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42732

Description

GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Visit 1 Study ID: 100388 Clinical Study ID: 100388 Study Title: Study in Healthy Children (<2 Years) to Evaluate the Safety and Efficacy of GSK Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM) and of GSK Biologicals' Combined Measles-Mumps-Rubella-Varicella Vaccine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00226499 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Varicella Vaccine Trade Name: BIO OKAH; Varilrix Study Indication: Varicella

Keywords

Versions (2)
  1. 8/19/17 8/19/17 -
  2. 9/17/21 9/17/21 -
Copyright Holder

glaxoSmithKline

Uploaded on

September 17, 2021

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License

Creative Commons BY-NC 3.0
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    GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Visit 1

    English

    GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Visit 1

    1 forms  
    Informed consent
    Description

    Informed consent

    Alias
    UMLS CUI-1
    C0021430
    Informed Consent Date
    Description

    I certify that Informed Consent has been obtained prior to any study procedure.

    Data type

    date

    Alias
    UMLS CUI [1]
    C2985782
    Demographics
    Description

    Demographics

    Alias
    UMLS CUI-1
    C1704791
    Center number
    Description

    Center number

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1301943
    UMLS CUI [1,2]
    C0600091
    Date of birth
    Description

    Date of birth

    Data type

    date

    Alias
    UMLS CUI [1]
    C0421451
    Gender
    Description

    Gender

    Data type

    text

    Alias
    UMLS CUI [1]
    C0079399
    Race
    Description

    Race

    Data type

    text

    Alias
    UMLS CUI [1]
    C0034510
    Other Race, please specify
    Description

    If you chose 'Other Race', please specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0034510
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C3845569
    Eligibility check
    Description

    Eligibility check

    Alias
    UMLS CUI-1
    C0013893
    Did the subject meet all the entry criteria?
    Description

    If No, tick all boxes corresponding to violations of any inclusion/exclusion criteria. Do not enter the subject into the study if he/she failed any inclusion or exclusion criteria below.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1516637
    Inclusion criteria
    Description

    Inclusion criteria

    Alias
    UMLS CUI-1
    C1512693
    Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) for the whole duration of the study.
    Description

    Compliance

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C1321605
    Male or female subject between 12 and 22 months (including the day before the 23-month birthday) of age at the time of the first vaccination.
    Description

    age at first vaccination

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0001779
    UMLS CUI [1,2]
    C0042196
    Subjects free of obvious health problems, as established by medical history and physical examination before entering the study.
    Description

    healthy subject

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1708335
    Written informed consent obtained from the parents/guardians of the subject after they have been informed on the risks and benefits of the study, in a language they clearly understand and before performance of any study procedure.
    Description

    Informed consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Subjects whose parents/guardians have direct access to telephone/mobile phone (either at home or at work).
    Description

    access to telephone

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1822200
    Subjects: (1) with at least one sibling (with negative history of varicella disease/vaccination) at home, or (2) attending day care center (subjects who are registered for attendance at day care center from 24 months of age may be considered for inclusion in the study), or (3) attending childminders, i.e. someone taking care of several children (with at least one child without a known positive history of varicella disease/vaccination), or (4) who are in contact for at least once a week with other children without a known positive history of varicella disease/vaccination, while playing in close physical contact for more than 5 minutes.
    Description

    contact to varicella

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1455968
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI-1
    C0680251
    Previous vaccination against measles, mumps, rubella and/or varicella.
    Description

    Previous vaccination against measles, mumps, rubella and/or varicella.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0042201
    UMLS CUI [2]
    C0042202
    UMLS CUI [3]
    C0042206
    UMLS CUI [4]
    C4302743
    History of previous measles, mumps, rubella and/or varicella/zoster diseases
    Description

    History of previous measles, mumps, rubella and/or varicella/zoster diseases

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0455465
    UMLS CUI [2]
    C0455466
    UMLS CUI [3]
    C0455467
    UMLS CUI [4]
    C0455469
    UMLS CUI [5]
    C0740380
    Known exposure to measles, mumps, rubella and/or varicella/zoster within 30 days prior to the start of the study.
    Description

    exposure to measles, mumps, rubella and/or varicella/zoster

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2732622
    UMLS CUI [2]
    C0920247
    UMLS CUI [3]
    C2720520
    UMLS CUI [4]
    C0262619
    UMLS CUI [5]
    C0750129
    Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day). Inhaled and topical steroids are allowed.
    Description

    Chronic administration of immunosuppressants or other immune-modifying drugs

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0021081
    UMLS CUI [1,2]
    C0279021
    Administration of immunoglobulins and/or any blood products within three months prior to the first vaccine dose or planned administration during the study period.
    Description

    Administration of immunoglobulins and/or any blood products

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0021027
    UMLS CUI [1,2]
    C0456388
    Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
    Description

    immunosuppressive or immunodeficient condition

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0021079
    UMLS CUI [1,2]
    C0021051
    Family history of congenital or hereditary immunodeficiency.
    Description

