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ID

32305

Beskrivning

Study ID: 109563 Clinical Study ID: 109563 Study Title: COMPAS:A phase III study to demonstrate efficacy of GSK Biologicals' 10-valent pneumococcal vaccine (GSK1024850A) against Community Acquired Pneumonia and Acute Otitis Media Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier https://clinicaltrials.gov/ct2/show/NCT00466947 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) Trade Name: BIO 10PN-PD-DIT; Synflorix Study Indication: Infections, Streptococcal The Study consists of three workbooks. Workbook 1: Argentina, all subjects + immuno & reacto subset Workbook 2: Panama, all subjects + immuno & reacto subset + carriage subset + additional immuno subset Workbook 3: Colombia, all subjects The protocol number for all workbooks: 109563 (10Pn-PD-DiT-028) There are ten visits in workbook 1 and 2, eight for workbook 3 (there are no visits 4 and 7): Visit 1: month 0, dose 1, 6-16 weeks of age Visit 2: month 2, dose 2, +/- 4 months of age, 49-83 days after visit 1 Visit 3: month 4, dose 3, +/- 6 months of age, 49-83 days after visit 2 Visit 4: month 5, +/- 7 months of age, 28-42 days after visit 3. Only for immuno & reacto subset + carriage subset. Visit 5: month 10-13, 12-15 months of age Visit 6: month 13-16, booster dose, 15-18 months of age, ≥ 28 days after visit 5 Visit 7: month 14-17, 16-19 months of age, 28-42 days after visit 6. Only for immuno & reacto subset, additional immuno subset + carriage subset. Visit 8: month 16-19, 18-21 months of age, ≥ 28 days after visit 6 Visit 9: month 22-25, 24-27 months of age Visit 10: Contact This document contains the study conclusion form. It's for all workbooks.

Länk

https://clinicaltrials.gov/ct2/show/NCT00466947

Nyckelord

Versioner (2)
  1. 2018-10-26 2018-10-26 -
  2. 2018-10-27 2018-10-27 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

26 oktober 2018

DOI

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Creative Commons BY-NC 3.0
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    Vaccination against pneumonia and otitis media, NCT00466947

    Engelsk

    Study conclusion

    1 Formulär  
    1. StudyEvent: ODM
      1. Study conclusion
    Administrative data
    Beskrivning

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject number
    Beskrivning

    Subject number

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    Workbook number
    Beskrivning

    Workbook number

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C2986015
    Date of study conclusion
    Beskrivning

    Date of study conclusion

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C1707478
    UMLS CUI [1,2]
    C0008972
    UMLS CUI [1,3]
    C0011008
    STUDY CONCLUSION: OCCURRENCE OF SERIOUS ADVERSE EVENT
    Beskrivning

    STUDY CONCLUSION: OCCURRENCE OF SERIOUS ADVERSE EVENT

    Alias
    UMLS CUI-1
    C1707478
    UMLS CUI-2
    C0008972
    UMLS CUI-3
    C1519255
    Did the subject experience any Serious Adverse Event during the study?
    Beskrivning

    Serious Adverse Event during study

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0347984
    UMLS CUI [1,3]
    C0008972
    If Serious Adverse Event during the study occured, please specify total number of SAE's
    Beskrivning

    Total number of SAE's

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0449788
    UMLS CUI [1,2]
    C1519255
    STATUS OF TREATMENT BLIND
    Beskrivning

    STATUS OF TREATMENT BLIND

    Alias
    UMLS CUI-1
    C0749659
    UMLS CUI-2
    C2347038
    Was the treatment blind broken during the study?
    Beskrivning

    Complete Serious Adverse Event report as appropriate. For workbook 2 you can also complete Non-Serious Adverse Event section as appropriate.

