ID

41661

Beschreibung

Study ID: 105874 Clinical Study ID: 105874 Study Title: Bridging Safety & Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine RTS,S/AS01E (0.5 mL Dose) to RTS,S/AS02D (0.5 mL Dose) Administered IM According to a 0, 1, 2-Month Schedule in Gabonese Children Aged 18 Months to 4 Years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00307021 https://clinicaltrials.gov/ct2/show/NCT00307021 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 Trade Name: N/A Study Indication: Malaria This study has a total of 7 visits. Visit 1 = Screening, Visits 2-6 are during the double-blind phase (Month 0-3) and Visit 7 is during the single-blind phase (Month 4-14). This form (Screening Conclusion) is to be filled out at Visit 1 (Day -28 to day 0).

Link

https://clinicaltrials.gov/ct2/show/NCT00307021

Stichworte

Versionen (2)
  1. 01.12.20 01.12.20 -
  2. 05.12.20 05.12.20 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

5. Dezember 2020

DOI

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Lizenz

Creative Commons BY-NC 4.0
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    Safety & Immunogenicity of two GSK Biologicals' Candidate Malaria Vaccines in young children, NCT00307021

    Englisch

    Screening Conclusion

    1 Formulare  
    1. StudyEvent: ODM
      1. Screening Conclusion
    Administrative Data
    Beschreibung

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Centre number
    Beschreibung

    Centre number

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0600091
    UMLS CUI [1,2]
    C0019994
    Subject number
    Beschreibung

    Subject number

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    Treatment number
    Beschreibung

    Treatment number

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1522541
    Date of visit
    Beschreibung

    Date of visit

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C1320303
    Screening Conclusion
    Beschreibung

    Screening Conclusion

    Alias
    UMLS CUI-1
    C1710477
    UMLS CUI-2
    C1707478
    Did the subject experience any Serious Adverse Event during screening? (only SAE related to study participation or to a concurrent medication need to be considered and reported)
    Beschreibung

    SAE during screening

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0347984
    UMLS CUI [1,3]
    C1710477
    If yes, specify total number of SAEs
    Beschreibung

    Number of SAEs during screening

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0449788
    UMLS CUI [1,2]
    C1519255
    UMLS CUI [1,3]
    C0347984
    UMLS CUI [1,4]
    C1710477
    Is the subject a screening failure? (Was the subject withdrawn prior to randomization or first vaccination?)
    Beschreibung

    Screen failure (withdrawn prior to randomization or first vaccination)

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1710476
    UMLS CUI [2,1]
    C0422727
    UMLS CUI [2,2]
    C0332152
    UMLS CUI [2,3]
    C0034656
    UMLS CUI [3,1]
    C0422727
    UMLS CUI [3,2]
    C0332152
    UMLS CUI [3,3]
    C0205435
    UMLS CUI [3,4]
    C0042196
    If yes, provide Major reason for failure (tick one box only)
    Beschreibung

    Major reason for screening failure

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1710476
    UMLS CUI [1,2]
    C1542147
    UMLS CUI [1,3]
    C0566251
    If protocol violation, please specify
    Beschreibung

    Reason for screening failure: protocol violation

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1710476
    UMLS CUI [1,2]
    C0566251
    UMLS CUI [1,3]
    C1709750
    UMLS CUI [1,4]
    C2348235
    If SAE please specify SAE No.
    Beschreibung

    Reason for screening failure: SAE

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C1710476
    UMLS CUI [1,2]
    C0566251
    UMLS CUI [1,3]
    C1519255
    UMLS CUI [1,4]
    C0237753
    If other reason, please specify
    Beschreibung

    Other reason for screening failure

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1710476
    UMLS CUI [1,2]
    C3840932
    UMLS CUI [1,3]
    C2348235
    Who made the decision?
    Beschreibung

    Decision

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0679006
    UMLS CUI [1,2]
    C1710476
    Investigator's signature
    Beschreibung

    Investigator's signature

    Alias
    UMLS CUI-1
    C2346576
    Investigator's signature
    Beschreibung

    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 dat below.

