beschrijving

    study continuation status

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0805733
    UMLS CUI [1,3]
    C0008976
    Please tick the ONE most appropriate reason.
    Beschrijving

    Reson for non continuation

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C0566251
    Please specify SAE N°
    Beschrijving

    Number of SAE

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0449788
    Other, please specify
    Beschrijving

    e.g.: consent withdrawal, Protocol violation, ...

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C3840932
    UMLS CUI [1,3]
    C1521902
    Please tick who took the decision.
    Beschrijving

    Decision taker

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C0679006
    Blood sample
    Beschrijving

    Blood sample

    Alias
    UMLS CUI-1
    C0005834
    Has a blood sample been taken?
    Beschrijving

    Blood sample

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0005834
    Date of Blood sample
    Beschrijving

    Please complete only if different from visit date.

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0011008
    Concomitant vaccination
    Beschrijving

    Concomitant vaccination

    Alias
    UMLS CUI-1
    C0042196
    UMLS CUI-2
    C2347852
    Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
    Beschrijving

    Concomitant vaccination

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0042196
    UMLS CUI [1,2]
    C2347852
    Concomitant vaccination
    Beschrijving

    Concomitant vaccination

    Alias
    UMLS CUI-1
    C0042196
    UMLS CUI-2
    C2347852
    Trade / (Generic) Name
    Beschrijving

    Trade name

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0592503
    UMLS CUI [1,2]
    C0042210
    Route
    Beschrijving

    Route of vaccine administration

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C2368628
    UMLS CUI [1,2]
    C0449444
    Administration date
    Beschrijving

    Date of vaccine administration

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C2368628
    Medication
    Beschrijving

    Medication

    Alias
    UMLS CUI-1
    C0013227
    Have any medications/treatments been administered during study period?
    Beschrijving

    Concomitant medication

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C2347852
    Medication
    Beschrijving

    Medication

    Alias
    UMLS CUI-1
    C0013227
    Trade / Generic Name
    Beschrijving

    Trade / Generic Name of medication

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0592503
    UMLS CUI [1,2]
    C0013227
    Medical Indication
    Beschrijving

    Medical Indication for medication

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C3146298
    Prophylactic
    Beschrijving

    Prophylactic medication

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0420172
    Total daily dose
    Beschrijving

    Total daily dose of medication

    Datatype

    float

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C2348070
    Route
    Beschrijving

    Drug administration route

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0013153
    Start
    Beschrijving

    Start date of medication

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0808070
    End
    Beschrijving

    End date of medication

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0806020
    Medication continuing at the end of the study?
    Beschrijving

    Medication continuous

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0549178
    Medical status at study end (Month 7)
    Beschrijving

    Medical status at study end (Month 7)

    Alias
    UMLS CUI-1
    C3899485
    Is the medical condition of the subject now the same as it was at study entry?
    Beschrijving

    If 'no', please record below.

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C3899485
    Disease
    Beschrijving

    Disease

    Alias
    UMLS CUI-1
    C0012634
    Name of disease
    Beschrijving

    Disease

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0012634
    Start date
    Beschrijving

    Start date of disease

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0808070
    Requiring medication?
    Beschrijving

    If 'yes', please complete the medication section.

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0332121
    Follow-up- Studies
    Beschrijving

    Follow-up- Studies

    Alias
    UMLS CUI-1
    C0016441
    UMLS CUI-2
    C0042210
    Would the subject be willing to participate in a follow-up study?
    Beschrijving

    If "No", please specify the most appropriate reason.

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0016441
    UMLS CUI [1,2]
    C2348568
    Please specify the most appropriate reason.
    Beschrijving

    Reason for non participation in follow-up

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0016441
    UMLS CUI [1,2]
    C2348568
    UMLS CUI [1,3]
    C0566251
    Please specify Adverse Events, or Serious Adverse Events.
    Beschrijving

    specify Adverse Events

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0559546
    UMLS CUI [1,2]
    C1521902
    UMLS CUI [2,1]
    C1519255
    UMLS CUI [2,2]
    C1521902
    Specify other reason
    Beschrijving

    Other reason for no follow-up

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C3840932
    UMLS CUI [1,3]
    C1521902
    Occurrence of serious adverse event
    Beschrijving

    Occurrence of serious adverse event

    Alias
    UMLS CUI-1
    C1519255
    Did the subject experience any Serious Adverse Event during the study period?
    Beschrijving

    Serious adverse event

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1519255
    If yes, please give the total number of SAE's.
    Beschrijving

    Number of SAE

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0449788
    UMLS CUI [1,2]
    C1519255
    Pregnancy information
    Beschrijving

    Pregnancy information

    Alias
    UMLS CUI-1
    C0032961
    Did the subject become pregnant during the study?
    Beschrijving

    If yes, please complete the Pregnancy Notification form.

