0 Evaluaciones
ID

34654

Descripción

Study ID:103812 & 104727 Clinical Study ID:103812 & 104727 Study Title: Study to assess safety and reactogenicity of booster dose of either an investigational vaccination regimen or DTPw-HBV/Hib when administered at 15 to 18 months of age and of a dose of Mencevax ACWY vaccine. Patient Level Data:N/A Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine Trade Name: Tritanrix HepB/Hiberix Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis

Palabras clave

Versiones (4)
  1. 16/01/19 16/01/19 -
  2. 18/01/19 18/01/19 -
  3. 22/01/19 22/01/19 -
  4. 22/01/19 22/01/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

22 gennaio 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
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    Safety and reactogenicity of booster dose of either an investigational vaccination regimen or DTPw HBVHib 103812 & 104727

    Inglés

    Visit 2 103812 (DTPW-HBV=HIB-MENAC-TT-014 BST:013&004 (15-18/24M) - Study Continuation; Date of Birth; Large swelling reaction; Concomitant vaccination

    1 formularios  
    Administrative
    Descripción

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Subject number
    Descripción

    Subject number

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2348585
    Check for Study Continuation
    Descripción

    Check for Study Continuation

    Alias
    UMLS CUI-1
    C0805733
    UMLS CUI-2
    C0008976
    Did the subject return for visit 2?
    Descripción

    If yes, please complete the next pages.

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0805733
    UMLS CUI [1,3]
    C0008976
    If subject did not return for visit 2, please tick the ONE most appropriate reason and skip the following pages of this visit.
    Descripción

    If subject did not return for visit 2, please tick the ONE most appropriate reason

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0805733
    UMLS CUI [1,3]
    C0008976
    UMLS CUI [2]
    C0392360
    Please specify Serious Adverse Event
    Descripción

    Please specify Serious Adverse Event

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2348235
    Please specify Non- serious adverse event
    Descripción

    Please specify Non- serious adverse event

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C2348235
    UMLS CUI [1,2]
    C1518404
    Specify other reason for subject didn't return for visit 2
    Descripción

    Specify other reason for subject didn't return for visit 2

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0805733
    UMLS CUI [1,3]
    C0008976
    UMLS CUI [1,4]
    C0392360
    UMLS CUI [2,1]
    C0205394
    UMLS CUI [2,2]
    C2348235
    Please tick who took descision
    Descripción

    Please tick who took decision

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0805733
    UMLS CUI [1,3]
    C0008976
    UMLS CUI [1,4]
    C0679006
    Date of Birth
    Descripción

    Date of Birth

    Alias
    UMLS CUI-1
    C0421451
    Date of birth
    Descripción

    Date of birth

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C0421451
    Large swelling reaction - Report of physical examination
    Descripción

    Large swelling reaction - Report of physical examination

    Alias
    UMLS CUI-1
    C0038999
    UMLS CUI-2
    C0443286
    UMLS CUI-3
    C0549177
    UMLS CUI-4
    C0031809
    1. Date of physical examination
    Descripción

    1. Date of physical examination

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C2826643
    Was the examination performed by a member of study personnel during the large swelling reaction period?
    Descripción

    Was the examination performed by a member of study personnel during the large swelling reaction period?

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0035173
    UMLS CUI [1,2]
    C0031809
    UMLS CUI [1,3]
    C0038999
    2. Date when the swelling was first considered to be a large swelling reaction:
    Descripción

    2. Date when the swelling was first considered to be a large swelling reaction

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0038999
    UMLS CUI [1,2]
    C0549177
    UMLS CUI [1,3]
    C0011008
    2.1 If swelling occuring within 24 hours after vaccination, please specify how long after vaccination:
    Descripción

    2.1 Specify how long after vaccination swelling occured

    Tipo de datos

    integer

    Unidades de medida
    • hours
    Alias
    UMLS CUI [1,1]
    C0038999
    UMLS CUI [1,2]
    C0042196
    UMLS CUI [1,3]
    C0040223
    hours
    3. Size of swelling:
    Descripción

    Measurement of the largest diameter

    Tipo de datos

    integer

    Unidades de medida
    • mm
    Alias
    UMLS CUI [1,1]
    C0038999
    UMLS CUI [1,2]
    C0456389
    mm
    4. Type of swelling
    Descripción

    Please specify in section 7.