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2346576
    Date
    Beschreibung

    Date of investigator's signature

    Datentyp

    date

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

    Printed Investigator's name

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2826892
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Screening Conclusion

    1 Formulare
    1. StudyEvent: ODM
      1. Screening Conclusion
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Centre number
    Item
    Centre number
    text
    C0600091 (UMLS CUI [1,1])
    C0019994 (UMLS CUI [1,2])
    Subject number
    Item
    Subject number
    text
    C2348585 (UMLS CUI [1])
    Treatment number
    Item
    Treatment number
    text
    C1522541 (UMLS CUI [1])
    Date of visit
    Item
    Date of visit
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Screening Conclusion
    C1710477 (UMLS CUI-1)
    C1707478 (UMLS CUI-2)
    Item
    Did the subject experience any Serious Adverse Event during screening? (only SAE related to study participation or to a concurrent medication need to be considered and reported)
    text
    C1519255 (UMLS CUI [1,1])
    C0347984 (UMLS CUI [1,2])
    C1710477 (UMLS CUI [1,3])
    SAE during screening
    Code List
    Did the subject experience any Serious Adverse Event during screening? (only SAE related to study participation or to a concurrent medication need to be considered and reported)
    CL Item
    No (N)
    CL Item
    Yes, specify total number of SAEs (Y)
    Number of SAEs during screening
    Item
    If yes, specify total number of SAEs
    integer
    C0449788 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    C0347984 (UMLS CUI [1,3])
    C1710477 (UMLS CUI [1,4])
    Item
    Is the subject a screening failure? (Was the subject withdrawn prior to randomization or first vaccination?)
    text
    C1710476 (UMLS CUI [1])
    C0422727 (UMLS CUI [2,1])
    C0332152 (UMLS CUI [2,2])
    C0034656 (UMLS CUI [2,3])
    C0422727 (UMLS CUI [3,1])
    C0332152 (UMLS CUI [3,2])
    C0205435 (UMLS CUI [3,3])
    C0042196 (UMLS CUI [3,4])
    Screen failure (withdrawn prior to randomization or first vaccination)
    Code List
    Is the subject a screening failure? (Was the subject withdrawn prior to randomization or first vaccination?)
    CL Item
    No (N)
    CL Item
    Yes, provide major reason for failure (Y)
    Item
    If yes, provide Major reason for failure (tick one box only)
    text
    C1710476 (UMLS CUI [1,1])
    C1542147 (UMLS CUI [1,2])
    C0566251 (UMLS CUI [1,3])
    Major reason for screening failure
    Code List
    If yes, provide Major reason for failure (tick one box only)
    CL Item
    Eligibility criteria not fulfilled (inclusion and exclusion criteria; please tick failing criteria on Eligibility form) (ELI)
    CL Item
    Protocol violation, please specify (PTV)
    CL Item
    Serious Adverse Event (please complete and submit SAE report and specify SAE No.) (SAE)
    CL Item
    Consent withdrawal / not willing to participate, not due to a serious adverse event (CWS)
    CL Item
    Migrated /moved from the study area (MIG)
    CL Item
    Lost to follow-up (LFU)
    CL Item
    Other, please specify (OTH)
    Reason for screening failure: protocol violation
    Item
    If protocol violation, please specify
    text
    C1710476 (UMLS CUI [1,1])
    C0566251 (UMLS CUI [1,2])
    C1709750 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    Reason for screening failure: SAE
    Item
    If SAE please specify SAE No.
    integer
    C1710476 (UMLS CUI [1,1])
    C0566251 (UMLS CUI [1,2])
    C1519255 (UMLS CUI [1,3])
    C0237753 (UMLS CUI [1,4])
    Other reason for screening failure
    Item
    If other reason, please specify
    text
    C1710476 (UMLS CUI [1,1])
    C3840932 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Item
    Who made the decision?
    text
    C0679006 (UMLS CUI [1,1])
    C1710476 (UMLS CUI [1,2])
    Decision
    Code List
    Who made the decision?
    CL Item
    Investigator (I)
    CL Item
    Parents/Guardian (P)
    Item Group
    Investigator's signature
    C2346576 (UMLS CUI-1)
    Investigator's signature
    Item
    Investigator's signature
    text
    C2346576 (UMLS CUI [1])
    Date of investigator's signature
    Item
    Date
    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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