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0749659
    UMLS CUI [1,2]
    C2347038
    If treatment was blind broken, complete the date
    Beskrivning

    Treatment blind broken, date

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0749659
    UMLS CUI [1,3]
    C2347038
    Treatment blind broken, reason
    Beskrivning

    Treatment blind broken, reason

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0749659
    UMLS CUI [1,2]
    C2347038
    UMLS CUI [1,3]
    C0566251
    If other reason for treatment blind broken, please specify
    Beskrivning

    Other reason for treatment blind broken

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0749659
    UMLS CUI [1,2]
    C2347038
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [1,4]
    C0566251
    ELIMINATION CRITERIA
    Beskrivning

    ELIMINATION CRITERIA

    Alias
    UMLS CUI-1
    C0680251
    Did any elimination criteria become applicable since last visit?
    Beskrivning

    Please tick all that applies in following items.

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0680251
    UMLS CUI [1,2]
    C1706839
    Chronic administration of immunosuppressants or other immune-modifying drugs.
    Beskrivning

    Chronic administration is defined as more than 14 days

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0680251
    UMLS CUI [1,2]
    C0021081
    UMLS CUI [1,3]
    C0205191
    UMLS CUI [1,4]
    C0005525
    Major congenital defects or serious chronic illness.
    Beskrivning

    Elimination criteria: Major congenital defects/serious chronic illness.

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0680251
    UMLS CUI [2,1]
    C0220810
    UMLS CUI [2,2]
    C0205164
    UMLS CUI [3,1]
    C0008679
    UMLS CUI [3,2]
    C0205404
    Any confirmed or suspected immunosuppressive or immunodeficient condition.
    Beskrivning

    Elimination criteria: confirmed/suspected immunosuppressive/immunodeficient condition.

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0680251
    UMLS CUI [2,1]
    C0750484
    UMLS CUI [2,2]
    C3829792
    UMLS CUI [3,1]
    C0750484
    UMLS CUI [3,2]
    C4048329
    UMLS CUI [4,1]
    C0242114
    UMLS CUI [4,2]
    C3829792
    UMLS CUI [5,1]
    C0242114
    UMLS CUI [5,2]
    C4048329
    Administration of immunoglobulins and/or any blood derived products.
    Beskrivning

    Elimination criteria: immunoglobulins/any blood derived products

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0680251
    UMLS CUI [2]
    C0021027
    UMLS CUI [3]
    C0456388
    Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s).
    Beskrivning

    Elimination criteria: use of investigational or non-registered product

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0680251
    UMLS CUI [2,1]
    C0304229
    UMLS CUI [2,2]
    C0042210
    UMLS CUI [2,3]
    C1444655
    UMLS CUI [2,4]
    C2348563
    Withdrawing from study
    Beskrivning

    Withdrawing from study

    Alias
    UMLS CUI-1
    C0422727
    Was the subject withdrawn from the study?
    Beskrivning

    If yes, note major reason. Therefore tick one of the following items

    Datatyp

    text

    Reason for withdrawal
    Beskrivning

    If you tick SAE, please complete and submit SAE report. If you tick AEX, please complete Non-serious Adverse Event section.

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C0392360
    UMLS CUI [1,3]
    C0008976
    If SAE, please specify SAE Number
    Beskrivning

    Please complete and submit SAE report

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0237753
    If AEX, please specify AE Number
    Beskrivning

    Please complete Non-serious Adverse Event section

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0237753
    If AEX, please specify solicited AE Code
    Beskrivning

    In workbook 1 and 2 only for immuno and reato subset.

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0683368
    UMLS CUI [1,2]
    C1517001
    UMLS CUI [1,3]
    C1518404
    UMLS CUI [1,4]
    C0805701
    If protocol violation, please specify
    Beskrivning

    Protocol violation

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C1709750
    If other reason for withdrawal, please specify
    Beskrivning

    Withdrawal, other reason

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C3840932
    Who made the decision
    Beskrivning

    Dicision made by

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0679006
    Date of last contact
    Beskrivning

    Date of last contact

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C0805839
    Was the subject in good condition at date of last contact
    Beskrivning

    If you tick No, please give details in Adverse Events section.