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0038999
    UMLS CUI [1,2]
    C0332307
    5a. Circumference of swollen limb (at the site of maximum swelling):
    Descripción

    5a. Circumference of swollen limb (at the site of maximum swelling):

    Tipo de datos

    integer

    Unidades de medida
    • mm
    Alias
    UMLS CUI [1,1]
    C0424682
    UMLS CUI [1,2]
    C0015385
    UMLS CUI [1,3]
    C0038999
    mm
    5b. Circumference of the opposite limb (at the same level):
    Descripción

    5b. Circumference of the opposite limb (at the same level):

    Tipo de datos

    integer

    Unidades de medida
    • mm
    Alias
    UMLS CUI [1,1]
    C0424682
    UMLS CUI [1,2]
    C0015385
    UMLS CUI [1,3]
    C1521805
    mm
    6a. Associated signs - Temperature
    Descripción

    Please record the temperature. If temperature has been taken more than once a day please report the highest value. Please check a Yes/ No box for each symptom occuring during the large swelling reaction period. If other symptoms are associated with the large swelling reaction. Please specify under section 7.

    Tipo de datos

    float

    Unidades de medida
    • °C
    Alias
    UMLS CUI [1]
    C0037088
    UMLS CUI [2]
    C0005903
    °C
    6a. Temperature measurement site
    Descripción

    6a. Temperature measurement site

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0489453
    6b. Redness
    Descripción

    6b. Redness

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0332575
    6b. Largest diameter of Redness
    Descripción

    6b. Largest diameter of Redness

    Tipo de datos

    integer

    Unidades de medida
    • mm
    Alias
    UMLS CUI [1,1]
    C0332575
    UMLS CUI [1,2]
    C0456389
    mm
    6c. Induration
    Descripción

    6c. Induration

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0332534
    6c. Largest diameter of induration
    Descripción

    6c. Induration largest diameter

    Tipo de datos

    integer

    Unidades de medida
    • mm
    Alias
    UMLS CUI [1,1]
    C0332534
    UMLS CUI [1,2]
    C0456389
    mm
    6d. Pain at administration site
    Descripción

    6d. Pain at administration site

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0521491
    6d. Intensity of pain at administration site
    Descripción

    6d. Intensity of pain at administration site

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0521491
    UMLS CUI [1,2]
    C1320357
    6e. Functional impairment
    Descripción

    6e. Functional impairment

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C4062321
    6e. Intensity of Functional impairment
    Descripción

    6e. Intensity of Functional impairment

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C4062321
    UMLS CUI [1,2]
    C0518690
    Large swelling reaction - Clinical case desciption and outcome of the adverse event
    Descripción

    Large swelling reaction - Clinical case desciption and outcome of the adverse event

    Alias
    UMLS CUI-1
    C0038999
    UMLS CUI-2
    C0443286
    UMLS CUI-3
    C0549177
    UMLS CUI-4
    C0678257
    UMLS CUI-5
    C0205210
    UMLS CUI-6
    C1705586
    7. Case description
    Descripción

    Please give a clinical description of the observed large swelling reaction, including a description of the joint involved and specific associated symptoms. Please mention also eventual dignostic(s) procedures and therapeutic interventions.

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0678257
    UMLS CUI [1,2]
    C0205210
    UMLS CUI [1,3]
    C0868928
    8. Last date when the swelling was still considered to be a large swelling reaction:
    Descripción

    8. Last date when the swelling was still considered to be a large swelling reaction

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0038999
    UMLS CUI [1,2]
    C0549177
    UMLS CUI [1,3]
    C0806020
    8.1 If swelling lasting for less than 24 hours, please specify duration (hours)
    Descripción

