0 Ratings

ID

34836

Description

Study ID: 107022 Clinical Study ID: 107022 Study Title: A phase IIb, controlled, randomised, multicenter, single blind study to demonstrate the Non-Inferiority of the low dose influenza vaccine with or without adjuvant AS03 compared with Fluarix (GlaxoSmithKline Biologicals) administered intramuscularly in elderly >= 60 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00321373 Study Link: https://clinicaltrials.gov/ct2/show/NCT00321373 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Candidate Influenza Vaccine GSK1247446A - 2 different formulations Trade Name: FluarixTM Study Indication: Influenza The purpose of this form is to document the subjects general medical history and the physical examination performed at visit 1. Please report medication(s) as specified in the protocol and fill in the Medication section. Visit 1: Day 0, Pre vaccination Visit 2: Day 21, Post vaccination 1 Phone contact: Day 30, post vaccination 1 Visit 3: Day 180, post vaccination 1

Link

https://clinicaltrials.gov/ct2/show/NCT00321373

Keywords

  1. 1/31/19 1/31/19 -
  2. 2/1/19 2/1/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 31, 2019

DOI

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License

Creative Commons BY-NC 3.0

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    Demonstration of the Non-Inferiority of the Low Dose Influenza Vaccine Compared with Fluarix NCT00321373

    General Medical History/Physical Examination

    Administrative Data
    Description

    Administrative Data

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

    Subject Number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    General Medical History, Phyiscal Examination
    Description

    General Medical History, Phyiscal Examination

    Alias
    UMLS CUI-1
    C0262926 (Medical History)
    SNOMED
    392521001
    LOINC
    LP6817-3
    UMLS CUI-2
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    Are you aware of any pre-existing conditions, signs or symptoms present prior to the start of the study?
    Description

    If yes, please give diagnosis and tick appropriate Past/Current box(es).

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0521987 (Pre-existing condition)
    SNOMED
    102478008
    UMLS CUI [2]
    C1457887 (Symptoms)
    LOINC
    MTHU021540
    General Medical History, Phyiscal Examination Record
    Description

    General Medical History, Phyiscal Examination Record

    Alias
    UMLS CUI-1
    C0262926 (Medical History)
    SNOMED
    392521001
    LOINC
    LP6817-3
    UMLS CUI-2
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    Diagnosis
    Description

    Diagnosis

    Data type

    text

    Alias
    UMLS CUI [1]
    C0011900 (Diagnosis)
    SNOMED
    439401001
    LOINC
    LP30831-9
    Past
    Description

    Past

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0455458 (PMH - past medical history)
    SNOMED
    417662000
    LOINC
    MTHU027722
    Current
    Description

    Current

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0521116 (Current (present time))
    SNOMED
    15240007
    UMLS CUI [1,2]
    C0011900 (Diagnosis)
    SNOMED
    439401001
    LOINC
    LP30831-9
    MedDRA System Organ Class
    Description

    MedDRA System Organ Class

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2347091 (MedDRA System Organ Class)

    Similar models

    General Medical History/Physical Examination

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject Number
    Item
    Subject Number
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    General Medical History, Phyiscal Examination
    C0262926 (UMLS CUI-1)
    C0031809 (UMLS CUI-2)
    Pre-existing Conditions, Signs or Symptoms
    Item
    Are you aware of any pre-existing conditions, signs or symptoms present prior to the start of the study?
    boolean
    C0521987 (UMLS CUI [1])
    C1457887 (UMLS CUI [2])
    Item Group
    General Medical History, Phyiscal Examination Record
    C0262926 (UMLS CUI-1)
    C0031809 (UMLS CUI-2)
    Diagnosis
    Item
    Diagnosis
    text
    C0011900 (UMLS CUI [1])
    Past
    Item
    Past
    boolean
    C0455458 (UMLS CUI [1])
    Current
    Item
    Current
    boolean
    C0521116 (UMLS CUI [1,1])
    C0011900 (UMLS CUI [1,2])
    Item
    MedDRA System Organ Class
    integer
    C2347091 (UMLS CUI [1])
    Code List
    MedDRA System Organ Class
    CL Item
    Skin and subcutaneous tissue (1)
    CL Item
    Musculoskeletal and connective tissue (2)
    CL Item
    Cardiac (3)
    CL Item
    Vascular (4)
    CL Item
    Respiratory, thoracic and mediastinal (5)
    CL Item
    Gastrointestinal (6)
    CL Item
    Hepatobiliary (7)
    CL Item
    Renal and urinary (8)
    CL Item
    Nervous system (9)
    CL Item
    Eye (10)
    CL Item
    Ear and labyrinth (11)
    CL Item
    Endocrine (12)
    CL Item
    Metabolism and nutrition (13)
    CL Item
    Blood and lymphatic system (14)
    CL Item
    Immune system (incl allergies, autoimmune disorders) (15)
    CL Item
    Infections and infestations (16)
    CL Item
    Neoplasms benign, malignantand unspecified (incl cysts. polyps) (17)
    CL Item
    Surgical and medicalprocedures (18)
    CL Item
    Other (99)

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