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42497

Beschreibung

Study ID: 106464 Clinical Study ID: 106464 Study Title: A Study of the Efficacy Against Episodes of Clinical Malaria Due to P. Falciparum Infection of GSK Biologicals Candidate Vaccine RTS, S/AS01, Administered According to a 0,1,2-months Schedule in Children Aged 5 to 17 Months Living in Tanzania & Kenya Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00380393 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK malaria vaccine 257049 Vaccine, Sanofi-Pasteur's Human Diploid Cell Rabies Vaccine Trade Name: N/A Study Indication: Malaria ODM derived from https://clinicaltrials.gov/ct2/show/study/NCT00380393. This Phase IIb randomized, double-blind, controlled study of the efficacy against episodes of clinical malaria due to Plasmodium falciparum infection of GlaxoSmithKline Biologicals’ candidate vaccine RTS, S/AS01E, administered IM according to a 0, 1, 2-month vaccination schedule in children aged 5 months to 17 months living in Tanzania and Kenya. This study includes the following 7 clinical study visits (3 different visit types) during a double-blind phase (Day -60 to Month 6 1/2) and a single-blind phase including an extension for a subset of patients (month 7 to month 14). Clinical visit 1: Baseline visit, screening, and randomisation (DAY -60 to 0) Clinical visit 2: Vaccination I (MONTH 0, DAY 0 | DOSE 1 | 0 - 60 DAYS AFTER VISIT 1) Clinical visit 3: Vaccination II (MONTH 1, DAY 30 | DOSE 2 | 21 - 35 DAYS AFTER VISIT 2) Clinical visit 4: Vaccination III (MONTH 2, DAY 60 | DOSE 3 | 21 - 35 DAYS AFTER VISIT 3) Clinical visit 5: Blood Sample, ACD (MONTH 3, DAY 90 | 21 - 42 DAYS AFTER VISIT 4) Clinical visit 6: Blood Sample, ACD (MONTH 6 1/2 | CROSS-SECTIONAL VISIT FOR ACD | FINAL STUDY VISIT FOR DOUBLE-BLIND PHASE) Clinical visit 7: Blood Sample, ACD (MONTH 14 | FINAL STUDY VISIT SINGLE-BLIND PHASE) Field-worker home visits: During the vaccination period, clinical visits are accompanied by daily field-worker visits for a one-week period subsequent to each vaccine administration at clinical visits 2, 3, and 4 (visit code 21-26 following clinical visit 2; visit code 27-32 following clinical visit 3; visit code 33-38 following clinical visit 4). After completion of the vaccination period, clinical visits are then accompanied by weekly field-worker home visits (visit code 39-40 following clinical visit 4/dose 3; visit code 41-55 following clinical visit 5; visit code 56-86 following clinical visit 6). These visits serve the additional purpose of Active Case Detection (ACD). Passive Case Detection (PCD) for clinical malaria disease is performed both during the course of the double-blind (day -60 to month 6 1/2) and the single-blind phase (month 7 to month 14). For all subjects enrolled, please complete the study conclusion form. 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/study/NCT00380393

Stichworte

Versionen (1)
  1. 2021-08-01 2021-08-01 -
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GlaxoSmithKline

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1 augusti 2021

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Creative Commons BY-NC 4.0
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    Efficacy of P. Falciparum Vaccine Against Malaria in Children NCT00380393

    Englisch

    Study Conclusion

    1 Formulare  
    1. StudyEvent: ODM
      1. Study Conclusion
    Administrative Documentation
    Beschreibung

    Administrative Documentation

    Alias
    UMLS CUI-1
    C1320722
    Date of visit
    Beschreibung

    Date of visit

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C1320303
    Subject number
    Beschreibung

    Subject number

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Please specify the study phase for which the form is filled in.
    Beschreibung

    Study phase

    Datentyp

    text

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

    Occurrence of Serious Adverse Events

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

    Serious adverse event during clinical trial period

    Datentyp

    boolean

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

    Serious adverse event during clinical trial period count specification

    Datentyp

    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, only to be completed for the double-blind phase questionnaire
    Beschreibung

    Status of Treatment Blind, only to be completed for the double-blind phase questionnaire

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

    Only to be completed for the double-blind phase questionnaire.