    8.1 If swelling lasting for less than 24 hours, please specify duration

    Tipo de datos

    integer

    Unidades de medida
    • hours
    Alias
    UMLS CUI [1,1]
    C0038999
    UMLS CUI [1,2]
    C0449238
    hours
    9. Outcome of the large swellling reaction:
    Descripción

    9. Outcome of the large swellling reaction

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0085565
    UMLS CUI [1,2]
    C0038999
    10. Is there an alternative explanation for the swelling? (e.g.: allergy, infection, trauma, underlying conditions)
    Descripción

    10. Is there an alternative explanation for the swelling

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0038999
    UMLS CUI [1,2]
    C0681841
    UMLS CUI [2]
    C0020517
    UMLS CUI [3]
    C0009450
    UMLS CUI [4]
    C3714660
    UMLS CUI [5]
    C0009488
    10.1 Specify alternative explanation for the swelling.
    Descripción

    10.1 Specify alternative explanation for the swelling

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0038999
    UMLS CUI [1,2]
    C0681841
    UMLS CUI [1,3]
    C2348235
    Concomitant Vaccination
    Descripción

    Concomitant Vaccination

    Alias
    UMLS CUI-1
    C0042196
    UMLS CUI-2
    C2347852
    Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
    Descripción

    undefined item

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C2368628
    UMLS CUI [2,1]
    C2368628
    UMLS CUI [2,2]
    C0205394
    Concomitant Vaccination specification
    Descripción

    Concomitant Vaccination specification

    Alias
    UMLS CUI-1
    C0042196
    UMLS CUI-2
    C2347852
    UMLS CUI-3
    C2348235
    Trade / (Generic) Name
    Descripción

    Trade / (Generic) Name

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2360065
    UMLS CUI [2]
    C0592502
    Route
    Descripción

    Route

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0013153
    Administration date
    Descripción

    Administration date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C2368628
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    Similar models

    Visit 2 103812 (DTPW-HBV=HIB-MENAC-TT-014 BST:013&004 (15-18/24M) - Study Continuation; Date of Birth; Large swelling reaction; Concomitant vaccination