    Family history of congenital or hereditary immunodeficiency.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0241889
    UMLS CUI [1,2]
    C0853602
    UMLS CUI [2,1]
    C0439660
    UMLS CUI [2,2]
    C0021051
    History of allergic diseases or reactions likely to be exacerbated by any component of the vaccines, including systemic allergy to egg proteins or neomycin.
    Description

    History of allergic diseases or reactions

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2106654
    UMLS CUI [2]
    C0567447
    UMLS CUI [3]
    C0571380
    Major congenital defects or serious chronic illness.
    Description

    Major congenital defects or serious chronic illness.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0000768
    UMLS CUI [1,2]
    C0205164
    UMLS CUI [2,1]
    C0008679
    UMLS CUI [2,2]
    C0205404
    Residence in the same household as newborns (0-4 weeks of age), pregnant mothers varicella-susceptible, persons with a known immunodeficiency or any other persons at high risk for varicella (At any point in time when such exclusion criterion becomes not applicable, potential study participants may come back at a later stage for study inclusion)..
    Description

    (At any point in time when such exclusion criterion becomes not applicable, potential study participants may come back at a later stage for study inclusion)

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0682072
    UMLS CUI [1,2]
    C0021051
    UMLS CUI [2]
    C1855205
    History of any neurologic disorders or seizures.
    Description

    History of any neurologic disorders or seizures.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0027765
    UMLS CUI [1,2]
    C0036572
    Use of any investigational or non-registered product (drug/vaccine other than the study vaccines) within 14 days prior to vaccination and planned use during the study period.
    Description

    Use of any investigational or non-registered product

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1524063
    UMLS CUI [1,2]
    C0013230
    Administration of a licensed vaccine within 14 days prior to vaccination and planned use until approximately 42 days after the last study vaccine dose (Day 84) with the exception of oral polio vaccine (OPV).
    Description

    Administration of a licensed vaccine

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1960631
    UMLS CUI [1,2]
    C1705847
    UMLS CUI [1,3]
    C0032375
    Randomisation / Treatment allocation
    Description

    Randomisation / Treatment allocation

    Alias
    UMLS CUI-1
    C0034656
    Record treatment number
    Description

    Record treatment number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1522541
    UMLS CUI [1,2]
    C0600091
    General medical history / physical examination
    Description

    General medical history / physical examination

    Alias
    UMLS CUI-1
    C0262926
    UMLS CUI-2
    C0031809
    Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?
    Description

    Please tick appropriate box(es) and give diagnosis.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0521987
    General medical history / physical examination
    Description

    General medical history / physical examination

    Alias
    UMLS CUI-1
    C0262926
    UMLS CUI-2
    C0031809
    anatomic site of symptoms
    Description

    anatomic site of symptoms

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1515974
    UMLS CUI [1,2]
    C0037088
    Diagnosis 1
    Description

    diagnosis 1

    Data type

    text

    Alias
    UMLS CUI [1]
    C0011900
    Diagnosis 2
    Description

    diagnosis 2

    Data type

    text

    Alias
    UMLS CUI [1]
    C0011900
    Past (diagnosis)
    Description

    diagnosis past

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0011900
    UMLS CUI [1,2]
    C1444637
    Present (diagnosis)
    Description

    diagnosis present

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0011900
    UMLS CUI [1,2]
    C0150312
    Laboratory tests
    Description

    Laboratory tests

    Alias
    UMLS CUI-1
    C0022885
    Has a blood sample been taken?
    Description

    Blood sample

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0005834
    Date blood sample taken
    Description

    Please complete only if different from visit date

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1277698
    UMLS CUI [1,2]
    C0011008
    Category of exposure
    Description

    Category of exposure

    Alias
    UMLS CUI-1
    C2220266
    UMLS CUI-2
    C0683312
    What category of exposure did the subject fall into at Inclusion?
    Description

    category of exposure

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2220266
    UMLS CUI [1,2]
    C0683312
    Vaccine administration
    Description

    Vaccine administration

    Alias
    UMLS CUI-1
    C2368628
    Pre-Vaccination temperature
    Description

    Pre-Vaccination temperature

    Data type

    float

    Measurement units
    • degree Celsius
    Alias
    UMLS CUI [1]
    C0005903
    degree Celsius
    Route
    Description

    anatomic site Temperature taken

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0005903
    UMLS CUI [1,2]
    C1515974
    Vaccine administration
    Description

    Vaccine administration

    Data type

    text

    Alias
    UMLS CUI [1]
    C2368628
    Replacement vial
    Description

    Replacement vial

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0184301
    UMLS CUI [1,2]
    C0559956
    UMLS CUI [1,3]
    C0600091
    Wrong vial number
    Description

    Wrong vial number

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0184301
    UMLS CUI [1,2]
    C0600091
    UMLS CUI [1,3]
    C3827420
    Has the study vaccine been administered according to the Protocol?
    Description