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0032961
    Elimination criteria
    Beschrijving

    Elimination criteria

    Alias
    UMLS CUI-1
    C0680251
    Did any elimination criteria become applicable during the study?
    Beschrijving

    Elimination criteria

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0680251
    Please specify elimination criteria.
    Beschrijving

    specify elimination criteria

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0680251
    UMLS CUI [1,2]
    C1521902
    Study conclusion
    Beschrijving

    Study conclusion

    Alias
    UMLS CUI-1
    C1707478
    UMLS CUI-2
    C0008972
    Was the subject withdrawn from study?
    Beschrijving

    Withdrawn from study

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    Please tick the ONE most appropriate category for drop out.
    Beschrijving

    Reason for withdrawal from study

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C0392360
    Please specify SAE N°
    Beschrijving

    Number of SAE

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0449788
    UMLS CUI [1,2]
    C1519255
    Please specify protocol violation.
    Beschrijving

    specify protocol violation

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C1709750
    UMLS CUI [1,2]
    C1521902
    Please specify other reason
    Beschrijving

    specify other reason

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C3840932
    UMLS CUI [1,2]
    C1521902
    UMLS CUI [1,3]
    C2348568
    Tick who took the decision for study withdrawal.
    Beschrijving

    decision study participation

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C0679006
    Date of last contact
    Beschrijving

    Date of last contact

    Datatype

    date

    Alias
    UMLS CUI [1]
    C0805839
    Compared to subject's medical condition at the beginning of the study (Day 0), is the medical condition the same at Month 7?
    Beschrijving

    Medical status

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C3899485
    Investigator's signature
    Beschrijving

    Investigator's signature

    Alias
    UMLS CUI-1
    C2346576
    Investigator's signature
    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

    Alias
    UMLS CUI [1]
    C2346576
    Printed Investigator's name
    Beschrijving

    Printed Investigator's name

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2826892
    Date
    Beschrijving

    Date of investigator's signature

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
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    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

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Check for study continuation
    C2348568 (UMLS CUI-1)
    Item
    Did the subject come at visit 4?
    integer
    C0545082 (UMLS CUI [1,1])
    C0805733 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [1,3])
    study continuation status
    Code List
    Did the subject come at visit 4?
    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])
    Reson for non continuation
    Code List
    Please tick the ONE most appropriate reason.
    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])
    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])
    Item
    Please tick who took the decision.
    integer
    C2348568 (UMLS CUI [1,1])
    C0679006 (UMLS CUI [1,2])
    Decision taker
    Code List
    Please tick who took the decision.
    CL Item
    Investigator’s decision  (1)
    CL Item
    Subject's decision (2)
    Item Group
    Blood sample
    C0005834 (UMLS CUI-1)
    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])
    Item Group
    Concomitant vaccination
    C0042196 (UMLS CUI-1)
    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])
    Concomitant vaccination
    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)
    Trade name
    Item
    Trade / (Generic) Name
    text
    C0592503 (UMLS CUI [1,1])
    C0042210 (UMLS CUI [1,2])
    Item
    Route
    text
    C2368628 (UMLS CUI [1,1])
    C0449444 (UMLS CUI [1,2])
    Route of vaccine administration
    Code List
    Route
    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])
    Item Group
    Medication
    C0013227 (UMLS CUI-1)
    Item
    Have any medications/treatments been administered during study period?
    integer
    C2347852 (UMLS CUI [1])
    Concomitant medication
    Code List
    Have any medications/treatments been administered during study period?
    CL Item
    No (1)
    CL Item
    Yes, please complete the following table. (2)
    Item Group
    Medication
    C0013227 (UMLS CUI-1)
    Trade / Generic Name of medication
    Item
    Trade / Generic Name
    text
    C0592503 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Medical Indication for medication
    Item
    Medical Indication
    text
    C0013227 (UMLS CUI [1,1])
    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])
    Item
    Route
    text
    C0013153 (UMLS CUI [1])
    Drug administration route
    Code List
    Route
    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])
    End date of medication
    Item
    End
    date
    C0013227 (UMLS CUI [1,1])
    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])
    Item Group
    Medical status at study end (Month 7)
    C3899485 (UMLS CUI-1)
    medical status
    Item
    Is the medical condition of the subject now the same as it was at study entry?
    boolean
    C3899485 (UMLS CUI [1])
    Item Group
    Disease
    C0012634 (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])
    Disease requires medication
    Item
    Requiring medication?
    boolean
    C0012634 (UMLS CUI [1,1])
    C0332121 (UMLS CUI [1,2])
    Item Group
    Follow-up- Studies
    C0016441 (UMLS CUI-1)
    C0042210 (UMLS CUI-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])
    Item
    Please specify the most appropriate reason.
    integer
    C0016441 (UMLS CUI [1,1])
    C2348568 (UMLS CUI [1,2])
    C0566251 (UMLS CUI [1,3])
    Reason for non participation in follow-up
    Code List
    Please specify the most appropriate reason.
    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])
    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])
    Item Group
    Occurrence of serious adverse event
    C1519255 (UMLS CUI-1)
    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])
    Item Group
    Pregnancy information
    C0032961 (UMLS CUI-1)
    Item
    Did the subject become pregnant during the study?
    integer
    C0032961 (UMLS CUI [1])
    Pregnancy
    Code List
    Did the subject become pregnant during the study?
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    Not applicable (not of childbearing potential or male) (3)
    Item Group
    Elimination criteria
    C0680251 (UMLS CUI-1)
    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])
    Item Group
    Study conclusion
    C1707478 (UMLS CUI-1)
    C0008972 (UMLS CUI-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])
    Reason for withdrawal from study
    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])
    specify protocol violation
    Item
    Please specify protocol violation.
    text
    C1709750 (UMLS CUI [1,1])
    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])
    Item
    Tick who took the decision for study withdrawal.
    integer
    C2348568 (UMLS CUI [1,1])
    C0679006 (UMLS CUI [1,2])
    decision study participation
    Code List
    Tick who took the decision for study withdrawal.
    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])
    Medical status
    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)
    Item Group
    Investigator's signature
    C2346576 (UMLS CUI-1)
    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])
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