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Subject number
    Item
    Subject number
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Check for Study Continuation
    C0805733 (UMLS CUI-1)
    C0008976 (UMLS CUI-2)
    Did the subject return for visit 2?
    Item
    Did the subject return for visit 2?
    boolean
    C0545082 (UMLS CUI [1,1])
    C0805733 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [1,3])
    Item
    If subject did not return for visit 2, please tick the ONE most appropriate reason and skip the following pages of this visit.
    text
    C0545082 (UMLS CUI [1,1])
    C0805733 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [1,3])
    C0392360 (UMLS CUI [2])
    If subject did not return for visit 2, please tick the ONE most appropriate reason
    Code List
    If subject did not return for visit 2, please tick the ONE most appropriate reason and skip the following pages of this visit.
    CL Item
    Serious adverse event (complete the Serious Adverse Event form) (SAE)
    CL Item
    Non- Serious adverse event (complete the Non- serious Adverse Event form) (AEX)
    CL Item
    Other, please specify (e.g.: consent withdrawal, Protocol violation,...) (OTH)
    Please specify Serious Adverse Event
    Item
    Please specify Serious Adverse Event
    text
    C1519255 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Please specify Non- serious adverse event
    Item
    Please specify Non- serious adverse event
    text
    C2348235 (UMLS CUI [1,1])
    C1518404 (UMLS CUI [1,2])
    Specify other reason for subject didn't return for visit 2
    Item
    Specify other reason for subject didn't return for visit 2
    text
    C0545082 (UMLS CUI [1,1])
    C0805733 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [1,3])
    C0392360 (UMLS CUI [1,4])
    C0205394 (UMLS CUI [2,1])
    C2348235 (UMLS CUI [2,2])
    Item
    Please tick who took descision
    text
    C0545082 (UMLS CUI [1,1])
    C0805733 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [1,3])
    C0679006 (UMLS CUI [1,4])
    Please tick who took decision
    Code List
    Please tick who took descision
    CL Item
    Investigator (I)
    CL Item
    Parents/ Guardians (P)
    Item Group
    Date of Birth
    C0421451 (UMLS CUI-1)
    Date of birth
    Item
    Date of birth
    date
    C0421451 (UMLS CUI [1])
    Item Group
    Large swelling reaction - Report of physical examination
    C0038999 (UMLS CUI-1)
    C0443286 (UMLS CUI-2)
    C0549177 (UMLS CUI-3)
    C0031809 (UMLS CUI-4)
    1. Date of physical examination
    Item
    1. Date of physical examination
    date
    C2826643 (UMLS CUI [1])
    Was the examination performed by a member of study personnel during the large swelling reaction period?
    Item
    Was the examination performed by a member of study personnel during the large swelling reaction period?
    boolean
    C0035173 (UMLS CUI [1,1])
    C0031809 (UMLS CUI [1,2])
    C0038999 (UMLS CUI [1,3])
    2. Date when the swelling was first considered to be a large swelling reaction
    Item
    2. Date when the swelling was first considered to be a large swelling reaction:
    date
    C0038999 (UMLS CUI [1,1])
    C0549177 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    2.1 Specify how long after vaccination swelling occured
    Item
    2.1 If swelling occuring within 24 hours after vaccination, please specify how long after vaccination:
    integer
    C0038999 (UMLS CUI [1,1])
    C0042196 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    3. Size of swelling
    Item
    3. Size of swelling:
    integer
    C0038999 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    Item
    4. Type of swelling
    integer
    C0038999 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    4. Type of swelling
    Code List
    4. Type of swelling
    CL Item
    Local swelling around injection site, not involving adjacent joint (1)
    CL Item
    Diffuse swelling, not involving adjacent joint (2)
    CL Item
    Swelling, involving adjacent joint (3)
    5a. Circumference of swollen limb (at the site of maximum swelling):
    Item
    5a. Circumference of swollen limb (at the site of maximum swelling):
    integer
    C0424682 (UMLS CUI [1,1])
    C0015385 (UMLS CUI [1,2])
    C0038999 (UMLS CUI [1,3])
    5b. Circumference of the opposite limb (at the same level):
    Item
    5b. Circumference of the opposite limb (at the same level):
    integer
    C0424682 (UMLS CUI [1,1])
    C0015385 (UMLS CUI [1,2])
    C1521805 (UMLS CUI [1,3])
    6a. Associated signs
    Item
    6a. Associated signs - Temperature
    float
    C0037088 (UMLS CUI [1])
    C0005903 (UMLS CUI [2])
    Item
    6a. Temperature measurement site
    text
    C0489453 (UMLS CUI [1])
    6a. Temperature measurement site
    Code List
    6a. Temperature measurement site
    CL Item
    Axillary (A)
    CL Item
    Oral (O)
    CL Item
    Typanic oral (X)