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0805839
    UMLS CUI [1,2]
    C1142435
    INVESTIGATOR'S SIGNATURE
    Beskrivning

    INVESTIGATOR'S SIGNATURE

    Alias
    UMLS CUI-1
    C2346576
    Investigator's signature
    Beskrivning

    Investigator's signature

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2346576
    Date of signature
    Beskrivning

    Date of signature

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
    Printed Investigator's name
    Beskrivning

    Printed Investigator's name

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2826892
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    Similar models

    Study conclusion

    1 Formulär
    1. StudyEvent: ODM
      1. Study conclusion
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject number
    Item
    Subject number
    text
    C2348585 (UMLS CUI [1])
    Item
    Workbook number
    integer
    C2986015 (UMLS CUI [1])
    Workbook number
    Code List
    Workbook number
    CL Item
    workbook 1 (1)
    CL Item
    workbook 2 (2)
    CL Item
    workbook 3 (3)
    Date of study conclusion
    Item
    Date of study conclusion
    date
    C1707478 (UMLS CUI [1,1])
    C0008972 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item Group
    STUDY CONCLUSION: OCCURRENCE OF SERIOUS ADVERSE EVENT
    C1707478 (UMLS CUI-1)
    C0008972 (UMLS CUI-2)
    C1519255 (UMLS CUI-3)
    Item
    Did the subject experience any Serious Adverse Event during the study?
    text
    C1519255 (UMLS CUI [1,1])
    C0347984 (UMLS CUI [1,2])
    C0008972 (UMLS CUI [1,3])
    Serious Adverse Event during study
    Code List
    Did the subject experience any Serious Adverse Event during the study?
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Total number of SAE's
    Item
    If Serious Adverse Event during the study occured, please specify total number of SAE's
    integer
    C0449788 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Item Group
    STATUS OF TREATMENT BLIND
    C0749659 (UMLS CUI-1)
    C2347038 (UMLS CUI-2)
    Item
    Was the treatment blind broken during the study?
    text
    C0749659 (UMLS CUI [1,1])
    C2347038 (UMLS CUI [1,2])
    Treatment blind broken
    Code List
    Was the treatment blind broken during the study?
    CL Item
    No  (N)
    CL Item
    Yes (Y)
    Treatment blind broken, date
    Item
    If treatment was blind broken, complete the date
    date
    C0011008 (UMLS CUI [1,1])
    C0749659 (UMLS CUI [1,2])
    C2347038 (UMLS CUI [1,3])
    Item
    Treatment blind broken, reason
    integer
    C0749659 (UMLS CUI [1,1])
    C2347038 (UMLS CUI [1,2])
    C0566251 (UMLS CUI [1,3])
    Treatment blind broken, reason
    Code List
    Treatment blind broken, reason
    CL Item
    Medical emergency requiring identification of investigational product for further treatments (1)
    CL Item
    Other (9)
    Other reason for treatment blind broken
    Item
    If other reason for treatment blind broken, please specify
    text
    C0749659 (UMLS CUI [1,1])
    C2347038 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C0566251 (UMLS CUI [1,4])
    Item Group
    ELIMINATION CRITERIA
    C0680251 (UMLS CUI-1)
    Item
    Did any elimination criteria become applicable since last visit?
    text
    C0680251 (UMLS CUI [1,1])
    C1706839 (UMLS CUI [1,2])
    Elimination criteria become applicable
    Code List
    Did any elimination criteria become applicable since last visit?
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Elimination criteria: immunosuppressants/immune-modifying drugs
    Item
    Chronic administration of immunosuppressants or other immune-modifying drugs.
    boolean
    C0680251 (UMLS CUI [1,1])
    C0021081 (UMLS CUI [1,2])
