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ID

32088

Beschrijving

Study ID: 103992 Clinical Study ID: 103992 Study Title: Evaluate immunogenicity, reactogenicity & safety of 2 doses of GSK Biologicals’ oral live attenuated HRV vaccine (RIX4414 at 106.5 CCID50) when given concomitantly with OPV versus given alone (HRV vaccine dose given 15 days after the OPV dose) in healthy infants in Bangladesh Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00139334 https://clinicaltrials.gov/ct2/show/NCT00139334 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Rotavirus Vaccine Trade Name: Rotarix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis This form is to be filled in at study conclusion (whether it is regular or preterm)

Link

https://clinicaltrials.gov/ct2/show/NCT00139334

Trefwoorden

Versies (1)
  1. 17-10-18 17-10-18 - Sarah Riepenhausen
Houder van rechten

GlaxoSmithKline

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17 oktober 2018

DOI

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Licentie

Creative Commons BY-NC 3.0
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    GSK Biologicals' oral HRV vaccine given with OPV in infants NCT00139334

    Engels

    Study Conclusion

    1 Formulieren  
    1. StudyEvent: ODM
      1. Study Conclusion
    Administrative Data
    Beschrijving

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Number
    Beschrijving

    subject number

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C2348585
    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

    If yes, specify total number of SAE's in the following item.

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1519255
    Number of serious adverse events
    Beschrijving

    Number of serious adverse events

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0449788
    Status of treatment blind
    Beschrijving

    Status of treatment blind

    Alias
    UMLS CUI-1
    C2347038
    UMLS CUI-2
    C0449438
    UMLS CUI-3
    C3897431
    Was the treatment blind broken during the study?
    Beschrijving

    if yes, complete date and tick one reason below / fill out the following items.

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C2347038
    UMLS CUI [1,2]
    C0449438
    UMLS CUI [1,3]
    C3897431
    Date of break of treatment blind
    Beschrijving

    Date of break of treatment blind

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0011008
    Reason for breaking treatment blind
    Beschrijving

    Complete Non-Serious Adverse Event section or Serious Adverse Event form as appropriate.

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0392360
    Other reason for breaking treatment blind, specify:
    Beschrijving

    Other reason for breaking treatment blind

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C3845569
    UMLS CUI [1,3]
    C0392360
    Elimination Criteria
    Beschrijving

    Elimination Criteria

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

    If yes, specify in the following item.

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0680251
    Elimination criteria, specify:
    Beschrijving

    Elimination criteria, specification

    Datatype

    text

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

    Withdrawal from Study

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

    If yes, please tick the one most appropriate category for withdrawal in the following item.

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0422727
    Please tick the ONE most appropriate category for withdrawal.
    Beschrijving

    Reason for withdrawal from study

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C0566251
    If SAE, please specify SAE number
    Beschrijving

    SAE number

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2349022
    If unsolicited non-serious AE, please specify uncolicited AE number
    Beschrijving

    If solicited non-serious adverse event, please complete the solicited AE code item.

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0237753
    UMLS CUI [1,3]
    C4055646
    If solicited AE, please specify solicited AE code:
    Beschrijving

    If unsolicited non-serious adverse event, please complete the unsolicited AE number item.

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C1517001
    UMLS CUI [1,2]
    C0877248
    UMLS CUI [1,3]
    C0805701
    If protocol violation, please specify
    Beschrijving

    Protocol violation

    Datatype

    text

    Alias
    UMLS CUI [1]
    C1709750
    Other category, please specify:
    Beschrijving

    Other reason for withdrawal

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C3840932
    UMLS CUI [1,3]
    C1521902
    Please tick who took the decision:
    Beschrijving

    Person to decide about withdrawal

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C0679006
    If withdrawn, Date of last contact
    Beschrijving

    Date of last contact

    Datatype

    date

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

    If no, please give details within the Adverse Event section.