    CL Item
    Tympanic rectal (Y)
    CL Item
    Rectal (R)
    6b. Redness
    Item
    6b. Redness
    boolean
    C0332575 (UMLS CUI [1])
    6b. Largest diameter of Redness
    Item
    6b. Largest diameter of Redness
    integer
    C0332575 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    6c. Induration
    Item
    6c. Induration
    boolean
    C0332534 (UMLS CUI [1])
    6c. Induration largest diameter
    Item
    6c. Largest diameter of induration
    integer
    C0332534 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    6d. Pain at administration site
    Item
    6d. Pain at administration site
    boolean
    C0521491 (UMLS CUI [1])
    Item
    6d. Intensity of pain at administration site
    integer
    C0521491 (UMLS CUI [1,1])
    C1320357 (UMLS CUI [1,2])
    6d. Intensity of pain at administration site
    Code List
    6d. Intensity of pain at administration site
    CL Item
    Grade 1 (Minor reaction to touch) (1)
    CL Item
    Cries / protests on touch (2)
    CL Item
    Cries when limbs is moved / spontaneously painful (3)
    6e. Functional impairment
    Item
    6e. Functional impairment
    boolean
    C4062321 (UMLS CUI [1])
    Item
    6e. Intensity of Functional impairment
    integer
    C4062321 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    6e. Functional impairment
    Code List
    6e. Intensity of Functional impairment
    CL Item
    Grade 1 (Easily tolerated, causing minimal discomfort and not interfering with everyday activities) (1)
    CL Item
    Grade 2 (Sufficiently discomforting to interfere with normal everyday activities) (2)
    CL Item
    Grade 3 (Prevents normal everyday activities) (3)
    Item Group
    Large swelling reaction - Clinical case desciption and outcome of the adverse event
    C0038999 (UMLS CUI-1)
    C0443286 (UMLS CUI-2)
    C0549177 (UMLS CUI-3)
    C0678257 (UMLS CUI-4)
    C0205210 (UMLS CUI-5)
    C1705586 (UMLS CUI-6)
    7. Case description
    Item
    7. Case description
    text
    C0678257 (UMLS CUI [1,1])
    C0205210 (UMLS CUI [1,2])
    C0868928 (UMLS CUI [1,3])
    8. Last date when the swelling was still considered to be a large swelling reaction
    Item
    8. Last date when the swelling was still considered to be a large swelling reaction:
    date
    C0038999 (UMLS CUI [1,1])
    C0549177 (UMLS CUI [1,2])
    C0806020 (UMLS CUI [1,3])
    8.1 If swelling lasting for less than 24 hours, please specify duration
    Item
    8.1 If swelling lasting for less than 24 hours, please specify duration (hours)
    integer
    C0038999 (UMLS CUI [1,1])
    C0449238 (UMLS CUI [1,2])
    Item
    9. Outcome of the large swellling reaction:
    integer
    C0085565 (UMLS CUI [1,1])
    C0038999 (UMLS CUI [1,2])
    9. Outcome of the large swellling reaction
    Code List
    9. Outcome of the large swellling reaction:
    CL Item
    Recovered / resolved (1)
    CL Item
    Recovering / resolving (2)
    CL Item
    Not recovered/ not resolved (please provide further follow- up data) (3)
    CL Item
    Recovered with sequelae / resolved with sequelae (please specify under section 7) (4)
    10. Is there an alternative explanation for the swelling
    Item
    10. Is there an alternative explanation for the swelling? (e.g.: allergy, infection, trauma, underlying conditions)
    boolean
    C0038999 (UMLS CUI [1,1])
    C0681841 (UMLS CUI [1,2])
    C0020517 (UMLS CUI [2])
    C0009450 (UMLS CUI [3])
    C3714660 (UMLS CUI [4])
    C0009488 (UMLS CUI [5])
    10.1 Specify alternative explanation for the swelling
    Item
    10.1 Specify alternative explanation for the swelling.
    text
    C0038999 (UMLS CUI [1,1])
    C0681841 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Item Group
    Concomitant Vaccination
    C0042196 (UMLS CUI-1)
    C2347852 (UMLS CUI-2)
    undefined item
    Item
    Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
    boolean
    C0304229 (UMLS CUI [1,1])
    C2368628 (UMLS CUI [1,2])
    C2368628 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    Item Group
    Concomitant Vaccination specification
    C0042196 (UMLS CUI-1)
    C2347852 (UMLS CUI-2)
    C2348235 (UMLS CUI-3)
    Trade / (Generic) Name
    Item
    Trade / (Generic) Name
    text
    C2360065 (UMLS CUI [1])
    C0592502 (UMLS CUI [2])
    Item
    Route
    text
    C0013153 (UMLS CUI [1])
    Route
    Code List
    Route
    CL Item
    Intradermal (ID)
    CL Item
    Inhalation (IH)
    CL Item
    Intramuscular (IM)
    CL Item
    Intravenous (IV)
    CL Item
    Intranasal (NA)
    CL Item
    Other (OTH)
    CL Item
    Parenteral (PE)
    CL Item
    Oral (PO)
    CL Item
    Subcutaneous (SC)
    CL Item
    Sublingual (SL)
    CL Item
    Transdermal (TD)
    CL Item
    Unknown (UNK)
    Administration date
    Item
    Administration date
    date
    C0011008 (UMLS CUI [1,1])
    C2368628 (UMLS CUI [1,2])
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