0 Evaluaciones
ID

36627

Descripción

Study ID: 102394 Clinical Study ID: 102394 Study Title: A Phase IV, partially double-blind study to demonstrate non-inferiority of GSK Biologicals’ Mencevax™ ACWY (new process) versus Mencevax™ ACWY (current process) when administered as a single dose to subjects aged 2-30 yrs Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00227422 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed clinical study under GSK sponsorship. The product that is studied in this clinical study, together with the rights to the data and results generated, has been transferred by GSK to Pfizer. GSK’s Clinical Study Register is no longer maintained for this study. To request access to clinical study data from Pfizer, go here: http://www.pfizer.com/research/clinical_trials/trial_data_and_results Generic Name: Meningococcal Serogroups A, C, W-135 and Y Vaccine Trade Name: Mencevax Study Indication: Infections, Meningococcal

Link

http://www.pfizer.com/research/clinical_trials/trial_data_and_results

Palabras clave

Versiones (1)
  1. 26/5/19 26/5/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

26 de mayo de 2019

DOI

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Licencia

Creative Commons BY-NC 3.0
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    Mencevax™ ACWY (new process) versus Mencevax™ ACWY (current process); NCT00227422

    Inglés

    Study Conclusion

    1 formularios  
    1. StudyEvent: ODM
      1. Study Conclusion
    Administrative Data
    Descripción

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Number
    Descripción

    Clinical Trial Subject Unique Identifier

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Occurrence of Serious Adverse Event
    Descripción

    Occurrence of Serious Adverse Event

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

    Serious Adverse Event

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1519255
    If Yes, specify total number of SAE's
    Descripción

    Serious Adverse Event, Count of entities

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0449788
    Pregnancy Information
    Descripción

    Pregnancy Information

    Alias
    UMLS CUI-1
    C0032961
    UMLS CUI-2
    C1533716
    Did the subject become pregnant during the study?
    Descripción

    Pregnancy, Clinical Trials

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0032961
    UMLS CUI [1,2]
    C0008976
    Status of Treatment Blind
    Descripción

    Status of Treatment Blind

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

    Subject Unblinding Event Record

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C3897431
    Complete Date
    Descripción

    Subject Unblinding Event Record, Date in time

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0011008
    Tick one reason below
    Descripción

    Subject Unblinding Event Record, Indication

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0392360
    Elimination Criteria
    Descripción

    Elimination Criteria

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

    Exclusion Criteria

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0680251
    Specify
    Descripción

    Exclusion Criteria

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0680251
    Withdraw
    Descripción

    Withdraw

    Alias
    UMLS CUI-1
    C2349954
    Was the subject withdrawn from the study?
    Descripción

    Withdraw

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C2349954
    Major reason for withdrawal (tick one box only).
    Descripción

    Withdraw, Indication

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C3146298
    UMLS CUI [1,3]
    C1522508
    Specifications
    Descripción

    Withdraw, Indication, Details

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C3146298
    UMLS CUI [1,3]
    C1522508
    Please tick who took decision
    Descripción

    Withdraw, Decision

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C0679006
    Date of last contact
    Descripción

    Withdraw, Date last contact

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C0805839
    Was the subject in good condition at date of last contact?
    Descripción

    Withdraw, Date last contact, General physical condition

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C0805839
    UMLS CUI [1,3]
    C1142435
    Investigator's Signature
    Descripción

    Investigator's Signature

    Alias
    UMLS CUI-1
    C2346576
    Investigator's signature
    Descripción

    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.