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0347984
    UMLS CUI [1,3]
    C2347804
    If yes, complete date.
    Beschreibung

    Subject unblinding event record date

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0011008
    If yes, tick one reason below.
    Beschreibung

    Complete Non-Serious Adverse Event section or a Serious Adverse Event report as appropriate.

    Datentyp

    text

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

    Subject unblinding event record other reason to specify

    Datentyp

    text

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

    Elimination Criteria

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

    Elimination criteria during clinical trial period

    Datentyp

    boolean

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

    Elimination criteria to specify

    Datentyp

    text

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

    Patient withdrawn from trial

    Datentyp

    boolean

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

    Please tick one box only. If serious adverse event [SAE], please complete and submit SAE report. If non-serious adverse event [AEX], please complete non-serious adverse event section. Note that non-serious adverse event [AEX] is only selectable as an option when completing the questionnaire for the double-blind phase.

    Datentyp

    text

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

    Death-related serious adverse event number to specify

    Datentyp

    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.
    Beschreibung

    Serious adverse event number to specify

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0237753
    UMLS CUI [1,3]
    C1521902
    If non-serious adverse event [AEX], please specify AE number.
    Beschreibung

    Or specify solicited AE code in the following item. Note that non-serious adverse events are only specifiable when completing the questionnaire for the double-blind phase.

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0237753
    UMLS CUI [1,3]
    C1521902
    If non-serious adverse event [AEX], please specify solicited adverse event code.
    Beschreibung

    Or specify non-serious adverse event number in the previous item. Note that non-serious adverse events are only specifiable when completing the questionnaire for the double-blind phase.

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C1517001
    UMLS CUI [1,3]
    C0805701
    UMLS CUI [1,4]
    C1521902
    If protocol violation [PTV], please specify.
    Beschreibung

    Protocol violation to specify

    Datentyp

    text

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

    Withdrawal other reason to specify

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C0566251
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [1,4]
    C1521902
    If yes, indicate who made the decision.
    Beschreibung

    Withdrawal decision maker

    Datentyp

    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.
    Beschreibung

    Withdrawal date of last contact

    Datentyp

    date

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

    If no, please give details in Adverse Events section.

    Datentyp

    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.
    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 date below.

    Alias
    UMLS CUI-1
    C2346576
    Investigator's signature
    Beschreibung

    Investigator signature

    Datentyp

    text

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

    Investigator name

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2826892
    Date
    Beschreibung

    Investigator signature date

    Datentyp

    date

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

    Study Conclusion

    1 Formulare
    1. StudyEvent: ODM
      1. Study Conclusion
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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
    Please specify the study phase for which the form is filled in.
    text
    C0205390 (UMLS CUI [1,1])
    C2603343 (UMLS CUI [1,2])
    Study phase
    Code List
    Please specify the study phase for which the form is filled in.
    CL Item
    double-blind phase ([D])
    CL Item
    single-blind phase ([S])
    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, only to be completed for the double-blind phase questionnaire
    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 period?
    boolean
    C3897431 (UMLS CUI [1,1])
    C0347984 (UMLS CUI [1,2])
    C2347804 (UMLS CUI [1,3])
    Subject unblinding event record date
    Item
    If yes, complete date.
    date
    C3897431 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    If yes, tick one reason below.
    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
    If yes, tick one reason below.
    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 period?
    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
    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])
    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])
    Non-serious adverse event number specification
    Item
    If non-serious adverse event [AEX], please specify AE number.
    integer
    C1518404 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    C1521902 (UMLS CUI [1,3])
    Item
    If non-serious adverse event [AEX], please specify solicited adverse event code.
    text
    C0877248 (UMLS CUI [1,1])
    C1517001 (UMLS CUI [1,2])
    C0805701 (UMLS CUI [1,3])
    C1521902 (UMLS CUI [1,4])
    Solicited adverse event code specification
    Code List
    If non-serious adverse event [AEX], please specify solicited adverse event code.
    CL Item
    Fever ([FE])
    CL Item
    Irritability/Fussiness ([IR])
    CL Item
    Drowsiness ([DR])
    CL Item
    Loss of appetite ([LO])
    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 yes, 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 yes, 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 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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