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42540

Description

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 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 ODM derived from https://clinicaltrials.gov/ct2/show/NCT00307021. A Phase II randomized, double-blind bridging study of the safety and immunogenicity of GlaxoSmithKline Plasmodium falciparum 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 vaccination schedule in children aged 18 months to 4 years living in Gabon. Clinical Visits: 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). Vaccine administration takes place during visits 2, 4, and 5 (Visit 2 = Dose 1; Visit 4 = Dose 2; Visit 5 = Dose 3). Field-worker Visits: During the double-blind phase, clinical visits are accompanied by daily field-worker visits subsequent to each vaccine administration visit. Additional field-worker visits also take place during months 4 to 13 of the single-blind phase. For all subjects enrolled, please complete the study conclusion form. The study conclusion should be documented subsequently to clinical visit 7 in separate forms for the double-blind and the single-blind phase respectively. The 'Status of Treatment Blind' item group only needs to be completed within the form for the double-blind phase. Note that informed consent has to be obtained prior to any study procedure.

Link

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

Keywords

Versions (1)
  1. 8/24/21 8/24/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 24, 2021

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License

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

    English

    Study Conclusion

    1 forms  
    1. StudyEvent: ODM
      1. Study Conclusion
    Administrative Documentation
    Description

    Administrative Documentation

    Alias
    UMLS CUI-1
    C1320722
    Date of visit
    Description

    Date of visit

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Subject number
    Description

    Subject number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Study phase
    Description

    Please specify the study phase for which the form is filled in.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0205390
    UMLS CUI [1,2]
    C2603343
    Occurrence of Serious Adverse Events
    Description

    Occurrence of Serious Adverse Events

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

    Serious adverse event during clinical trial period

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0347984
    UMLS CUI [1,3]
    C2347804
    If yes, specify total number of SAEs.
    Description

    Serious adverse event during clinical trial period count specification

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0347984
    UMLS CUI [1,3]
    C2347804
    UMLS CUI [1,4]
    C0750480
    UMLS CUI [1,5]
    C1521902
    Status of Treatment Blind
    Description

    Status of Treatment Blind

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

    Only to be completed for the double-blind phase version of the form. If yes, complete date and tick one reason in the following items.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0347984
    UMLS CUI [1,3]
    C2347804
    Date of breaking treatment blind
    Description

    Subject unblinding event record date

    Data type

    date

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

    Please tick one reason. If [9] other, please specify in the following item. Also complete Non-Serious Adverse Event section or a Serious Adverse Event report as appropriate.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0566251
    UMLS CUI [1,3]
    C0205225
    If other, please specify
    Description

    Subject unblinding event record other reason to specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0566251
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [1,4]
    C1521902
    Elimination Criteria
    Description

    Elimination Criteria

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

    Elimination criteria during clinical trial period

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0680251
    UMLS CUI [1,2]
    C0347984
    UMLS CUI [1,3]
    C2347804
    If yes, please specify.
    Description

    Elimination criteria to specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0680251
    UMLS CUI [1,2]
    C1521902
    Was the subject withdrawn from the study?
    Description

    For the double-blind phase: Is the subject withdrawn from the double-blind phase? (A subject is withdrawn from the interim analysis if he/she did not come for the doublie blind phase - interim analysis timepoint visit.)

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0422727
    If yes, indicate the major reason for withdrawal.
    Description

    Please tick one box only. If serious adverse event [SAE], please complete and submit SAE report.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C0566251
    UMLS CUI [1,3]
    C0205225
    If death [DEA], please specify SAE number.
    Description

    Death-related serious adverse event number to specify

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1705232
    UMLS CUI [1,2]
    C1519255
    UMLS CUI [1,3]
    C0237753
    UMLS CUI [1,4]
    C1521902
    If serious adverse event [SAE], please specify SAE number.
    Description

    Serious adverse event number to specify

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0237753
    UMLS CUI [1,3]
    C1521902
    If protocol violation [PTV], please specify.
    Description

    Protocol violation to specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1709750
    UMLS CUI [1,2]
    C1521902
    If other [OTH], please specify.
    Description

    Withdrawal other reason to specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C0566251
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [1,4]
    C1521902
    If subject was withdrawn from the study, indicate who made the decision.
    Description

    Withdrawal decision maker

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C0679006
    If subject was withdrawn from the study, indicate the date of the last contact.
    Description

    Withdrawal date of last contact

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C0805839
    If subject was withdrawn from the study, was the subject in good condition at date of last contact?
    Description

    If no, please give details in Adverse Events section.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C1142435
    UMLS CUI [1,3]
    C0805839
    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.
    Description

    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.