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1142435
    UMLS CUI [1,2]
    C0681850
    Investigator's signature
    Beschrijving

    Investigator's signature

    Alias
    UMLS CUI-1
    C2346576
    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. Investigator's Signature
    Beschrijving

    Investigator's signature

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2346576
    Date of signature
    Beschrijving

    Date of signature

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
    Printed investigator's name
    Beschrijving

    Printed investigator's name

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2826892
    Terug naar het begin van de pagina

    Similar models

    Study Conclusion

    1 Formulieren
    1. StudyEvent: ODM
      1. Study Conclusion
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    subject number
    Item
    Subject Number
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    Occurrence of Serious Adverse Event
    C1519255 (UMLS CUI-1)
    Occurence or serious adverse events
    Item
    Did the subject experience any Serious Adverse Event during the study period ?
    boolean
    C1519255 (UMLS CUI [1])
    Number of serious adverse events
    Item
    Number of serious adverse events
    integer
    C1519255 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    Item Group
    Status of treatment blind
    C2347038 (UMLS CUI-1)
    C0449438 (UMLS CUI-2)
    C3897431 (UMLS CUI-3)
    Status of treatment blind
    Item
    Was the treatment blind broken during the study?
    boolean
    C2347038 (UMLS CUI [1,1])
    C0449438 (UMLS CUI [1,2])
    C3897431 (UMLS CUI [1,3])
    Date of break of treatment blind
    Item
    Date of break of treatment blind
    date
    C3897431 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Reason for breaking treatment blind
    integer
    C3897431 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    Reason from breaking treatment blind
    Code List
    Reason for breaking treatment blind
    CL Item
    Medical emergency requiring identification of investigational product for further treatments (1)
    CL Item
    Other (9)
    Other reason for breaking treatment blind
    Item
    Other reason for breaking treatment blind, specify:
    text
    C3897431 (UMLS CUI [1,1])
    C3845569 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
    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])
    Elimination criteria, specification
    Item
    Elimination criteria, specify:
    text
    C0680251 (UMLS CUI [1,1])
    C1521902 (UMLS CUI [1,2])
    Item Group
    Withdrawal from Study
    C0422727 (UMLS CUI-1)
    Withdrawal from study
    Item
    Was the subject withdrawn from study?
    boolean
    C0422727 (UMLS CUI [1])
    Item
    Please tick the ONE most appropriate category for withdrawal.
    text
    C2348568 (UMLS CUI [1,1])
    C0566251 (UMLS CUI [1,2])
    Reason for withdrawal from study
    Code List
    Please tick the ONE most appropriate category for withdrawal.
    CL Item
    Serious adverse event (Check Serious adverse Event form and specify SAE number below). (SAE)
    CL Item
    Non-serious adverse event (Check the Non-serious adverse Event section and specify unsolicited AE number or solicited AE code below) (AEX)
    CL Item
    protocol viloation (please specify below) (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 (please, specify below) (OTH)
    SAE number
    Item
    If SAE, please specify SAE number
    integer
    C1519255 (UMLS CUI [1,1])
    C2349022 (UMLS CUI [1,2])
    unsolicited AE number
    Item
    If unsolicited non-serious AE, please specify uncolicited AE number
    integer
    C1518404 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    C4055646 (UMLS CUI [1,3])
    Solicited AE code
    Item
    If solicited AE, please specify solicited AE code:
    text
    C1517001 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    C0805701 (UMLS CUI [1,3])
    Protocol violation
    Item
    If protocol violation, please specify
    text
    C1709750 (UMLS CUI [1])
    Other reason for withdrawal
    Item
    Other category, please specify:
    text
    C0422727 (UMLS CUI [1,1])
    C3840932 (UMLS CUI [1,2])
    C1521902 (UMLS CUI [1,3])
    Item
    Please tick who took the decision:
    text
    C0422727 (UMLS CUI [1,1])
    C0679006 (UMLS CUI [1,2])
    Person to decide about withdrawal
    Code List
    Please tick who took the decision:
    CL Item
    investigator (I)
    CL Item
    parents/guardians (P)
    Date of last contact
    Item
    If withdrawn, Date of last contact
    date
    C0805839 (UMLS CUI [1])
    Condition at last contact
    Item
    Was the subject in good condition at date of last contact?
    boolean
    C1142435 (UMLS CUI [1,1])
    C0681850 (UMLS CUI [1,2])
    Item Group
    Investigator's signature
    C2346576 (UMLS CUI-1)
    Investigator's signature
    Item
    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. 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])
    Terug naar het begin van de pagina 

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