    Protocol: Side: Left Site: Upper arm (Deltoid) Route: S.C.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2368628
    UMLS CUI [1,2]
    C1515974
    UMLS CUI [1,3]
    C0013153
    Side (vaccine administered)
    Description

    Only answer if vaccine wasn't administered according to protocol.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2368628
    UMLS CUI [1,2]
    C0444532
    UMLS CUI [1,3]
    C0443246
    Site (vaccine administered)
    Description

    Only answer if vaccine wasn't administered according to protocol.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2368628
    UMLS CUI [1,2]
    C1515974
    Route (vaccine administered)
    Description

    Only answer if vaccine wasn't administered according to protocol.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2368628
    UMLS CUI [1,2]
    C0013153
    Comments (on vaccine administration)
    Description

    Comments on vaccine administration

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2368628
    UMLS CUI [1,2]
    C0947611
    Date of vaccination
    Description

    fill in only if different from visit date

    Data type

    date

    Alias
    UMLS CUI [1]
    C4301990
    Why was the vaccine not administered?
    Description

    Please tick the ONE most appropriate category for non administration

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2368628
    UMLS CUI [1,2]
    C0392360
    SAE No
    Description

    Please specify number of SAE if that is the reason, why vaccine wasn't administered.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0449788
    Please specify unsolicited AE No
    Description

    number of unsolicited adverse event

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0449788
    Please specify 'other' most appropriate category for non administration.
    Description

    e.g.: consent withdrawal, protocol violation, non-serious AE for non-subset...

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3840932
    UMLS CUI [1,2]
    C1521902
    UMLS CUI [1,3]
    C2368628
    Unsolicited adverse event
    Description

    Unsolicited adverse event

    Alias
    UMLS CUI-1
    C0877248
    UMLS CUI-2
    C0042196
    Has the subject experienced any serious or non-serious unsolicited adverse events within 42 days post-vaccination 1?
    Description

    non-serious unsolicited adverse event

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0231291
    UMLS CUI [2,1]
    C1518404
    UMLS CUI [2,2]
    C0231291
    Solicited adverse events - Local symptoms
    Description

    Solicited adverse events - Local symptoms

    Alias
    UMLS CUI-1
    C1457887
    UMLS CUI-2
    C0205276
    UMLS CUI-3
    C0042196
    Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
    Description

    If Yes is ticked, please complete all following items.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0851536
    UMLS CUI [1,2]
    C0037088
    Redness
    Description

    Administration site erythema

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3805283
    Size (of redness at administration site) Day 0
    Description

    Size of erythema at administration site Day 0

    Data type

    integer

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C3805283
    UMLS CUI [1,2]
    C0456389
    mm
    Size (of redness at administration site) Day 1
    Description

    Size of erythema at administration site Day 1

    Data type

    integer

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C3805283
    UMLS CUI [1,2]
    C0456389
    mm
    Size (of redness at administration site) Day 2
    Description

    Size of erythema at administration site Day 2

    Data type

    integer

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C3805283
    UMLS CUI [1,2]
    C0456389
    mm
    Size (of redness at administration site) Day 3
    Description

    Size of erythema at administration site Day 3

    Data type

    integer

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C3805283
    UMLS CUI [1,2]
    C0456389
    mm
    Ongoing after Day 3?
    Description

    Erythema ongoing after day 3

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3805283
    UMLS CUI [1,2]
    C0549178
    Date of last day of symptoms
    Description

    Date of last day of symptoms

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0332575
    UMLS CUI [1,3]
    C2700396
    Swelling
    Description

    Administration site swelling

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3854415
    Size (of swelling at administration site) Day 0
    Description

    Size of swelling at administration site Day 0

    Data type

    integer

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C3854415
    UMLS CUI [1,2]
    C0456389
    mm
    Size (of swelling at administration site) Day 1
    Description

    Size of swelling at administration site Day 1

    Data type

    integer

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C3854415
    UMLS CUI [1,2]
    C0456389
    mm
    Size (of swelling at administration site) Day 2
    Description

    Size of swelling at administration site Day 2

    Data type

    integer

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C3854415
    UMLS CUI [1,2]
    C0456389
    mm
    Size (of swelling at administration site) Day 3
    Description

    Size of swelling at administration site Day 3

    Data type

    integer

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C3854415
    UMLS CUI [1,2]
    C0456389
    mm
    Ongoing after day 3?
    Description

    Swelling ongoing after day 3

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3854415
    UMLS CUI [1,2]
    C0549178
    Date of last day of symptoms
    Description

    Date of last day of symptoms

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0038999
    UMLS CUI [1,3]
    C2700396
    Pain
    Description

    Administration site pain

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0521491
    Intensity (of pain at administration site) Day 0
    Description

    Intensity: 0: None 1: Mild 2: Moderate 3: Severe

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0521491
    UMLS CUI [1,2]
    C1320357
    Intensity (of pain at administration site) Day 1
    Description