    Alias
    UMLS CUI-1
    C2346576
    Investigator's signature
    Description

    Investigator signature

    Data type

    text

    Alias
    UMLS CUI [1]
    C2346576
    Printed investigator's name
    Description

    Investigator name

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826892
    Date
    Description

    Investigator signature date

    Data type

    date

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

    Study Conclusion

    1 forms
    1. StudyEvent: ODM
      1. Study Conclusion
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Documentation
    C1320722 (UMLS CUI-1)
    Date of visit
    Item
    Date of visit
    date
    C1320303 (UMLS CUI [1])
    Subject number
    Item
    Subject number
    integer
    C2348585 (UMLS CUI [1])
    Item
    Study phase
    integer
    C0205390 (UMLS CUI [1,1])
    C2603343 (UMLS CUI [1,2])
    Study phase
    Code List
    Study phase
    CL Item
    double-blind phase (1)
    (Comment:en)
    CL Item
    single-blind phase (2)
    (Comment:en)
    Item Group
    Occurrence of Serious Adverse Events
    C1519255 (UMLS CUI-1)
    Serious adverse event during clinical trial period
    Item
    Did the subject experience any Serious Adverse Event during the study period?
    boolean
    C1519255 (UMLS CUI [1,1])
    C0347984 (UMLS CUI [1,2])
    C2347804 (UMLS CUI [1,3])
    Serious adverse event during clinical trial period count specification
    Item
    If yes, specify total number of SAEs.
    integer
    C1519255 (UMLS CUI [1,1])
    C0347984 (UMLS CUI [1,2])
    C2347804 (UMLS CUI [1,3])
    C0750480 (UMLS CUI [1,4])
    C1521902 (UMLS CUI [1,5])
    Item Group
    Status of Treatment Blind
    C0749659 (UMLS CUI-1)
    C2347038 (UMLS CUI-2)
    Subject unblinding event record during clinical trial period
    Item
    Was the treatment blind broken during the study?
    boolean
    C3897431 (UMLS CUI [1,1])
    C0347984 (UMLS CUI [1,2])
    C2347804 (UMLS CUI [1,3])
    Subject unblinding event record date
    Item
    Date of breaking treatment blind
    date
    C3897431 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Reason for breaking treatment blind
    text
    C3897431 (UMLS CUI [1,1])
    C0566251 (UMLS CUI [1,2])
    C0205225 (UMLS CUI [1,3])
    Subject unblinding event record reason and justification
    Code List
    Reason for breaking treatment blind
    CL Item
    Medical emergency requiring identification of investigational product for further treatments ([1])
    CL Item
    Other ([9])
    Subject unblinding event record other reason to specify
    Item
    If other, please specify
    text
    C3897431 (UMLS CUI [1,1])
    C0566251 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C1521902 (UMLS CUI [1,4])
    Item Group
    Elimination Criteria
    C0680251 (UMLS CUI-1)
    Elimination criteria during clinical trial period
    Item
    Did any elimination criteria become applicable during the study?
    boolean
    C0680251 (UMLS CUI [1,1])
    C0347984 (UMLS CUI [1,2])
    C2347804 (UMLS CUI [1,3])
    Elimination criteria to specify
    Item
    If yes, please specify.
    text
    C0680251 (UMLS CUI [1,1])
    C1521902 (UMLS CUI [1,2])
    Patient withdrawn from trial
    Item
    Was the subject withdrawn from the study?
    boolean
    C0422727 (UMLS CUI [1])
    Item
    If yes, indicate the major reason for withdrawal.
    text
    C0422727 (UMLS CUI [1,1])
    C0566251 (UMLS CUI [1,2])
    C0205225 (UMLS CUI [1,3])
    Withdrawal reason and justification primary
    Code List
    If yes, indicate the major reason for withdrawal.
    CL Item
    Death ([DEA])
    CL Item
    Serious adverse event ([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])
    Death-related serious adverse event number to specify
    Item
    If death [DEA], please specify SAE number.
    integer
    C1705232 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    C0237753 (UMLS CUI [1,3])
    C1521902 (UMLS CUI [1,4])
    Serious adverse event number to specify
    Item
    If serious adverse event [SAE], please specify SAE number.
    integer
    C1519255 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    C1521902 (UMLS CUI [1,3])
    Protocol violation to specify
    Item
    If protocol violation [PTV], please specify.
    text
    C1709750 (UMLS CUI [1,1])
    C1521902 (UMLS CUI [1,2])
    Withdrawal other reason to specify
    Item
    If other [OTH], please specify.
    text
    C0422727 (UMLS CUI [1,1])
    C0566251 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C1521902 (UMLS CUI [1,4])
    Item
    If subject was withdrawn from the study, indicate who made the decision.
    text
    C0422727 (UMLS CUI [1,1])
    C0679006 (UMLS CUI [1,2])
    Trial Screen Failure | withdrawal before randomization | withdrawal before vaccination
    Code List
    If subject was withdrawn from the study, indicate who made the decision.
    CL Item
    Investigator ([I])
    CL Item
    Parents/Guardians ([P])
    Withdrawal date of last contact
    Item
    If subject was withdrawn from the study, indicate the date of the last contact.
    date
    C0422727 (UMLS CUI [1,1])
    C0805839 (UMLS CUI [1,2])
    Withdrawal general physical condition date last contact
    Item
    If subject was withdrawn from the study, was the subject in good condition at date of last contact?
    boolean
    C0422727 (UMLS CUI [1,1])
    C1142435 (UMLS CUI [1,2])
    C0805839 (UMLS CUI [1,3])
    Item Group
    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.
    C2346576 (UMLS CUI-1)
    Investigator signature
    Item
    Investigator's signature
    text
    C2346576 (UMLS CUI [1])
    Investigator name
    Item
    Printed investigator's name
    text
    C2826892 (UMLS CUI [1])
    Investigator signature date
    Item
    Date
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
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