    C0205191 (UMLS CUI [1,3])
    C0005525 (UMLS CUI [1,4])
    Elimination criteria: Major congenital defects/serious chronic illness.
    Item
    Major congenital defects or serious chronic illness.
    boolean
    C0680251 (UMLS CUI [1])
    C0220810 (UMLS CUI [2,1])
    C0205164 (UMLS CUI [2,2])
    C0008679 (UMLS CUI [3,1])
    C0205404 (UMLS CUI [3,2])
    Elimination criteria: confirmed/suspected immunosuppressive/immunodeficient condition.
    Item
    Any confirmed or suspected immunosuppressive or immunodeficient condition.
    boolean
    C0680251 (UMLS CUI [1])
    C0750484 (UMLS CUI [2,1])
    C3829792 (UMLS CUI [2,2])
    C0750484 (UMLS CUI [3,1])
    C4048329 (UMLS CUI [3,2])
    C0242114 (UMLS CUI [4,1])
    C3829792 (UMLS CUI [4,2])
    C0242114 (UMLS CUI [5,1])
    C4048329 (UMLS CUI [5,2])
    Elimination criteria: immunoglobulins/any blood derived products
    Item
    Administration of immunoglobulins and/or any blood derived products.
    boolean
    C0680251 (UMLS CUI [1])
    C0021027 (UMLS CUI [2])
    C0456388 (UMLS CUI [3])
    Elimination criteria: use of investigational or non-registered product
    Item
    Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s).
    boolean
    C0680251 (UMLS CUI [1])
    C0304229 (UMLS CUI [2,1])
    C0042210 (UMLS CUI [2,2])
    C1444655 (UMLS CUI [2,3])
    C2348563 (UMLS CUI [2,4])
    Item Group
    Withdrawing from study
    C0422727 (UMLS CUI-1)
    Item
    Was the subject withdrawn from the study?
    text
    Withdrawal from study
    Code List
    Was the subject withdrawn from the study?
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Item
    Reason for withdrawal
    text
    C2349954 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [1,3])
    Reason for withdrawal
    Code List
    Reason for withdrawal
    CL Item
    Serious adverse event (SAE)
    CL Item
    Non-Serious adverse event (AEX)
    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)
    SAE Number
    Item
    If SAE, please specify SAE Number
    integer
    C1519255 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    AE Number
    Item
    If AEX, please specify AE Number
    integer
    C1518404 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Solicited AE Code
    Item
    If AEX, please specify solicited AE Code
    integer
    C0683368 (UMLS CUI [1,1])
    C1517001 (UMLS CUI [1,2])
    C1518404 (UMLS CUI [1,3])
    C0805701 (UMLS CUI [1,4])
    Protocol violation
    Item
    If protocol violation, please specify
    text
    C1709750 (UMLS CUI [1])
    Withdrawal, other reason
    Item
    If other reason for withdrawal, please specify
    text
    C2349954 (UMLS CUI [1,1])
    C3840932 (UMLS CUI [1,2])
    Item
    Who made the decision
    text
    C0679006 (UMLS CUI [1])
    Dicision made by
    Code List
    Who made the decision
    CL Item
    Investigator  (I)
    CL Item
    Parents/Guardians (P)
    Date of last contact
    Item
    Date of last contact
    date
    C0805839 (UMLS CUI [1])
    Item
    Was the subject in good condition at date of last contact
    text
    C0805839 (UMLS CUI [1,1])
    C1142435 (UMLS CUI [1,2])
    Condition at date of last contact
    Code List
    Was the subject in good condition at date of last contact
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Item Group
    INVESTIGATOR'S SIGNATURE
    C2346576 (UMLS CUI-1)
    Investigator's signature
    Item
    Investigator's signature
    text
    C2346576 (UMLS CUI [1])
    Date of signature
    Item
    Date of signature
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Printed Investigator's name
    Item
    Printed Investigator's name
    text
    C2826892 (UMLS CUI [1])
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