    Intensity: 0: None 1: Mild 2: Moderate 3: Severe

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0521491
    UMLS CUI [1,2]
    C1320357
    Intensity (of pain at administration site) Day 2
    Description

    Intensity: 0: None 1: Mild 2: Moderate 3: Severe

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0521491
    UMLS CUI [1,2]
    C1320357
    Intensity (of pain at administration site) Day 3
    Description

    Intensity: 0: None 1: Mild 2: Moderate 3: Severe

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0521491
    UMLS CUI [1,2]
    C1320357
    Ongoing after day 3?
    Description

    Pain ongoing after day 3

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0521491
    UMLS CUI [1,2]
    C0549178
    Date of last day of symptoms
    Description

    Date of last day of symptoms

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0030193
    UMLS CUI [1,3]
    C2700396
    Solicited adverse events - General symptoms
    Description

    Solicited adverse events - General symptoms

    Alias
    UMLS CUI-1
    C1457887
    UMLS CUI-2
    C0042196
    UMLS CUI-3
    C0877248
    Has the subject experienced any of the following signs/symptoms during 42 days post-vaccination 1?
    Description

    If Yes is ticked, please complete all following items.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0037088
    UMLS CUI [1,2]
    C2368628
    Fever
    Description

    ≥37.5 °C axillary/≥38.0 °C rectal route If yes, please complete the Temperature section.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0015967
    UMLS CUI [1,2]
    C2368628
    General rash / exanthema
    Description

    excluding varicella / zoster If yes, please complete the Rash / Exanthema section.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0015230
    UMLS CUI [1,2]
    C2368628
    Parotid / salivary gland swelling
    Description

    If yes, please complete the Parotid / Salivary Gland Swelling section.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0240925
    UMLS CUI [1,2]
    C2368628
    Febrile convulsions – suspected signs of meningism
    Description

    If yes, please complete the Febrile Convulsions – Suspected Signs of Meningism section.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009952
    UMLS CUI [1,2]
    C2368628
    UMLS CUI [2,1]
    C0025287
    UMLS CUI [2,2]
    C2368628
    Varicella / zoster
    Description

    If yes, please complete the Varicella / Zoster section.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0008049
    UMLS CUI [1,2]
    C2368628
    UMLS CUI [2,1]
    C0740380
    UMLS CUI [2,2]
    C2368628
    Temperature
    Description

    Temperature

    Alias
    UMLS CUI-1
    C0039476
    Route
    Description

    Direct measurement of axillary/ rectal temperature within 15 days post-vaccination 1. Only ONE route of temperature measurement should be used consistently for a given subject. Fever: Axillary: > 37.5°C Rectal: > 38.0°C

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0005903
    UMLS CUI [1,2]
    C1515974
    Temperature
    Description

    Temperature

    Alias
    UMLS CUI-1
    C0039476
    Episode No
    Description

    Day 1 - 42

    Data type

    integer

    Temperature
    Description

    Temperature

    Data type

    float

    Measurement units
    • Degree Celsius
    Alias
    UMLS CUI [1]
    C0039476
    Degree Celsius
    Not taken (Temperature)
    Description

    Temperature not taken

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0039476
    Causality
    Description

    Only fill in if fever.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0015967
    UMLS CUI [1,2]
    C3641099
    UMLS CUI [1,3]
    C2368628
    Medically attended Visit?
    Description

    Medically attended Visit?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1386497
    UMLS CUI [1,3]
    C0015967
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    Similar models

    GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Visit 1

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Informed consent
    C0021430 (UMLS CUI-1)
    Informed Consent Date
    Item
    Informed Consent Date
    date
    C2985782 (UMLS CUI [1])
    Item Group
    Demographics
    C1704791 (UMLS CUI-1)
    Center number
    Item
    Center number
    text
    C1301943 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Date of birth
    Item
    Date of birth
    date
    C0421451 (UMLS CUI [1])
    Item
    Gender
    text
    C0079399 (UMLS CUI [1])
    Gender
    Code List
    Gender
    CL Item
    Male (M)
    CL Item
    Female (F)
    Item
    Race
    text
    C0034510 (UMLS CUI [1])
    Race
    Code List
    Race
    CL Item
    Black (1)
    CL Item
    Arabic/North African (4)
    CL Item
    White/Caucasian (2)
    CL Item
    East & South East Asian (5)
    CL Item
    South Asian (6)
    CL Item
    American Hispanic (7)
    CL Item
    Japanese (8)
    CL Item
    Other (9)
    Other Race
    Item
    Other Race, please specify
    text
    C0034510 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C3845569 (UMLS CUI [1,3])
    Item Group
    Eligibility check
    C0013893 (UMLS CUI-1)
    meet entry criteria
    Item
    Did the subject meet all the entry criteria?
    boolean
    C1516637 (UMLS CUI [1])
    Item Group
    Inclusion criteria
    C1512693 (UMLS CUI-1)
    Compliance
    Item
    Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) for the whole duration of the study.
    boolean
    C2348568 (UMLS CUI [1,1])
    C1321605 (UMLS CUI [1,2])
    age at first vaccination
    Item
    Male or female subject between 12 and 22 months (including the day before the 23-month birthday) of age at the time of the first vaccination.
    boolean
    C0001779 (UMLS CUI [1,1])
    C0042196 (UMLS CUI [1,2])
    healthy subject
    Item
    Subjects free of obvious health problems, as established by medical history and physical examination before entering the study.
    boolean
    C1708335 (UMLS CUI [1])
    Informed consent
    Item
    Written informed consent obtained from the parents/guardians of the subject after they have been informed on the risks and benefits of the study, in a language they clearly understand and before performance of any study procedure.
    boolean
    C0021430 (UMLS CUI [1])
    access to telephone
    Item
    Subjects whose parents/guardians have direct access to telephone/mobile phone (either at home or at work).
    boolean
    C1822200 (UMLS CUI [1])
    contact to varicella
    Item
    Subjects: (1) with at least one sibling (with negative history of varicella disease/vaccination) at home, or (2) attending day care center (subjects who are registered for attendance at day care center from 24 months of age may be considered for inclusion in the study), or (3) attending childminders, i.e. someone taking care of several children (with at least one child without a known positive history of varicella disease/vaccination), or (4) who are in contact for at least once a week with other children without a known positive history of varicella disease/vaccination, while playing in close physical contact for more than 5 minutes.
    boolean
    C1455968 (UMLS CUI [1])
    Item Group
    Exclusion Criteria
    C0680251 (UMLS CUI-1)
    Previous vaccination against measles, mumps, rubella and/or varicella.
    Item
    Previous vaccination against measles, mumps, rubella and/or varicella.
    boolean
    C0042201 (UMLS CUI [1])
    C0042202 (UMLS CUI [2])
    C0042206 (UMLS CUI [3])
    C4302743 (UMLS CUI [4])
    History of previous measles, mumps, rubella and/or varicella/zoster diseases
    Item
    History of previous measles, mumps, rubella and/or varicella/zoster diseases
    boolean
    C0455465 (UMLS CUI [1])
    C0455466 (UMLS CUI [2])
    C0455467 (UMLS CUI [3])
    C0455469 (UMLS CUI [4])
    C0740380 (UMLS CUI [5])
    exposure to measles, mumps, rubella and/or varicella/zoster
    Item
    Known exposure to measles, mumps, rubella and/or varicella/zoster within 30 days prior to the start of the study.
    boolean
    C2732622 (UMLS CUI [1])
    C0920247 (UMLS CUI [2])
    C2720520 (UMLS CUI [3])
    C0262619 (UMLS CUI [4])
    C0750129 (UMLS CUI [5])
    Chronic administration of immunosuppressants or other immune-modifying drugs
    Item
    Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day). Inhaled and topical steroids are allowed.
    boolean
    C0021081 (UMLS CUI [1,1])
    C0279021 (UMLS CUI [1,2])
    Administration of immunoglobulins and/or any blood products
    Item
    Administration of immunoglobulins and/or any blood products within three months prior to the first vaccine dose or planned administration during the study period.
    boolean
    C0021027 (UMLS CUI [1,1])
    C0456388 (UMLS CUI [1,2])
    immunosuppressive or immunodeficient condition
    Item
    Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
    boolean
    C0021079 (UMLS CUI [1,1])
    C0021051 (UMLS CUI [1,2])
    Family history of congenital or hereditary immunodeficiency.
    Item
    Family history of congenital or hereditary immunodeficiency.
    boolean
    C0241889 (UMLS CUI [1,1])
    C0853602 (UMLS CUI [1,2])