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2346576
    Date
    Descripción

    Investigator Signature, Date in time

    Tipo de datos

    date

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

    Investigator Name

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2826892
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    Similar models

    Study Conclusion

    1 formularios
    1. StudyEvent: ODM
      1. Study Conclusion
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Clinical Trial Subject Unique Identifier
    Item
    Subject Number
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    Occurrence of Serious Adverse Event
    C1519255 (UMLS CUI-1)
    Serious Adverse Event
    Item
    Did the subject experience any Serious Adverse Event during the study period?
    boolean
    C1519255 (UMLS CUI [1])
    Serious Adverse Event, Count of entities
    Item
    If Yes, specify total number of SAE's
    integer
    C1519255 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    Item Group
    Pregnancy Information
    C0032961 (UMLS CUI-1)
    C1533716 (UMLS CUI-2)
    Item
    Did the subject become pregnant during the study?
    text
    C0032961 (UMLS CUI [1,1])
    C0008976 (UMLS CUI [1,2])
    Pregnancy, Clinical Trials
    Code List
    Did the subject become pregnant during the study?
    CL Item
    No (1)
    CL Item
    Yes (2)
    CL Item
    Not Applicable (not of childbearing potential or male) (3)
    Item Group
    Status of Treatment Blind
    C0749659 (UMLS CUI-1)
    C2347038 (UMLS CUI-2)
    Subject Unblinding Event Record
    Item
    Was the treatment blind broken during the study?
    boolean
    C3897431 (UMLS CUI [1])
    Subject Unblinding Event Record, Date in time
    Item
    Complete Date
    date
    C3897431 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Tick one reason below
    text
    C3897431 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    Withdraw, Decision
    Code List
    Tick one reason below
    CL Item
    Medical emergency requiring identification of investigational product for further treatments. (1)
    CL Item
    Other, specify (2)
    Item Group
    Elimination Criteria
    C0680251 (UMLS CUI-1)
    Exclusion Criteria
    Item
    Did any elimination criteria become applicable during the study?
    boolean
    C0680251 (UMLS CUI [1])
    Exclusion Criteria
    Item
    Specify
    text
    C0680251 (UMLS CUI [1])
    Item Group
    Withdraw
    C2349954 (UMLS CUI-1)
    Withdraw
    Item
    Was the subject withdrawn from the study?
    boolean
    C2349954 (UMLS CUI [1])
    Item
    Major reason for withdrawal (tick one box only).
    text
    C2349954 (UMLS CUI [1,1])
    C3146298 (UMLS CUI [1,2])
    C1522508 (UMLS CUI [1,3])
    Withdraw, Indication
    Code List
    Major reason for withdrawal (tick one box only).
    CL Item
    Serious adverse event (Please specify SAE N°) (1)
    CL Item
    Non-Serious adverse event (Please specify unsolicited AE N° or solicited AE code) (2)
    CL Item
    Protocol violation, please specify (3)
    CL Item
    Consent withdrawal, not due to an adverse event. (4)
    CL Item
    Migrated / moved from the study area (5)
    CL Item
    Lost to follow-up. (6)
    CL Item
    Other, please specify (7)
    Withdraw, Indication, Details
    Item
    Specifications
    text
    C2349954 (UMLS CUI [1,1])
    C3146298 (UMLS CUI [1,2])
    C1522508 (UMLS CUI [1,3])
    Item
    Please tick who took decision
    text
    C2349954 (UMLS CUI [1,1])
    C0679006 (UMLS CUI [1,2])
    Withdraw, Decision
    Code List
    Please tick who took decision
    CL Item
    Investigator (1)
    CL Item
    Subject (2)
    Withdraw, Date last contact
    Item
    Date of last contact
    date
    C2349954 (UMLS CUI [1,1])
    C0805839 (UMLS CUI [1,2])
    Withdraw, Date last contact, General physical condition
    Item
    Was the subject in good condition at date of last contact?
    boolean
    C2349954 (UMLS CUI [1,1])
    C0805839 (UMLS CUI [1,2])
    C1142435 (UMLS CUI [1,3])
    Item Group
    Investigator's Signature
    C2346576 (UMLS CUI-1)
    Investigator Signature
    Item
    Investigator's signature
    text
    C2346576 (UMLS CUI [1])
    Investigator Signature, Date in time
    Item
    Date
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Investigator Name
    Item
    Printed Investigator's name
    text
    C2826892 (UMLS CUI [1])
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