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ID

36625

Description

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 GSK’s Clinical Study Register is no longer maintained for this study.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

Lien

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

Mots-clés

Versions (1)
  1. 26/05/2019 26/05/2019 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

26 mai 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
Modèle Commentaires :

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    Mencevax™ ACWY (new process) versus Mencevax™ ACWY (current process); NCT00227422

    Anglais

    Medication

    1 Formulaires  
    1. StudyEvent: ODM
      1. Medication
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject Number
    Description

    Clinical Trial Subject Unique Identifier

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Medication
    Description

    Medication

    Alias
    UMLS CUI-1
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    Have any medications/treatments been administered during study period?
    Description

    Pharmaceutical Preparations

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    Trade / Generic Name
    Description

    Pharmaceutical Preparations, Medication name

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,2]
    C2360065 (Medication name)
    LOINC
    MTHU027854
    Medical Indication
    Description

    Pharmaceutical Preparations, Indication

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,2]
    C3146298 (Indication)
    Total daily dose
    Description

    Pharmaceutical Preparations, Daily Dose, Total

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,2]
    C2348070 (Daily Dose)
    UMLS CUI [1,3]
    C0439810 (Total)
    SNOMED
    255619001
    LOINC
    LP21089-5
    Route
    Description

    Pharmaceutical Preparations, Drug Administration Routes

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,2]
    C0013153 (Drug Administration Routes)
    SNOMED
    410675002
    LOINC
    LP40261-7
    Start Date
    Description

    Pharmaceutical Preparations, Start Date

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,2]
    C0808070 (Start Date)
    End Date
    Description

    Pharmaceutical Preparations, End Date

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,2]
    C0806020 (End date)
    SNOMED
    454551000124105
    LOINC
    MTHU008302
    Tick box if continuing at end of study
    Description

    Pharmaceutical Preparations, Continuous

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,2]
    C0549178 (Continuous)
    SNOMED
    255238004
    LOINC
    LA16902-1
    Retour au début de la page

    Similar models

    Medication

    1 Formulaires
    1. StudyEvent: ODM
      1. Medication
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Clinical Trial Subject Unique Identifier
    Item
    Subject Number
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    Medication
    C0013227 (UMLS CUI-1)
    Pharmaceutical Preparations
    Item
    Have any medications/treatments been administered during study period?
    boolean
    C0013227 (UMLS CUI [1])
    Pharmaceutical Preparations, Medication name
    Item
    Trade / Generic Name
    text
    C0013227 (UMLS CUI [1,1])
    C2360065 (UMLS CUI [1,2])
    Pharmaceutical Preparations, Indication
    Item
    Medical Indication
    text
    C0013227 (UMLS CUI [1,1])
    C3146298 (UMLS CUI [1,2])
    Pharmaceutical Preparations, Daily Dose, Total
    Item
    Total daily dose
    text
    C0013227 (UMLS CUI [1,1])
    C2348070 (UMLS CUI [1,2])
    C0439810 (UMLS CUI [1,3])
    Pharmaceutical Preparations, Drug Administration Routes
    Item
    Route
    text
    C0013227 (UMLS CUI [1,1])
    C0013153 (UMLS CUI [1,2])
    Pharmaceutical Preparations, Start Date
    Item
    Start Date
    date
    C0013227 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Pharmaceutical Preparations, End Date
    Item
    End Date
    date
    C0013227 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Pharmaceutical Preparations, Continuous
    Item
    Tick box if continuing at end of study
    boolean
    C0013227 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    Retour au début de la page 

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