    C0439660 (UMLS CUI [2,1])
    C0021051 (UMLS CUI [2,2])
    History of allergic diseases or reactions
    Item
    History of allergic diseases or reactions likely to be exacerbated by any component of the vaccines, including systemic allergy to egg proteins or neomycin.
    boolean
    C2106654 (UMLS CUI [1])
    C0567447 (UMLS CUI [2])
    C0571380 (UMLS CUI [3])
    Major congenital defects or serious chronic illness.
    Item
    Major congenital defects or serious chronic illness.
    boolean
    C0000768 (UMLS CUI [1,1])
    C0205164 (UMLS CUI [1,2])
    C0008679 (UMLS CUI [2,1])
    C0205404 (UMLS CUI [2,2])
    persons with a known immunodeficiency or any other persons at high risk for varicella
    Item
    Residence in the same household as newborns (0-4 weeks of age), pregnant mothers varicella-susceptible, persons with a known immunodeficiency or any other persons at high risk for varicella (At any point in time when such exclusion criterion becomes not applicable, potential study participants may come back at a later stage for study inclusion)..
    boolean
    C0682072 (UMLS CUI [1,1])
    C0021051 (UMLS CUI [1,2])
    C1855205 (UMLS CUI [2])
    History of any neurologic disorders or seizures.
    Item
    History of any neurologic disorders or seizures.
    boolean
    C0027765 (UMLS CUI [1,1])
    C0036572 (UMLS CUI [1,2])
    Use of any investigational or non-registered product
    Item
    Use of any investigational or non-registered product (drug/vaccine other than the study vaccines) within 14 days prior to vaccination and planned use during the study period.
    boolean
    C1524063 (UMLS CUI [1,1])
    C0013230 (UMLS CUI [1,2])
    Administration of a licensed vaccine
    Item
    Administration of a licensed vaccine within 14 days prior to vaccination and planned use until approximately 42 days after the last study vaccine dose (Day 84) with the exception of oral polio vaccine (OPV).
    boolean
    C1960631 (UMLS CUI [1,1])
    C1705847 (UMLS CUI [1,2])
    C0032375 (UMLS CUI [1,3])
    Item Group
    Randomisation / Treatment allocation
    C0034656 (UMLS CUI-1)
    Record treatment number
    Item
    Record treatment number
    integer
    C1522541 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Item Group
    General medical history / physical examination
    C0262926 (UMLS CUI-1)
    C0031809 (UMLS CUI-2)
    pre-existing conditions
    Item
    Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?
    boolean
    C0521987 (UMLS CUI [1])
    Item Group
    General medical history / physical examination
    C0262926 (UMLS CUI-1)
    C0031809 (UMLS CUI-2)
    Item
    anatomic site of symptoms
    integer
    C1515974 (UMLS CUI [1,1])
    C0037088 (UMLS CUI [1,2])
    anatomic site of symptoms
    Code List
    anatomic site of symptoms
    CL Item
    Cutaneous (10)
    CL Item
    Eyes (5)
    CL Item
    Ears-Nose-Throat (6)
    CL Item
    Cardiovascular (2)
    CL Item
    Respiratory (3)
    CL Item
    Gastrointestinal (1)
    CL Item
    Muskuloskeletal (7)
    CL Item
    Neurological (8)
    CL Item
    Genitourinary (12)
    CL Item
    Haematology (11)
    CL Item
    Allergies (4)
    CL Item
    Endocrine (9)
    CL Item
    Other (specify) (99)
    diagnosis 1
    Item
    Diagnosis 1
    text
    C0011900 (UMLS CUI [1])
    diagnosis 2
    Item
    Diagnosis 2
    text
    C0011900 (UMLS CUI [1])
    diagnosis past
    Item
    Past (diagnosis)
    boolean
    C0011900 (UMLS CUI [1,1])
    C1444637 (UMLS CUI [1,2])
    diagnosis present
    Item
    Present (diagnosis)
    boolean
    C0011900 (UMLS CUI [1,1])
    C0150312 (UMLS CUI [1,2])
    Item Group
    Laboratory tests
    C0022885 (UMLS CUI-1)
    Blood sample
    Item
    Has a blood sample been taken?
    boolean
    C0005834 (UMLS CUI [1])
    Date blood sample taken
    Item
    Date blood sample taken
    boolean
    C1277698 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    Category of exposure
    C2220266 (UMLS CUI-1)
    C0683312 (UMLS CUI-2)
    Item
    What category of exposure did the subject fall into at Inclusion?
    integer
    C2220266 (UMLS CUI [1,1])
    C0683312 (UMLS CUI [1,2])
    category of exposure
    Code List
    What category of exposure did the subject fall into at Inclusion?
    CL Item
    At least one sibling (with negative history of varicella disease/vaccination) at home (1)
    CL Item
    Attending day care center (subjects who are registered for attendance at day care center from (2)
    CL Item
    Who are in contact for at least once a week with other children without a known positive history of varicella disease/vaccination, while playing in close physical contact for more than 5 minutes. (4)
    CL Item
    Attending childminders, i.e. someone taking care of several children (with at least one child without a known positive history of varicella disease/vaccination), (3)
    CL Item
    Who are in contact for at least once a week with other children without a known positive history of varicella disease/vaccination, while playing in close physical contact for more than 5 minutes. (4)
    Item Group
    Vaccine administration
    C2368628 (UMLS CUI-1)
    Pre-Vaccination temperature
    Item
    Pre-Vaccination temperature
    float
    C0005903 (UMLS CUI [1])
    Item
    Route
    text
    C0005903 (UMLS CUI [1,1])
    C1515974 (UMLS CUI [1,2])
    anatomic site Temperature taken
    Code List
    Route
    CL Item
    Axillary (A)
    CL Item
    Rectal (R)
    Item
    Vaccine administration
    text
    C2368628 (UMLS CUI [1])
    Vaccine administration
    Code List
    Vaccine administration
    CL Item
    Study Vaccine (S)
    CL Item
    Replacement vial (R)
    CL Item
    Wrong vial number (W)
    CL Item
    Not administered (N)
    Replacement vial
    Item
    Replacement vial
    text
    C0184301 (UMLS CUI [1,1])
    C0559956 (UMLS CUI [1,2])
    C0600091 (UMLS CUI [1,3])
    Wrong vial number
    Item
    Wrong vial number
    text
    C0184301 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    C3827420 (UMLS CUI [1,3])
    vaccine administered according to protocol
    Item
    Has the study vaccine been administered according to the Protocol?
    boolean
    C2368628 (UMLS CUI [1,1])
    C1515974 (UMLS CUI [1,2])
    C0013153 (UMLS CUI [1,3])
    Item
    Side (vaccine administered)
    text
    C2368628 (UMLS CUI [1,1])
    C0444532 (UMLS CUI [1,2])
    C0443246 (UMLS CUI [1,3])
    Side (vaccine administered)
    Code List
    Side (vaccine administered)
    CL Item
    Right (R)
    CL Item
    Left (L)
    Item
    Site (vaccine administered)
    text
    C2368628 (UMLS CUI [1,1])
    C1515974 (UMLS CUI [1,2])
    Site (vaccine administered)
    Code List
    Site (vaccine administered)
    CL Item
    Thigh (3)
    CL Item
    Buttock (6)
    CL Item
    Upper arm (Deltoid) (10)
    CL Item
    Lower arm (11)
    Item
    Route (vaccine administered)
    text
    C2368628 (UMLS CUI [1,1])
    C0013153 (UMLS CUI [1,2])
    Route (vaccine administered)
    Code List
    Route (vaccine administered)
    CL Item
    i.m. (IM)
    CL Item
    s.c. (SC)
    Comments on vaccine administration
    Item
    Comments (on vaccine administration)
    text
    C2368628 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    Date of vaccination
    Item
    Date of vaccination
    date
    C4301990 (UMLS CUI [1])
    Item
    Why was the vaccine not administered?
    text
    C2368628 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    Why was the vaccine not administered?
    Code List
    Why was the vaccine not administered?
    CL Item
    Serious adverse event (complete the Serious Adverse Event form) (SAE)
    CL Item
    Non-Serious adverse event (complete the Non-serious Adverse Event section) (AEX)
    CL Item
    Other, please specify (e.g.: consent withdrawal, protocol violation, non-serious AE for non-subset...) (OTH)
    Number of serious adverse event
    Item
    SAE No
    integer
    C1519255 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    number of unsolicited adverse event
    Item
    Please specify unsolicited AE No
    integer
    C0877248 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    specify other reason
    Item
    Please specify 'other' most appropriate category for non administration.
    text
    C3840932 (UMLS CUI [1,1])
    C1521902 (UMLS CUI [1,2])
    C2368628 (UMLS CUI [1,3])
    Item Group
    Unsolicited adverse event
    C0877248 (UMLS CUI-1)
    C0042196 (UMLS CUI-2)
    Item
    Has the subject experienced any serious or non-serious unsolicited adverse events within 42 days post-vaccination 1?
    text
    C1519255 (UMLS CUI [1,1])
    C0231291 (UMLS CUI [1,2])
    C1518404 (UMLS CUI [2,1])
    C0231291 (UMLS CUI [2,2])
    non-serious unsolicited adverse event
    Code List
    Has the subject experienced any serious or non-serious unsolicited adverse events within 42 days post-vaccination 1?
    CL Item
    Information not available (U)
    CL Item
    No Vaccine administered (NA)
    CL Item
    No (N)
    CL Item
    Yes, fill in the Non-Serious Adverse Event (for subset only) pages or Serious Adverse Event form. (Y)
    Item Group
    Solicited adverse events - Local symptoms
    C1457887 (UMLS CUI-1)
    C0205276 (UMLS CUI-2)
    C0042196 (UMLS CUI-3)
    Item
    Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
    text
    C0851536 (UMLS CUI [1,1])
    C0037088 (UMLS CUI [1,2])
    signs or symptoms at administration site
    Code List
    Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
    CL Item
    Information not available (U)
    CL Item
    No vaccine administered (NA)
    CL Item
    No (N)
    CL Item
    Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (Y)
    Administration site erythema
    Item
    Redness
    boolean
    C3805283 (UMLS CUI [1])
    Size of erythema at administration site Day 0
    Item
    Size (of redness at administration site) Day 0
    integer
    C3805283 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    Size of erythema at administration site Day 1
    Item
    Size (of redness at administration site) Day 1
    integer
    C3805283 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    Size of erythema at administration site Day 2
    Item
    Size (of redness at administration site) Day 2
    integer
    C3805283 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    Size of erythema at administration site Day 3
    Item
    Size (of redness at administration site) Day 3
    integer
    C3805283 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    Erythema ongoing after day 3
    Item
    Ongoing after Day 3?
    boolean
    C3805283 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    Date of last day of symptoms
    Item
    Date of last day of symptoms
    date
    C0011008 (UMLS CUI [1,1])
    C0332575 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Administration site swelling
    Item
    Swelling
    boolean
    C3854415 (UMLS CUI [1])
    Size of swelling at administration site Day 0
    Item
    Size (of swelling at administration site) Day 0
    integer
    C3854415 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    Size of swelling at administration site Day 1
    Item
    Size (of swelling at administration site) Day 1
    integer
    C3854415 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    Size of swelling at administration site Day 2
    Item
    Size (of swelling at administration site) Day 2
    integer
    C3854415 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    Size of swelling at administration site Day 3
    Item
    Size (of swelling at administration site) Day 3
    integer
    C3854415 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    Swelling ongoing after day 3
    Item
    Ongoing after day 3?
    boolean
    C3854415 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    Date of last day of symptoms
    Item
    Date of last day of symptoms
    date
    C0011008 (UMLS CUI [1,1])
    C0038999 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Administration site pain
    Item
    Pain
    boolean
    C0521491 (UMLS CUI [1])
    Intensity of pain at administration site Day 0
    Item
    Intensity (of pain at administration site) Day 0
    integer
    C0521491 (UMLS CUI [1,1])
    C1320357 (UMLS CUI [1,2])
    Intensity of pain at administration site Day 1
    Item
    Intensity (of pain at administration site) Day 1
    integer
    C0521491 (UMLS CUI [1,1])
    C1320357 (UMLS CUI [1,2])
    Intensity of pain at administration site Day 2
    Item
    Intensity (of pain at administration site) Day 2
    integer
    C0521491 (UMLS CUI [1,1])
    C1320357 (UMLS CUI [1,2])
    Intensity of pain at administration site Day 3
    Item
    Intensity (of pain at administration site) Day 3
    integer
    C0521491 (UMLS CUI [1,1])
    C1320357 (UMLS CUI [1,2])
    Pain ongoing after day 3
    Item
    Ongoing after day 3?
    boolean
    C0521491 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    Date of last day of symptoms
    Item
    Date of last day of symptoms
    date
    C0011008 (UMLS CUI [1,1])
    C0030193 (UMLS CUI [1,2])
    C2700396 (UMLS CUI [1,3])
    Item Group
    Solicited adverse events - General symptoms
    C1457887 (UMLS CUI-1)
    C0042196 (UMLS CUI-2)
    C0877248 (UMLS CUI-3)
    Item
    Has the subject experienced any of the following signs/symptoms during 42 days post-vaccination 1?
    text
    C0037088 (UMLS CUI [1,1])
    C2368628 (UMLS CUI [1,2])
    undefined item
    Code List
    Has the subject experienced any of the following signs/symptoms during 42 days post-vaccination 1?
    CL Item
    Information not available (U)
    CL Item
    No Vaccine administered (NA)
    CL Item
    No (N)
    CL Item
    Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (Y)
    Fever after vaccine administration
    Item
    Fever
    boolean
    C0015967 (UMLS CUI [1,1])
    C2368628 (UMLS CUI [1,2])
    General rash / exanthema after vaccine administration
    Item
    General rash / exanthema
    boolean
    C0015230 (UMLS CUI [1,1])
    C2368628 (UMLS CUI [1,2])
    salivary gland swelling
    Item
    Parotid / salivary gland swelling
    boolean
    C0240925 (UMLS CUI [1,1])
    C2368628 (UMLS CUI [1,2])
    Febrile convulsions or suspected signs of meningism after vaccine administration
    Item
    Febrile convulsions – suspected signs of meningism
    boolean
    C0009952 (UMLS CUI [1,1])
    C2368628 (UMLS CUI [1,2])
    C0025287 (UMLS CUI [2,1])
    C2368628 (UMLS CUI [2,2])
    Varicella or Varicella zoster after vaccine administration
    Item
    Varicella / zoster
    boolean
    C0008049 (UMLS CUI [1,1])
    C2368628 (UMLS CUI [1,2])
    C0740380 (UMLS CUI [2,1])
    C2368628 (UMLS CUI [2,2])
    Item Group
    Temperature
    C0039476 (UMLS CUI-1)
    Item
    Route
    text
    C0005903 (UMLS CUI [1,1])
    C1515974 (UMLS CUI [1,2])
    temperature route
    Code List
    Route
    CL Item
    Axillary (A)
    CL Item
    Rectal (R)
    Item Group
    Temperature
    C0039476 (UMLS CUI-1)
    Episode No
    Item
    Episode No
    integer
    Temperature
    Item
    Temperature
    float
    C0039476 (UMLS CUI [1])
    Temperature not taken
    Item
    Not taken (Temperature)
    boolean
    C0039476 (UMLS CUI [1])
    Causality with vaccination fever
    Item
    Causality
    boolean
    C0015967 (UMLS CUI [1,1])
    C3641099 (UMLS CUI [1,2])
    C2368628 (UMLS CUI [1,3])
    Medically attended Visit?
    Item
    Medically attended Visit?
    boolean
    C0545082 (UMLS CUI [1,1])
    C1386497 (UMLS CUI [1,2])
    C0015967 (UMLS CUI [1,3])
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